{"id":5900,"date":"2026-03-09T16:23:31","date_gmt":"2026-03-09T08:23:31","guid":{"rendered":"https:\/\/www.ncgt.org.cn\/ncgt\/?p=5900"},"modified":"2026-03-09T16:32:12","modified_gmt":"2026-03-09T08:32:12","slug":"%e7%bb%86%e8%83%9e%e5%a4%96%e5%9b%8a%e6%b3%a1-%e5%a4%96%e6%b3%8c%e4%bd%93%e5%88%b6%e5%89%82%e8%b4%a8%e9%87%8f%e7%a0%94%e7%a9%b6%e7%9a%84%e5%9b%b0%e5%a2%83%e4%b8%8e%e6%8c%91%e6%88%98","status":"publish","type":"post","link":"https:\/\/www.ncgt.org.cn\/ncgt\/2026\/03\/09\/%e7%bb%86%e8%83%9e%e5%a4%96%e5%9b%8a%e6%b3%a1-%e5%a4%96%e6%b3%8c%e4%bd%93%e5%88%b6%e5%89%82%e8%b4%a8%e9%87%8f%e7%a0%94%e7%a9%b6%e7%9a%84%e5%9b%b0%e5%a2%83%e4%b8%8e%e6%8c%91%e6%88%98\/","title":{"rendered":"\u7ec6\u80de\u5916\u56ca\u6ce1\/\u5916\u6ccc\u4f53\u5236\u5242\u8d28\u91cf\u7814\u7a76\u7684\u56f0\u5883\u4e0e\u6311\u6218\u2014\u2014\u5199\u7ed9\u90a3\u4e9b\u6b63\u5728\u6478\u7d22\u524d\u884c\u7684\u7814\u53d1\u8005\u4eec"},"content":{"rendered":"\n

\u6765\u6e90\uff1a\u7ec6\u80de\u8d28\u91cf\u68c0\u6d4b\u6280\u672f\u7814\u53d1\u5e73\u53f0<\/p>\n\n\n\n

\u5efa\u8bbe\u5355\u4f4d\uff1a\u6df1\u5733\u79d1\u8bfa\u533b\u5b66\u68c0\u9a8c\u5b9e\u9a8c\u5ba4<\/p>\n\n\n\n

\u65f6\u95f4\uff1a2026-03-08<\/p>\n\n\n\n

\n\t
\n\t\t
\n\t\t\t\"Shape1\"<\/span>\n\t\t<\/section>\n\t\t

\n\t\t\t\u5199\u5728\u524d\u9762\u7684\u8bdd<\/span><\/strong><\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\u6700\u8fd1\uff0c\u6211\u4eec\u9646\u7eed\u63a5\u5230\u4e00\u4e9b\u4f01\u4e1a\u7814\u53d1\u4eba\u5458\u7684\u54a8\u8be2\uff0c\u95ee\u9898\u5f88\u5177\u4f53\uff0c\u4e5f\u5f88\u68d8\u624b\u3002<\/span><\/span>\u4ed6\u4eec\u6b63\u5728\u63a8\u8fdb\u5916\u6ccc\u4f53\u5236\u5242\u6216\u7ec6\u80de\u5916\u56ca\u6ce1\uff08<\/span><\/span><\/span><\/span>Extracellular Vesicles<\/span><\/span>\uff0c\u7b80\u79f0<\/span><\/span><\/span>EV<\/span><\/span>\uff09\u5236\u5242\u7684<\/span><\/span><\/span>IIT<\/span><\/span><\/span>\u7814\u7a76\uff08\u7814\u7a76\u8005\u53d1\u8d77\u7684\u4e34\u5e8a\u8bd5\u9a8c\uff09\uff0c\u60f3\u627e\u4e00\u5bb6\u6709\u8d44\u8d28\u7684\u7b2c\u4e09\u65b9\u68c0\u6d4b\u673a\u6784\u505a\u8d28\u91cf\u590d\u6838\uff0c\u5374\u56db\u5904\u78b0\u58c1\u3002<\/span><\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\u6709\u4eba\u6253\u7535\u8bdd\u7ed9\u4e2d\u56fd\u98df\u54c1\u836f\u54c1\u68c0\u5b9a\u7814\u7a76\u9662\uff08\u4e2d\u68c0\u9662\uff09\uff0c\u5f97\u77e5\u4e2d\u68c0\u9662\u5b98\u7f51\u867d\u5df2\u5c06\u201c\u5176\u4ed6\u521b\u65b0\u578b\u5e72\u7ec6\u80de\u76f8\u5173\u836f\u7269\uff08\u5982\u7ec6\u80de\u5916\u56ca\u6ce1\u7b49\uff09\u8d28\u91cf\u8bc4\u4ef7\u7814\u7a76\u201d\u5217\u5165\u5e72\u7ec6\u80de\u5408\u540c\u68c0\u9a8c\u7c7b\u522b\uff08\u300a\u4e2d\u68c0\u9662\u5e72\u7ec6\u80de\u5408\u540c\u68c0\u9a8c\u5e38\u89c1\u95ee\u9898\uff08\u4e13\u9898\u7b2c\u4e00\u671f\uff09\u300b\uff0c<\/span><\/span><\/span>2025<\/span>\u5e74<\/span><\/span>8<\/span>\u6708\u53d1\u5e03\uff09\uff0c\u4f46\u7535\u8bdd\u54a8\u8be2\u65f6\uff0c\u5de5\u4f5c\u4eba\u5458\u660e\u786e\u544a\u77e5\uff1a\u201c\u76ee\u524d\u7ec6\u80de\u5916\u56ca\u6ce1\u7684\u5206\u6790\u65b9\u6cd5\u8fd8\u4e0d\u6210\u719f\uff0c\u8be5\u7c7b\u68c0\u6d4b\u670d\u52a1\u6682\u4e0d\u63a5\u6536\u6837\u54c1\u3002\u201d<\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\u6709\u4eba\u53bb\u67e5<\/span><\/span>CMA<\/span>\uff08\u4e2d\u56fd\u8ba1\u91cf\u8ba4\u8bc1\uff09\u4f53\u7cfb\uff0c\u53d1\u73b0\u8fd9\u4e2a\u65b9\u5411\u6839\u672c\u6ca1\u6709\u5bf9\u5e94\u7684\u8d44\u8d28\u53d1\u653e\u3002\u6709\u4eba\u7ffb\u904d<\/span><\/span>CNAS<\/span>\uff08\u4e2d\u56fd\u5408\u683c\u8bc4\u5b9a\u56fd\u5bb6\u8ba4\u53ef\u59d4\u5458\u4f1a\uff09\u7684\u8ba4\u53ef\u9879\u76ee\u6e05\u5355\uff0c\u4e5f\u627e\u4e0d\u5230<\/span><\/span>"<\/span>\u7ec6\u80de\u5916\u56ca\u6ce1<\/span><\/span>"<\/span>\u6216<\/span><\/span>"<\/span>\u5916\u6ccc\u4f53<\/span><\/span>"<\/span>\u5bf9\u5e94\u7684\u68c0\u6d4b\u5206\u7c7b\u3002<\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\u8fd9\u4e0d\u662f\u67d0\u4e00\u5bb6\u673a\u6784\u7684\u7279\u6b8a\u60c5\u51b5\uff0c\u800c\u662f\u6574\u4e2a\u884c\u4e1a\u5171\u540c\u9762\u5bf9\u7684\u73b0\u5b9e\uff0c\u7ec6\u80de\u5916\u56ca\u6ce1\u5236\u5242\u7684\u8d28\u91cf\u5206\u6790\u65b9\u6cd5\uff0c\u81f3\u4eca\u4ecd\u662f\u5168\u7403\u6027\u7684\u96be\u9898\u3002<\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\u672c\u6587\u5e0c\u671b\u4ece\u6280\u672f\u548c\u76d1\u7ba1\u4e24\u4e2a\u5c42\u9762\uff0c\u8ba4\u771f\u68b3\u7406\u8fd9\u4e00\u9886\u57df\u8d28\u91cf\u7814\u7a76\u4e0e\u5206\u6790\u65b9\u6cd5\u5f00\u53d1\u7684\u6838\u5fc3\u6311\u6218\uff0c\u540c\u65f6\u4e3a\u6b63\u5728\u63a8\u8fdb\u76f8\u5173\u7814\u7a76\u7684\u4f01\u4e1a\u63d0\u4f9b\u4e00\u4e9b\u5207\u5b9e\u53ef\u884c\u7684\u601d\u8def\u548c\u5efa\u8bae\u3002<\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\n\t\t<\/p>\n\t\t

\n\t\t\t\u4e00\u3001\u8ba4\u8bc6\u7ec6\u80de\u5916\u56ca\u6ce1\uff1a\u4e00\u4e2a\u8ff7\u4eba\u5374\u96be\u4ee5\u6349\u6478\u7684\u4e16\u754c<\/strong><\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t1.1 <\/strong><\/span><\/span>\u5916\u6ccc\u4f53\u4e0e\u7ec6\u80de\u5916\u56ca\u6ce1\u7684\u5173\u7cfb<\/strong><\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\u8bf4\u8d77<\/span>\u5916\u6ccc\u4f53\uff08<\/strong><\/span><\/span>Exosome<\/strong><\/span>\uff09<\/strong><\/span>\uff0c\u5f88\u591a\u4eba\u8111\u6d77\u91cc\u6d6e\u73b0\u7684\u662f\u4e00\u79cd\u76f4\u5f84<\/span><\/span>30-150nm<\/span>\u3001\u7531\u7ec6\u80de\u5206\u6ccc\u51fa\u6765\u3001\u643a\u5e26\u86cb\u767d\u8d28\u548c\u6838\u9178\u7684\u7eb3\u7c73\u7ea7\u5c0f\u56ca\u6ce1\u3002\u8fc7\u53bb\u5341\u51e0\u5e74\uff0c\u5916\u6ccc\u4f53\u8fd9\u4e2a\u8bcd\u5728\u5b66\u672f\u754c\u548c\u5546\u4e1a\u754c\u90fd\u88ab\u9891\u7e41\u63d0\u53ca\uff0c\u4fe8\u7136\u6210\u4e3a\u518d\u751f\u533b\u5b66\u548c\u7cbe\u51c6\u8bca\u65ad\u7684<\/span><\/span>"<\/span>\u660e\u661f\u5206\u5b50<\/span><\/span>"<\/span>\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\u7136\u800c\uff0c\u56fd\u9645\u7ec6\u80de\u5916\u56ca\u6ce1\u5b66\u4f1a\uff08<\/span><\/span>International Society for Extracellular Vesicles<\/span>\uff0c<\/span><\/span>ISEV<\/span>\uff09\u81ea<\/span><\/span>2011<\/span>\u5e74\u6210\u7acb\u4ee5\u6765\uff0c\u4e00\u76f4\u5728\u63a8\u52a8\u8fd9\u4e00\u9886\u57df\u547d\u540d\u89c4\u8303\u5316\u7684\u5de5\u4f5c\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t2018<\/span>\u5e74\u53d1\u5e03\u7684<\/span><\/span>MISEV2018<\/span>\u5efa\u8bae\u6309\u7c92\u5f84\u5c06\u56ca\u6ce1\u5206\u4e3a\u201c\u4e2d<\/span><\/span>\/<\/span>\u5927\u578b<\/span><\/span>EVs<\/span>\uff08<\/span><\/span>m\/l EVs<\/span>\uff09\u201d\u548c\u201c\u5c0f\u578b<\/span><\/span>EVs<\/span>\uff08<\/span><\/span>sEVs<\/span>\uff09\u201d\uff0c\u4ee5\u56de\u907f\u5916\u6ccc\u4f53\u8fd9\u4e00\u6765\u6e90\u4e0d\u786e\u5b9a\u7684\u79f0\u8c13\u3002\u5230\u4e86<\/span><\/span>2024<\/span>\u5e74<\/span><\/span>2<\/span>\u6708\u6b63\u5f0f\u53d1\u5e03\u7684<\/span><\/span>MISEV2023<\/span>\uff0c\u66f4\u8fdb\u4e00\u6b65\u660e\u786e\u6307\u51fa\uff1a<\/span><\/span>sEV<\/span>\uff08\u5c0f\u578b\u7ec6\u80de\u5916\u56ca\u6ce1\uff09\u4e0e\u5916\u6ccc\u4f53\u5e76\u4e0d\u540c\u4e49\uff0c\u5355\u4e2a\u56ca\u6ce1\u7684\u5927\u5c0f\u548c\u5bc6\u5ea6\u4f1a\u56e0\u68c0\u6d4b\u65b9\u6cd5\u4e0d\u540c\u800c\u5448\u73b0\u5dee\u5f02\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\tMISEV2023<\/span>\u660e\u786e\u5efa\u8bae\uff1a<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\u9664\u975e\u80fd\u591f\u4e13\u95e8\u5206\u79bb\u5e76\u786e\u8ba4\u56ca\u6ce1\u7684\u751f\u7269\u53d1\u751f\u9014\u5f84\uff0c\u5426\u5219\u4e0d\u8981\u4f7f\u7528\u201c\u5916\u6ccc\u4f53\u201d\u8fd9\u4e00\u57fa\u4e8e\u751f\u7269\u53d1\u751f\u9014\u5f84\u7684\u672f\u8bed<\/span>\u3002<\/em><\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\u8fd9\u610f\u5473\u7740\uff0c\u6211\u4eec\u901a\u5e38\u53e3\u4e2d\u6240\u8bf4\u7684\u201c\u5916\u6ccc\u4f53\u5236\u5242\u201d\uff0c\u5728\u4e25\u683c\u7684\u79d1\u5b66\u5b9a\u4e49\u4e0b\uff0c\u5e94\u66f4\u51c6\u786e\u5730\u79f0\u4e3a\u201c\u7ec6\u80de\u5916\u56ca\u6ce1\u5236\u5242\u201d\u3002\u4e24\u8005\u5e76\u975e\u5b8c\u5168\u7b49\u540c\uff0c\u8fd9\u4e00\u7ec6\u5fae\u5dee\u522b\u5728\u8d28\u91cf\u7814\u7a76\u4e2d\u6709\u91cd\u8981\u610f\u4e49\uff0c\u56e0\u4e3a\u4f60\u65e0\u6cd5\u51c6\u786e\u5b9a\u4e49\u7684\u4e1c\u897f\uff0c\u81ea\u7136\u4e5f\u65e0\u6cd5\u51c6\u786e\u6d4b\u91cf\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t1.2 <\/strong><\/span><\/span>\u7ec6\u80de\u5916\u56ca\u6ce1\u7684\u56db\u5927\u4ea7\u54c1\u7c7b\u522b<\/strong><\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\u6839\u636e<\/span><\/span>ISEV<\/span>\u7acb\u573a\u6587\u4ef6\uff0c<\/span><\/span>EV<\/span>\u7c7b\u6cbb\u7597\u4ea7\u54c1\u6309\u6d3b\u6027\u6210\u5206\u6765\u6e90\u53ef\u4ee5\u5206\u4e3a\u56db\u5927\u7c7b\uff1a<\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\u7b2c\u4e00\u7c7b\uff1a\u6765\u81ea\u975e\u9057\u4f20\u4fee\u9970\u7ec6\u80de\u7684\u5929\u7136<\/span><\/span>EVs<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\u7b2c\u4e8c\u7c7b\uff1a\u6765\u81ea\u9057\u4f20\u4fee\u9970\u7ec6\u80de\uff08\u4f46\u4e0d\u542b\u8f6c\u57fa\u56e0\u4ea7\u7269\uff09\u7684\u5929\u7136<\/span><\/span>EVs<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\u7b2c\u4e09\u7c7b\uff1a\u88c5\u8f7d\u4e86\u5408\u6210\u5316\u5b66\u7269\u8d28\u6216\u7279\u5b9a\u91cd\u7ec4\u5206\u5b50\u7684<\/span><\/span>EVs<\/span>\u836f\u7269\u9012\u9001\u7cfb\u7edf\uff08<\/span><\/span>DDS<\/span><\/span>\uff09<\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\u7b2c\u56db\u7c7b\uff1a\u6765\u81ea\u9057\u4f20\u4fee\u9970\u7ec6\u80de\u4e14\u542b\u6709\u8f6c\u57fa\u56e0\u4ea7\u7269\u7684<\/span><\/span>EVs<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\u5176\u4e2d\u7b2c\u4e00\u81f3\u4e09\u7c7b\u88ab\u5f52\u5165\u751f\u7269\u5236\u54c1\u8303\u7574\uff0c\u7b2c\u56db\u7c7b\u5c5e\u4e8e\u57fa\u56e0\u6cbb\u7597\u4ea7\u54c1\u5b50\u7c7b\u522b\u3002\u524d\u4e24\u7c7b\u901a\u79f0\u201c<\/span><\/span>\u5929\u7136<\/strong><\/span><\/span><\/span>EVs<\/strong><\/span>\uff08<\/strong><\/span><\/span>Native EVs<\/strong><\/span>\uff09<\/strong><\/span><\/span>\u201d\uff0c\u540e\u4e24\u7c7b\u901a\u79f0\u201c<\/span><\/span>\u5de5\u7a0b\u5316<\/strong><\/span><\/span><\/span>EVs<\/strong><\/span>\uff08<\/strong><\/span><\/span>Engineered EVs<\/strong><\/span>\uff09<\/strong><\/span><\/span>\u201d\u3002<\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\u8fd9\u79cd\u5206\u7c7b\u4e0d\u4ec5\u5177\u6709\u5b66\u672f\u610f\u4e49\uff0c\u66f4\u6709\u76f4\u63a5\u7684\u76d1\u7ba1\u542b\u4e49\u3002\u4e0d\u540c\u7c7b\u522b\u7684\u4ea7\u54c1\uff0c\u9700\u8981\u9762\u5bf9\u7684\u8d28\u91cf\u7814\u7a76\u8981\u6c42\u3001\u5b89\u5168\u6027\u8bc4\u4f30\u601d\u8def\u548c\u4e34\u5e8a\u7533\u62a5\u8def\u5f84\u90fd\u4f1a\u6709\u6240\u4e0d\u540c\u3002<\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t1.3 EVs<\/strong><\/span><\/span>\u4e3a\u4f55\u5982\u6b64\u96be\u4ee5\u6807\u51c6\u5316\uff1f<\/strong><\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\u7b80\u5355\u5730\u8bf4\uff1a<\/span><\/span>EVs<\/span>\u662f\u751f\u547d\u4f53\u5185\u5929\u7136\u5b58\u5728\u7684\u901a\u4fe1\u5de5\u5177\uff0c\u800c\u975e\u4eba\u5de5\u8bbe\u8ba1\u7684\u5747\u4e00\u4ea7\u54c1\u3002\u6bcf\u4e00\u4e2a<\/span><\/span>EV<\/span>\u90fd\u662f\u7ec6\u80de\u5728\u7279\u5b9a\u72b6\u6001\u4e0b\u5206\u6ccc\u7684\u201c\u4fe1\u4f7f\u201d\uff0c\u643a\u5e26\u7684\u5206\u5b50\u7ec4\u6210\uff08\u86cb\u767d\u8d28\u3001\u6838\u9178\u3001\u8102\u8d28\u3001\u7cd6\u94fe\u4fee\u9970\uff09\u9ad8\u5ea6\u4f9d\u8d56\u4e8e\u751f\u4ea7\u7ec6\u80de\u7684\u7c7b\u578b\u3001\u72b6\u6001\u548c\u6240\u5904\u7684\u5fae\u73af\u5883\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\u54ea\u6015\u662f\u540c\u4e00\u4f9b\u4f53\u7684\u540c\u4e00\u6279\u7ec6\u80de\uff0c\u5728\u4e0d\u540c\u4f20\u4ee3\u6b21\u6570\u3001\u4e0d\u540c\u57f9\u517b\u6761\u4ef6\u3001\u4e0d\u540c\u6536\u83b7\u65f6\u95f4\u70b9\u4e0b\uff0c\u4ea7\u51fa<\/span><\/span>EVs<\/span>\u7684\u7279\u5f81\u90fd\u53ef\u80fd\u53d1\u751f\u663e\u8457\u53d8\u5316\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\u6b63\u662f\u8fd9\u79cd\u5185\u751f\u7684\u3001\u96be\u4ee5\u6d88\u9664\u7684\u201c<\/span>\u5f02\u8d28\u6027\uff08<\/strong><\/span><\/span>Heterogeneity<\/strong><\/span>\uff09<\/strong><\/span>\u201d\uff0c\u6784\u6210\u4e86\u7ec6\u80de\u5916\u56ca\u6ce1\u8d28\u91cf\u7814\u7a76\u7684\u6700\u5927\u6311\u6218\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\n\t\t<\/p>\n\t\t

\n\t\t\t\u4e8c\u3001\u8d28\u91cf\u7814\u7a76\u7684\u6838\u5fc3\u6846\u67b6\uff1a\u6211\u4eec\u9700\u8981\u8868\u5f81\u4ec0\u4e48\uff1f<\/strong><\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\u5728\u6df1\u5165\u8ba8\u8bba\u56f0\u96be\u4e4b\u524d\uff0c\u6211\u4eec\u9996\u5148\u9700\u8981\u7406\u89e3\uff1a\u5bf9\u4e8e\u4e00\u4e2a<\/span><\/span>EV<\/span>\u5236\u5242\uff0c\u8d28\u91cf\u7814\u7a76\u7684\u6838\u5fc3\u6846\u67b6\u5305\u542b\u54ea\u4e9b\u8981\u7d20\uff1f<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t2.1 <\/strong><\/span><\/span>\u56fd\u9645\u4e3b\u8981\u76d1\u7ba1\u6307\u5357\u7684\u5171\u8bc6<\/strong><\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\u76ee\u524d\uff0c\u5728\u7ec6\u80de\u5916\u56ca\u6ce1\u6cbb\u7597\u4ea7\u54c1\u7684\u8d28\u91cf\u7814\u7a76\u65b9\u9762\uff0c\u5df2\u53d1\u5e03\u6709\u53c2\u8003\u610f\u4e49\u7684\u76d1\u7ba1\u6307\u5357\u4e3b\u8981\u5305\u62ec\uff1a<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t1.\u65e5\u672c\u836f\u54c1\u548c\u533b\u7597\u5668\u68b0\u5c40\uff08<\/span><\/span>PMDA<\/span>\uff09\u79d1\u5b66\u59d4\u5458\u4f1a\u62a5\u544a\uff08<\/span><\/span>2024<\/span>\u5e74\u53d1\u8868\u4e8e\u300a<\/span><\/span>Pharmaceutical Research<\/span>\u300b\u6742\u5fd7\uff09\uff1a\u7cfb\u7edf\u68b3\u7406\u4e86<\/span><\/span>EV<\/span>\u6cbb\u7597\u4ea7\u54c1\u5728\u751f\u4ea7\u3001\u7eaf\u5316\u3001\u8868\u5f81\u3001\u8d28\u91cf\u8bc4\u4f30\u4e0e\u63a7\u5236\u3001\u5b89\u5168\u6027\u8bc4\u4f30\u53ca\u4e34\u5e8a\u5f00\u53d1\u7b49\u65b9\u9762\u7684\u73b0\u72b6\u4e0e\u6311\u6218\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t2.\u97e9\u56fd\u98df\u54c1\u533b\u836f\u54c1\u5b89\u5168\u90e8\uff08<\/span><\/span>MFDS<\/span>\uff09\u53d1\u5e03\u7684\u300a\u7ec6\u80de\u5916\u56ca\u6ce1\u6cbb\u7597\u4ea7\u54c1\u8d28\u91cf\u3001\u975e\u4e34\u5e8a\u548c\u4e34\u5e8a\u8bc4\u4f30\u6307\u5357\u300b\uff08<\/span><\/span>2024<\/span>\u5e74<\/span><\/span>9<\/span>\u6708\u82f1\u6587\u7248\uff09\uff1a\u8fd9\u662f\u76ee\u524d\u5168\u7403\u8303\u56f4\u5185\u5bf9<\/span><\/span>EV<\/span>\u4ea7\u54c1\u8d28\u91cf\u63a7\u5236\u8981\u6c42\u9610\u8ff0\u6700\u4e3a\u7cfb\u7edf\u7684\u5b98\u65b9\u6307\u5357\u4e4b\u4e00\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t3.ISEV<\/span>\u53d1\u5e03\u7684<\/span><\/span>MISEV2023<\/span>\uff1a\u867d\u4e3a\u7814\u7a76\u6307\u5357\u800c\u975e\u76d1\u7ba1\u6587\u4ef6\uff0c\u4f46\u4e3a<\/span><\/span>EVs<\/span>\u76f8\u5173\u7814\u7a76\u63d0\u4f9b\u4e86\u6700\u6743\u5a01\u7684\u65b9\u6cd5\u5b66\u53c2\u8003\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t4.\u4e2d\u56fd\u56fd\u5185\u56e2\u4f53\u6807\u51c6\uff1a\u7531\u4e2d\u56fd\u7ec6\u80de\u751f\u7269\u5b66\u5b66\u4f1a\u7b49\u673a\u6784\u7275\u5934\u53d1\u5e03\u7684\u82e5\u5e72\u5916\u6ccc\u4f53\u76f8\u5173\u56e2\u4f53\u6807\u51c6\uff0c\u5185\u5bb9\u6d89\u53ca\u57fa\u672c\u5b9a\u4e49\u3001\u8d28\u91cf\u8bc4\u4ef7\u6307\u6807\u5efa\u8bae\u7b49\uff0c\u603b\u4f53\u5c1a\u5904\u4e8e\u8d77\u6b65\u9636\u6bb5\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\u7efc\u5408\u4e0a\u8ff0\u6587\u4ef6\uff0c<\/span><\/span>EV<\/span>\u6cbb\u7597\u5236\u5242\u7684\u8d28\u91cf\u7814\u7a76\u6846\u67b6\u901a\u5e38\u6db5\u76d6\u516d\u4e2a\u6838\u5fc3\u7ef4\u5ea6\uff1a\u8d77\u59cb\u7269\u6599\uff08\u751f\u4ea7\u7ec6\u80de\uff09\u8d28\u91cf\u8868\u5f81\u3001\u5236\u5907\u5de5\u827a\u7814\u7a76\u3001<\/span><\/span>EVs<\/span>\u7279\u5f02\u6027\u8d28\u91cf\u8868\u5f81\u3001\u6742\u8d28\u63a7\u5236\u3001\u75c5\u6bd2\u5b89\u5168\u6027\u8bc4\u4f30\uff0c\u4ee5\u53ca\u7a33\u5b9a\u6027\u7814\u7a76\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t
\n\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\t\t\u8d28\u91cf\u7814\u7a76\u7ef4\u5ea6<\/strong><\/span><\/span><\/span><\/span>\n\t\t\t\t\t\t\t<\/p>\n\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t

\n\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\t\t\u6838\u5fc3\u5185\u5bb9\u8981\u6c42<\/strong><\/span><\/span><\/span><\/span>\n\t\t\t\t\t\t\t<\/p>\n\t\t\t\t\t\t<\/td>\n\t\t\t\t\t<\/tr>\n\t\t\t\t\t

\n\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\t\t\u8d77\u59cb\u7269\u6599\uff08\u751f\u4ea7\u7ec6\u80de\uff09\u8d28\u91cf\u8868\u5f81<\/span><\/span><\/span><\/span>\n\t\t\t\t\t\t\t<\/p>\n\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t

\n\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\t\t\u7ec6\u80de\u5e93\u5efa\u7acb\u4e0e\u9274\u5b9a\u3001\u7ec6\u80de\u7279\u6027\u786e\u8ba4\u3001\u75c5\u6bd2\u5b89\u5168\u6027\u68c0\u6d4b<\/span><\/span><\/span><\/span>\n\t\t\t\t\t\t\t<\/p>\n\t\t\t\t\t\t<\/td>\n\t\t\t\t\t<\/tr>\n\t\t\t\t\t

\n\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\t\t\u5236\u5907\u5de5\u827a\u7814\u7a76<\/span><\/span><\/span><\/span>\n\t\t\t\t\t\t\t<\/p>\n\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t

\n\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\t\t\u57f9\u517b\u6761\u4ef6\u63a7\u5236\u3001<\/span><\/span><\/span><\/span>EVs<\/span><\/span><\/span><\/span>\u5206\u79bb\u7eaf\u5316\u65b9\u6cd5\u5f00\u53d1\u4e0e\u5de5\u827a\u9a8c\u8bc1<\/span><\/span><\/span><\/span>\n\t\t\t\t\t\t\t<\/p>\n\t\t\t\t\t\t<\/td>\n\t\t\t\t\t<\/tr>\n\t\t\t\t\t

\n\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\t\tEVs<\/span><\/span><\/span><\/span>\u7279\u5f02\u6027\u8d28\u91cf\u8868\u5f81<\/span><\/span><\/span><\/span>\n\t\t\t\t\t\t\t<\/p>\n\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t

\n\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\t\t\u7ec4\u6210\u5206\u6790\uff08\u86cb\u767d\u8d28<\/span><\/span><\/span><\/span>\/<\/span><\/span><\/span><\/span>\u6838\u9178<\/span><\/span><\/span><\/span>\/<\/span><\/span><\/span><\/span>\u8102\u8d28\uff09\u3001\u7406\u5316\u6027\u8d28\uff08\u7c92\u5f84<\/span><\/span><\/span><\/span>\/<\/span><\/span><\/span><\/span>\u7c92\u6570<\/span><\/span><\/span><\/span>\/Zeta<\/span><\/span><\/span><\/span>\u7535\u4f4d\uff09\u3001\u751f\u7269\u6d3b\u6027\uff08\u6548\u4ef7\u68c0\u6d4b\uff09<\/span><\/span><\/span><\/span>\n\t\t\t\t\t\t\t<\/p>\n\t\t\t\t\t\t<\/td>\n\t\t\t\t\t<\/tr>\n\t\t\t\t\t

\n\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\t\t\u6742\u8d28\u63a7\u5236<\/span><\/span><\/span><\/span>\n\t\t\t\t\t\t\t<\/p>\n\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t

\n\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\t\t\u5de5\u827a\u76f8\u5173\u6742\u8d28\u3001\u4ea7\u54c1\u76f8\u5173\u6742\u8d28\u7684\u5b9a\u6027\u5b9a\u91cf\u5206\u6790\u53ca\u9650\u5ea6\u8bbe\u5b9a<\/span><\/span><\/span><\/span>\n\t\t\t\t\t\t\t<\/p>\n\t\t\t\t\t\t<\/td>\n\t\t\t\t\t<\/tr>\n\t\t\t\t\t

\n\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\t\t\u75c5\u6bd2\u5b89\u5168\u6027\u8bc4\u4f30<\/span><\/span><\/span><\/span>\n\t\t\t\t\t\t\t<\/p>\n\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t

\n\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\t\t\u4f9b\u4f53\u75c5\u6bd2\u7b5b\u67e5\u3001\u7ec6\u80de\u5e93\u75c5\u6bd2\u5b89\u5168\u68c0\u6d4b\u3001\u8fc7\u7a0b\u63a7\u5236\uff08\u6ce8\uff1a\u4f20\u7edf\u75c5\u6bd2\u6e05\u9664\u5de5\u827a\u4e0d\u9002\u7528\uff09<\/span><\/span><\/span><\/span>\n\t\t\t\t\t\t\t<\/p>\n\t\t\t\t\t\t<\/td>\n\t\t\t\t\t<\/tr>\n\t\t\t\t\t

\n\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\t\t\u7a33\u5b9a\u6027\u7814\u7a76<\/span><\/span><\/span><\/span>\n\t\t\t\t\t\t\t<\/p>\n\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t

\n\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\t\t\u5b9e\u65f6<\/span><\/span><\/span><\/span>\/<\/span><\/span><\/span><\/span>\u52a0\u901f<\/span><\/span><\/span><\/span>\/<\/span><\/span><\/span><\/span>\u5f3a\u5236\u964d\u89e3\u7a33\u5b9a\u6027\u7814\u7a76\uff0c\u8d27\u67b6\u671f\u786e\u5b9a\uff0c\u5173\u952e\u8d28\u91cf\u5c5e\u6027\u76d1\u6d4b<\/span><\/span><\/span><\/span>\n\t\t\t\t\t\t\t<\/p>\n\t\t\t\t\t\t<\/td>\n\t\t\t\t\t<\/tr>\n\t\t\t\t<\/tbody>\n\t\t\t<\/table>\n\t\t<\/center>\n\t\t

\n\t\t\t\n\t\t<\/p>\n\t\t

\n\t\t\t\u4e09\u3001\u751f\u4ea7\u7ec6\u80de\u8d28\u91cf\u63a7\u5236\uff1a\u597d\u7684\u8d77\u70b9\uff0c\u624d\u6709\u597d\u7684\u7ec8\u70b9<\/strong><\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\u201c\u5175\u9a6c\u672a\u52a8\uff0c\u7cae\u8349\u5148\u884c\uff01\u201d<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\u5728<\/span><\/span>EV<\/span>\u5236\u5242\u7684\u8d28\u91cf\u7814\u7a76\u4e2d\uff0c\u751f\u4ea7\u7ec6\u80de\u7684\u8d28\u91cf\u662f\u4e00\u5207\u7684\u8d77\u70b9\u3002\u7136\u800c\u8fd9\u4e2a\u8d77\u70b9\uff0c\u5145\u6ee1\u53d8\u6570\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t3.1 <\/strong><\/span><\/span>\u7ec6\u80de\u6765\u6e90\u7684\u591a\u6837\u6027\u5e26\u6765\u7684\u6311\u6218<\/strong><\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\tEV<\/span>\u5236\u5242\u7684\u751f\u4ea7\u7ec6\u80de\u6765\u6e90\u5e7f\u6cdb\uff0c\u4eba\u81ea\u4f53\u7ec6\u80de\u3001\u4eba\u540c\u79cd\u5f02\u4f53\u7ec6\u80de\uff08\u4ee5\u95f4\u5145\u8d28\u5e72<\/span><\/span>\/<\/span>\u57fa\u8d28\u7ec6\u80de<\/span><\/span>MSC<\/span>\u4e3a\u4ee3\u8868\uff09\u3001<\/span><\/span>iPSC\/ESC<\/span>\u884d\u751f\u7ec6\u80de\u3001\u6c38\u751f\u5316\u7ec6\u80de\u7cfb\u2026\u2026\u4e0d\u540c\u6765\u6e90\u7684\u7ec6\u80de\uff0c\u5728\u7ec6\u80de\u5e93\u5efa\u7acb\u7684\u53ef\u884c\u6027\u3001\u5747\u4e00\u6027\u8981\u6c42\u548c\u5b89\u5168\u6027\u98ce\u9669\u65b9\u9762\u5b58\u5728\u6839\u672c\u6027\u5dee\u5f02\uff08\u89c1\u4e0b\u8868\uff09\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t
\n\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\t\t\u7ec6\u80de\u6765\u6e90<\/strong><\/span><\/span><\/span><\/span>\n\t\t\t\t\t\t\t<\/p>\n\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t

\n\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\t\t\u5efa\u7acb\u5236\u9020\u7528\u7ec6\u80de\u5e93<\/strong><\/span><\/span><\/span><\/span>\n\t\t\t\t\t\t\t<\/p>\n\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t

\n\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\t\t\u5efa\u7acb\u5355\u514b\u9686\u7ec6\u80de\u5e93<\/strong><\/span><\/span><\/span><\/span>\n\t\t\t\t\t\t\t<\/p>\n\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t

\n\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\t\t\u7ec6\u80de\u5747\u4e00\u6027<\/strong><\/span><\/span><\/span><\/span>\n\t\t\t\t\t\t\t<\/p>\n\t\t\t\t\t\t<\/td>\n\t\t\t\t\t<\/tr>\n\t\t\t\t\t

\n\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\t\t\u81ea\u4f53\u539f\u4ee3\u7ec6\u80de<\/span><\/span><\/span><\/span>\n\t\t\t\t\t\t\t<\/p>\n\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t

\n\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\t\t\u4e0d\u53ef\u80fd\uff08\u4e0d\u5fc5\u8981\uff09<\/span><\/span><\/span><\/span>\n\t\t\t\t\t\t\t<\/p>\n\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t

\n\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\t\t\u4e0d\u53ef\u80fd<\/span><\/span><\/span><\/span>\n\t\t\t\t\t\t\t<\/p>\n\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t

\n\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\t\t\u4e0d\u53ef\u80fd<\/span><\/span><\/span><\/span>\n\t\t\t\t\t\t\t<\/p>\n\t\t\t\t\t\t<\/td>\n\t\t\t\t\t<\/tr>\n\t\t\t\t\t

\n\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\t\t\u540c\u79cd\u5f02\u4f53\u539f\u4ee3\u7ec6\u80de<\/span><\/span><\/span><\/span>\n\t\t\t\t\t\t\t<\/p>\n\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t

\n\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\t\t\u53ef\u80fd<\/span><\/span><\/span><\/span>\n\t\t\t\t\t\t\t<\/p>\n\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t

\n\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\t\t\u56f0\u96be<\/span><\/span><\/span><\/span>\n\t\t\t\t\t\t\t<\/p>\n\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t

\n\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\t\t\u56f0\u96be<\/span><\/span><\/span><\/span>\n\t\t\t\t\t\t\t<\/p>\n\t\t\t\t\t\t<\/td>\n\t\t\t\t\t<\/tr>\n\t\t\t\t\t

\n\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\t\tiPSC\/ESC<\/span><\/span><\/span><\/span>\u6765\u6e90\u7ec6\u80de<\/span><\/span><\/span><\/span>\n\t\t\t\t\t\t\t<\/p>\n\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t

\n\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\t\t\u53ef\u80fd<\/span><\/span><\/span><\/span>\n\t\t\t\t\t\t\t<\/p>\n\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t

\n\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\t\t\u53ef\u80fd<\/span><\/span><\/span><\/span>\n\t\t\t\t\t\t\t<\/p>\n\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t

\n\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\t\t\u53ef\u80fd<\/span><\/span><\/span><\/span>\n\t\t\t\t\t\t\t<\/p>\n\t\t\t\t\t\t<\/td>\n\t\t\t\t\t<\/tr>\n\t\t\t\t\t

\n\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\t\t\u6c38\u751f\u5316\u7ec6\u80de\u7cfb<\/span><\/span><\/span><\/span>\n\t\t\t\t\t\t\t<\/p>\n\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t

\n\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\t\t\u53ef\u80fd<\/span><\/span><\/span><\/span>\n\t\t\t\t\t\t\t<\/p>\n\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t

\n\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\t\t\u53ef\u80fd<\/span><\/span><\/span><\/span>\n\t\t\t\t\t\t\t<\/p>\n\t\t\t\t\t\t<\/td>\n\t\t\t\t\t\t

\n\t\t\t\t\t\t\t

\n\t\t\t\t\t\t\t\t\u53ef\u80fd<\/span><\/span><\/span><\/span>\n\t\t\t\t\t\t\t<\/p>\n\t\t\t\t\t\t<\/td>\n\t\t\t\t\t<\/tr>\n\t\t\t\t<\/tbody>\n\t\t\t<\/table>\n\t\t<\/center>\n\t\t

\n\t\t\t\n\t\t<\/p>\n\t\t

\n\t\t\t\u5bf9\u4e8e\u540c\u79cd\u5f02\u4f53\u6765\u6e90\u7684\u7ec6\u80de\uff08\u5982<\/span><\/span>MSC<\/span>\uff09\uff0c\u4e0d\u540c\u4f9b\u4f53\u95f4\u7684\u6027\u72b6\u5dee\u5f02\u672c\u8eab\u5c31\u96be\u4ee5\u6d88\u9664\u3002\u6709\u7814\u7a76\u8868\u660e\uff0c\u6765\u81ea\u4e0d\u540c\u4f9b\u4f53\u7684<\/span><\/span>MSC<\/span>\u5206\u6ccc\u7684<\/span><\/span>EVs<\/span>\uff0c\u5728\u5bf9\u708e\u75c7\u6a21\u578b\u7684\u6cbb\u7597\u6548\u679c\u4e0a\u53ef\u80fd\u5b58\u5728\u663e\u8457\u5dee\u5f02\u3002\u8fd9\u610f\u5473\u7740\uff0c\u5373\u4fbf\u5efa\u7acb\u4e86\u7ec6\u80de\u5e93\uff0c\u4e5f\u9700\u8981\u5728\u6bcf\u6b21\u66f4\u65b0\u7ec6\u80de\u5e93\u65f6\u9a8c\u8bc1\u65b0\u65e7\u6279\u6b21<\/span><\/span>EVs<\/span>\u4ea7\u54c1\u7684\u53ef\u6bd4\u6027\uff0c\u8fd9\u5bf9\u4e8e\u5c1a\u5728\u65e9\u671f\u7814\u53d1\u9636\u6bb5\u7684\u4f01\u4e1a\u800c\u8a00\uff0c\u662f\u4e0d\u5c0f\u7684\u5de5\u4f5c\u91cf\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t3.2 <\/strong><\/span><\/span>\u6c38\u751f\u5316\u7ec6\u80de\u7684\u7279\u6b8a\u98ce\u9669<\/strong><\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\u4f7f\u7528\u6c38\u751f\u5316\u7ec6\u80de\u7cfb\u751f\u4ea7<\/span><\/span>EVs<\/span>\uff0c\u5177\u6709\u53ef\u5927\u89c4\u6a21\u57f9\u517b\u3001\u6279\u95f4\u7a33\u5b9a\u6027\u8f83\u597d\u7684\u4f18\u52bf\u3002\u4f46<\/span><\/span><\/span>PMDA<\/span><\/span><\/span>\u62a5\u544a\u6307\u51fa\uff0c\u6765\u81ea\u6c38\u751f\u5316\u7ec6\u80de\u7684<\/span><\/span><\/span>EVs<\/span><\/span><\/span>\u4e2d\uff0c\u53ef\u80fd\u542b\u6709\u5927\u91cf\u89c6\u9ec4\u9187\u8f6c\u5ea7\u5b50\u7684<\/span><\/span><\/span>RNA<\/span><\/span><\/span>\u548c<\/span><\/span><\/span>DNA<\/span><\/span><\/span>\u5e8f\u5217\uff0c\u8fd9\u7c7b\u5e8f\u5217\u7406\u8bba\u4e0a\u53ef\u4ee5\u901a\u8fc7\u8f6c\u5ea7\u5b50\u673a\u5236\u5c06\u6c38\u751f\u5316\u7ec6\u80de\u7684\u6076\u6027\u8868\u578b\u4f20\u9012\u7ed9\u6b63\u5e38\u7ec6\u80de\u3002<\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\u867d\u7136\u76ee\u524d\u5c1a\u65e0\u660e\u786e\u8bc1\u636e\u8bc1\u660e\u6765\u6e90\u4e8e\u643a\u5e26\u764c\u57fa\u56e0\u7684\u6c38\u751f\u5316\u7ec6\u80de\u7684<\/span><\/span>EVs<\/span>\u5177\u6709\u81f4\u764c\u6f5c\u529b\uff0c\u4f46\u7406\u8bba\u98ce\u9669\u4e0d\u53ef\u5ffd\u89c6\uff0c\u4e14\u76ee\u524d\u5c1a\u65e0\u6210\u719f\u7684\u4f53\u5916\u8bd5\u9a8c\u65b9\u6cd5\u6765\u7cfb\u7edf\u8bc4\u4f30<\/span><\/span>EVs<\/span>\u7684\u81f4\u764c\u98ce\u9669\uff0c\u8fd9\u662f\u4e00\u4e2a\u7814\u7a76\u65b9\u6cd5\u5c42\u9762\u5c1a\u5b58\u7a7a\u767d\u7684\u9886\u57df\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t3.3 <\/strong><\/span><\/span>\u57f9\u517b\u6761\u4ef6\u7684\u7cbe\u7ec6\u63a7\u5236<\/strong><\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\u7ec6\u80de\u5206\u6ccc<\/span><\/span>EVs<\/span>\u7684\u6570\u91cf\u548c\u8d28\u91cf\uff0c\u4f1a\u53d7\u5230\u57f9\u517b\u57fa\u7ec4\u6210\uff08\u662f\u5426\u542b\u8840\u6e05\u3001\u662f\u5426\u542b\u7ec6\u80de\u56e0\u5b50\uff09\u3001\u57f9\u517b\u6e29\u5ea6\u3001\u6c27\u6c14\u6d53\u5ea6\u3001<\/span><\/span>CO\u2082<\/span>\u6d53\u5ea6\u3001\u7ec6\u80de\u5bc6\u5ea6\u7b49\u591a\u79cd\u56e0\u7d20\u7684\u5f71\u54cd\u3002\u5176\u4e2d\uff0c\u80ce\u725b\u8840\u6e05\uff08<\/span><\/span>FBS<\/span>\uff09\u7684\u4f7f\u7528\u662f\u4e00\u4e2a\u503c\u5f97\u7279\u522b\u5173\u6ce8\u7684\u95ee\u9898\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\tFBS<\/span>\u4e2d\u672c\u8eab\u542b\u6709\u5927\u91cf\u725b\u6e90\u6027<\/span><\/span>EVs<\/span>\uff0c\u5982\u679c\u76f4\u63a5\u4f7f\u7528\u542b<\/span><\/span>FBS<\/span>\u7684\u57f9\u517b\u57fa\uff0c\u4ea7\u51fa\u7269\u4e2d\u5c06\u4e0d\u53ef\u907f\u514d\u5730\u6df7\u5165\u725b\u6e90<\/span><\/span>EVs<\/span>\uff0c\u8fd9\u4e0d\u4ec5\u5f71\u54cd\u4ea7\u54c1\u8d28\u91cf\uff0c\u8fd8\u53ef\u80fd\u5f15\u53d1\u610f\u5916\u7684\u514d\u75ab\u53cd\u5e94\u3002\u97e9\u56fd<\/span><\/span>MFDS<\/span>\u6307\u5357\u548c\u65e5\u672c<\/span><\/span>PMDA<\/span>\u62a5\u544a\u5747\u5efa\u8bae\uff1a\u5728<\/span><\/span><\/span>GMP<\/span><\/span><\/span>\u751f\u4ea7\u9636\u6bb5\uff0c\u9664\u7279\u6b8a\u60c5\u51b5\u5916\uff0c\u5e94\u907f\u514d\u4f7f\u7528<\/span><\/span><\/span>FBS<\/span><\/span><\/span>\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\u6b64\u5916\uff0c\u51cb\u4ea1\u7ec6\u80de\uff08<\/span><\/span>apoptotic cell<\/span>\uff09\u4ea7\u751f\u7684\u51cb\u4ea1\u5c0f\u4f53\uff08<\/span><\/span>apoptotic bodies<\/span>\uff09\u4e0e\u6b63\u5e38\u5206\u6ccc\u7684<\/span><\/span>EVs<\/span>\u5728\u529f\u80fd\u4e0a\u6709\u672c\u8d28\u533a\u522b\uff0c\u5176\u5b58\u5728\u53ef\u80fd\u5e72\u6270\u4ea7\u54c1\u7684\u751f\u7269\u6d3b\u6027\u8bc4\u4f30\u3002\u56e0\u6b64\uff0c\u5728\u5236\u5907\u8fc7\u7a0b\u4e2d\u76d1\u63a7\u7ec6\u80de\u7684\u51cb\u4ea1\u7387\uff0c\u5e76\u5c06\u5176\u63a7\u5236\u5728\u5408\u7406\u8303\u56f4\u5185\uff0c\u662f\u57f9\u517b\u5de5\u827a\u63a7\u5236\u7684\u91cd\u8981\u5185\u5bb9\u4e4b\u4e00\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\n\t\t<\/p>\n\t\t

\n\t\t\t\u56db\u3001\u5206\u79bb\u7eaf\u5316\u65b9\u6cd5\uff1a\u5404\u6709\u4f18\u52a3\uff0c\u96be\u6709\u5b8c\u7f8e<\/strong><\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\tEVs<\/span>\u7684\u5206\u79bb\u7eaf\u5316\uff0c\u662f\u8d28\u91cf\u7814\u7a76\u4e2d\u53e6\u4e00\u4e2a\u6838\u5fc3\u96be\u9898\u3002\u65b9\u6cd5\u9009\u62e9\u4e0d\u4ec5\u5f71\u54cd\u4ea7\u54c1\u7684\u7eaf\u5ea6\u548c\u6536\u7387\uff0c\u8fd8\u4f1a\u76f4\u63a5\u5f71\u54cd<\/span><\/span>EVs<\/span>\u7684\u751f\u7269\u5b66\u6d3b\u6027\u2014\u2014\u6709\u7814\u7a76\u8868\u660e\uff0c\u4e0d\u540c\u5206\u79bb\u65b9\u6cd5\u83b7\u5f97\u7684<\/span><\/span>EVs<\/span>\uff0c\u5176\u86cb\u767d\u8d28\u7ec4\u5b66\u548c\u6838\u9178\u8c31\u4ee5\u53ca\u5728\u52a8\u7269\u4f53\u5185\u7684\u751f\u7269\u5206\u5e03\u5747\u5b58\u5728\u663e\u8457\u5dee\u5f02\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t4.1 <\/strong><\/span><\/span>\u5e38\u7528\u5206\u79bb\u7eaf\u5316\u65b9\u6cd5\u53ca\u5176\u5c40\u9650\u6027<\/strong><\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\uff08<\/strong><\/span><\/span>1<\/strong><\/span>\uff09\u8d85\u901f\u79bb\u5fc3\u6cd5\uff08<\/strong><\/span><\/span>Ultracentrifugation<\/strong><\/span>\uff09<\/strong><\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\u5728\u5b66\u672f\u7814\u7a76\u4e2d\u4f7f\u7528\u6700\u5e7f\u6cdb\uff0c\u4f46\u5b58\u5728\u660e\u663e\u7684\u89c4\u6a21\u5316\u9650\u5236\u2014\u2014\u5355\u6b21\u5904\u7406\u6837\u54c1\u91cf\u6709\u9650\uff0c\u8017\u65f6\u957f\uff0c\u4e14\u91cd\u590d\u6027\u56e0\u64cd\u4f5c\u4eba\u5458\u548c\u8bbe\u5907\u5dee\u5f02\u800c\u5b58\u5728\u53d8\u5f02\u3002\u66f4\u91cd\u8981\u7684\u662f\uff0c\u8d85\u901f\u79bb\u5fc3\u65e0\u6cd5\u6709\u6548\u53bb\u9664\u4e0e<\/span><\/span>EVs<\/span>\u5927\u5c0f\u76f8\u8fd1\u7684\u86cb\u767d\u8d28\u805a\u96c6\u4f53\uff0c\u8fd9\u4e9b<\/span><\/span>"<\/span>\u6742\u8d28<\/span><\/span>"<\/span>\u4f1a\u6df7\u5165\u6700\u7ec8\u4ea7\u54c1\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\uff08<\/strong><\/span><\/span>2<\/strong><\/span>\uff09<\/strong><\/span>\u805a\u5408\u7269\u6c89\u6dc0\u6cd5\uff08\u5982<\/strong><\/span><\/span>PEG<\/strong><\/span>\u6c89\u6dc0\uff09<\/strong><\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\u64cd\u4f5c\u7b80\u4fbf\uff0c\u4f46\u4f1a\u5c06\u5927\u91cf\u6e38\u79bb\u86cb\u767d\u8d28\u4e00\u5e76\u6c89\u6dc0\uff0c\u4ea7\u54c1\u7eaf\u5ea6\u8f83\u4f4e\uff0c\u540c\u65f6\u5b58\u5728\u6c89\u6dc0\u5242\u6b8b\u7559\u7684\u5b89\u5168\u6027\u98ce\u9669\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\uff08<\/strong><\/span><\/span>3<\/strong><\/span>\uff09\u5c3a\u5bf8\u6392\u963b\u8272\u8c31\u6cd5\uff08<\/strong><\/span><\/span>SEC<\/strong><\/span>\uff09<\/strong><\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\u6309\u7c92\u5f84\u5927\u5c0f\u5206\u79bb\uff0c\u5206\u8fa8\u7387\u8f83\u597d\uff0c\u53ef\u4e00\u5b9a\u7a0b\u5ea6\u4e0a\u5b9e\u73b0\u89c4\u6a21\u5316\uff0c\u5df2\u6709\u8f83\u591a\u6587\u732e\u62a5\u9053\u5176\u5728<\/span><\/span>EVs<\/span>\u7eaf\u5316\u4e2d\u7684\u5e94\u7528\u3002\u4f46\u5f53\u86cb\u767d\u8d28\u805a\u96c6\u4f53\u6216\u5176\u4ed6\u540c\u7b49\u5927\u5c0f\u7684\u975e<\/span><\/span>EV<\/span>\u7269\u8d28\u5b58\u5728\u65f6\uff0c\u7eaf\u5316\u6548\u7387\u4f1a\u53d7\u5f71\u54cd\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\uff08<\/strong><\/span><\/span>4<\/strong><\/span>\uff09<\/strong><\/span><\/span>\u4eb2\u548c\u7eaf\u5316\u6cd5\uff08Affinity-based purification\uff09<\/strong><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\u5229\u7528<\/span><\/span>EVs<\/span>\u8868\u9762\u6807\u8bb0\u5206\u5b50\uff08\u5982<\/span><\/span>CD63<\/span>\u3001<\/span><\/span>CD9<\/span>\u7b49\uff09\u8fdb\u884c\u6355\u83b7\uff0c\u7eaf\u5316\u7279\u5f02\u6027\u9ad8\u3002<\/span>\u4f46<\/span><\/span>EV<\/span>\u6807\u8bb0\u5206\u5b50\u5e76\u975e\u5b58\u5728\u4e8e\u6240\u6709<\/span><\/span>EVs<\/span>\uff0c\u56e0\u6b64\u4eb2\u548c\u7eaf\u5316\u6240\u5f97<\/span><\/span>EVs<\/span>\u662f\u5426\u5177\u6709\u9884\u671f\u7684\u751f\u7269\u5b66\u6d3b\u6027\uff0c\u9700\u8981\u7ed3\u5408\u5f02\u8d28\u6027\u7279\u5f81\u52a0\u4ee5\u786e\u8ba4\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\u76ee\u524d\u5c1a\u65e0\u4efb\u4f55\u4e00\u79cd\u65b9\u6cd5\u88ab\u56fd\u9645\u793e\u4f1a\u516c\u8ba4\u4e3a<\/span><\/span>EV<\/span>\u7eaf\u5316\u7684\u91d1\u6807\u51c6\uff0c\u4e0d\u540c\u673a\u6784\u7528\u4e0d\u540c\u7684\u65b9\u6cd5\u83b7\u5f97\u5916\u6ccc\u4f53\uff0c\u8fdb\u884c\u6548\u679c\u6bd4\u8f83\u65f6\u9762\u4e34\u4e25\u91cd\u7684\u65b9\u6cd5\u5b66\u6df7\u6dc6\u95ee\u9898\uff0c\u8fd9\u4e5f\u662f\u8be5\u9886\u57df\u7814\u7a76\u7ed3\u679c\u96be\u4ee5\u91cd\u590d\u7684\u91cd\u8981\u539f\u56e0\u4e4b\u4e00\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t4.2 <\/strong><\/span><\/span>\u6742\u8d28\u63a7\u5236\uff1a\u4e00\u573a\u6ca1\u6709\u7ec8\u70b9\u7684\u6218\u6597<\/strong><\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\tEV<\/span>\u5236\u5242\u4e2d\u53ef\u80fd\u5b58\u5728\u7684\u6742\u8d28\u6765\u6e90\u4f17\u591a\uff0c\u5305\u62ec\uff1a<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t1.EV<\/span>\u76f8\u5173\u7269\u8d28\uff1a\u7f3a\u4e4f\u6d3b\u6027\u6210\u5206\u7684\u975e\u76ee\u6807<\/span><\/span>EVs<\/span>\u3001\u5236\u5907\u6216\u50a8\u5b58\u8fc7\u7a0b\u4e2d\u964d\u89e3\u4ea7\u751f\u7684<\/span><\/span>EV<\/span>\u53d8\u4f53<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t2.\u7269\u6765\u6e90\u6742\u8d28\uff1a\u5bbf\u4e3b\u7ec6\u80de<\/span><\/span>DNA<\/span>\u7247\u6bb5\u3001\u5bbf\u4e3b\u7ec6\u80de\u86cb\u767d\u3001\u8102\u8d28\u4f53\u7b49<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t3.\u5de5\u827a\u6765\u6e90\u6742\u8d28\uff1a\u57f9\u517b\u57fa\u6210\u5206\uff08\u8840\u6e05\u86cb\u767d\u3001\u7ec6\u80de\u56e0\u5b50\uff09\u3001\u7eaf\u5316\u8bd5\u5242\u6b8b\u7559\uff08\u6297\u4f53\u3001\u8272\u8c31\u914d\u4f53\uff09\u3001\u5185\u6bd2\u7d20\u7b49<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t4.\u73af\u5883\u6765\u6e90\u6742\u8d28\uff1a\u751f\u4ea7\u64cd\u4f5c\u95f4\u4e2d\u7684\u6c14\u6eb6\u80f6\u9897\u7c92\uff1b\u6765\u81ea\u5b9e\u9a8c\u8017\u6750\uff08\u5982\u79bb\u5fc3\u7ba1\u3001\u67aa\u5934\u7b49\uff09\u7684\u4eba\u5de5\u5fae\u9897\u7c92<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\u6700\u4ee4\u4eba\u5934\u75bc\u7684\u662f\uff1a\u4e0e<\/span><\/span>EVs<\/span>\u5927\u5c0f\u76f8\u8fd1\u7684\u7269\u8d28\uff0c\u4e00\u65e6\u6df7\u5165\uff0c\u51e0\u4e4e\u65e0\u6cd5\u901a\u8fc7\u5e38\u89c4\u65b9\u6cd5\u5c06\u5176\u53bb\u9664\u3002\u6b63\u56e0\u5982\u6b64\uff0c\u4ece\u6e90\u5934\u63a7\u5236\u6742\u8d28\u7684\u5f15\u5165\uff0c\u6bd4\u4e8b\u540e\u53bb\u9664\u66f4\u4e3a\u91cd\u8981\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\u6b64\u5916\uff0c<\/span><\/span>EVs<\/span><\/span><\/span>\u8868\u9762\u53ef\u80fd\u5f62\u6210<\/span><\/span>\u86cb\u767d\u8d28\u51a0\uff08<\/span><\/strong><\/span><\/span>protein corona<\/span><\/span><\/strong><\/span>\uff09<\/span><\/strong><\/span>\uff0c\u6765\u81ea\u8840\u6d46\u6216\u57f9\u517b\u57fa\u4e2d\u7684\u86cb\u767d\u8d28\u5438\u9644\u5728<\/span><\/span><\/span>EVs<\/span><\/span><\/span>\u8868\u9762\uff0c\u8fd9\u4e9b\u86cb\u767d\u8d28\u65e2\u53ef\u80fd\u5f71\u54cd<\/span><\/span><\/span>EVs<\/span><\/span><\/span>\u7684\u751f\u7269\u6d3b\u6027\uff0c\u4e5f\u53ef\u80fd\u5728\u514d\u75ab\u5e94\u7b54\u5c42\u9762\u4ea7\u751f\u610f\u5916\u6548\u5e94<\/span>\u3002\u6709\u7814\u7a76\u8ba4\u4e3a\uff0c\u8fd9\u7c7b<\/span>\u51a0\u86cb\u767d<\/strong><\/span>\u4e0d\u5e94\u7b80\u5355\u5730\u89c6\u4e3a\u6742\u8d28\uff0c\u800c\u5e94\u5c06\u5176\u4f5c\u4e3a<\/span><\/span>EVs<\/span>\u5236\u5242\u6574\u4f53\u751f\u7269\u6d3b\u6027\u7ec4\u6210\u7684\u4e00\u90e8\u5206\u52a0\u4ee5\u7406\u89e3\u3002\u8fd9\u4e00\u8ba4\u77e5\u672c\u8eab\u5c31\u53cd\u6620\u4e86<\/span><\/span>EVs<\/span>\u8d28\u91cf\u7814\u7a76\u7684\u590d\u6742\u6027\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\n\t\t<\/p>\n\t\t

\n\t\t\t\u4e94\u3001<\/strong><\/span><\/span><\/span>EVs<\/strong><\/span><\/span>\u7279\u5f02\u6027\u8d28\u91cf\u8868\u5f81\uff1a\u65e2\u65e0\u91d1\u6807\u51c6\uff0c\u53c8\u65e0\u5b8c\u7f8e\u65b9\u6cd5<\/strong><\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t5.1 <\/strong><\/span><\/span>\u7c92\u5f84\u4e0e\u7c92\u6570\u6d4b\u5b9a\uff1a\u6bcf\u79cd\u4eea\u5668\u90fd\u8bf4\u7740\u201c\u4e0d\u540c\u7684\u8bed\u8a00\u201d<\/strong><\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\u5bf9<\/span><\/span>EVs<\/span>\u8fdb\u884c\u7c92\u5f84\u5206\u5e03\u548c\u7c92\u5b50\u6570\u91cf\u7684\u6d4b\u5b9a\uff0c\u662f\u6700\u57fa\u7840\u7684\u7406\u5316\u8868\u5f81\u5185\u5bb9\uff0c\u5374\u5df2\u7ecf\u8ba9\u7814\u7a76\u8005\u4eec\u9887\u8d39\u5468\u6298\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\n\t\t<\/p>\n\t\t

\n\t\t\t1.\u7eb3\u7c73\u9897\u7c92\u8ffd\u8e2a\u5206\u6790\uff08<\/strong><\/span><\/span>NTA<\/strong><\/span>\uff09<\/strong><\/span>\uff1a\u76ee\u524d\u6700\u5e38\u7528\u7684\u5355\u7c92\u5b50\u5206\u6790\u65b9\u6cd5\uff0c\u53ef\u540c\u65f6\u83b7\u5f97\u7c92\u5f84\u5206\u5e03\u548c\u7c92\u5b50\u6570\u6d53\u5ea6\uff1b\u7f3a\u70b9\u662f\u5bf9\u591a\u5206\u6563\u4f53\u7cfb\u7684\u6d4b\u91cf\u7cbe\u5ea6\u6709\u9650\uff0c\u4e14\u6d4b\u91cf\u7ed3\u679c\u9ad8\u5ea6\u4f9d\u8d56\u4e8e\u4eea\u5668\u578b\u53f7\u548c\u64cd\u4f5c\u53c2\u6570\uff0c\u4e0d\u540c\u5b9e\u9a8c\u5ba4\u3001\u4e0d\u540c\u4eea\u5668\u4e4b\u95f4\u7684\u6570\u636e\u53ef\u6bd4\u6027\u8f83\u5dee\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\"Picture<\/span>\n\t\t<\/section>\n\t\t

\n\t\t\t\n\t\t<\/p>\n\t\t

\n\t\t\t2.\u52a8\u6001\u5149\u6563\u5c04\uff08<\/strong><\/span><\/span>DLS<\/strong><\/span>\uff09<\/strong><\/span>\uff1a\u6d4b\u91cf\u539f\u7406\u6210\u719f\uff0c\u64cd\u4f5c\u7b80\u4fbf\uff0c\u4f46\u5bf9\u4e8e<\/span><\/span>EVs<\/span>\u8fd9\u6837\u9ad8\u5ea6\u591a\u5206\u6563\u7684\u4f53\u7cfb\uff0c\u5f80\u5f80\u53ea\u80fd\u7ed9\u51fa\u4f53\u79ef\u52a0\u6743\u5e73\u5747\u7c92\u5f84\uff0c\u65e0\u6cd5\u51c6\u786e\u53cd\u6620\u7c92\u5f84\u5206\u5e03\u60c5\u51b5\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\"Picture<\/span>\n\t\t<\/section>\n\t\t

\n\t\t\t3.\u53ef\u8c03\u8c10\u7535\u963b\u8109\u51b2\u4f20\u611f\uff08<\/strong><\/span><\/span>TRPS<\/span><\/strong><\/span>\uff09<\/strong><\/span>\uff1a\u5206\u8fa8\u7387\u8f83\u9ad8\uff0c\u4f46\u64cd\u4f5c\u590d\u6742\uff0c\u901a\u91cf\u8f83\u4f4e\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\"Picture<\/span>\n\t\t<\/section>\n\t\t

\n\t\t\t\n\t\t<\/p>\n\t\t

\n\t\t\t4.\u4f4e\u6e29\u900f\u5c04\u7535\u955c\uff08<\/strong><\/span><\/span>Cryo-EM<\/strong><\/span>\uff09<\/strong><\/span>\uff1a\u80fd\u591f\u5728\u63a5\u8fd1\u81ea\u7136\u72b6\u6001\u4e0b\u89c2\u5bdf<\/span><\/span>EVs<\/span>\uff0c\u662f\u76ee\u524d\u6700\u5177\u8bf4\u670d\u529b\u7684\u5f62\u6001\u5b66\u5206\u6790\u65b9\u6cd5\uff1b\u4f46\u901a\u91cf\u6781\u4f4e\uff0c\u7edf\u8ba1\u610f\u4e49\u6709\u9650\uff0c\u65e0\u6cd5\u5b9e\u73b0\u5927\u89c4\u6a21\u5e38\u89c4\u8d28\u68c0\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\"Picture<\/span>\n\t\t<\/section>\n\t\t

\n\t\t\t\n\t\t<\/p>\n\t\t

\n\t\t\tPMDA<\/span>\u62a5\u544a\u548c\u97e9\u56fd<\/span><\/span>MFDS<\/span>\u6307\u5357\u5747\u5f3a\u8c03\uff0c<\/span><\/span>EVs<\/span>\u7c92\u5f84\u5206\u5e03\u7684\u6d4b\u91cf\u7ed3\u679c\u5bb9\u6613\u53d7\u68c0\u6d4b\u65b9\u6cd5\uff08\u539f\u7406\uff09\u548c\u4eea\u5668\u578b\u53f7\u5f71\u54cd\uff0c\u4e0d\u540c\u5b9e\u9a8c\u5ba4\u95f4\u76f4\u63a5\u6bd4\u8f83\u65f6\u9700\u683c\u5916\u8c28\u614e\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t5.2 EVs<\/strong><\/span><\/span>\u7ec4\u6210\u5206\u6790\uff1a<\/strong><\/span><\/span><\/span>"<\/strong><\/span><\/span>\u8ba4\u8138<\/strong><\/span><\/span><\/span>"<\/strong><\/span><\/span>\u6bd4\u4f60\u60f3\u8c61\u7684\u96be<\/strong><\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\tEV<\/span>\u6807\u8bb0\u5206\u5b50\u662f\u9274\u5b9a<\/span><\/span>EVs<\/span>\u7684\u91cd\u8981\u4f9d\u636e\u3002\u76ee\u524d\u8f83\u4e3a\u5e7f\u6cdb\u8ba4\u53ef\u7684\u6807\u8bb0\u5206\u5b50\u5305\u62ec\uff1a<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t1.\u56db\u8de8\u819c\u86cb\u767d\u5bb6\u65cf\uff08<\/span><\/span>Tetraspanins<\/span>\uff09\uff1a<\/span><\/span>CD9<\/span>\u3001<\/span><\/span>CD63<\/span>\u3001<\/span><\/span>CD81<\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t2.\u665a\u671f\u5185\u4f53\u76f8\u5173\u86cb\u767d\uff1a<\/span><\/span>Tsg101<\/span>\u3001<\/span><\/span>Alix<\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t3.\u5185\u4f53\u6765\u6e90<\/span><\/span>EVs<\/span>\u6807\u8bb0\uff1a\u795e\u7ecf\u8282\u82f7\u8102<\/span><\/span>GM1<\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\u7136\u800c\uff0c\u76ee\u524d\u6ca1\u6709\u4efb\u4f55\u4e00\u79cd\u86cb\u767d\u8d28\u88ab\u786e\u8ba4\u4e3a<\/span><\/span>EVs<\/span>\u7684\u7279\u5f02\u6027\u6807\u8bb0\u7269\u3002\u6240\u8c13<\/span><\/span>EV<\/span>\u6807\u8bb0\u53ea\u662f\u5728<\/span><\/span>EVs<\/span>\u4e2d\u76f8\u5bf9\u5bcc\u96c6\uff0c\u800c\u975e<\/span><\/span>EVs<\/span>\u72ec\u6709\u3002<\/span><\/span>ISEV<\/span>\u7acb\u573a\u6587\u4ef6\u5efa\u8bae\u81f3\u5c11\u5206\u6790<\/span><\/span>3<\/span>\u79cd<\/span><\/span>EVs<\/span>\u7279\u6709\u6216<\/span><\/span>EV<\/span>\u76f8\u5173\u86cb\u767d\uff1b\u4f46<\/span><\/span>MISEV2023<\/span>\u540c\u65f6\u6307\u51fa\uff0c\u5bf9\u4e8e\u6cbb\u7597\u7528<\/span><\/span>EVs<\/span>\u5236\u5242\uff0c<\/span><\/span>MISEV<\/span>\u5408\u89c4\u6027\u5e76\u975e\u5fc5\u987b\u6ee1\u8db3\u7684\u6761\u4ef6\uff0c\u5173\u952e\u5728\u4e8e\u4e0e\u4ea7\u54c1\u7279\u5b9a\u529f\u80fd\u76f8\u5173\u7684\u6807\u8bb0\u7269\u548c\u8d28\u91cf\u6307\u6807\u7684\u68c0\u6d4b\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\tMISEV2023<\/span><\/span><\/span>\u8fd8\u7279\u522b\u63d0\u51fa\u4e86<\/span><\/span><\/span>EVs<\/span><\/span><\/span>\u62d3\u6251\u7ed3\u6784\u5206\u6790\u7684\u5fc5\u8981\u6027\uff0c\u5373\u9700\u8981\u786e\u8ba4<\/span><\/span><\/span>EVs<\/span><\/span><\/span>\u5404\u7ec4\u5206\u662f\u4f4d\u4e8e\u56ca\u6ce1\u5185\u90e8\u8fd8\u662f\u8868\u9762\uff0c\u56e0\u4e3a\u751f\u4ea7\u6216\u50a8\u5b58\u8fc7\u7a0b\u4e2d\u56ca\u6ce1\u7684\u964d\u89e3\u6216\u7ed3\u6784\u53d8\u5316\u53ef\u80fd\u5bfc\u81f4\u62d3\u6251\u7ed3\u6784\u6539\u53d8\uff0c\u8fdb\u800c\u5f71\u54cd\u529f\u80fd<\/span>\u3002\u8fd9\u4e00\u8981\u6c42\u5bf9\u5206\u6790\u65b9\u6cd5\u63d0\u51fa\u4e86\u66f4\u9ad8\u7684\u6280\u672f\u95e8\u69db\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t5.3 <\/strong><\/span><\/span>\u6548\u4ef7\u68c0\u6d4b\uff08<\/strong><\/span><\/span><\/span>Potency Assay<\/strong><\/span><\/span>\uff09\uff1a\u6700\u96be\u7684\u90e8\u5206<\/strong><\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\u5982\u679c\u8bf4\u7c92\u5f84\u6d4b\u5b9a\u548c\u7ec4\u6210\u5206\u6790\u662f\u201c\u8ba4\u6e05<\/span><\/span>EVs<\/span>\u957f\u4ec0\u4e48\u6837\u201d\uff0c\u90a3\u4e48\u6548\u4ef7\u68c0\u6d4b\u5c31\u662f\u201c\u786e\u8ba4<\/span><\/span>EVs<\/span>\u80fd\u505a\u4ec0\u4e48\u201d\uff0c\u8fd9\u662f\u8d28\u91cf\u7814\u7a76\u4e2d\u6280\u672f\u96be\u5ea6\u6700\u9ad8\u3001\u65b9\u6cd5\u5efa\u7acb\u6700\u56f0\u96be\u7684\u90e8\u5206\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\u6548\u4ef7\u68c0\u6d4b\uff08<\/strong><\/span><\/span>Potency Assay<\/strong><\/span>\uff09<\/strong><\/span>\u7684\u76ee\u7684\uff0c\u662f\u8bc4\u4ef7\u6216\u9884\u6d4b<\/span><\/span>EVs<\/span>\u5236\u5242\u5728\u4e34\u5e8a\u5e94\u7528\u4e2d\u7684\u7597\u6548\u3002\u4e00\u4e2a\u7406\u60f3\u7684\u6548\u4ef7\u68c0\u6d4b\u65b9\u6cd5\u5e94\u5f53\uff1a<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\u2460\u80fd\u591f\u53cd\u6620<\/span><\/span>EVs<\/span>\u7684\u4e34\u5e8a\u4f5c\u7528\u673a\u5236\uff1b<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\u2461\u5177\u6709\u826f\u597d\u7684\u5b9a\u91cf\u6027\u548c\u91cd\u73b0\u6027\uff1b<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\u2462\u53ef\u4ee5\u5728\u5e38\u89c4\u8d28\u91cf\u63a7\u5236\u4e2d\u5b9e\u9645\u4f7f\u7528\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

\n\t\t\t\u7136\u800c\u73b0\u5b9e\u60c5\u51b5\u662f\uff1a<\/strong><\/span><\/span>\n\t\t<\/p>\n\t\t

    \n\t\t\t
    \n\t\t\t\t

    \n\t\t\t\t\t1.\u8bb8\u591a<\/strong><\/span><\/span>EVs<\/strong><\/span>\u7684\u4f5c\u7528\u673a\u5236\u5c1a\u672a\u5b8c\u5168\u9610\u660e\u3002<\/strong><\/span><\/span>\n\t\t\t\t<\/p>\n\t\t\t<\/section>\n\t\t<\/ul>\n\t\t

    \n\t\t\tEVs<\/span>\u662f\u591a\u6210\u5206\u3001\u591a\u9776\u70b9\u7684\u590d\u5408\u529f\u80fd\u5b9e\u4f53\uff0c\u5176\u6cbb\u7597\u6548\u679c\u53ef\u80fd\u6765\u81ea\u591a\u79cd\u86cb\u767d\u8d28\u3001<\/span><\/span>RNA<\/span>\u548c\u8102\u8d28\u7684\u534f\u540c\u4f5c\u7528\uff0c\u5355\u4e00\u673a\u5236\u5f80\u5f80\u65e0\u6cd5\u89e3\u91ca\u5168\u90e8\u6548\u5e94\u3002\u5728\u673a\u5236\u5c1a\u4e0d\u6e05\u6670\u7684\u60c5\u51b5\u4e0b\uff0c\u5efa\u7acb\u80fd\u591f\u201c\u53cd\u6620\u4e34\u5e8a\u4f5c\u7528\u673a\u5236\u201d\u7684\u4f53\u5916\u6548\u4ef7\u68c0\u6d4b\u51e0\u4e4e\u65e0\u4ece\u4e0b\u624b\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

      \n\t\t\t
      \n\t\t\t\t

      \n\t\t\t\t\t2.\u7ec6\u80de\u6548\u4ef7\u68c0\u6d4b\u7684\u91cd\u73b0\u6027\u666e\u904d\u4e0d\u7406\u60f3\u3002<\/strong><\/span><\/span>\n\t\t\t\t<\/p>\n\t\t\t<\/section>\n\t\t<\/ul>\n\t\t

      \n\t\t\t\u4e0d\u540c\u6279\u6b21\u7ec6\u80de\u3001\u4e0d\u540c\u4f20\u4ee3\u6b21\u6570\u3001\u4e0d\u540c\u64cd\u4f5c\u8005\uff0c\u90fd\u53ef\u80fd\u5bfc\u81f4\u6548\u4ef7\u68c0\u6d4b\u7ed3\u679c\u51fa\u73b0\u663e\u8457\u6ce2\u52a8\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t
        \n\t\t\t\t

        \n\t\t\t\t\t3.\u53c2\u8003\u6807\u51c6\u54c1\uff08<\/strong><\/span><\/span>Reference Standard<\/strong><\/span>\uff09\u7684\u7f3a\u4e4f\u3002<\/strong><\/span><\/span>\n\t\t\t\t<\/p>\n\t\t\t<\/section>\n\t\t<\/ul>\n\t\t

        \n\t\t\tEVs<\/span>\u9886\u57df\u76ee\u524d\u5c1a\u65e0\u7ecf\u8fc7\u5e7f\u6cdb\u8ba4\u53ef\u7684\u6807\u51c6\u54c1\u6216\u53c2\u8003\u7269\u8d28\uff0c\u5404\u7814\u7a76\u673a\u6784\u5404\u81ea\u4e3a\u6218\uff0c\u68c0\u6d4b\u7ed3\u679c\u7f3a\u4e4f\u53ef\u6bd4\u6027\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\tPMDA<\/span>\u62a5\u544a\u5efa\u8bae\uff1a<\/span>\u5e94\u5c3d\u91cf\u8bbe\u7acb\u591a\u7ef4\u5ea6\u3001\u591a\u5c42\u6b21\u7684\u6548\u4ef7\u68c0\u6d4b\u4f53\u7cfb\uff0c\u65e2\u5305\u62ec\u4f53\u5916\u751f\u5316\u68c0\u6d4b\uff08\u5982\u6d3b\u6027\u6210\u5206\u5b9a\u91cf\u3001\u9176\u6d3b\u6027\u68c0\u6d4b\uff09\uff0c\u4e5f\u5305\u62ec\u7ec6\u80de\u6c34\u5e73\u7684\u529f\u80fd\u68c0\u6d4b\uff08\u5982\u7ec6\u80de\u589e\u6b96\u3001\u8fc1\u79fb\u3001\u514d\u75ab\u8c03\u8282\u529f\u80fd\uff09\uff0c\u5fc5\u8981\u65f6\u8fd8\u9700\u5f00\u5c55\u4f53\u5185\u52a8\u7269\u6a21\u578b\u7684\u6d3b\u6027\u9a8c\u8bc1\u3002\u901a\u8fc7\u201c<\/em><\/span>\u6b63\u4ea4\u5206\u6790\uff08<\/strong><\/em><\/span><\/span>orthogonal approach<\/strong><\/em><\/span>\uff09<\/strong><\/em><\/span>\u201d\u7b56\u7565\uff0c\u4ece\u591a\u4e2a\u89d2\u5ea6\u8bc4\u4f30<\/em><\/span><\/span>EVs<\/em><\/span>\u7684\u751f\u7269\u5b66\u6d3b\u6027\u7279\u5f81\u3002<\/em><\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\n\t\t<\/p>\n\t\t

        \n\t\t\t\u516d\u3001\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\uff1a\u89c4\u8303\u6027\u8981\u6c42\u4e0e\u73b0\u5b9e\u7684\u843d\u5dee<\/strong><\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u65b9\u6cd5\u5f00\u53d1\u4e4b\u540e\uff0c\u8fd8\u9700\u8981\u5f00\u5c55<\/span>\u65b9\u6cd5\u9a8c\u8bc1\uff08<\/strong><\/span><\/span>Method Validation<\/strong><\/span>\uff09<\/strong><\/span>\uff0c\u4ee5\u786e\u8ba4\u6240\u5efa\u7acb\u7684\u68c0\u6d4b\u65b9\u6cd5\u5177\u5907\u8db3\u591f\u7684\u51c6\u786e\u6027\u3001\u7cbe\u5bc6\u6027\u3001\u7279\u5f02\u6027\u3001\u7ebf\u6027\u548c\u8010\u7528\u6027\u3002\u8fd9\u662f\u6240\u6709\u751f\u7269\u5236\u54c1\u8d28\u91cf\u7814\u7a76\u90fd\u5fc5\u987b\u7ecf\u5386\u7684\u8fc7\u7a0b\uff0c\u5728<\/span><\/span>EVs<\/span>\u9886\u57df\u5374\u9762\u4e34\u989d\u5916\u7684\u6311\u6218\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t6.1 <\/strong><\/span><\/span>\u4e13\u5c5e\u6027\u9a8c\u8bc1\u7684\u96be\u9898<\/strong><\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u4e13\u5c5e\u6027\uff08<\/strong><\/span><\/span>Specificity<\/strong><\/span>\uff09\u9a8c\u8bc1<\/strong><\/span>\u8981\u6c42\u8bc1\u660e\u6240\u5efa\u7acb\u7684\u65b9\u6cd5\u80fd\u591f\u533a\u5206\u76ee\u6807<\/span><\/span>EVs<\/span>\u4e0e\u5176\u4ed6\u53ef\u80fd\u5e72\u6270\u68c0\u6d4b\u7684\u7269\u8d28\u3002\u4f46\u5728<\/span><\/span>EVs<\/span>\u9886\u57df\uff0c\u7531\u4e8e\u7f3a\u4e4f<\/span><\/span>EVs<\/span>\u7279\u5f02\u6027\u6807\u8bb0\u7269\uff0c\u5982\u4f55\u8bbe\u8ba1\u5408\u9002\u7684\u5e72\u6270\u7269\u548c\u9634\u6027\u5bf9\u7167\u672c\u8eab\u5c31\u662f\u4e00\u4e2a\u96be\u9898\u3002\u4f8b\u5982\uff0c\u7528\u4e8e\u6d4b\u5b9a<\/span><\/span>EVs<\/span>\u6570\u91cf\u7684<\/span><\/span>NTA<\/span>\u65b9\u6cd5\uff0c\u65e0\u6cd5\u533a\u5206<\/span><\/span>EVs<\/span>\u4e0e\u540c\u7b49\u5927\u5c0f\u7684\u86cb\u767d\u8d28\u805a\u96c6\u4f53\u6216\u8102\u8d28\u9897\u7c92\u3002\u5355\u72ec\u9a8c\u8bc1<\/span><\/span><\/span>NTA<\/span><\/span><\/span>\u65b9\u6cd5\u7684\u4e13\u5c5e\u6027\uff0c\u9700\u8981\u5f15\u5165\u4e0d\u542b<\/span><\/span><\/span>EVs<\/span><\/span><\/span>\u4f46\u542b\u6709\u540c\u7b49\u5927\u5c0f\u975e<\/span><\/span><\/span>EV<\/span><\/span><\/span>\u9897\u7c92\u7684\u6837\u54c1\u4f5c\u4e3a\u5e72\u6270\u57fa\u8d28\uff0c\u800c\u5236\u5907\u8fd9\u6837\u4e00\u79cd\u9ad8\u5ea6\u53d7\u63a7\u7684\u201c\u65e0<\/span><\/span><\/span>EVs\u201d<\/span><\/span><\/span>\u5e72\u6270\u57fa\u8d28\uff0c\u5728\u5b9e\u8df5\u4e2d\u5e76\u4e0d\u5bb9\u6613<\/span>\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t6.2 <\/strong><\/span><\/span>\u53c2\u8003\u7269\u8d28\u7684\u7f3a\u5931<\/strong><\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u5728\u751f\u7269\u5236\u54c1\u6548\u4ef7\u68c0\u6d4b\u4e2d\uff0c\u53c2\u8003\u6807\u51c6\u54c1\u662f\u951a\u5b9a\u68c0\u6d4b\u7ed3\u679c\u3001\u6d88\u9664\u5b9e\u9a8c\u95f4\u53d8\u5f02\u7684\u91cd\u8981\u5de5\u5177\u3002\u7136\u800c\uff0c<\/span><\/span>EVs<\/span>\u9886\u57df\u76ee\u524d\u5c1a\u65e0\u7ecf\u8fc7\u5e7f\u6cdb\u8ba4\u53ef\u7684\u6807\u51c6\u54c1\u6216\u53c2\u8003\u7269\u8d28\uff0c\u8fd9\u4f7f\u5f97\u65b9\u6cd5\u9a8c\u8bc1\u4e2d\u7684\u7edd\u5bf9\u5b9a\u91cf\u66f4\u52a0\u56f0\u96be\u3002\u76ee\u524d\uff0c\u90e8\u5206\u7814\u7a76\u673a\u6784\u91c7\u7528\u201c<\/span>\u76f8\u5bf9\u6548\u4ef7\u5355\u4f4d<\/strong><\/span>\u201d\u7684\u5f62\u5f0f\u8868\u8fbe\u68c0\u6d4b\u7ed3\u679c\uff08\u5982\u4ee5\u67d0\u4e00\u7279\u5b9a\u6279\u6b21<\/span><\/span>EVs<\/span>\u7684\u68c0\u6d4b\u503c\u4f5c\u4e3a\u53c2\u6bd4\u503c\u8fdb\u884c\u76f8\u5bf9\u6bd4\u8f83\uff09\uff0c\u4f46\u8fd9\u79cd\u65b9\u5f0f\u7684\u6eaf\u6e90\u6027\u8f83\u5f31\uff0c\u5728\u76d1\u7ba1\u5ba1\u8bc4\u4e2d\u53ef\u63a5\u53d7\u6027\u6709\u9650\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t6.3 <\/strong><\/span><\/span>\u65b9\u6cd5\u8f6c\u79fb\u548c\u6bd4\u5bf9\u7684\u56f0\u5883<\/strong><\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u56fd\u9645\u4e0a\u5df2\u6709\u7814\u7a76\u4e13\u9879\u6bd4\u8f83\u4e86\u591a\u5bb6\u673a\u6784\u7528\u76f8\u540c\u6837\u54c1\u5728\u4e0d\u540c\u4eea\u5668\u4e0a\u7684<\/span><\/span>NTA<\/span>\u6d4b\u91cf\u7ed3\u679c\uff0c\u53d1\u73b0\u7c92\u5b50\u6d53\u5ea6\u7684\u5b9e\u9a8c\u5ba4\u95f4\u53d8\u5f02\u53ef\u8fbe\u6570\u500d\u4e4b\u591a\u3002\u8fd9\u610f\u5473\u7740\uff0c\u5728<\/span><\/span><\/span>EVs<\/span><\/span><\/span>\u4ea7\u54c1\u7684\u8d28\u91cf\u6807\u51c6\u4e2d\uff0c\u5982\u679c\u4ee5\u7c92\u5b50\u6570\u4f5c\u4e3a\u68c0\u9a8c\u6307\u6807\uff0c\u5fc5\u987b\u975e\u5e38\u660e\u786e\u5730\u89c4\u5b9a\u6240\u7528\u4eea\u5668\u578b\u53f7\u3001\u68c0\u6d4b\u53c2\u6570\u548c\u64cd\u4f5c\u89c4\u7a0b\uff0c\u5426\u5219\u65b9\u6cd5\u7684\u5b9e\u9a8c\u5ba4\u95f4\u91cd\u73b0\u6027\u65e0\u4ece\u4fdd\u8bc1<\/span>\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t6.4 <\/strong><\/span><\/span>\u751f\u7269\u5b66\u529f\u80fd\u68c0\u6d4b\u7684\u9ad8\u5185\u5728\u53d8\u5f02\u6027<\/strong><\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u7528\u4e8e\u6548\u4ef7\u68c0\u6d4b\u7684\u7ec6\u80de\u529f\u80fd\u8bd5\u9a8c\uff08\u5982\u514d\u75ab\u7ec6\u80de\u6291\u5236\u7387\u6d4b\u5b9a\u3001\u7ec6\u80de\u8fc1\u79fb\u8bd5\u9a8c\uff09\uff0c\u672c\u8eab\u7684\u6279\u95f4\u91cd\u73b0\u6027\u5c31\u8f83\u5dee\u3002<\/span><\/span>EVs<\/span>\u6837\u54c1\u7684\u50a8\u5b58\u6761\u4ef6\u3001\u89e3\u51bb\u65b9\u5f0f\u3001\u68c0\u6d4b\u65f6\u7684\u9776\u7ec6\u80de\u6279\u6b21\u548c\u4f20\u4ee3\u6b21\u6570\uff0c\u90fd\u4f1a\u5bf9\u7ed3\u679c\u4ea7\u751f\u663e\u8457\u5f71\u54cd\u3002\u5982\u4f55\u901a\u8fc7\u4e25\u683c\u7684\u6807\u51c6\u64cd\u4f5c\u89c4\u7a0b\uff08<\/span><\/span>SOP<\/span>\uff09\u5c06\u8fd9\u4e9b\u53d8\u5f02\u63a7\u5236\u5728\u53ef\u63a5\u53d7\u8303\u56f4\u5185\uff0c\u662f<\/span><\/span>EV<\/span>\u4ea7\u54c1\u6548\u4ef7\u68c0\u6d4b\u65b9\u6cd5\u9a8c\u8bc1\u7684\u6838\u5fc3\u96be\u70b9\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\n\t\t<\/p>\n\t\t

        \n\t\t\t\u4e03\u3001\u75c5\u6bd2\u5b89\u5168\u6027\u8bc4\u4f30\uff1a\u4e00\u4e2a\u7279\u6b8a\u7684\u56f0\u5883<\/strong><\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u5728\u4f20\u7edf\u751f\u7269\u5236\u54c1\uff08\u5982\u5355\u514b\u9686\u6297\u4f53\uff09\u7684\u751f\u4ea7\u4e2d\uff0c\u7ecf\u8fc7\u9a8c\u8bc1\u7684\u75c5\u6bd2\u706d\u6d3b\u548c\u53bb\u9664\u5de5\u827a\uff08\u5982\u4f4e<\/span><\/span>pH<\/span>\u706d\u6d3b\u3001\u7eb3\u6ee4\u7b49\uff09\u662f\u4fdd\u969c\u4ea7\u54c1\u75c5\u6bd2\u5b89\u5168\u6027\u7684\u5173\u952e\u624b\u6bb5\u3002\u7136\u800c\uff0c<\/span><\/span>EVs<\/span>\u4e0e\u75c5\u6bd2\u5728\u7c92\u5f84\u3001\u8868\u9762\u7535\u8377\u548c\u8102\u8d28\u53cc\u5206\u5b50\u5c42\u7ed3\u6784\u7b49\u7269\u7406\u5316\u5b66\u7279\u6027\u4e0a\u6781\u4e3a\u76f8\u4f3c\uff0c\u8fd9\u5bfc\u81f4\u4e86\u4e00\u4e2a\u68d8\u624b\u7684\u95ee\u9898\uff1a<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\tEVs<\/span>\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u51e0\u4e4e\u65e0\u6cd5\u76f4\u63a5\u5e94\u7528\u9488\u5bf9\u751f\u7269\u6280\u672f\u4ea7\u54c1\u7684\u75c5\u6bd2\u6e05\u9664\u5de5\u827a\u3002\u5bf9<\/span><\/span><\/span>EVs<\/span><\/span><\/span>\u6709\u6548\u7684\u8fc7\u6ee4\u6761\u4ef6\u5f80\u5f80\u4e5f\u4f1a\u540c\u65f6\u53bb\u9664<\/span><\/span><\/span>EVs<\/span><\/span><\/span>\u672c\u8eab\uff1b\u5e38\u89c4\u7684\u75c5\u6bd2\u706d\u6d3b\u624b\u6bb5\uff08\u5982\u8f90\u5c04\u3001\u4f4e<\/span><\/span><\/span>pH<\/span><\/span><\/span>\u5904\u7406\uff09\u5219\u53ef\u80fd\u7834\u574f<\/span><\/span><\/span>EVs<\/span><\/span><\/span>\u7684\u7ed3\u6784\u548c\u6d3b\u6027<\/span>\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u56e0\u6b64\uff0c<\/span><\/span>PMDA<\/span>\u62a5\u544a\u660e\u786e\u6307\u51fa\uff1a<\/span>\u5bf9\u4e8e<\/em><\/span><\/span>EVs<\/em><\/span>\u800c\u8a00\uff0c\u75c5\u6bd2\u5b89\u5168\u6027\u6700\u91cd\u8981\u7684\u4fdd\u969c\u63aa\u65bd\uff0c\u662f\u4ece\u6e90\u5934\u786e\u4fdd\u751f\u4ea7\u7ec6\u80de\u4e0d\u643a\u5e26\u75c5\u6bd2\uff0c\u5373\u901a\u8fc7\u4e25\u683c\u7684\u4f9b\u4f53\u7b5b\u67e5\u548c\u7ec6\u80de\u5e93\u75c5\u6bd2\u68c0\u6d4b\u6765\u5b9e\u73b0\u75c5\u6bd2\u5b89\u5168\u6027\u7ba1\u63a7\uff0c\u800c\u975e\u4f9d\u8d56\u5de5\u827a\u6e05\u9664\u3002<\/em><\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u5728\u539f\u6db2\u6536\u83b7\u9636\u6bb5\uff0c\u5fc5\u987b\u5f00\u5c55\u5916\u6e90\u6027\u75c5\u6bd2\u68c0\u6d4b\u3002\u7531\u4e8e<\/span><\/span>EVs<\/span>\u6d53\u7f29\u6b65\u9aa4\u4f1a\u540c\u6b65\u6d53\u7f29\u53ef\u80fd\u5b58\u5728\u7684\u75c5\u6bd2\uff0c\u5728\u6d53\u7f29\u540e\u5f00\u5c55\u75c5\u6bd2\u68c0\u6d4b\uff0c\u5f80\u5f80\u6bd4\u5728\u6d53\u7f29\u524d\u66f4\u4e3a\u5408\u9002\u3002\u6b64\u5916\uff0c\u90e8\u5206\u975e\u5305\u819c\u75c5\u6bd2\u5728\u7ec6\u80de\u91ca\u653e\u65f6\u53ef\u80fd\u5f62\u6210\u5305\u819c\uff0c\u4e5f\u9700\u8981\u5728\u75c5\u6bd2\u5b89\u5168\u6027\u6d4b\u8bd5\u8bbe\u8ba1\u4e2d\u7ed9\u4e88\u7279\u522b\u5173\u6ce8\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\n\t\t<\/p>\n\t\t

        \n\t\t\t\u516b\u3001\u56fd\u5185\u76d1\u7ba1\u73b0\u72b6\uff1a\u7ad9\u5728\u653f\u7b56\u7684\u5341\u5b57\u8def\u53e3<\/strong><\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t8.1 <\/strong><\/span><\/span>\u73b0\u884c\u6cd5\u89c4\u6846\u67b6\u7684\u9002\u7528\u6027\u5206\u6790<\/strong><\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u5728\u4e2d\u56fd\uff0c<\/span><\/span>EV<\/span>\u6cbb\u7597\u4ea7\u54c1\u7684\u76d1\u7ba1\u5f52\u5c5e\u76ee\u524d\u5c1a\u65e0\u4e13\u9879\u89c4\u5b9a\u3002<\/span><\/span>EV<\/span>\u5236\u5242\u4e0d\u542b\u6d3b\u7ec6\u80de\uff0c\u901a\u5e38\u4e0d\u6309\u7ec6\u80de\u6cbb\u7597\u4ea7\u54c1\u8fdb\u884c\u5f52\u7c7b\uff1b\u4f46<\/span><\/span>EV<\/span>\u5236\u5242\u6765\u6e90\u4e8e\u6d3b\u7684\u751f\u7269\u4f53\uff0c\u5176\u5236\u9020\u9700\u8981\u7279\u6b8a\u7684\u516c\u5171\u536b\u751f\u63a7\u5236\u63aa\u65bd\uff0c\u5c5e\u4e8e\u751f\u7269\u5236\u54c1\u7684\u7ba1\u7406\u8303\u7574\u3002\u5982\u679c<\/span><\/span>EVs<\/span>\u6765\u6e90\u4e8e\u7ecf\u8fc7\u57fa\u56e0\u4fee\u9970\u7684\u7ec6\u80de\uff08\u5982\u5de5\u7a0b\u5316<\/span><\/span>EVs<\/span>\uff09\uff0c\u5219\u53ef\u80fd\u88ab\u5f52\u7c7b\u4e3a\u57fa\u56e0\u6cbb\u7597\u4ea7\u54c1\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u76ee\u524d\uff0c<\/span><\/span>NMPA<\/span>\u5c1a\u672a\u4e13\u95e8\u9488\u5bf9<\/span><\/span>EV<\/span>\u6cbb\u7597\u4ea7\u54c1\u53d1\u5e03\u6280\u672f\u6307\u5357\u3002\u76f8\u5173\u7684\u53c2\u8003\u89c4\u8303\u4e3b\u8981\u6765\u81ea\u4e8e\u7ec6\u80de\u6cbb\u7597\u4ea7\u54c1\u6280\u672f\u6307\u5bfc\u539f\u5219\u3001\u751f\u7269\u5236\u54c1\u8d28\u91cf\u63a7\u5236\u89c4\u8303\u53ca<\/span><\/span>ICH<\/span>\u7cfb\u5217\u6307\u5bfc\u539f\u5219\uff08\u5982<\/span><\/span>ICH Q5A<\/span>\u75c5\u6bd2\u5b89\u5168\u6027\u3001<\/span><\/span>ICH Q5D<\/span>\u7ec6\u80de\u5e95\u7269\u3001<\/span><\/span>ICH Q6B<\/span>\u751f\u7269\u6280\u672f\u4ea7\u54c1\u8d28\u91cf\u6807\u51c6\u7b49\uff09\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t8.2 <\/strong><\/span><\/span>\u56fd\u5185\u56e2\u4f53\u6807\u51c6\u7684\u8fdb\u5c55\u4e0e\u5c40\u9650<\/strong><\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u8fd1\u5e74\u6765\uff0c\u4e2d\u56fd\u7ec6\u80de\u751f\u7269\u5b66\u5b66\u4f1a\u3001\u4e2d\u56fd\u533b\u7597\u4fdd\u5065\u56fd\u9645\u4ea4\u6d41\u4fc3\u8fdb\u4f1a\u7b49\u673a\u6784\u76f8\u7ee7\u53d1\u5e03\u4e86\u82e5\u5e72\u5916\u6ccc\u4f53\u76f8\u5173\u56e2\u4f53\u6807\u51c6\uff0c\u5185\u5bb9\u6d89\u53ca\u5916\u6ccc\u4f53\u7684\u57fa\u672c\u672f\u8bed\u548c\u5b9a\u4e49\u3001\u5916\u6ccc\u4f53\u63d0\u53d6\u548c\u9274\u5b9a\u65b9\u6cd5\u7684\u57fa\u672c\u8981\u6c42\u7b49\uff0c\u5bf9\u4e8e\u63a8\u52a8\u884c\u4e1a\u5171\u8bc6\u5177\u6709\u79ef\u6781\u610f\u4e49\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u4f46\u5b58\u5728\u4ee5\u4e0b\u660e\u663e\u5c40\u9650\uff1a<\/strong><\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t1.\u56e2\u4f53\u6807\u51c6\u4e0d\u5177\u6709\u6cd5\u89c4\u6548\u529b\uff0c\u5373\u4fbf\u5b8c\u5168\u7b26\u5408\u56e2\u4f53\u6807\u51c6\u8981\u6c42\uff0c\u4e5f\u4e0d\u7b49\u540c\u4e8e\u6ee1\u8db3<\/span><\/span>NMPA<\/span>\u5bf9\u65b0\u836f\u7533\u62a5\u7684\u6280\u672f\u5ba1\u8bc4\u8981\u6c42<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t2.\u73b0\u6709\u56e2\u4f53\u6807\u51c6\u7684\u6280\u672f\u8981\u6c42\u76f8\u5bf9\u57fa\u7840\uff0c\u5bf9\u4e8e\u6cbb\u7597\u7528<\/span><\/span>EVs<\/span>\u5236\u5242\u6240\u9700\u7684\u4e25\u683c\u8d28\u91cf\u63a7\u5236\u8981\u6c42\uff08\u5982\u6548\u4ef7\u68c0\u6d4b\u65b9\u6cd5\u3001\u75c5\u6bd2\u5b89\u5168\u6027\u8bc4\u4f30\u3001\u5de5\u827a\u9a8c\u8bc1<\/span>\u7b49\uff09\u8986\u76d6\u4e0d\u8db3<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t3.\u56e2\u4f53\u6807\u51c6\u4e4b\u95f4\u5c1a\u5b58\u5728\u4e00\u5b9a\u7684\u4e0d\u4e00\u81f4\u6027\uff0c\u90e8\u5206\u6807\u51c6\u5728\u6280\u672f\u8981\u6c42\u4e0a\u4e0e\u56fd\u9645\u4e3b\u6d41\u6307\u5357\uff08<\/span><\/span>MISEV2023<\/span>\u7b49\uff09\u5b58\u5728\u5dee\u8ddd<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u4e5d\u3001\u6700\u73b0\u5b9e\u7684\u56f0\u5883\uff1a\u8c01\u6765\u5e2e\u6211\u505a\u8d28\u91cf\u590d\u6838\uff1f<\/strong><\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u73b0\u5728\uff0c\u8ba9\u6211\u4eec\u56de\u5230\u6587\u7ae0\u5f00\u5934\u90a3\u4e2a\u95ee\u9898\u2014\u2014\u60f3\u5f00\u5c55<\/span><\/span>EV<\/span>\u5236\u5242<\/span><\/span>IIT<\/span>\u7814\u7a76\u7684\u4f01\u4e1a\uff0c\u5982\u4f55\u627e\u5230\u6709\u8d44\u8d28\u7684\u7b2c\u4e09\u65b9\u68c0\u6d4b\u673a\u6784\u505a\u8d28\u91cf\u590d\u6838\uff1f\u8fd9\u4e2a\u95ee\u9898\u4e4b\u6240\u4ee5\u68d8\u624b\uff0c\u662f\u56e0\u4e3a\u5b83\u89e6\u53ca\u4e86\u4e00\u4e2a\u7ed3\u6784\u6027\u56f0\u5883\uff1a<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u4e00\u65b9\u9762\uff0c\u76d1\u7ba1\u5c42\u9762\u8981\u6c42<\/span><\/span>IIT<\/span>\u7814\u7a76\u7684\u4ea7\u54c1\u5fc5\u987b\u7ecf\u8fc7\u8d28\u91cf\u68c0\u9a8c\uff1b\u53e6\u4e00\u65b9\u9762\uff0c\u5177\u5907\u76f8\u5e94\u68c0\u6d4b\u80fd\u529b\u548c\u8d44\u8d28\u7684\u673a\u6784\uff0c\u76ee\u524d\u5728\u56fd\u5185\u6781\u5ea6\u7a00\u7f3a\u751a\u81f3\u7a7a\u767d\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u4e2d\u68c0\u9662\uff1a<\/strong><\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u867d\u5df2\u5c06<\/span><\/span>EV<\/span>\u8d28\u91cf\u8bc4\u4ef7\u7814\u7a76\u5217\u5165\u5408\u540c\u68c0\u9a8c\u76ee\u5f55\uff08\u300a\u4e2d\u68c0\u9662\u5e72\u7ec6\u80de\u5408\u540c\u68c0\u9a8c\u5e38\u89c1\u95ee\u9898\uff08\u4e13\u9898\u7b2c\u4e00\u671f\uff09\u300b\uff0c<\/span><\/span>2025<\/span>\u5e74<\/span><\/span>8<\/span>\u6708\uff09\uff0c\u4f46\u5b9e\u9645\u64cd\u4f5c\u4e2d\u56e0\u5206\u6790\u65b9\u6cd5\u4e0d\u6210\u719f\u800c\u6682\u4e0d\u63a5\u6536\u6837\u54c1\u3002\u4e2d\u68c0\u9662\u7684\u8fd9\u4e00\u6001\u5ea6\uff0c\u65e2\u662f\u8bda\u5b9e\u7684\u2014\u2014\u5b83\u53cd\u6620\u4e86\u65b9\u6cd5\u5b66\u73b0\u72b6\u7684\u5ba2\u89c2\u5c40\u9650\uff0c\u4e5f\u662f\u4ee4\u4eba\u9057\u61be\u7684\u2014\u2014\u56e0\u4e3a\u5bf9\u4e8e\u4f01\u4e1a\u6765\u8bf4\uff0c\u4e2d\u68c0\u9662\u7684\u80cc\u4e66\u6700\u5177\u8bf4\u670d\u529b\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\tCMA<\/strong><\/span>\u8ba4\u8bc1\u4f53\u7cfb\uff1a<\/strong><\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u56fd\u5bb6\u8ba4\u8bc1\u8ba4\u53ef\u76d1\u7763\u7ba1\u7406\u59d4\u5458\u4f1a\uff08<\/span><\/span>CNCA<\/span><\/span>\uff09\u6388\u6743\u7684<\/span><\/span>CMA<\/span><\/span><\/span>\u8d44\u8d28\uff0c\u9488\u5bf9\u7684\u662f\u68c0\u6d4b\u65b9\u6cd5\u5df2\u6709\u660e\u786e\u56fd\u5bb6\u6807\u51c6\u6216\u884c\u4e1a\u6807\u51c6\u7684\u68c0\u6d4b\u9879\u76ee<\/span>\u3002\u7531\u4e8e<\/span><\/span>EV<\/span>\u76f8\u5173\u68c0\u6d4b\u76ee\u524d\u7f3a\u4e4f\u7ecf\u6279\u51c6\u7684\u56fd\u5bb6<\/span><\/span>\/<\/span>\u884c\u4e1a\u6807\u51c6\uff0c<\/span><\/span>CMA<\/strong><\/span>\u4f53\u7cfb\u65e0\u6cd5\u5bf9\u8fd9\u7c7b\u68c0\u6d4b\u9879\u76ee\u53d1\u653e\u8ba4\u8bc1<\/strong><\/span>\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\tCNAS<\/strong><\/span>\u8ba4\u53ef\u4f53\u7cfb\uff1a<\/strong><\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u4e2d\u56fd\u5408\u683c\u8bc4\u5b9a\u56fd\u5bb6\u8ba4\u53ef\u59d4\u5458\u4f1a\uff08<\/span><\/span>CNAS<\/span>\uff09\u7684\u5b9e\u9a8c\u5ba4\u8ba4\u53ef\uff0c\u540c\u6837\u8981\u6c42\u68c0\u6d4b\u65b9\u6cd5\u5177\u5907\u53ef\u8ffd\u6eaf\u6027\u548c\u53c2\u8003\u6807\u51c6\u3002\u5728<\/span><\/span>CNAS<\/span>\u73b0\u6709\u7684\u80fd\u529b\u9a8c\u8bc1\u8ba1\u5212\u548c\u5b9e\u9a8c\u5ba4\u8ba4\u53ef\u8303\u56f4\u4e2d\uff0c<\/span>\u5c1a\u672a\u8bbe\u7acb\u4e13\u95e8\u9488\u5bf9\u7ec6\u80de\u5916\u56ca\u6ce1\u6216\u5916\u6ccc\u4f53\u68c0\u6d4b\u7684\u8ba4\u53ef\u5206\u7c7b<\/strong><\/span>\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u5546\u4e1a\u7b2c\u4e09\u65b9\u5b9e\u9a8c\u5ba4\uff1a<\/strong><\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u90e8\u5206\u6709\u7ec6\u80de\u6cbb\u7597\u4ea7\u54c1\u68c0\u6d4b\u7ecf\u9a8c\u7684\u7b2c\u4e09\u65b9\u5b9e\u9a8c\u5ba4\u53ef\u80fd\u5177\u5907\u4e00\u5b9a\u7684<\/span><\/span>EVs<\/span>\u68c0\u6d4b\u80fd\u529b\uff0c\u4f46\u5176<\/span><\/span>EVs<\/span>\u68c0\u6d4b\u65b9\u6cd5\u591a\u5904\u4e8e\u81ea\u7814\u3001\u672a\u7ecf\u7cfb\u7edf\u9a8c\u8bc1\u7684\u72b6\u6001\uff1b\u65e0\u6cd5\u63d0\u4f9b\u5177\u6709\u6cd5\u89c4\u8ba4\u53ef\u6548\u529b\u7684\u68c0\u9a8c\u62a5\u544a\uff1b\u4e0d\u540c\u673a\u6784\u4e4b\u95f4\u7684\u68c0\u6d4b\u80fd\u529b\u548c\u6c34\u5e73\u53c2\u5dee\u4e0d\u9f50\uff0c\u9009\u62e9\u65f6\u9700\u8c28\u614e\u8bc4\u4f30\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\n\t\t<\/p>\n\t\t

        \n\t\t\t\u5341\u3001\u7ed9\u7814\u53d1\u4f01\u4e1a\u7684\u5efa\u8bae\uff1a\u5728\u4e0d\u786e\u5b9a\u6027\u4e2d\u627e\u5230\u524d\u8fdb\u7684\u8def<\/strong><\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u9762\u5bf9\u4e0a\u8ff0\u56f0\u5883\uff0c\u7814\u53d1\u4f01\u4e1a\u5e94\u5982\u4f55\u5e94\u5bf9\uff1f\u4ee5\u4e0b\u662f\u6211\u4eec\u57fa\u4e8e\u5bf9\u76d1\u7ba1\u653f\u7b56\u548c\u6280\u672f\u73b0\u72b6\u7684\u7406\u89e3\uff0c\u63d0\u51fa\u7684\u51e0\u70b9\u5207\u5b9e\u5efa\u8bae\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u5efa\u8bae\u4e00\uff1a\u4e3b\u52a8\u4e0e\u76d1\u7ba1\u673a\u6784\u6c9f\u901a\uff0c\u4e89\u53d6\u65e9\u671f\u6307\u5bfc<\/strong><\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u5728\u5f00\u5c55<\/span><\/span>IIT<\/span>\u7814\u7a76\u4e4b\u524d\uff0c\u5f3a\u70c8\u5efa\u8bae\u4f01\u4e1a\u4e3b\u52a8\u5411<\/span><\/span>NMPA<\/span>\u836f\u5ba1\u4e2d\u5fc3\uff08<\/span><\/span>CDE<\/span>\uff09\u7533\u8bf7\u6c9f\u901a\u4ea4\u6d41\u4f1a\u8bae\uff0c\u5c31\u4ea7\u54c1\u7684\u76d1\u7ba1\u5206\u7c7b\u3001\u5173\u952e\u8d28\u91cf\u5c5e\u6027\uff08<\/span><\/span>CQAs<\/span>\uff09\u7684\u754c\u5b9a\u3001\u62df\u91c7\u7528\u7684\u5206\u6790\u65b9\u6cd5\u6846\u67b6\u662f\u5426\u53ef\u63a5\u53d7\u3001\u4ee5\u53ca\u5bf9\u4e8e\u7f3a\u4e4f\u6210\u719f\u6807\u51c6\u65b9\u6cd5\u7684\u9879\u76ee\u7684\u5904\u7406\u601d\u8def\u7b49\u6838\u5fc3\u95ee\u9898\u5bfb\u6c42\u76d1\u7ba1\u610f\u89c1\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u8fd9\u79cd\u4e3b\u52a8\u6c9f\u901a\uff0c\u65e2\u80fd\u5e2e\u52a9\u4f01\u4e1a\u63d0\u524d\u4e86\u89e3\u76d1\u7ba1\u9884\u671f\uff0c\u4e5f\u80fd\u5728\u4e00\u5b9a\u7a0b\u5ea6\u4e0a\u4e3a\u4f01\u4e1a\u5efa\u7acb\u81ea\u6709\u5206\u6790\u65b9\u6cd5\u7684\u5408\u7406\u6027\u63d0\u4f9b\u652f\u6491\u2014\u2014\u76d1\u7ba1\u673a\u6784\u7684\u4e66\u9762\u53cd\u9988\u610f\u89c1\uff0c\u5728\u540e\u7eed\u5ba1\u8bc4\u4e2d\u5177\u6709\u91cd\u8981\u53c2\u8003\u4ef7\u503c\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\n\t\t<\/p>\n\t\t

        \n\t\t\t\u5efa\u8bae\u4e8c\uff1a\u5efa\u7acb\u4ea7\u54c1\u7279\u5f02\u6027\u7684\u8d28\u91cf\u7814\u7a76\u65b9\u6848<\/strong><\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u9274\u4e8e<\/span><\/span>EV<\/span>\u5236\u5242\u9886\u57df\u7f3a\u4e4f\u7edf\u4e00\u6807\u51c6\uff0c\u4f01\u4e1a\u5fc5\u987b\u8d70\u4e00\u6761\u201c<\/span>\u4e2a\u6848\u5206\u6790\u3001\u4ea7\u54c1\u7279\u5f02\u6027<\/strong><\/span>\u201d\u7684\u8def\u7ebf\uff1a<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t1.\u660e\u786e<\/strong><\/span>\u4ea7<\/strong><\/span>\u54c1\u5b9a\u4f4d\u548c\u6d3b\u6027\u6210\u5206\u5047<\/strong><\/span>\u8bf4<\/strong><\/span>\uff1a<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u9996\u5148\u786e\u5b9a<\/span>\u4ea7<\/span>\u54c1\u5c5e\u4e8e\u54ea\u4e00<\/span>\u7c7b<\/span><\/span>EVs<\/span>\uff0c\u5176\u6d3b\u6027\u6210\u5206\u7684\u5de5\u4f5c\u5047\u8bf4\u548c\u4f5c\u7528\u673a\u5236\u7684\u5047\u8bf4\u662f\u4ec0\u4e48\u3002\u8fd9\u662f\u4e00\u5207\u8d28\u91cf\u7814\u7a76\u8bbe\u8ba1\u7684\u524d\u63d0\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t2.\u5efa\u7acb\u6700\u5c0f\u5316\u4f46\u6709\u4ee3\u8868\u6027\u7684\u8d28\u91cf\u6307\u6807\u4f53\u7cfb\uff1a<\/strong><\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u53c2\u8003<\/span><\/span>MISEV2023<\/span>\u5efa\u8bae\u548c\u97e9\u56fd<\/span><\/span>MFDS<\/span>\u6307\u5357\uff0c\u7ed3\u5408\u4ea7\u54c1\u7279\u70b9\uff0c\u5efa\u7acb\u80fd\u591f\u53cd\u6620\u4ea7\u54c1\u540c\u4e00\u6027\uff08<\/span><\/span>Identity<\/span>\uff09\u3001\u5b89\u5168\u6027\uff08<\/span><\/span>Safety<\/span>\uff09\u548c\u6548\u529b\uff08<\/span><\/span>Potency<\/span>\uff09\u7684\u6838\u5fc3\u68c0\u6d4b\u9879\u76ee\uff0c\u800c\u975e\u8ffd\u6c42\u9762\u9762\u4ff1\u5230\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t3.\u4f18\u5148\u5efa\u7acb\u53ef\u91cf\u5316\u7684\u529f\u80fd\u6027\u6548\u4ef7\u68c0\u6d4b\uff1a<\/strong><\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u5373\u4fbf\u5b58\u5728\u65b9\u6cd5\u5b66\u6311\u6218\uff0c\u4e5f\u5fc5\u987b\u5c1d\u8bd5\u5efa\u7acb\u81f3\u5c11\u4e00\u79cd\u80fd\u591f\u53cd\u6620\u4ea7\u54c1\u529f\u80fd\u7684\u4f53\u5916\u68c0\u6d4b\u65b9\u6cd5\uff0c\u5e76\u5bf9\u5176\u8fdb\u884c\u7cfb\u7edf\u7684\u65b9\u6cd5\u9884\u9a8c\u8bc1\uff08<\/span><\/span>pre-validation<\/span>\uff09\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t4.\u5efa\u7acb\u6279\u6b21\u5185\u53c2\u8003\u7269\u8d28\uff08<\/strong><\/span><\/span>In-house Reference Standard<\/strong><\/span>\uff09\uff1a<\/strong><\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u5373\u4fbf\u6ca1\u6709\u56fd\u9645\u901a\u7528\u6807\u51c6\u54c1\uff0c\u4e5f\u53ef\u4ee5\u901a\u8fc7\u5236\u5907\u5e76\u59a5\u5584\u50a8\u5b58\u4ee3\u8868\u6027\u6279\u6b21\u7684\u4ea7\u54c1\uff0c\u5efa\u7acb\u5185\u90e8\u53c2\u8003\u6807\u51c6\uff0c\u7528\u4e8e\u4e0d\u540c\u6279\u6b21\u4e4b\u95f4\u7684\u76f8\u5bf9\u6548\u4ef7\u6bd4\u8f83\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\n\t\t<\/p>\n\t\t

        \n\t\t\t\u5efa\u8bae\u4e09\uff1a\u9009\u62e9\u6709\u7efc\u5408\u80fd\u529b\u7684\u7b2c\u4e09\u65b9\u5408\u4f5c\u673a\u6784<\/strong><\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u5728\u5f53\u524d\u8d44\u8d28\u8ba4\u53ef\u4f53\u7cfb\u7a7a\u767d\u7684\u60c5\u51b5\u4e0b\uff0c\u4f01\u4e1a\u5728\u9009\u62e9\u7b2c\u4e09\u65b9\u68c0\u6d4b\u5408\u4f5c\u673a\u6784\u65f6\uff0c\u5efa\u8bae\u7efc\u5408\u8003\u91cf\u4ee5\u4e0b\u51e0\u4e2a\u7ef4\u5ea6\uff1a<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\uff08<\/strong><\/span><\/span>1<\/strong><\/span>\uff09\u6280\u672f\u80fd\u529b\u5c42\u9762\uff1a<\/strong><\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t

        \n\t\t\t\ta.\u662f\u5426\u6709\u6210\u719f\u7684\u7ec6\u80de\u6cbb\u7597\u4ea7\u54c1\u6216\u751f\u7269\u5236\u54c1\u68c0\u6d4b\u7ecf\u9a8c\uff1f<\/span><\/span>\n\t\t\t<\/p>\n\t\t\t

        \n\t\t\t\t

        \n\t\t\t\t\tb.\u662f\u5426\u5df2\u5efa\u7acb\u5e76\u9884\u9a8c\u8bc1\u4e86\u76f8\u5173\u7684\u5206\u6790\u65b9\u6cd5\uff08\u7c92\u5f84\u6d4b\u5b9a\u3001\u6807\u8bb0\u86cb\u767d\u68c0\u6d4b\u3001\u529f\u80fd\u6d3b\u6027\u68c0\u6d4b\uff09\uff1f<\/span><\/span>\n\t\t\t\t<\/p>\n\t\t\t\t

        \n\t\t\t\t\t

        \n\t\t\t\t\t\tc.\u662f\u5426\u5177\u5907\u5b8c\u6574\u7684<\/span><\/span>GMP<\/span>\u68c0\u6d4b\u73af\u5883\uff08\u6d01\u51c0\u5b9e\u9a8c\u5ba4\u3001\u5fae\u751f\u7269\u68c0\u6d4b\u8bbe\u65bd\uff09\uff1f<\/span><\/span>\n\t\t\t\t\t<\/p>\n\t\t\t\t\t

        \n\t\t\t\t\t\t

        \n\t\t\t\t\t\t\td.\u662f\u5426\u6709\u4e13\u95e8\u4ece\u4e8b<\/span><\/span>EVs<\/span>\u76f8\u5173\u68c0\u6d4b\u7814\u7a76\u7684\u6280\u672f\u56e2\u961f\uff1f<\/span><\/span>\n\t\t\t\t\t\t<\/p>\n\t\t\t\t\t<\/section>\n\t\t\t\t<\/section>\n\t\t\t<\/section>\n\t\t<\/section>\n\t\t

        \n\t\t\t\uff08<\/strong><\/span><\/span>2<\/strong><\/span>\uff09\u8d28\u91cf\u7ba1\u7406\u4e0e\u5408\u89c4\u5c42\u9762\uff1a<\/strong><\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t

        \n\t\t\t\ta.\u662f\u5426\u5df2\u901a\u8fc7<\/span><\/span>CNAS<\/span>\u8ba4\u53ef\uff1f<\/span><\/span>\n\t\t\t<\/p>\n\t\t\t

        \n\t\t\t\tb.\u62a5\u544a\u7684\u683c\u5f0f\u548c\u5185\u5bb9\u662f\u5426\u7b26\u5408\u76d1\u7ba1\u6863\u6848\u7684\u8981\u6c42\uff08\u5177\u5907\u552f\u4e00\u6807\u8bc6\u3001\u68c0\u6d4b\u65b9\u6cd5\u63cf\u8ff0\u3001\u7ed3\u679c\u8868\u8ff0\u7b49\u89c4\u8303\u8981\u7d20\uff09\uff1f<\/span><\/span>\n\t\t\t<\/p>\n\t\t\t

        \n\t\t\t\tc.\u662f\u5426\u5177\u5907\u5408\u6cd5\u7684\u7ecf\u8425\u8d44\u8d28\uff08\u5982\u533b\u7597\u673a\u6784\u6267\u4e1a\u8bb8\u53ef\u8bc1\u3001\u8425\u4e1a\u6267\u7167\uff09\uff1f<\/span><\/span>\n\t\t\t<\/p>\n\t\t<\/section>\n\t\t

        \n\t\t\t\u5728\u7f3a\u4e4f<\/span><\/span>EVs<\/span>\u4e13\u9879\u8d44\u8d28\u8ba4\u53ef\u7684\u5f53\u4e0b\uff0c\u9009\u62e9\u5177\u5907\u5176\u4ed6\u751f\u7269\u5236\u54c1<\/span><\/span>\/<\/span>\u7ec6\u80de\u6cbb\u7597\u68c0\u6d4b\u80fd\u529b\u7684\u77e5\u540d\u7b2c\u4e09\u65b9\u5b9e\u9a8c\u5ba4\u5408\u4f5c\uff0c\u5e76\u5728\u5408\u540c\u4e2d\u660e\u786e\u7ea6\u5b9a\u68c0\u6d4b\u65b9\u6cd5\u3001\u5224\u5b9a\u6807\u51c6\u548c\u8d23\u4efb\u5f52\u5c5e\uff0c\u662f\u76ee\u524d\u76f8\u5bf9\u53ef\u884c\u7684\u8def\u5f84\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\n\t\t<\/p>\n\t\t

        \n\t\t\t\u5efa\u8bae\u56db\uff1a\u5229\u7528\u5927\u5b66\u53ca\u79d1\u7814\u9662\u6240\u7684\u6280\u672f\u529b\u91cf<\/strong><\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u56fd\u5185\u90e8\u5206\u9ad8\u6821\u548c\u79d1\u7814\u9662\u6240\u5728<\/span><\/span>EVs<\/span>\u7814\u7a76\u9886\u57df\u79ef\u7d2f\u4e86\u76f8\u5f53\u7684\u6280\u672f\u5b9e\u529b\uff0c\u914d\u5907\u6709<\/span><\/span>Cryo-EM<\/span>\u3001\u9ad8\u7cbe\u5ea6<\/span><\/span>NTA<\/span>\u3001\u7eb3\u7c73\u6d41\u5f0f\u5206\u6790\u4eea\uff08\u5982<\/span><\/span>NanoFCM<\/span>\uff09\u7b49\u4e13\u4e1a\u8bbe\u5907\u3002\u867d\u7136\u9ad8\u6821\u5e73\u53f0\u901a\u5e38\u4e0d\u5177\u5907\u51fa\u5177\u6cd5\u89c4\u8ba4\u53ef\u68c0\u9a8c\u62a5\u544a\u7684\u8d44\u8d28\uff0c\u4f46\u5176\u53ef\u4ee5\u5728\u7814\u7a76\u5f00\u53d1\u9636\u6bb5\u63d0\u4f9b\u53c2\u8003\u6027\u68c0\u6d4b\u6570\u636e\u3001\u534f\u52a9\u4f01\u4e1a\u5f00\u5c55\u5206\u6790\u65b9\u6cd5\u9884\u9a8c\u8bc1\uff0c\u4ee5\u53ca\u63d0\u4f9b\u6280\u672f\u54a8\u8be2\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u4f01\u4e1a\u53ef\u8003\u8651\u4ee5\u79d1\u7814\u5408\u4f5c\u7684\u5f62\u5f0f\u4e0e\u5177\u5907\u76f8\u5e94\u80fd\u529b\u7684\u9ad8\u6821\u5efa\u7acb\u5408\u4f5c\u5173\u7cfb\uff0c\u5c06\u9ad8\u6821\u4f5c\u4e3a\u6280\u672f\u652f\u6491\uff0c\u5c06\u6709<\/span><\/span>GMP<\/span>\u68c0\u6d4b\u7ecf\u9a8c\u7684\u7b2c\u4e09\u65b9\u673a\u6784\uff08\u5982\u79d1\u8bfa\u5b9e\u9a8c\u5ba4\uff09\u4f5c\u4e3a\u6b63\u5f0f\u68c0\u9a8c\u5408\u4f5c\u65b9\uff0c\u5f62\u6210\u201c\u6280\u672f\u5f00\u53d1<\/span><\/span>+<\/span>\u89c4\u8303\u68c0\u6d4b\u201c\u7684\u4e24\u6bb5\u5f0f\u5206\u5de5\u6a21\u5f0f\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\n\t\t<\/p>\n\t\t

        \n\t\t\t\u5efa\u8bae\u4e94\uff1a\u79ef\u6781\u53c2\u4e0e\u884c\u4e1a\u6807\u51c6\u5236\u5b9a<\/strong><\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u5f53\u524d\u7684\u56f0\u5883\uff0c\u5728\u4e00\u5b9a\u7a0b\u5ea6\u4e0a\u6765\u81ea\u4e8e\u884c\u4e1a\u6574\u4f53\u5904\u4e8e\u65b9\u6cd5\u5b66\u79ef\u7d2f\u9636\u6bb5\u3001\u5c1a\u672a\u5f62\u6210\u8db3\u591f\u7684\u793e\u4f1a\u5171\u8bc6\u3002\u5bf9\u4e8e\u6709\u5b9e\u529b\u7684\u9886\u5148\u4f01\u4e1a\uff0c\u79ef\u6781\u53c2\u4e0e\u884c\u4e1a\u6807\u51c6\u5236\u5b9a\u5de5\u4f5c\uff0c\u662f\u5728\u63a8\u52a8\u884c\u4e1a\u8fdb\u6b65\u7684\u540c\u65f6\u3001\u63d0\u524d\u5e03\u5c40\u6280\u672f\u8bdd\u8bed\u6743\u7684\u91cd\u8981\u7b56\u7565\u3002\u53ef\u4ee5\u5173\u6ce8\u5e76\u79ef\u6781\u53c2\u4e0e\u4e2d\u56fd\u7ec6\u80de\u751f\u7269\u5b66\u5b66\u4f1a\u3001\u4e2d\u56fd\u836f\u5b66\u4f1a\u3001\u5168\u56fd\u751f\u5316\u68c0\u6d4b\u6807\u51c6\u5316\u6280\u672f\u59d4\u5458\u4f1a\u7b49\u673a\u6784\u7275\u5934\u7684<\/span><\/span>EVs<\/span>\u76f8\u5173\u56e2\u4f53\u6807\u51c6\u5236\u5b9a\u5de5\u4f5c\uff0c\u53ca\u65f6\u8ddf\u8e2a\u56fd\u9645\u524d\u6cbf\u65b9\u6cd5\u5b66\u8fdb\u5c55\uff0c\u5e76\u5c06<\/span><\/span>ISEV<\/span>\u6700\u65b0\u53d1\u5e03\u7684\u65b9\u6cd5\u5b66\u6307\u5357\u7528\u4e8e\u81ea\u8eab\u65b9\u6cd5\u5efa\u7acb\u7684\u8bbe\u8ba1\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\n\t\t<\/p>\n\t\t

        \n\t\t\t\u5341\u4e00\u3001\u5bf9\u68c0\u6d4b\u673a\u6784\u7684\u547c\u5401\uff1a\u505a\u597d\u8fce\u63a5\u6d6a\u6f6e\u7684\u51c6\u5907<\/strong><\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u7ec6\u80de\u5916\u56ca\u6ce1\u5236\u5242\u662f\u751f\u7269\u533b\u836f\u9886\u57df\u4e00\u4e2a\u9887\u53d7\u671f\u5f85\u7684\u65b0\u65b9\u5411\u3002\u5168\u7403\u8303\u56f4\u5185\uff0c\u767b\u8bb0\u5728\u6848\u7684<\/span><\/span>EV<\/span>\u76f8\u5173\u4e34\u5e8a\u8bd5\u9a8c\u6570\u91cf\u5728\u8fc7\u53bb\u4e94\u5e74\u5185\u5df2\u589e\u957f\u4e86\u6570\u500d\u3002\u968f\u7740\u56fd\u5185\u5916\u76d1\u7ba1\u6846\u67b6\u7684\u9010\u6b65\u5b8c\u5584\uff0c\u76f8\u5173\u4ea7\u54c1\u7684<\/span><\/span>IND\/IIT<\/span>\u7533\u8bf7\u5fc5\u5c06\u8fce\u6765\u4e00\u4e2a\u660e\u663e\u7684\u589e\u957f\u671f\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u5bf9\u4e8e\u6709\u5fd7\u4e8e\u8fdb\u5165\u8fd9\u4e00\u9886\u57df\u7684\u68c0\u6d4b\u673a\u6784\uff0c\u73b0\u5728\u6070\u662f\u6700\u597d\u7684\u51c6\u5907\u65f6\u95f4\uff1a<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u5efa\u7acb\u6280<\/strong><\/span>\u672f\u50a8\u5907<\/strong><\/span>\uff1a<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u63d0\u524d\u90e8\u7f72<\/span><\/span>Cryo-EM<\/span>\u3001\u9ad8\u7cbe\u5ea6<\/span><\/span>NTA<\/span>\u3001\u5355\u9897\u7c92\u6d41\u5f0f\uff08\u5982<\/span><\/span>NanoFCM<\/span>\u7b49\uff09\u7b49\u5173\u952e\u8bbe\u5907\uff0c\u57f9\u517b\u5177\u5907<\/span><\/span>EVs<\/span>\u68c0\u6d4b\u4e13\u4e1a\u77e5\u8bc6\u7684\u6280\u672f\u56e2\u961f\uff0c\u79ef\u7d2f\u5b9e\u9645\u6837\u54c1\u7684\u68c0\u6d4b\u7ecf\u9a8c\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u63a8<\/strong><\/span>\u8fdb<\/strong><\/span>\u65b9\u6cd5\u5f00<\/strong><\/span>\u53d1<\/strong><\/span>\u548c<\/strong><\/span>\u9884\u9a8c\u8bc1<\/strong><\/span>\uff1a<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u9488\u5bf9<\/span>\u7c92\u5f84<\/span>\u6d4b<\/span>\u5b9a\u3001<\/span><\/span>EVs<\/span>\u6807\u8bb0\u86cb\u767d\u68c0\u6d4b\u3001\u529f\u80fd\u6d3b\u6027\u68c0\u6d4b\u3001\u5185\u6bd2\u7d20\u68c0\u6d4b\u3001\u65e0\u83cc\u68c0\u6d4b\u3001\u652f\u539f\u4f53\u68c0\u6d4b\u7b49\u6838\u5fc3\u9879\u76ee\uff0c\u5f00\u5c55\u7cfb\u7edf\u7684\u65b9\u6cd5\u5f00\u53d1\u548c\u9884\u9a8c\u8bc1\u5de5\u4f5c\uff0c\u5efa\u7acb\u5b8c\u6574\u7684\u65b9\u6cd5\u6587\u4ef6\u4f53\u7cfb\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u53c2\u4e0e<\/strong><\/span>\u6807<\/strong><\/span>\u51c6\u5236\u5b9a\u548c\u80fd\u529b<\/strong><\/span>\u9a8c\u8bc1<\/strong><\/span>\uff1a<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u53c2\u52a0\u56fd\u5185\u5916<\/span><\/span>EVs<\/span>\u68c0\u6d4b\u7684\u80fd\u529b\u9a8c\u8bc1\u8ba1\u5212\uff08<\/span><\/span>PT\/EQA<\/span>\uff09\uff0c\u4e89\u53d6\u5728<\/span><\/span>CNAS<\/span>\u9996\u6279\u5f00\u5c55<\/span><\/span>EVs<\/span>\u68c0\u6d4b\u8ba4\u53ef\u65f6\u5177\u5907\u7533\u8bf7\u8d44\u683c\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u670d<\/strong><\/span>\u52a1<\/strong><\/span>\u5ef6\u4f38<\/strong><\/span>\uff1a<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u5411\u7814<\/span>\u53d1<\/span>\u4f01<\/span>\u4e1a<\/span>\u63d0\u4f9b\u4ece<\/span>\u8d28<\/span>\u91cf\u7814\u7a76\u65b9\u6848\u54a8<\/span>\u8be2<\/span>\u3001\u65b9\u6cd5\u5f00<\/span>\u53d1<\/span>\u652f\u6301\u5230\u5e38<\/span>\u89c4\u8d28<\/span>\u91cf<\/span>\u68c0\u9a8c<\/span>\u7684\u5168<\/span>\u94fe<\/span>\u6761\u670d<\/span>\u52a1<\/span>\uff0c\u5e2e\u52a9\u4f01<\/span>\u4e1a\u5e94\u5bf9\u8fd9<\/span>\u4e00<\/span>\u9636<\/span>\u6bb5\u7279\u6709\u7684\u6311<\/span>\u6218<\/span>\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u6df1\u5733\u79d1\u8bfa\u533b\u5b66\u68c0\u9a8c\u5b9e\u9a8c\u5ba4\u59cb\u7ec8\u5c06\u201c\u4ee5\u79d1\u5b66\u670d\u52a1\u4e34\u5e8a\u201c\u4f5c\u4e3a\u6838\u5fc3\u4f7f\u547d\uff0c\u9762\u5bf9\u7ec6\u80de\u5916\u56ca\u6ce1\u68c0\u6d4b\u9886\u57df\u7684\u65b9\u6cd5\u5b66\u6311\u6218\uff0c\u6211\u4eec\u6b63\u5728\u6301\u7eed\u6295\u5165\u6280\u672f\u7814\u53d1\u529b\u91cf\uff0c\u52aa\u529b\u6210\u4e3a\u56fd\u5185\u8fd9\u4e00\u9886\u57df\u7684\u5148\u884c\u63a2\u7d22\u8005\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u6211\u4eec\u76f8\u4fe1\uff0c\u4e25\u8c28\u7684\u79d1\u5b66\u79ef\u7d2f\u548c\u6301\u7eed\u7684\u6280\u672f\u6295\u5165\uff0c\u7ec8\u5c06\u4e3a\u4f01\u4e1a\u5ba2\u6237\u63d0\u4f9b\u53ef\u9760\u7684\u8d28\u91cf\u4fdd\u969c\u652f\u6301\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\n\t\t<\/p>\n\t\t

        \n\t\t\t\u5341\u4e8c\u3001\u7ed3\u8bed\uff1a\u8d70\u5728\u524d\u9762\u7684\u8def\uff0c\u4e0d\u90fd\u662f\u5bbd\u9614\u7684<\/strong><\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\n\t\t<\/p>\n\t\t

        \n\t\t\t\u7ec6\u80de\u5916\u56ca\u6ce1\u5236\u5242\u662f\u4e00\u4e2a\u5145\u6ee1\u79d1\u5b66\u9b45\u529b\uff0c\u4e5f\u5145\u6ee1\u672a\u77e5\u6311\u6218\u7684\u9886\u57df\u3002\u5b83\u7684\u72ec\u7279\u6027\uff0c\u6765\u81ea\u751f\u547d\u4f53\u7684\u5929\u7136\u901a\u4fe1\u8f7d\u4f53\u3001\u9ad8\u5ea6\u7684\u5206\u5b50\u5f02\u8d28\u6027\u3001\u5c1a\u672a\u5b8c\u5168\u9610\u660e\u7684\u4f5c\u7528\u673a\u5236\uff0c\u51b3\u5b9a\u4e86\u5b83\u7684\u8d28\u91cf\u7814\u7a76\u4e0d\u53ef\u80fd\u662f\u4e00\u6761\u5e73\u5766\u7684\u5927\u8def\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u6b63\u5982\u65e5\u672c<\/span><\/span>PMDA<\/span>\u62a5\u544a\u6700\u540e\u6240\u8bf4\u7684\uff1a\u201c<\/span><\/span>EV<\/em><\/span>\u6280\u672f\u9886\u57df\u6b63\u5728\u5feb\u901f\u53d1\u5c55\uff0c\u6301\u7eed\u6d8c\u73b0\u51fa\u5927\u91cf\u65b0\u6280\u672f\u8fdb\u5c55\uff0c\u56e0\u6b64\u76f8\u5173\u6587\u4ef6\u5e94\u5b9a\u671f\u5ba1\u67e5\u548c\u66f4\u65b0\uff0c\u4ee5\u7eb3\u5165\u6700\u65b0\u7684\u6280\u672f\u53d1\u5c55<\/em><\/span>\u3002\u201d<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u8fd9\u65e2\u662f\u6311\u6218\uff0c\u4e5f\u662f\u673a\u9047\u3002\u5bf9\u4e8e\u76d1\u7ba1\u673a\u6784\u6765\u8bf4\uff0c\u9700\u8981\u5728\u4fdd\u8bc1\u60a3\u8005\u5b89\u5168\u7684\u524d\u63d0\u4e0b\uff0c\u4fdd\u6301\u5bf9\u65b0\u65b9\u6cd5\u3001\u65b0\u6807\u51c6\u7684\u5f00\u653e\u6001\u5ea6\uff1b\u5bf9\u4e8e\u68c0\u6d4b\u673a\u6784\u6765\u8bf4\uff0c\u9700\u8981\u5728\u76d1\u7ba1\u7a7a\u767d\u671f\u4e3b\u52a8\u79ef\u7d2f\u6280\u672f\u5b9e\u529b\uff0c\u800c\u4e0d\u662f\u7b49\u5f85\u6807\u51c6\u6210\u719f\u540e\u518d\u8ddf\u8fdb\uff1b\u5bf9\u4e8e\u7814\u53d1\u4f01\u4e1a\u6765\u8bf4\uff0c\u9700\u8981\u5728\u4e0d\u786e\u5b9a\u6027\u4e2d\u627e\u5230\u6700\u5408\u7406\u7684\u8d28\u91cf\u7814\u7a76\u8def\u5f84\uff0c\u540c\u65f6\u4e0e\u76d1\u7ba1\u673a\u6784\u4fdd\u6301\u5145\u5206\u7684\u6c9f\u901a\u3002<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u8fd9\u6761\u8def\u786e\u5b9e\u4e0d\u5bbd\u9614\uff0c\u4f46\u662f\u6b63\u6709\u8d8a\u6765\u8d8a\u591a\u7684\u4eba\u5728\u4e00\u8d77\u8d70\u3002<\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\n\t\t<\/p>\n\t\t

        \n\t\t\t\u8def\u867d\u6f2b\u6f2b\uff0c\u79d1\u5b66\u81ea\u6709\u5c3a\u5ea6\uff1b\u65b9\u5411\u82e5\u660e\uff0c\u56f0\u96be\u7ec8\u4f1a\u88ab\u7167\u4eae\u3002<\/strong><\/em><\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\n\t\t<\/p>\n\t\t

        \n\t\t\t\u53c2\u8003\u8d44\u6599<\/strong><\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t1. Takakura Y, Hanayama R, Akiyoshi K, et al. Quality and Safety Considerations for Therapeutic Products Based on Extracellular Vesicles. Pharmaceutical Research, 2024, 41:1573\u20131594.<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t2. National Institute of Food and Drug Safety Evaluation (NIFDS), Republic of Korea. Guideline on Quality, Non-clinical and Clinical Assessment of Extracellular Vesicles Therapy Products (Guidance for Industry). September 2024.<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t3. Welsh JA, Goberdhan DCI, O'Driscoll L, et al. Minimal information for studies of extracellular vesicles (MISEV2023): From basic to advanced approaches. Journal of Extracellular Vesicles, 2024, 13:e12404.<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t4. Th\u00e9ry C, Witwer KW, Aikawa E, et al. Minimal information for studies of extracellular vesicles 2018 (MISEV2018). Journal of Extracellular Vesicles, 2018, 7:1535750.<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t5. Lener T, Gimona M, Aigner L, et al. Applying extracellular vesicles based therapeutics in clinical trials – an ISEV position paper. Journal of Extracellular Vesicles, 2015, 4:30087.<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t6. Gimona M, Brizzi MF, Choo ABH, et al. Critical considerations for the development of potency tests for therapeutic applications of mesenchymal stromal cell-derived small extracellular vesicles. <\/span><\/span>Cytotherapy, 2021, 23:373\u2013380.<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t7. <\/span><\/span>\u4e2d\u68c0\u9662\u5e72\u7ec6\u80de\u5408\u540c\u68c0\u9a8c\u5e38\u89c1\u95ee\u9898\uff08\u4e13\u9898\u7b2c\u4e00\u671f\uff09<\/span><\/span><\/span>. <\/span><\/span>\u4e2d\u56fd\u98df\u54c1\u836f\u54c1\u68c0\u5b9a\u7814\u7a76\u9662<\/span><\/span><\/span>, 2025<\/span><\/span>\u5e74<\/span><\/span><\/span>8<\/span><\/span>\u6708<\/span><\/span><\/span>4<\/span><\/span>\u65e5<\/span><\/span><\/span>.<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t8. ICH Q5A(R2): Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin.<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t9. ICH Q5D: Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological\/Biological Products.<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t10. ICH Q6B: Specifications: Test Procedures and Acceptance Criteria for Biotechnological\/Biological Products.<\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\n\t\t<\/p>\n\t\t

        \n\t\t\t\u672c\u6587\u7531\u6df1\u5733\u79d1\u8bfa\u533b\u5b66\u68c0\u9a8c\u5b9e\u9a8c\u5ba4\u6280\u672f\u56e2\u961f\u64b0\u5199\uff0c\u4ec5\u4f9b\u5b66\u672f\u4ea4\u6d41\u53c2\u8003\uff0c\u4e0d\u6784\u6210\u4efb\u4f55\u5f62\u5f0f\u7684\u76d1\u7ba1\u5efa\u8bae\u3002\u5982\u9700\u5c31\u7279\u5b9a\u4ea7\u54c1\u7684\u8d28\u91cf\u7814\u7a76\u65b9\u6848\u5bfb\u6c42\u4e13\u4e1a\u5efa\u8bae\uff0c\u8bf7\u4e3b\u52a8\u4e0e\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3\uff08<\/em><\/span><\/span><\/span>CDE<\/em><\/span><\/span>\uff09\u8fdb\u884c\u6c9f\u901a\u4ea4\u6d41\uff0c\u5e76\u8054\u7cfb\u5177\u5907\u76f8\u5e94\u4e13\u4e1a\u80fd\u529b\u7684\u673a\u6784\u534f\u5546\u3002<\/em><\/span><\/span><\/span>\n\t\t<\/p>\n\t\t

        \n\t\t\t\u5982\u60a8\u5728\u7ec6\u80de\u5916\u56ca\u6ce1<\/em><\/span><\/span><\/span>\/<\/em><\/span><\/span>\u5916\u6ccc\u4f53\u5236\u5242\u7684\u8d28\u91cf\u7814\u7a76\u6216\u68c0\u6d4b\u670d\u52a1\u65b9\u9762\u6709\u9700\u6c42\u6216\u7591\u95ee\uff0c\u6b22\u8fce\u8054\u7cfb\u6df1\u5733\u79d1\u8bfa\u533b\u5b66\u68c0\u9a8c\u5b9e\u9a8c\u5ba4\u3002\u6211\u4eec\u4e0e\u60a8\u4e00\u540c\uff0c\u5728\u8fd9\u6761\u5145\u6ee1\u6311\u6218\u7684\u8def\u4e0a\u6301\u7eed\u63a2\u7d22\u3002<\/em><\/span><\/span><\/span>\n\t\t<\/p>\n\t<\/section>\n<\/section>\n","protected":false},"excerpt":{"rendered":"

        \u6765\u6e90\uff1a\u7ec6\u80de\u8d28\u91cf\u68c0\u6d4b\u6280\u672f\u7814\u53d1\u5e73\u53f0 \u5efa\u8bbe\u5355\u4f4d\uff1a\u6df1\u5733\u79d1\u8bfa\u533b\u5b66\u68c0\u9a8c\u5b9e\u9a8c\u5ba4 \u65f6\u95f4\uff1a2026-03-08 \u5199\u5728\u524d\u9762\u7684\u8bdd \u6700\u8fd1\uff0c\u6211\u4eec\u9646\u7eed\u63a5\u5230\u4e00\u4e9b\u4f01\u4e1a\u7814\u53d1\u4eba\u5458\u7684\u54a8\u8be2\uff0c\u95ee\u9898\u5f88\u5177\u4f53\uff0c\u4e5f\u5f88\u68d8\u624b\u3002\u4ed6\u4eec\u6b63\u5728\u63a8\u8fdb\u5916\u6ccc\u4f53\u5236\u5242\u6216\u7ec6\u80de\u5916\u56ca\u6ce1\uff08Extracellular Vesicles\uff0c\u7b80\u79f0EV\uff09\u5236\u5242\u7684IIT\u7814\u7a76\uff08\u7814\u7a76\u8005\u53d1\u8d77\u7684\u4e34\u5e8a\u8bd5\u9a8c\uff09\uff0c\u60f3\u627e\u4e00\u5bb6\u6709\u8d44\u8d28\u7684\u7b2c\u4e09\u65b9\u68c0\u6d4b\u673a\u6784\u505a\u8d28\u91cf\u590d\u6838\uff0c\u5374\u56db\u5904\u78b0\u58c1\u3002 \u6709\u4eba\u6253\u7535\u8bdd\u7ed9\u4e2d\u56fd\u98df\u54c1\u836f\u54c1\u68c0\u5b9a\u7814\u7a76\u9662\uff08\u4e2d\u68c0\u9662\uff09\uff0c\u5f97 [\u2026]<\/span><\/p>\n","protected":false},"author":1,"featured_media":5889,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[35],"tags":[],"_links":{"self":[{"href":"https:\/\/www.ncgt.org.cn\/ncgt\/wp-json\/wp\/v2\/posts\/5900"}],"collection":[{"href":"https:\/\/www.ncgt.org.cn\/ncgt\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.ncgt.org.cn\/ncgt\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.ncgt.org.cn\/ncgt\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.ncgt.org.cn\/ncgt\/wp-json\/wp\/v2\/comments?post=5900"}],"version-history":[{"count":3,"href":"https:\/\/www.ncgt.org.cn\/ncgt\/wp-json\/wp\/v2\/posts\/5900\/revisions"}],"predecessor-version":[{"id":5903,"href":"https:\/\/www.ncgt.org.cn\/ncgt\/wp-json\/wp\/v2\/posts\/5900\/revisions\/5903"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.ncgt.org.cn\/ncgt\/wp-json\/wp\/v2\/media\/5889"}],"wp:attachment":[{"href":"https:\/\/www.ncgt.org.cn\/ncgt\/wp-json\/wp\/v2\/media?parent=5900"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.ncgt.org.cn\/ncgt\/wp-json\/wp\/v2\/categories?post=5900"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.ncgt.org.cn\/ncgt\/wp-json\/wp\/v2\/tags?post=5900"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}