{"id":34940,"date":"2018-09-14T01:00:00","date_gmt":"2018-09-17T05:48:01","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/09\/17\/%e5%b9%b2%e8%b4%a7-fda%e4%b8%93%e5%ae%b6%e5%b8%a6%e4%bd%a0%e6%b7%b1%e5%ba%a6%e8%a7%a3%e6%9e%90%e7%b2%92%e5%ba%a6%e6%8e%a7%e5%88%b6%ef%bc%81\/"},"modified":"2018-09-17T13:48:03","modified_gmt":"2018-09-17T05:48:03","slug":"%e5%b9%b2%e8%b4%a7-fda%e4%b8%93%e5%ae%b6%e5%b8%a6%e4%bd%a0%e6%b7%b1%e5%ba%a6%e8%a7%a3%e6%9e%90%e7%b2%92%e5%ba%a6%e6%8e%a7%e5%88%b6%ef%bc%81","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/34940\/","title":{"rendered":"\u5e72\u8d27 | FDA\u4e13\u5bb6\u5e26\u4f60\u6df1\u5ea6\u89e3\u6790\u7c92\u5ea6\u63a7\u5236\uff01"},"content":{"rendered":"
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\u2299<\/span>\u5982\u4f55\u79d1\u5b66\u5236\u5b9a\u7c92\u5ea6\u7684\u53ef\u63a5\u53d7\u6807\u51c6\uff1f<\/span><\/p>\n


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Zhigang Sun <\/span><\/em><\/strong><\/span><\/p>\n<\/section>\n

Zhigang Sun is a Review Chemist in the Division of Chemistry II, Office of Generic Drugs, Center for Drug Evaluation and Research, FDA. Before joining FDA in 2006, he worked as a senior development scientist at Malvern Instruments Inc. Zhigang received his Ph.D. in Chemical Engineering from Purdue University in 2001 and he has authored orco-authored over 20 journal articles, patents, and book chapter. Readers may contact the author directly at: <\/em>zhigang.sun@fda.hhs.gov<\/em><\/p>\n


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Naiqi Ya<\/span><\/em><\/strong><\/span><\/p>\n<\/section>\n

Naiqi Ya is a Team Leader in the Divison of Chemistry II, Office of Generic Drugs, Center for Drug Evaluation and Research, FDA. In his current capacity, he is responsible for reviewing chemistry and manufacturing control sections of new drug applications (ANDA\/IND\/NDA). Prior to joining FDA in 1996, he held a position at Biocraft Laboratories, Inc.,where his responsibilities included developing and validating analytical methods for drug substances and drug products. He received his Ph.D. in Bioanalytical and Biophysical Chemistry from New York University in 1994.<\/em>
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RichardC. Adams<\/strong><\/span><\/em><\/span><\/p>\n<\/section>\n

Richard C. Adams is the Deputy Director in theDivision of Chemistry II, Office of Generic Drugs, Center for Drug Evaluation and Research, FDA. He joined FDA\u2019s Office of Generic Drugs in 1990 as a review chemist and later became Branch Supervisor, and Deputy Division Director. He has served on numerous office and center technical committees and ad hoc working groups and has chaired the Center Stability Technical Committee. Prior to joining CDER, he worked with Pfizer, Inc. at their Central Research Facility in Groton, CT, having responsibilities as a Senior Research Scientist and Project Leader in Process Research and Development. Richard holds a B.S. in Chemistry from the University of Maine and an M.B.A. from the University of New Haven.<\/em>
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Florence Fang<\/span><\/em><\/strong><\/span><\/p>\n<\/section>\n

Florence Fang is the Director in the Division of Chemistry II, Office of Generic Drugs, Center for Drug Evaluation and Research, FDA. She has been involved with the chemistry review function for abbreviated new drug applications for twenty years. Prior to the regulatory work at the Food and drug Administration, she was with Alza in the development of biodegradable polymers and drug delivery systems. She also worked at Gillette Research Institute in keratin chemistry. She holds a B.S. in Chemistry from Purdue University and a M.S. in Biochemistry from the University of Wisconsin at Madison.<\/em><\/p>\n<\/section>\n<\/section>\n

The views and opinions expressed in this article are only of the authors and do not necessarily reflect the views or policies of the FDA.<\/em>
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<\/span><\/p>\n

2.2 \u7247\u5242\u751f\u4ea7\uff1a\u5236\u7c92<\/span><\/strong><\/em>
<\/p>\n

<\/span><\/strong><\/em>
<\/p>\n

\u9664\u76f4\u63a5\u538b\u7247\u5916\uff0c\u7247\u5242\u8fd8\u53ef\u4ee5\u901a\u8fc7\u6e7f\u6cd5\u6216\u5e72\u6cd5\u5236\u7c92\u65b9\u5f0f\u6765\u751f\u4ea7\u3002\u5236\u7c92\u672c\u8d28\u4e0a\u662f\u9897\u7c92\u653e\u5927\u8fc7\u7a0b\u7684\u4e00\u79cd\uff0c\u65e2\u80fd\u63d0\u9ad8\u6d41\u52a8\u6027\uff0c\u53c8\u80fd\u63d0\u9ad8\u538b\u7247\u7279\u6027[6]\u3002\u5728\u5e72\u6cd5\u5236\u7c92\u8fc7\u7a0b\u4e2d\uff0c\u539f\u6599\u836f\u548c\u7a00\u91ca\u5242\u7684\u7c89\u4f53\u9897\u7c92\u4f1a\u5728\u9ad8\u538b\u4e0b\u805a\u96c6\uff08\u901a\u8fc7\u6324\u538b\u5f62\u6210\u5e26\u72b6\u5f62\u5f0f\uff09\uff0c\u7136\u540e\u5728\u538b\u5236\u524d\u8fdb\u884c\u7c89\u788e\u548c\u7b5b\u5206\u3002\u5728\u6e7f\u6cd5\u5236\u7c92\u8fc7\u7a0b\u4e2d\uff0c\u5c06\u6eb6\u6db2\u52a0\u5165\u5230\u539f\u6599\u836f\u548c\u7a00\u91ca\u5242\u7684\u7c89\u672b\u4e2d\u4ea7\u751f\u805a\u7ed3\uff0c\u7136\u540e\u5728\u538b\u7247\u524d\uff0c\u8fdb\u884c\u5e72\u71e5\u3001\u6574\u7c92\u548c\u8fc7\u7b5b\u5236\u6210\u9897\u7c92\u3002\u5728\u8fd9\u4e24\u79cd\u60c5\u51b5\u4e0b\uff0c\u7531\u4e8e\u5355\u4e00\u539f\u6599\u836f\u548c\u7a00\u91ca\u5242\u5728\u5236\u7c92\u8fc7\u7a0b\u4e2d\u88ab\u9897\u7c92\u5316\uff08\u81f3\u5c11\u5728\u4e00\u5b9a\u7a0b\u5ea6\u4e0a\uff09\uff0c\u6240\u4ee5\u7247\u5242\u7684\u8d28\u91cf\u76f4\u63a5\u53d7\u5230\u9897\u7c92\uff08\u539f\u6599\u836f\u548c\u7a00\u91ca\u5242\u7684\u6df7\u5408\u7269\uff09\u7684\u5f71\u54cd\uff0c\u800c\u4e0d\u662f\u5355\u4e2a\u539f\u6599\u836f\u6216\u7a00\u91ca\u5242\u9897\u7c92\u7684\u5f71\u54cd\u3002\u56e0\u6b64\uff0c\u63a7\u5236\u7c92\u5ea6\u5206\u5e03\u548c\u9897\u7c92\u6d41\u52a8\u6027\u5bf9\u6700\u7ec8\u7684\u6df7\u5408\u548c\u538b\u7247\u8fc7\u7a0b\u5177\u6709\u6f5c\u5728\u7684\u5173\u952e\u4f5c\u7528\u3002<\/span><\/p>\n


<\/p>\n

\u6b63\u5982\u7f8e\u56fdFDA\u53e3\u670d\u56fa\u4f53\u5236\u5242\u7814\u53d1\u548c\u9a8c\u8bc1\u6279\u51c6\u524d\u53ca\u6279\u51c6\u540e\u68c0\u67e5\u6307\u5357(1994)\u4e2d\u6240\u6307\u51fa\u7684\u90a3\u6837\uff1a\u5728\u5236\u7c92\u4e2d\uff0c\u7528\u4e8e\u8bf4\u660e\u6279\u95f4\u7c92\u5ea6\u4e00\u81f4\u6027\u7684\u4e3b\u8981\u7269\u7406\u53c2\u6570\u662f\u9897\u7c92\u7684\u7c92\u5ea6\u3002<\/span>\u8fd9\u5bf9\u751f\u7269\u6279\uff08biobatch\uff09\u4e0e\u751f\u4ea7\u6279\u8fdb\u884c\u6bd4\u8f83\u4ee5\u53ca\u5bf9\u5de5\u827a\u4fee\u6539\u6216\u53d8\u66f4\u540c\u6837\u91cd\u8981\u3002\u7c92\u5ea6\u4f1a\u63d0\u4f9b\u6709\u7528\u7684\u53ef\u6bd4\u6027\u4fe1\u606f\u3002\u9897\u7c92\u7684\u5927\u5c0f\uff0c\u751a\u81f3\u662f\u9897\u7c92\u7684\u7c7b\u578b\u90fd\u4f1a\u5f71\u54cd\u7247\u7684\u5b54\u9699\u5927\u5c0f\uff0c\u5e76\u5bf9\u6eb6\u51fa\u4ea7\u751f\u5f71\u54cd\u3002<\/span>\u4f8b\u5982\uff0c\u5305\u8863\u7247\u7684\u6eb6\u51fa\u5931\u8d25\u53ef\u80fd\u662f\u7531\u4e8e\u6574\u7c92\u7b5b\u7f51\u5927\u5c0f\u53d8\u5316\u5f15\u8d77\u7684\uff0c\u4ea7\u751f\u4e86\u8f83\u5927\u7684\u9897\u7c92\uff0c\u5bfc\u81f4\u5f88\u4f4e\u7684\u6eb6\u51fa[10]\u3002\u56e0\u6b64\uff0c\u9897\u7c92\u7684\u7c92\u5ea6\u6807\u51c6\u5efa\u8bae\u4f5c\u4e3a\u5236\u7c92\u5de5\u5e8f\u7684\u4e00\u90e8\u5206\u3002\u7531\u4e8e\u5728\u6e7f\u6cd5\u6216\u5e72\u6cd5\u5236\u7c92\u8fc7\u7a0b\u4e2d\u6709\u4e00\u4e2a\u9884\u6df7\u5408\u8fc7\u7a0b\uff0c\u5982\u679c\u8fd9\u4e9b\u6210\u5206\u5bf9\u603b\u6df7\u7c89\u672b\u6216\u6210\u54c1\u7684\u5747\u5300\u6027\u6709\u663e\u8457\u5f71\u54cd\uff0c\u90a3\u4e48\u5c31\u9700\u8981\u5bf9\u539f\u6599\u836f\u548c\u5173\u952e\u8f85\u6599\u7684\u7c92\u5ea6\u5206\u5e03\u8fdb\u884c\u63a7\u5236\u3002<\/span><\/p>\n


<\/span><\/p>\n

2.3 \u591a\u5c42\u5305\u8863\u7f13\u91ca\u80f6\u56ca\u7684\u751f\u4ea7<\/span><\/strong><\/span><\/em>
<\/p>\n


<\/span><\/strong><\/span><\/em><\/p>\n

\u8bb8\u591a\u7f13\u91ca\u5236\u5242\uff08ER\uff09\u90fd\u662f\u7531\u5c0f\u7684\u5305\u8863\u7cd6\u4e38\u586b\u5145\u5230\u80f6\u56ca\u4e2d\u5236\u6210\u7684\uff0c\u8fd9\u4e9b\u5c0f\u4e38\u7684\u751f\u4ea7\u6d89\u53ca\u5230\u836f\u7269\u5c42\u5305\u8863\u548c\u7f13\u91ca\u5c42\u5305\u8863\u8fc7\u7a0b\uff0c\u672c\u8d28\u4e0a\u662f\u9897\u7c92\u589e\u5927\u7684\u8fc7\u7a0b\u3002\u5728\u591a\u5c42\u5305\u8863\u5de5\u827a\u8fc7\u7a0b\u4e2d\uff0c\u9897\u7c92\u5927\u5c0f\u7684\u589e\u52a0\u5982\u56fe1\u6240\u793a\u3002\u5728\u4e0d\u540c\u5305\u8863\u9636\u6bb5\u5bf9\u9897\u7c92\u5927\u5c0f\u7684\u53d8\u5316\u8fdb\u884c\u76d1\u6d4b\u548c\u63a7\u5236\uff0c\u53ef\u4e3a\u63a7\u5236\u4ea7\u54c1\u7684\u8d28\u91cf\u63d0\u4f9b\u6709\u6548\u65b9\u6cd5\u3002<\/span>Heinicket\u7b49\u4eba\u7814\u7a76\u4e86\u9897\u7c92\u5927\u5c0f\u4e0e\u5305\u8863\u539a\u5ea6\u4e4b\u95f4\u7684\u5173\u7cfb[11]\uff0c\u5e76\u8bc1\u660e\u4e86\u805a\u5408\u7269\u5305\u8863\u539a\u5ea6\u53ef\u4ee5\u901a\u8fc7\u52a8\u6001\u6210\u50cf\u5206\u6790\uff08DynamicImaging Analysis\uff0cDIA\uff09\u6765\u6d4b\u91cf\uff0c\u8fd9\u4e3a\u591a\u9897\u7c92\u4ea7\u54c1\u7684\u5305\u8863\u63d0\u4f9b\u4e86\u4e00\u79cd\u6f5c\u5728\u7684\u66ff\u4ee3\u5206\u89e3\u6d4b\u8bd5\u65b9\u6cd5[12]\u3002\u9664\u4e86\u6210\u50cf\u5206\u6790\uff0c\u8fd8\u53ef\u4ee5\u7528\u7b80\u5355\u7684\u7b5b\u5206\u5206\u6790\u65b9\u6cd5\u5bf9\u4e0d\u540c\u9636\u6bb5\u7684\u9897\u7c92\u5927\u5c0f\u7684\u53d8\u5316\u8fdb\u884c\u5b9a\u91cf\u8bc4\u4f30\u3002<\/p>\n


<\/p>\n

\"\u5e72\u8d27<\/p>\n

\u56fe1-\u591a\u5c42\u5305\u8863\u8fc7\u7a0b\u4e2d\u5c0f\u4e38\u7c92\u5ea6\u5206\u5e03\u7684\u53d8\u5316<\/strong><\/p>\n


<\/strong><\/p>\n

\u8868<\/span>1<\/span>\u4e2d\u663e\u793a\u4e86\u5728\u4e0d\u540c\u7684\u751f\u4ea7\u9636\u6bb5\u5982\u4f55\u6539\u53d8\u9897\u7c92\u5927\u5c0f\u5206\u5e03\u7684\u4e00\u4e2a\u4f8b\u5b50\u3002\u5bf9\u4e8e\u6279\u95f4\u4e00\u81f4\u6027\uff0c\u8fd9\u4e9b\u9897\u7c92\u7c92\u5f84\u7684\u6d4b\u5b9a\u5728\u4e0d\u540c\u9636\u6bb5\u90fd\u63d0\u4f9b\u4e86\u6709\u7528\u7684\u4fe1\u606f\u3002\u6b64\u5916\uff0c\u9897\u7c92\u5bbd\u7684\u7c92\u5ea6\u5206\u5e03\u53ef\u80fd\u4f1a\u5bfc\u81f4\u9897\u7c92\u7684\u5206\u79bb\uff0c\u5e76\u4f1a\u5f71\u54cd\u5230\u9897\u7c92\u7684\u5747\u5300\u6027\uff0c\u56e0\u6b64\uff0c\u9897\u7c92\u5927\u5c0f\u5206\u5e03\u7684\u63a7\u5236\u4e0d\u4ec5\u5bf9\u5305\u8863\u6709\u91cd\u8981\u7684\u5f71\u54cd\uff0c\u800c\u4e14\u5bf9\u6df7\u5408\u8fc7\u7a0b\u4e5f\u5f88\u91cd\u8981\u3002<\/span>\u5728\u6b64\uff0c\u5bf9\u521d\u59cb\u7684\u7cd6\u7403\u3001\u5305\u836f\u7269\u5c42\u9897\u7c92\u3001\u5305\u7f13\u91ca\u5c42\u9897\u7c92\u548c\u6700\u7ec8\u6df7\u5408\u9897\u7c92\uff0c\u5efa\u8bae\u5236\u5b9a\u53ef\u63a5\u53d7\u7684\u7c92\u5ea6\u6807\u51c6\u3002\u9488\u5bf9\u539f\u6599\u836f\uff0c\u5982\u679c\u5176\u5b8c\u5168\u6eb6\u89e3\u5728\u5305\u8863\u6eb6\u6db2\u4e2d\uff0c\u4e00\u822c\u4e0d\u9700\u8981\u5236\u5b9a\u7c92\u5ea6\u6807\u51c6\u3002\u4f46\u662f\uff0c\u5982\u679c\u539f\u6599\u836f\u6df7\u60ac\u5728\u5305\u8863\u6db2\u4e2d\uff0c\u90a3\u4e48\u4e5f\u6700\u597d\u5236\u5b9a\u4e00\u4e2a\u7c92\u5ea6\u6807\u51c6\u3002<\/span><\/p>\n


<\/span><\/p>\n

\u88681-\u591a\u5c42\u5305\u8863\u8fc7\u7a0b\u4e2d\u5c0f\u4e38\u7c92\u5ea6\u5206\u5e03\u7684\u6539\u53d8<\/strong><\/p>\n

\"\u5e72\u8d27<\/p>\n

<\/span><\/strong><\/span><\/em>
<\/p>\n<\/section>\n

\n

\u6b64\u5916\uff0c\u9664\u4e86\u63a7\u5236\u7c92\u5ea6\u5206\u5e03\u5916\uff0c\u836f\u7269\u5c42\u548c\u7f13\u91ca\u5c42\u7684\u5305\u8863\u5747\u5300\u6027\u662f\u4ea7\u54c1\u8d28\u91cf\u7684\u5173\u952e\u56e0\u7d20\u3002\u7531\u4e8e\u5c0f\u4e38\u7684\u4f53\u79ef\u5c0f\uff0c\u91cd\u91cf\u7684\u6d4b\u5b9a\u5bf9\u5305\u8863\u5747\u5300\u6027\u7684\u63a7\u5236\u662f\u6ca1\u6709\u610f\u4e49\u7684\u3002\u76f8\u53cd\uff0c\u5bf9\u4e8e\u6bcf\u4e2a\u5305\u8863\u9636\u6bb5\uff0c\u5305\u8863\u5747\u5300\u6027\u5e94\u5728\u9002\u5f53\u7684\u53d6\u6837\u8ba1\u5212\u4e0b\uff0c\u901a\u8fc7\u6536\u96c6\u5230\u7684\u591a\u4e2a\u4f4d\u7f6e\u7684\u5355\u4f4d\u5242\u91cf\u6837\u54c1\u4e2d\u539f\u6599\u836f\u542b\u91cf\u548c\u542b\u91cf\u5747\u5300\u5ea6\u6765\u8bc4\u4f30\u7684\u3002<\/span>\u5f53\u539f\u6599\u836f\u5e73\u5747\u542b\u91cf\u4e0e\u9884\u671f\u663e\u8457\u4e0d\u540c\u6216\u4e0d\u540c\u4f4d\u7f6e\u95f4\u5b58\u5728\u8f83\u5927\u5dee\u5f02\u65f6\uff0c\u5305\u8863\u8fc7\u7a0b\u53ef\u80fd\u672a\u5f97\u5230\u5f88\u597d\u7684\u63a7\u5236\u3002\u540c\u6837\uff0c\u5728\u5c01\u88c5\u524d\u7684\u7ec8\u6df7\u5668\u6216\u5bb9\u5668\u4e2d\uff0c\u901a\u8fc7\u5bf9\u591a\u4e2a\u4f4d\u7f6e\u91c7\u53d6\u5408\u9002\u7684\u53d6\u6837\u65b9\u5f0f\u6240\u6536\u96c6\u5230\u7684\u6837\u54c1\u8fdb\u884c\u6eb6\u51fa\u5ea6\u6d4b\u8bd5\uff0c\u662f\u8bc4\u4ef7\u7f13\u91ca\u5c42\u5305\u8863\u5747\u5300\u6027\u7684\u4e00\u4e2a\u6709\u7528\u65b9\u6cd5\u3002<\/p>\n


<\/p>\n

\n
\n
\n
\n
\n
3<\/strong><\/section>\n<\/section>\n<\/section>\n
\u5982\u4f55\u5efa\u7acb\u5408\u9002\u7684\u7c92\u5ea6\u6807\u51c6\uff1f<\/strong><\/span><\/section>\n<\/section>\n<\/section>\n<\/section>\n


<\/p>\n<\/section>\n


<\/p>\n

\u4e00\u65e6\u786e\u5b9a\u9700\u8981\u5236\u5b9a\u7c89\u4f53\u7684\u7c92\u5ea6\u6807\u51c6\uff0c\u4e0b\u4e00\u4e2a\u95ee\u9898\u5c31\u662f\u5982\u4f55\u5efa\u7acb\u4e00\u4e2a\u6070\u5f53\u7684\u7c92\u5ea6\u6807\u51c6\u3002\u8bb8\u591a\u65b0\u836f\u7533\u62a5\u548c\u4eff\u5236\u836f\u7533\u62a5\u8d44\u6599\u4e2d\uff0c\u7531\u4e8e\u7c92\u5ea6\u6807\u51c6\u5728\u5236\u5b9a\u65f6\u8003\u8651\u4e0d\u5145\u5206\uff0c\u65e0\u6cd5\u8fbe\u5230\u63a7\u5236\u7c89\u4f53\u7c92\u5ea6\u5206\u5e03\u7684\u8981\u6c42\u3002\u56e0\u6b64\uff0c\u4e3a\u4e86\u6ee1\u8db3\u6cd5\u89c4\u7684\u8981\u6c42\uff0c\u4e86\u89e3\u7c92\u5ea6\u6807\u51c6\u4e2d\u5e94\u5305\u542b\u54ea\u4e9b\u4fe1\u606f\u5c31\u663e\u5f97\u5c24\u4e3a\u91cd\u8981\u3002\u5728ICH Q6A\u6307\u5bfc\u539f\u5219\u4e2d\uff0c\u8d28\u91cf\u6807\u51c6\u4ee5\u6d4b\u8bd5\u5217\u8868\u7684\u5f62\u5f0f\u88ab\u5b9a\u4e49\u51fa\u6765\uff0c\u5e76\u5bf9\u53c2\u8003\u65b9\u6cd5\u3001\u9002\u5408\u7684\u63a5\u53d7\u6807\u51c6\u4ee5\u53ca\u6d4b\u8bd5\u6570\u503c\u7684\u9650\u5ea6\u3001\u8303\u56f4\u6216\u5176\u4ed6\u8981\u6c42\u505a\u4e86\u63cf\u8ff0\u3002\u63a5\u4e0b\u53bb\u6211\u4eec\u5c06\u4ece\u4e00\u4e2a\u5408\u9002\u7684\u7c92\u5ea6\u6807\u51c6\u5efa\u7acb\u8fc7\u7a0b\u5c55\u5f00\u8ba8\u8bba\uff0c\u5176\u4e2d\u5305\u62ec\u5206\u6790\u65b9\u6cd5\u3001\u65b9\u6cd5\u9a8c\u8bc1\u548c\u53ef\u63a5\u53d7\u6807\u51c6\u3002\u7b5b\u5206\u6cd5\u548c\u6fc0\u5149\u884d\u5c04\u6cd5\u662f\u53e3\u670d\u56fa\u4f53\u5236\u5242\u6700\u5e38\u7528\u7684\u7c92\u5ea6\u6d4b\u5b9a\u65b9\u6cd5\uff0c\u4ee5\u4e0b\u5c06\u56f4\u7ed5\u8fd9\u4e24\u4e2a\u65b9\u6cd5\u5f00\u5c55\u63a2\u8ba8\u3002<\/p>\n


<\/p>\n

3.1\u5206\u6790\u65b9\u6cd5<\/span><\/em><\/span><\/strong><\/p>\n


<\/p>\n

\u5173\u4e8e\u5206\u6790\u65b9\u6cd5\uff0cUSP\u901a\u5219<786>\u548c<429>\u4e2d\u5206\u522b\u63d0\u4f9b\u4e86\u7b5b\u5206\u6cd5\u548c\u6fc0\u5149\u884d\u5c04\u6cd5\u7684\u5177\u4f53\u8981\u6c42\u3002\u4f46\u662f\uff0c\u5728\u7533\u62a5\u8d44\u6599\u4e2d\uff0c\u5f88\u591a\u5e76\u6ca1\u6709\u5b8c\u5168\u9075\u5faaUSP\u7684\u8981\u6c42\u3002<\/p>\n


<\/p>\n

\u4e00\u822c\u6765\u8bf4\uff0c\u7b5b\u5206\u6cd5\u6216\u6fc0\u5149\u884d\u5c04\u6cd5\u6d4b\u5b9a\u7c92\u5ea6\u5305\u62ec\u4ee5\u4e0b\u6b65\u9aa4\uff1a\uff081\uff09\u7c89\u672b\u7684\u62bd\u6837\uff0c\uff082\uff09\u5bf9\u62bd\u6837\u6837\u54c1\u8fdb\u884c\u53d6\u6837\u4f5c\u4e3a\u5206\u6790\u6837\u54c1\uff0c\uff083\uff09\u6837\u54c1\u7684\u5236\u5907\u6216\u5206\u6563\uff0c\uff084\uff09\u4eea\u5668\u8bbe\u7f6e\u548c\u786e\u8ba4\uff0c\uff086\uff09\u7c92\u5f84\u6d4b\u5b9a\uff0c\uff086\uff09\u6570\u636e\u5206\u6790\u548c\u8bf4\u660e\uff0c\uff087\uff09\u62a5\u544a\u7c92\u5ea6\u7ed3\u679c[13]\u3002<\/span>\u56e0\u6b64\uff0c\u4e00\u4e2a\u5b8c\u6574\u7684\u5206\u6790\u65b9\u6cd5\u5e94\u8be5\u5305\u62ec\u6240\u6709\u8fd9\u4e9b\u4fe1\u606f\u3002\u5728\u8fd9\u4e9b\u9636\u6bb5\u4e2d\uff0c\u5982\u4f55\u4ece\u7c89\u4f53\u4e2d\u83b7\u5f97\u5c11\u91cf\u80fd\u4ee3\u8868\u7c92\u5ea6\u5206\u5e03\u7684\u6837\u54c1\u5f88\u5173\u952e\u3002Allen\u5df2\u7ecf\u8bc1\u660e\uff0c\u9009\u62e9\u5408\u9002\u7684\u53d6\u6837\u5668\u5c06\u5927\u5927\u63d0\u9ad8\u7c92\u5ea6\u6d4b\u5b9a\u7684\u91cd\u73b0\u6027[14]\u3002\u53e6\u5916\uff0c\u5bf9\u4e8e\u7c92\u5f84\u5c0f\u6216\u6709\u7c98\u6027\u7684\u9897\u7c92\uff0c\u9009\u62e9\u5408\u9002\u7684\u6837\u54c1\u5206\u6563\u65b9\u6cd5\u4e5f\u662f\u81f3\u5173\u91cd\u8981\u7684\uff0c\u8fd9\u4e9b\u9897\u7c92\u6709\u805a\u96c6\u7684\u8d8b\u52bf\u3002\u6837\u54c1\u5206\u6563\u7684\u76ee\u7684\u662f\u5c3d\u53ef\u80fd\u5730\u51cf\u5f31\u6837\u54c1\u5206\u6790\u4e2d\u9897\u7c92\u7684\u805a\u96c6\uff0c\u540c\u65f6\u907f\u514d\u8fc7\u5ea6\u4f7f\u7528\u5206\u6563\u529b\u800c\u9020\u6210\u9897\u7c92\u635f\u8017\u3002\u901a\u5e38\u6765\u8bf4\uff0c\u5728\u7c92\u5ea6\u6d4b\u5b9a\u4e2d\u51fa\u73b0\u7684\u8bef\u5dee\u5927\u591a\u662f\u7531\u4e8e\u53d6\u6837\u6216\u6837\u54c1\u5206\u6563\u7f3a\u9677\u9020\u6210\uff0c\u800c\u4e0d\u662f\u56e0\u4e3a\u4eea\u5668\u95ee\u9898\u4ea7\u751f\u7684\u3002\u56e0\u6b64\uff0c\u7c92\u5ea6\u6807\u51c6\u4e2d\uff0c\u5efa\u8bae\u5728\u5206\u6790\u65b9\u6cd5\u90e8\u5206\u8be6\u7ec6\u63cf\u8ff0\u53d6\u6837\u548c\u6837\u54c1\u5206\u6563\u65b9\u9762\u7684\u5177\u4f53\u64cd\u4f5c\u3002<\/span><\/p>\n


<\/p>\n

\u5bf9\u4e8e\u6fc0\u5149\u884d\u5c04\u6cd5\uff0c\u6570\u636e\u5206\u6790\u548c\u8bf4\u660e\u540c\u6837\u91cd\u8981\uff0c\u82e5\u5149\u5b66\u6a21\u578b\u9009\u62e9\u4e0d\u5408\u9002\uff08\u5982Mie\u6216Runover\u7406\u8bba\uff09\u6216\u6298\u5c04\u7387\u503c\u90fd\u6709\u53ef\u80fd\u4f1a\u5bfc\u81f4\u7c92\u5ea6\u5206\u5e03\u7684\u663e\u8457\u504f\u5dee[15]\u3002\u56e0\u6b64\uff0c\u4e3a\u4e86\u5f97\u5230\u66f4\u597d\u7684\u91cd\u73b0\u6027\uff0c\u6709\u5fc5\u8981\u5728\u62a5\u544a\u4e2d\u5c06\u5149\u5b66\u6a21\u578b\u548c\u6298\u5c04\u7387\u503c\u5199\u6e05\u695a\u3002\u786c\u4ef6\u548c\u8f6f\u4ef6\u65b9\u9762\u540c\u6837\u5b58\u5728\u4e00\u4e9b\u660e\u663e\u5dee\u5f02\uff0c\u4e0d\u4ec5\u662f\u4e0d\u540c\u5382\u5546\u7684\u8bbe\u5907\uff0c\u751a\u81f3\u8fde\u540c\u4e00\u5382\u5546\u7684\u4e0d\u540c\u578b\u53f7\u8bbe\u5907\u90fd\u5b58\u5728\u5f88\u5927\u5dee\u522b\uff0c\u56e0\u6b64\uff0c\u5efa\u8bae\u63d0\u4f9b\u6fc0\u5149\u884d\u5c04\u4eea\u7684\u8db3\u591f\u4fe1\u606f\uff0c\u5305\u62ec\u7528\u4e8e\u5206\u6790\u4f7f\u7528\u7684\u8f6f\u4ef6\u3002<\/span><\/p>\n


<\/p>\n

3.2\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1<\/strong><\/em><\/span><\/p>\n

<\/em>
<\/p>\n

\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u662f\u901a\u8fc7\u5b9e\u9a8c\u5ba4\u7814\u7a76\u6765\u8bc1\u660e\u65b9\u6cd5\u7684\u6027\u80fd\u53c2\u6570\u7b26\u5408\u9884\u671f\u7684\u5206\u6790\u5e94\u7528\u76ee\u7684\u7684\u8fc7\u7a0b[16]\u3002\u7531\u4e8e\u7c92\u5ea6\u5206\u6790\u65b9\u6cd5\u7684\u72ec\u7279\u6027\uff0c\u5176\u65b9\u6cd5\u9a8c\u8bc1\u4e0d\u540c\u4e8eICH Q2A\u3001Q2B\u4ee5\u53caUSP\u901a\u5219<1225>[17-18]\u4e2d\u63cf\u8ff0\u7684\u9a8c\u8bc1\u5185\u5bb9\u3002\u4e00\u822c\u6765\u8bf4\uff0c\u7c92\u5ea6\u65b9\u6cd5\u9a8c\u8bc1\u901a\u5e38\u9700\u8981\u5bf9\u7cbe\u5bc6\u5ea6\uff08\u91cd\u590d\u6027\u548c\u4e2d\u95f4\u7cbe\u5bc6\u5ea6\uff09\u548c\u8010\u7528\u6027\u8fdb\u884c\u8bc4\u4ef7\u3002\u5728ICH\u4e2d\u6d89\u53ca\u5230\u7684\u5176\u4ed6\u9a8c\u8bc1\u53c2\u6570\uff0c\u5982\u4e13\u5c5e\u6027\u3001\u7ebf\u6027\u4e0e\u8303\u56f4\u3001\u51c6\u786e\u5ea6\u3001\u68c0\u6d4b\u9650\u548c\u5b9a\u91cf\u9650\u7b49\u90fd\u4e0d\u4f5c\u4e3a\u7c92\u5ea6\u65b9\u6cd5\u9a8c\u8bc1\u7684\u8981\u6c42\u3002<\/span><\/p>\n

 <\/p>\n

\u7cbe\u5bc6\u5ea6\u4e2d\u7684\u91cd\u590d\u6027\u662f\u6307\u5728\u77ed\u65f6\u95f4\u5185\uff0c\u7531\u5b9e\u9a8c\u5ba4\u7684\u540c\u4e00\u5b9e\u9a8c\u4eba\u5458\u4f7f\u7528\u540c\u4e00\u53f0\u4eea\u5668\u8fdb\u884c\u9a8c\u8bc1\u7684\u8fc7\u7a0b\u3002\u4e2d\u95f4\u7cbe\u5bc6\u5ea6\u662f\u6307\u5728\u540c\u4e00\u5b9e\u9a8c\u5ba4\uff0c\u5728\u4e0d\u540c\u65f6\u95f4\u7531\u4e0d\u540c\u5b9e\u9a8c\u4eba\u5458\u4f7f\u7528\u4e0d\u540c\u4eea\u5668\u8fdb\u884c\u6d4b\u5b9a\u7684\u8fc7\u7a0b[16]\u3002\u5982\u679c\u5c06\u7c92\u5ea6\u65b9\u6cd5\u8f6c\u79fb\u5230\u5176\u4ed6\u5b9e\u9a8c\u5ba4\uff0c\u5219\u9700\u8981\u5bf9\u4e0d\u540c\u5b9e\u9a8c\u5ba4\u6240\u4f7f\u7528\u7684\u65b9\u6cd5\u8fdb\u884c\u91cd\u73b0\u6027\u8bc4\u4ef7\u3002<\/p>\n


<\/p>\n

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<\/p>\n

3.3\u53ef\u63a5\u53d7\u6807\u51c6<\/span><\/em><\/strong><\/p>\n


<\/span><\/em><\/strong><\/p>\n

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<\/p>\n

\u5bf9\u4e8e\u6fc0\u5149\u884d\u5c04\u6cd5\uff0cD10\u3001D50\u548cD90\u7684\u9650\u5ea6\u5e38\u88ab\u4f5c\u4e3a\u53ef\u63a5\u53d7\u6807\u51c6\u3002<\/span>\u8fd9\u4e9b\u53c2\u6570\u4ee3\u8868\u7684\u662f\u6837\u54c1\u4e2d\u4e00\u5b9a\u5927\u5c0f\u9897\u7c92\u7684\u7d2f\u79ef\u5206\u5e03\u767e\u5206\u6bd4\uff0cD10\u3001D50\u6216D90\u6307\u7684\u662f\u7d2f\u79ef\u7c92\u5ea6\u5206\u5e03\u4e3a10%\u300150%\u548c90%\u7684\u5bf9\u5e94\u503c\uff0c\u5176\u4ee3\u8868\u4e86\u7c92\u5f84\u5c0f\u4e8e\u5b83\u7684\u6bd4\u4f8b\u536010%\u300150%\u548c90%\u3002\u4f8b\u5982\uff0c\u56fe2\u4e2d\u901a\u8fc7\u6fc0\u5149\u884d\u5c04\u6cd5\u6d4b\u5b9a\u5f97\u5230\u7684\u7c92\u5f84\u5927\u5c0f\u6570\u636e\u88ab\u7ed8\u5236\u6210\u7d2f\u79ef\u7c92\u5ea6\u5206\u5e03\u3002\u5b83\u8868\u660eD50\u662f200\u03bcm\uff0c\u4ee3\u886850%\u7684\u7c92\u5f84\u4f4e\u4e8e200\u03bcm\uff08\u5373\uff1a\u4e2d\u503c\u7c92\u5f84\uff09\u3002\u7c7b\u4f3c\u7684\uff0cD10\u548cD90\u5206\u522b\u662f74\u03bcm\u548c411\u03bcm\uff0c\u8fd9\u8868\u660e10%\u7684\u7c92\u5f84\u4f4e\u4e8e74\u03bcm\uff0c90%\u7684\u7c92\u5f84\u90fd\u4f4e\u4e8e411\u03bcm\u3002\u5e94\u8be5\u6ce8\u610f\u7684\u662f\uff0c\u5bf9\u4e8e\u5355\u4e00\u7c92\u5b50\u7684\u6d4b\u5b9a\uff0cD10\u3001D50\u548cD90\u4e0d\u662f\u4e00\u4e2a\u8303\u56f4\uff0c\u800c\u662f\u4e00\u4e2a\u503c\u3002\u8fd9\u4e9b\u503c\u5728\u4e0d\u540c\u7684\u6d4b\u5b9a\u6216\u4e0d\u540c\u7684\u6837\u54c1\u4e2d\u4f1a\u6709\u6240\u6539\u53d8\u3002<\/p>\n

\"\u5e72\u8d27
<\/p>\n

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<\/p>\n

\u7c92\u5ea6\u5206\u5e03\u53ef\u4ee5\u901a\u8fc7D10\u3001D50\u548cD90\u5206\u522b\u8bbe\u7f6e\u4e0a\u9650\u548c\u4e0b\u9650\u6765\u63a7\u5236\u3002\u5982\u56fe3\u6240\u793a\uff0c\u5982\u679c\u84dd\u7ebf\u4e0a\u7684\u94bb\u77f3\u70b9\u8868\u793a\u76ee\u6807\u6216\u671f\u671b\u7684\u7c92\u5ea6\u5206\u5e03\uff0cD10\u3001D50\u548cD90\u7684\u4e0a\u9650\u548c\u4e0b\u9650\u63d0\u4f9b\u4e86\u6837\u54c1\u7c92\u5ea6\u5206\u5e03\u53d8\u5316\u7684\u63a7\u5236\u7b56\u7565\uff0c\u4f7f\u5f97\u7eff\u7ebf\u548c\u7ea2\u7ebf\u4e4b\u95f4\u7684\u6837\u54c1\u6ca1\u6709\u5bf9\u4ea7\u54c1\u6027\u80fd\u6216\u751f\u4ea7\u9020\u6210\u4e0d\u5229\u5f71\u54cd\u3002\u8bbe\u7f6e\u4e0a\u9650\u548c\u4e0b\u9650\u503c\uff0c\u5f88\u5927\u7a0b\u5ea6\u4e0a\u53d6\u51b3\u4e8e\u7c92\u5ea6\u5206\u5e03\u7684\u5f71\u54cd\u6709\u591a\u5927\uff0c\u8fd9\u901a\u5e38\u662f\u57fa\u4e8e\u5148\u524d\u7684\u7406\u8bba\u6216\u5b9e\u9a8c\u8bbe\u8ba1\uff08DOE\uff09\u7684\u7ed3\u679c\u3002<\/span>\u5982\u4f55\u8bbe\u7f6e\u8fd9\u4e9b\u9650\u5ea6\uff0c\u9700\u8981\u4e00\u5b9a\u7684\u652f\u6301\u6027\u6570\u636e\u6765\u8bc1\u660e\uff0c\u540c\u65f6\u4e5f\u5e94\u8be5\u5305\u62ec\u5728\u836f\u54c1\u7533\u62a5\u4e2d\u3002\u5728\u8bb8\u591aNDA\u548cANDAs\u4e2d\uff0c\u4ec5\u5bf9D10\u3001D50\u6216D90\u5efa\u7acb\u4e86\u4e0a\u9650\u6216\u4e0b\u9650\u3002\u5728\u6ca1\u6709\u79d1\u5b66\u4f9d\u636e\u7684\u60c5\u51b5\u4e0b\uff0c\u8fd9\u79cd\u5355\u4fa7\u9650\u5ea6\u662f\u4e0d\u53ef\u63a5\u53d7\u7684\uff0c\u56e0\u4e3a\u5b83\u4e0d\u80fd\u5bf9\u7c89\u4f53\u7684\u7c92\u5ea6\u5206\u5e03\u8fdb\u884c\u5145\u5206\u7684\u63a7\u5236\u3002<\/span><\/p>\n

\"\u5e72\u8d27<\/p>\n

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<\/p>\n


<\/p>\n

\u5bf9\u4e8e\u7b5b\u5206\u6cd5\uff0c\u5efa\u8bae\u6d4b\u91cf\u6837\u54c1\u7684\u6574\u4e2a\u7c92\u5f84\u5206\u5e03\uff0c\u800c\u4e0d\u662f\u6d4b\u5b9a\u4e00\u4e24\u4e2a\u7b5b\u5b50\u4e0a\u7684\u9897\u7c92\u6bd4\u4f8b\u3002\u4e00\u65e6\u4ece\u7b5b\u5206\u6cd5\u6d4b\u5b9a\u4e2d\u5f97\u5230\u7d2f\u79ef\u7c92\u5ea6\u5206\u5e03\uff0c\u5c31\u53ef\u4ee5\u901a\u8fc7\u6fc0\u5149\u884d\u5c04\u6cd5\u4e2d\u4f7f\u7528\u7684\u7c7b\u4f3c\u65b9\u6cd5\u6765\u786e\u5b9aD10\u3001D50\u548cD90\u7684\u63a5\u53d7\u6807\u51c6\u3002\u5982\u56fe4\u6240\u793a\uff0c\u66f4\u5e38\u89c1\u7684\u60c5\u51b5\u662f\u4e09\u4e2a\u7b5b\u53f7\uff08\u6216\u7c92\u5ea6\uff09\u7684\u7d2f\u79ef\u6bd4\u4f8b\u7684\u4e0a\u9650\u548c\u4e0b\u9650\u88ab\u5b9a\u4e3a\u53ef\u63a5\u53d7\u6807\u51c6\u3002\u5728\u8fd9\u79cd\u60c5\u51b5\u4e0b\uff0c\u4e0d\u662f\u63a7\u5236\u5927\u5c0f\u53d8\u5316\uff0c\u800c\u662f\u63a7\u5236\u4e09\u4e2a\u56fa\u5b9a\u7b5b\u5206\u7684\u7d2f\u79ef\u6bd4\u4f8b\u7684\u53d8\u5316\uff0c\u4ee5\u786e\u4fdd\u66f4\u597d\u7684\u63a7\u5236\u7c92\u5ea6\u5206\u5e03\u3002\u56e0\u6b64\uff0c\u5efa\u8bae\u9009\u62e9\u4e09\u4e2a\u7b5b\u5b50\uff0c\u76ee\u6807\u7d2f\u79ef\u91cf\u7ea6\u4e3a10%\u300150%\u548c90%\uff0c\u4ee5\u5145\u5206\u4ee3\u8868\u6574\u4e2a\u7c92\u5ea6\u5206\u5e03\u3002<\/span><\/p>\n

<\/span><\/strong><\/p>\n

\u56fe4-\u91c7\u7528\u7b5b\u5206\u6cd5\u6d4b\u5b9a\u7684\u7c92\u5b50\u7c92\u5ea6\u5206\u5e03\u7684\u63a5\u53d7\u6807\u51c6\u3002\u5e26\u6709\u94bb\u77f3\u70b9\u7684\u84dd\u7ebf\u8868\u793a\u76ee\u6807\u6216\u671f\u671b\u7684\u7c92\u5ea6\u5206\u5e03\u3002\u5e26\u6709\u4e09\u89d2\u5f62\u70b9\u7684\u7eff\u7ebf\u4ee3\u8868\u4e86\u7c92\u5ea6\u5206\u5e03\u7684\u4e0a\u9650\u3002\u7528\u65b9\u70b9\u8868\u793a\u7684\u7ea2\u7ebf\u8868\u793a\u7c92\u5ea6\u5206\u5e03\u7684\u4e0b\u9650\u3002<\/strong><\/p>\n


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<\/p>\n

\n
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4<\/strong><\/section>\n<\/section>\n<\/section>\n
\u7ed3 \u8bba<\/strong><\/span><\/section>\n<\/section>\n<\/section>\n<\/section>\n


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<\/p>\n

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http:\/\/www.americanpharmaceuticalreview.com\/Featured-Articles\/36779-Particle-Size-Specifications-for-Solid-Oral-Dosage-Forms-A-Regulatory-Perspective\/<\/span><\/p>\n


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\u6765\u6e90\uff1a\u836f\u4e8b\u7eb5\u6a2a\u7ffb\u8bd1<\/span><\/p>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"

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