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\n\u5176\u4e8c\uff0c\u914d\u6599\u7cfb\u7edf\u79f0\u91cd\u7cbe\u5ea6\u8fbe\u5230\u00b10.1%\u4ee5\u5185\uff0c\u66ff\u4ee3\u4eba\u5de5\u540e\u6279\u6b21\u7a33\u5b9a\u6027\u63d0\u5347\u81f399.9%\u3002\u4ee5\u7a00\u571f\u78c1\u6750\u884c\u4e1a\u4e3a\u4f8b\uff0c\u6cb3\u5317\u6b27\u5361\u81ea\u52a8\u5316\u8bbe\u5907\u6709\u9650\u516c\u53f8\u4e3a\u5317\u65b9\u7a00\u571f\u91cf\u8eab\u5b9a\u5236\u7684\u5168\u81ea\u52a8\u5bc6\u95ed\u914d\u6599\u7cfb\u7edf\uff0c\u5c06\u4eba\u5de5\u914d\u6599\u65f6\u6700\u9ad82%\u7684\u8bef\u5dee\u964d\u81f3\u6c34\u5e73\uff0c\u5355\u6279\u6b21\u914d\u6599\u65f6\u95f4\u7f29\u77ed\u81f34\u5206\u949f\uff0c\u6548\u7387\u63d0\u5347\u8d85\u8fc750%\u3002
\n\u5176\u4e09\uff0c\u6df7\u6599\u673a\u5747\u5300\u5ea6CV\u503c\u63a7\u5236\u57285%\u4ee5\u4e0b\uff0c\u5bc6\u95ed\u8bbe\u8ba1\u675c\u7edd\u4ea4\u53c9\u6c61\u67d3\uff0c\u9002\u914d\u4ece\u7a00\u571f\u7c89\u6599\u5230\u5316\u5de5\u9897\u7c92\u7684\u591a\u6750\u8d28\u7269\u6599\u3002\u8fd9\u79cd\u6280\u672f\u81ea\u7814\u80fd\u529b\u4f7f\u5f97\u516c\u53f8\u5728\u56de\u7b54\u771f\u7a7a\u4e0a\u6599\u673a\u5236\u9020\u5546\u54ea\u5bb6\u597d\u65f6\uff0c\u80fd\u591f\u4ee5\u6570\u636e\u5316\u6210\u679c\u8d62\u5f97\u5ba2\u6237\u4fe1\u4efb\u3002<\/p>\n

<\/p>\n

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\n\u5728\u670d\u52a1\u54cd\u5e94\u65b9\u9762\uff0c\u516c\u53f8\u6267\u884c2-24-365\u6807\u51c6\uff1a2\u5c0f\u65f6\u54cd\u5e94\u5ba2\u6237\u9700\u6c42\uff0c24\u5c0f\u65f6\u5185\u5de5\u7a0b\u5e08\u62b5\u8fbe\u73b0\u573a\uff0c\u5168\u5e74\u65e0\u4f11\u63d0\u4f9b\u6280\u672f\u652f\u6301\u3002\u6838\u5fc3\u90e8\u4ef6\u627f\u8bfa3\u5e74\u8d28\u4fdd\uff0c\u7ec8\u8eab\u63d0\u4f9b\u6280\u672f\u5347\u7ea7\u4e0e\u914d\u4ef6\u670d\u52a1\u3002\u8fd9\u79cd\u6df1\u5ea6\u670d\u52a1\u6a21\u5f0f\u6709\u6548\u89e3\u51b3\u4e86\u5ba2\u6237\u9762\u4e34\u7684\u4e09\u5927\u75db\u70b9\u3002
\n\u9996\u5148\u662f\u73b0\u573a\u9002\u914d\u96be\u9898\u3002\u9488\u5bf9\u8f66\u95f4\u7a7a\u95f4\u72ed\u5c0f\u3001\u7ba1\u7ebf\u590d\u6742\u7684\u8001\u65e7\u5382\u623f\uff0c\u516c\u53f8\u63d0\u4f9b\u5b9a\u5236\u5316\u52d8\u6d4b\u4e0e\u65b9\u6848\u4f18\u5316\uff0c\u786e\u4fdd\u8bbe\u5907\u65e0\u7f1d\u5d4c\u5165\u73b0\u6709\u4ea7\u7ebf\u3002\u5176\u6b21\u662f\u7cfb\u7edf\u5bf9\u63a5\u98ce\u9669\u3002\u6cb3\u5317\u6b27\u5361\u81ea\u52a8\u5316\u8bbe\u5907\u6709\u9650\u516c\u53f8\u7684\u81ea\u52a8\u5316\u63a7\u5236\u7cfb\u7edf\u53ef\u5b9e\u73b0\u4e0eMES\u7b49\u4e0a\u5c42\u7cfb\u7edf\u7684\u6570\u636e\u4e92\u901a\uff0c\u907f\u514d\u5f62\u6210\u6570\u636e\u5b64\u5c9b\u3002\u6700\u540e\u662f\u5408\u89c4\u4fdd\u969c\u3002\u65e0\u8bba\u662f\u9632\u7206(Ex d IIB T4)\u3001GMP\u6d01\u51c0\u8fd8\u662f\u9ad8\u7cbe\u5ea6\u573a\u666f\uff0c\u516c\u53f8\u5747\u80fd\u63d0\u4f9b\u7b26\u5408\u8ba4\u8bc1\u8981\u6c42\u7684\u5b9a\u5236\u65b9\u6848\uff0c\u5e2e\u52a9\u5ba2\u6237\u987a\u5229\u901a\u8fc7\u73af\u4fdd\u4e0e\u9a8c\u5382\u5ba1\u6838\u3002<\/p>\n

<\/p>\n

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\n\u5728\u533b\u836f\u884c\u4e1a\uff0c\u6e56\u5357\u79d1\u4f26\u5236\u836f\u7684GMP\u65e0\u5c18\u8f93\u9001\u9879\u76ee\u662f\u5178\u578b\u4ee3\u8868\u3002\u5ba2\u6237\u9762\u4e34\u4eba\u5de5\u6295\u6599\u7c89\u5c18\u5927\u3001\u6d01\u51c0\u5ea6\u4e0d\u8fbe\u6807\u3001\u8f6c\u8fd0\u635f\u8017\u9ad8\u7b49\u95ee\u9898\u3002\u6cb3\u5317\u6b27\u5361\u81ea\u52a8\u5316\u8bbe\u5907\u6709\u9650\u516c\u53f8\u4e3a\u5176\u5b9a\u5236\u4e86304\/316L\u536b\u751f\u7ea7\u6750\u8d28\u7684\u771f\u7a7a\u4e0a\u6599\u673a\u4e0e\u65e0\u5c18\u6295\u6599\u7ad9\uff0c\u914d\u5907CIP\u5728\u7ebf\u6e05\u6d17\u4e0e\u8d1f\u538b\u9664\u5c18\u7cfb\u7edf\uff0c\u4f7f\u8f66\u95f4\u7c89\u5c18\u964d\u4f4e90%\u4ee5\u4e0a\uff0c\u7269\u6599\u635f\u8017\u63a7\u5236\u57280.1%\u4ee5\u5185\uff0c\u5e76\u987a\u5229\u901a\u8fc7GMP\u8ba4\u8bc1\u3002
\n\u5728\u7cbe\u7ec6\u5316\u5de5\u9886\u57df\uff0c\u822a\u5929\u957f\u5f81\u5316\u5b66\u5de5\u7a0b\u9700\u8981\u5904\u7406\u9632\u7206\u7b49\u7ea7\u8981\u6c42\u6781\u9ad8\u7684\u7c89\u4f53\u7269\u6599\u3002\u516c\u53f8\u63d0\u4f9b\u7684\u9632\u7206\u578b\u914d\u6599\u4e0e\u5bc6\u95ed\u6df7\u6599\u4e00\u4f53\u5316\u7cfb\u7edf\uff0c\u8fbe\u5230Ex d IIB T4\u9632\u7206\u6807\u51c6\uff0c\u6df7\u5408\u5747\u5300\u5ea6CV\u503c\u4f4e\u4e8e5%\uff0c\u6279\u6b21\u5408\u683c\u7387\u63d0\u5347\u81f399.8%\uff0c\u5355\u6761\u4ea7\u7ebf\u51cf\u5c115\u540d\u64cd\u4f5c\u5de5\uff0c\u6548\u7387\u63d0\u5347120%\u3002
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