{"id":80511,"date":"2019-02-20T00:00:50","date_gmt":"2019-02-26T08:03:45","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/80511\/"},"modified":"2019-02-26T16:03:51","modified_gmt":"2019-02-26T08:03:51","slug":"20e6d25a6a","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/80511\/","title":{"rendered":"ICH Q3C(R7)\u6742\u8d28\uff1a\u6b8b\u7559\u6eb6\u5242\u6307\u5bfc\u539f\u5219\uff08\u4e2d\u6587\u7ffb\u8bd1\u516c\u5f00\u5f81\u6c42\u610f\u89c1\u7a3f\uff09"},"content":{"rendered":"
\n

\u4eba\u7528\u836f\u54c1\u6ce8\u518c\u6280\u672f\u8981\u6c42\u56fd\u9645\u534f\u8c03\u4f1a<\/span><\/span><\/p>\n

 <\/span><\/p>\n

ICH <\/span><\/strong>\u534f\u8c03\u6307\u5bfc\u539f\u5219<\/span><\/strong><\/p>\n

 <\/span><\/strong><\/p>\n

\u6742\u8d28\uff1a\u6b8b\u7559\u6eb6\u5242\u7684\u6307\u5bfc\u539f\u5219<\/span><\/span><\/strong><\/p>\n

Q3C<\/span><\/strong>\uff08<\/span><\/span><\/strong>R7<\/span><\/strong>\uff09<\/span><\/span><\/strong><\/p>\n

 <\/span><\/strong><\/p>\n


<\/p>\n

\u73b0\u884c\u7b2c\u56db\u9636\u6bb5\u7248\u672c<\/span><\/span><\/p>\n

2018<\/span> <\/span>\u5e74<\/span> <\/span>10<\/span> <\/span>\u6708<\/span> <\/span>15<\/span> <\/span>\u65e5<\/span><\/span><\/p>\n

 <\/span><\/p>\n


<\/p>\n

\u672c\u6307\u5bfc\u539f\u5219\u7531\u76f8\u5e94\u7684<\/span> <\/span>ICH <\/span>\u4e13\u5bb6\u5de5\u4f5c\u7ec4\u5236\u5b9a\uff0c\u5e76\u6839\u636e<\/span> <\/span>ICH <\/span>\u8fdb\u7a0b\u5df2\u63d0\u4ea4\u7ed9\u7ba1\u7406\u5f53\u5c40\u5f81<\/span><\/span>\u8be2\u610f\u89c1\u3002\u5728<\/span> <\/span>ICH <\/span>\u8fdb\u7a0b\u7684\u7b2c\u56db\u9636\u6bb5\uff0c\u6700\u540e\u7684\u8349\u6848\u88ab\u63a8\u8350\u7ed9\u6b27\u76df\u3001\u65e5\u672c\u3001\u7f8e\u56fd\u3001\u52a0\u62ff\u5927\u548c<\/span><\/span>\u745e\u58eb\u7684\u7ba1\u7406\u673a\u6784\u91c7\u7eb3\u3002<\/span><\/span><\/p>\n


<\/p>\n

Q3C<\/span><\/strong>\uff08<\/span><\/strong>R7<\/span><\/strong>\uff09<\/span><\/strong><\/p>\n

<\/span>\u6587\u4ef6\u5386\u53f2<\/span><\/strong><\/p>\n

 <\/span><\/strong><\/p>\n

\u6bcd\u6307\u5bfc\u539f\u5219\uff1a\u6742\u8d28\uff1a\u6b8b\u7559\u6eb6\u5242\u7684\u6307\u5bfc\u539f\u5219<\/span><\/span><\/strong><\/p>\n\n\n\n\n
\n

 <\/span><\/strong><\/p>\n

Q3C<\/span><\/p>\n<\/td>\n

\n

\u6307\u5bfc\u59d4\u5458\u4f1a\u7ecf\u7b2c\u4e8c\u9636\u6bb5\u540e\u6279\u51c6\uff0c\u5e76\u53d1\u5e03\u4ee5\u4fbf\u5411\u516c\u4f17\u5f81\u6c42\u610f<\/span><\/p>\n

\u89c1\u3002<\/span><\/p>\n<\/td>\n

\n

 <\/span><\/strong><\/p>\n

1996 <\/span>\u5e74 <\/span>11 <\/span>\u6708 <\/span>6<\/span> <\/span>\u65e5<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

 <\/span><\/strong><\/p>\n

Q3C<\/span><\/p>\n<\/td>\n

\n

\u6307\u5bfc\u59d4\u5458\u4f1a\u7ecf\u7b2c\u56db\u9636\u6bb5\u540e\u6279\u51c6\uff0c\u5e76\u5efa\u8bae <\/span>ICH<\/span> <\/span>\u7684 <\/span>3<\/span> <\/span>\u4e2a\u76d1\u7ba1<\/span>\u673a\u6784\u91c7\u7eb3\u3002<\/span><\/p>\n<\/td>\n

\n

 <\/span><\/strong><\/p>\n

1997 <\/span>\u5e74 <\/span>7 <\/span>\u6708 <\/span>17<\/span> <\/span>\u65e5<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\u5bf9\u6bcd\u6307\u5bfc\u539f\u5219\u6240\u542b<\/span> <\/span><\/strong>THF<\/span><\/strong> <\/span><\/strong>\u7684<\/span>  <\/span><\/strong>PDE<\/span><\/strong> <\/span><\/strong>\u4fe1\u606f\u7684\u4fee\u8ba2<\/span><\/span><\/strong><\/p>\n\n\n\n\n
\n

Q3C<\/span>\uff08<\/span>R1<\/span>\uff09<\/span><\/p>\n

\u6ce8\uff1a<\/span>2005<\/span> <\/span>\u5e74 <\/span>11<\/span> <\/span>\u6708<\/span>\u4fee\u8ba2\u524d\u672c\u7248\u672c\u547d<\/span>\u540d\u4e3a <\/span>Q3C<\/span>\uff08<\/span>M<\/span>\uff09\uff1a<\/span><\/p>\n

THF<\/span><\/p>\n<\/td>\n

\n

\u56db\u6c22\u544b\u5583\uff08<\/span>THF<\/span>\uff09<\/span>\u7684\u6bcf\u65e5\u5141\u8bb8\u66b4\u9732\u91cf<\/span>\uff08<\/span> <\/span>PDE<\/span> <\/span>\uff09<\/span>\uff1a\u6839\u636e\u65b0\u7684<\/span>\u6bd2\u7406\u5b66\u6570\u636e\u4fee\u8ba2 <\/span>PDE<\/span>\u3002<\/span><\/p>\n

\u6307\u5bfc\u59d4\u5458\u4f1a\u7ecf\u7b2c\u4e8c\u9636\u6bb5\u540e\u6279\u51c6 <\/span>THF<\/span> <\/span>\u7684\u65b0 <\/span>PDE<\/span>\uff0c\u5e76\u53d1\u5e03\u4ee5<\/span>\u4fbf\u5411\u516c\u4f17\u5f81\u6c42\u610f\u89c1\u3002<\/span><\/p>\n<\/td>\n

\n

2000 <\/span>\u5e74 <\/span>7 <\/span>\u6708 <\/span>20<\/span> <\/span>\u65e5<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Q3C<\/span>\uff08<\/span>R1<\/span>\uff09<\/span><\/p>\n

\u6ce8\uff1a<\/span>2005<\/span> <\/span>\u5e74 <\/span>11<\/span> <\/span>\u6708<\/span>\u4fee\u8ba2\u524d\u672c\u7248\u672c\u547d<\/span>\u540d\u4e3a <\/span>Q3C<\/span>\uff08<\/span>M<\/span>\uff09\uff1a<\/span><\/p>\n

THF<\/span><\/p>\n<\/td>\n

\n

\u6307\u5bfc\u59d4\u5458\u4f1a\u7ecf\u7b2c\u56db\u9636\u6bb5\u540e\u6279\u51c6\uff0c\u5e76\u5efa\u8bae <\/span>ICH<\/span> <\/span>\u7684 <\/span>3<\/span> <\/span>\u4e2a\u76d1\u7ba1<\/span>\u673a\u6784\u91c7\u7eb3\u3002<\/span><\/p>\n<\/td>\n

\n

2002 <\/span>\u5e74 <\/span>9 <\/span>\u6708 <\/span>12<\/span> <\/span>\u65e5<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/span><\/strong><\/p>\n

\u5bf9\u6bcd\u6307\u5bfc\u539f\u5219\u6240\u542b<\/span> <\/span><\/strong>NMP<\/span><\/strong> <\/span><\/strong>\u7684<\/span>  <\/span><\/strong>PDE<\/span><\/strong> <\/span><\/strong>\u4fe1\u606f\u7684\u4fee\u8ba2<\/span><\/span><\/strong><\/p>\n\n\n\n\n\n\n
\n

Q3C<\/span>\uff08<\/span>R2<\/span>\uff09<\/span><\/p>\n

\u6ce8\uff1a<\/span>2005<\/span> <\/span>\u5e74 <\/span>11<\/span> <\/span>\u6708<\/span>\u4fee\u8ba2\u524d\u672c\u7248\u672c\u547d<\/span>\u540d\u4e3a <\/span>Q3C<\/span>\uff08<\/span>M<\/span>\uff09\uff1a<\/span><\/p>\n

NMP<\/span><\/p>\n<\/td>\n

\n

N-<\/span>\u7532\u57fa\u5421\u54af\u70f7\u916e\uff08<\/span>NMP<\/span>\uff09<\/span>\u7684\u6bcf\u65e5\u5141\u8bb8\u66b4\u9732\u91cf<\/span>\uff08<\/span>PDE<\/span>\uff09<\/span>\uff1a\u6839\u636e<\/span>\u65b0\u7684\u6bd2\u7406\u5b66\u6570\u636e\u4fee\u8ba2 <\/span>PDE<\/span>\u3002<\/span><\/p>\n

\u6307\u5bfc\u59d4\u5458\u4f1a\u7ecf\u7b2c\u4e8c\u9636\u6bb5\u540e\u6279\u51c6\u4fee\u8ba2\u7248\uff0c\u5e76\u53d1\u5e03\u4ee5\u4fbf\u5411\u516c\u4f17\u5f81\u6c42\u610f\u89c1\u3002<\/span><\/p>\n<\/td>\n

\n

2000 <\/span>\u5e74 <\/span>7 <\/span>\u6708 <\/span>20 <\/span>\u65e5<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Q3C<\/span>\uff08<\/span>R2<\/span>\uff09<\/span><\/p>\n

\u6ce8\uff1a<\/span>2005<\/span> <\/span>\u5e74 <\/span>11<\/span> <\/span>\u6708<\/span>\u4fee\u8ba2\u524d\u672c\u7248\u672c\u547d<\/span>\u540d\u4e3a <\/span>Q3C<\/span>\uff08<\/span>M<\/span>\uff09\uff1a<\/span><\/p>\n

NMP<\/span><\/p>\n<\/td>\n

\n

\u6307\u5bfc\u59d4\u5458\u4f1a\u7ecf\u7b2c\u56db\u9636\u6bb5\u540e\u6279\u51c6\uff0c\u5e76\u5efa\u8bae <\/span>ICH<\/span> <\/span>\u7684 <\/span>3<\/span> <\/span>\u4e2a\u76d1\u7ba1\u673a\u6784\u91c7\u7eb3\u3002<\/span><\/p>\n<\/td>\n

\n

2002 <\/span>\u5e74 <\/span>9 <\/span>\u6708 <\/span>12 <\/span>\u65e5<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Q3C<\/span>\uff08<\/span>R3<\/span>\uff09<\/span><\/p>\n

\u6ce8\uff1a<\/span>2005<\/span> <\/span>\u5e74 <\/span>11<\/span> <\/span>\u6708<\/span>\u4fee\u8ba2\u524d\u672c\u7248\u672c\u547d<\/span>\u540d\u4e3a <\/span>Q3C<\/span>\uff08<\/span>M<\/span>\uff09\uff1a<\/span><\/p>\n

NMP<\/span><\/p>\n<\/td>\n

\n

\u6307\u5bfc\u59d4\u5458\u4f1a\u6279\u51c6\u7684\u8ba1\u7b97\u516c\u5f0f\u52d8\u8bef\u3002<\/span><\/p>\n<\/td>\n

\n

2002 <\/span>\u5e74 <\/span>10 <\/span>\u6708 <\/span>28<\/span><\/p>\n

\u65e5<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Q3C<\/span>\uff08<\/span>R3<\/span>\uff09<\/span><\/p>\n<\/td>\n

\n

\u7531\u4e8e<\/span>2<\/span> <\/span>\u4e2a\u66f4\u65b0<\/span>\uff08<\/span>N<\/span>–<\/span>\u7532\u57fa\u5421\u54af\u70f7\u916e\u7684<\/span>P<\/span>DE<\/span> <\/span>\u548c\u56db\u6c22\u544b\u5583\u7684<\/span>P<\/span>DE<\/span>\uff09\uff0c<\/span><\/p>\n

\u6bcd\u6307\u5bfc\u539f\u5219\u73b0\u5df2\u66f4\u540d\u4e3a <\/span>Q3C<\/span>\uff08<\/span>R3<\/span>\uff09\uff0c<\/span>\u5e76\u5df2\u5c06 <\/span>NMP<\/span> <\/span>\u66f4\u65b0\u7684\u52d8<\/span>\u8bef\u6dfb\u52a0\u5230\u6bcd\u6307\u5bfc\u539f\u5219\u4e2d\u3002<\/span><\/p>\n<\/td>\n

\n

2005 <\/span>\u5e74 <\/span>11 <\/span>\u6708<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n


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

\u7f16\u7801<\/span><\/p>\n<\/td>\n

\n

\u5386\u53f2<\/span><\/p>\n<\/td>\n

\n

\u65e5\u671f<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\u6bcd\u6307\u5bfc\u539f\u5219\uff1a\u6742\u8d28\uff1a\u6b8b\u7559\u6eb6\u5242\u7684\u6307\u5bfc\u539f\u5219<\/span><\/span><\/strong><\/p>\n\n\n\n
\n

Q3C<\/span>\uff08<\/span>R4<\/span>\uff09<\/span><\/p>\n<\/td>\n

\n

\u66f4\u65b0\u8868 <\/span>2<\/span>\u3001\u8868 <\/span>3<\/span> <\/span>\u548c\u9644\u5f55 <\/span>1<\/span>\uff0c\u4ee5\u53cd\u6620\u5bf9 <\/span>N-<\/span>\u7532\u57fa\u5421\u54af\u70f7\u916e\u548c\u56db<\/span>\u6c22\u544b\u5583\u7684 <\/span>PDE<\/span> <\/span>\u8fdb\u884c\u7684\u4fee\u8ba2\u3002<\/span><\/p>\n<\/td>\n

\n

2009 <\/span>\u5e74 <\/span>2<\/span> <\/span>\u6708<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\u5bf9\u6bcd\u6307\u5bfc\u539f\u5219\u6240\u542b\u5f02\u4e19\u57fa\u82ef\u7684<\/span> <\/span><\/strong>PDE <\/span><\/strong>\u4fe1\u606f\u7684\u4fee\u8ba2<\/span><\/span><\/strong><\/p>\n\n\n\n\n
\n

Q3C<\/span>\uff08<\/span>R5<\/span>\uff09<\/span><\/p>\n<\/td>\n

\n

\u5f02\u4e19\u57fa\u82ef\u7684\u6bcf\u65e5\u5141\u8bb8\u66b4\u9732\u91cf<\/span>\uff08<\/span>PDE<\/span>\uff09\uff1a<\/span>\u6839\u636e\u65b0\u7684\u6bd2\u7406\u5b66\u6570\u636e<\/span>\u4fee\u8ba2 <\/span>PDE<\/span>\u3002<\/span><\/p>\n

\u6307\u5bfc\u59d4\u5458\u4f1a\u7ecf\u7b2c\u4e8c\u9636\u6bb5\u540e\u6279\u51c6\uff0c\u5e76\u53d1\u5e03\u4ee5\u4fbf\u5411\u516c\u4f17\u5f81\u6c42\u610f<\/span><\/p>\n

\u89c1\u3002<\/span><\/p>\n<\/td>\n

\n

2010 <\/span>\u5e74 <\/span>3 <\/span>\u6708 <\/span>26<\/span> <\/span>\u65e5<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Q3C<\/span>\uff08<\/span>R5<\/span>\uff09<\/span><\/p>\n<\/td>\n

\n

\u6307\u5bfc\u59d4\u5458\u4f1a\u7ecf\u7b2c\u56db\u9636\u6bb5\u540e\u6279\u51c6\u5f02\u4e19\u57fa\u82ef\u7684 <\/span>PDE<\/span>\uff0c\u5e76\u5efa\u8bae<\/span>ICH <\/span>\u7684 <\/span>3 <\/span>\u4e2a\u76d1\u7ba1\u673a\u6784\u91c7\u7eb3\u3002<\/span><\/p>\n

\u5f02\u4e19\u57fa\u82ef\u6587\u6863\u7684 <\/span>PDE <\/span>\u5df2\u7ecf\u4f5c\u4e3a\u7b2c <\/span>IV <\/span>\u90e8\u5206\u6574\u5408\u5728\u6838\u5fc3 <\/span>Q3C<\/span><\/p>\n

\uff08<\/span>R4<\/span>\uff09\u6307\u5bfc\u539f\u5219\u4e2d\uff0c\u6307\u5bfc\u539f\u5219\u66f4\u540d\u4e3a <\/span>Q3C<\/span>\uff08<\/span>R5<\/span>\uff09\u3002<\/span><\/p>\n

\u5df2\u5bf9\u8868 <\/span>2<\/span>\u3001\u8868 <\/span>3<\/span> <\/span>\u548c\u9644\u5f55 <\/span>1<\/span> <\/span>\u8fdb\u884c\u66f4\u65b0\uff0c\u4ee5\u53cd\u6620\u5bf9\u5f02\u4e19\u57fa\u82ef\u7684<\/span><\/p>\n

PDE <\/span>\u8fdb\u884c\u7684\u4fee\u8ba2\u3002<\/span><\/p>\n<\/td>\n

\n

2011 <\/span>\u5e74 <\/span>2 <\/span>\u6708 <\/span>4<\/span> <\/span>\u65e5<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\u4fee\u8ba2\u6bcd\u6307\u5bfc\u539f\u5219\u6240\u542b\u7532\u57fa\u5f02\u4e01\u57fa\u916e\u7684<\/span> <\/span><\/strong>PDE <\/span><\/strong>\u4fe1\u606f\uff0c\u5e76\u7eb3\u5165\u4e09\u4e59\u80fa\u7684<\/span> <\/span><\/strong>PDE<\/span><\/strong><\/p>\n\n\n\n\n
\n

Q3C<\/span>\uff08<\/span>R6<\/span>\uff09<\/span><\/p>\n<\/td>\n

\n

\u4e09\u4e59\u80fa\u548c\u7532\u57fa\u5f02\u4e01\u57fa\u916e\u7684\u6bcf\u65e5\u5141\u8bb8\u66b4\u9732\u91cf\uff08<\/span>PDE<\/span>\uff09\uff1a\u6839\u636e\u65b0\u7684\u6bd2\u7406\u5b66\u6570\u636e\u4fee\u8ba2 <\/span>PDE<\/span>\u3002<\/span><\/p>\n

\u5927\u4f1a\u5728\u7b2c\u4e8c\u9636\u6bb5\u6279\u51c6\uff0c\u5e76\u53d1\u5e03\u4ee5\u4fbf\u5411\u516c\u4f17\u5f81\u6c42\u610f\u89c1\u3002<\/span><\/p>\n<\/td>\n

\n

2015 <\/span>\u5e74 <\/span>6 <\/span>\u6708 <\/span>11<\/span><\/p>\n

\u65e5<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Q3C<\/span>\uff08<\/span>R6<\/span>\uff09<\/span><\/p>\n<\/td>\n

\n

\u5927\u4f1a\u5728\u7b2c\u56db\u9636\u6bb5\u6279\u51c6\u4e09\u4e59\u80fa\u548c\u7532\u57fa\u5f02\u4e01\u57fa\u916e\u7684 <\/span>PDE<\/span>\uff0c\u5e76\u5efa\u8bae <\/span>ICH <\/span>\u7684 <\/span>3 <\/span>\u4e2a\u76d1\u7ba1\u673a\u6784\u91c7\u7eb3\u3002<\/span><\/p>\n

\u4e09\u4e59\u80fa\u548c\u7532\u57fa\u5f02\u4e01\u57fa\u916e\u6587\u6863\u7684<\/span>PDE <\/span>\u5df2\u7ecf\u4f5c\u4e3a\u7b2c<\/span>V <\/span>\u90e8\u5206\u6574\u5408<\/span>\u5728\u6838\u5fc3 <\/span>Q3C<\/span>\uff08<\/span>R5<\/span>\uff09<\/span>\u6307\u5bfc\u539f\u5219\u4e2d\uff0c\u6307\u5bfc\u539f\u5219\u66f4\u540d\u4e3a <\/span>Q3C<\/span>\uff08<\/span>R6<\/span>\uff09<\/span>\u3002<\/span><\/p>\n

\u5df2\u5bf9\u8868 <\/span>2<\/span>\u3001\u8868 <\/span>3 <\/span>\u548c\u9644\u5f55 <\/span>1 <\/span>\u8fdb\u884c\u66f4\u65b0\uff0c\u4ee5\u53cd\u6620\u5bf9\u4e09\u4e59\u80fa\u548c\u7532\u57fa\u5f02\u4e01\u57fa\u916e\u7684 <\/span>PDE <\/span>\u8fdb\u884c\u7684\u4fee\u8ba2\u3002<\/span><\/p>\n<\/td>\n

\n

2016 <\/span>\u5e74 <\/span>11 <\/span>\u6708 <\/span>9<\/span><\/p>\n

\u65e5<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

<\/span>\u66f4\u6b63\u4e86\u4e59\u4e8c\u9187\u7684<\/span> <\/span><\/strong>PDE <\/span><\/strong>\u4fe1\u606f<\/span><\/span><\/strong><\/p>\n

<\/mpcpc><\/p>\n

\u6742\u8d28\uff1a\u6b8b\u7559\u6eb6\u5242\u7684\u6307\u5bfc\u539f\u5219<\/span><\/span><\/strong><\/h1>\n

ICH <\/span><\/strong>\u534f\u8c03\u6307\u5bfc\u539f\u5219<\/span><\/strong><\/p>\n

\u76ee\u5f55<\/span><\/strong><\/p>\n

  \u7b2c\u4e00\u90e8\u5206\uff1a<\/span><\/strong><\/p>\n

1. <\/span>\u5f15\u8a00<\/span><\/span><\/strong>1<\/span><\/strong><\/h1>\n

2. <\/span>\u6307<\/span><\/span><\/strong>\u5bfc<\/span><\/span><\/strong>\u539f\u5219\u7684\u9002\u7528<\/span><\/span><\/strong>\u8303<\/span><\/span><\/strong>\u56f4<\/span><\/span><\/strong>1<\/span><\/strong><\/h1>\n

3. <\/span>\u901a\u5219<\/span><\/span><\/strong>2<\/span><\/strong><\/h1>\n

3.1 <\/span>\u57fa\u4e8e\u98ce\u9669\u8bc4\u4f30\u7684\u6b8b\u7559\u6eb6\u5242\u7684\u5206\u7c7b<\/span><\/span>2<\/span><\/p>\n

3.2 <\/span>\u5efa\u7acb\u66b4\u9732\u9650\u5ea6\u7684\u65b9\u6cd5<\/span><\/span>2<\/span><\/p>\n

3.3 <\/span>2<\/span> <\/span>\u7c7b\u6eb6\u5242\u9650\u5ea6\u7684\u8868\u793a\u65b9\u6cd5<\/span><\/span>2<\/span><\/p>\n

3.4 <\/span>\u5206\u6790\u65b9\u6cd5<\/span><\/span>4<\/span><\/p>\n

3.5 <\/span>\u6b8b\u7559\u6eb6\u5242\u7684\u62a5\u544a\u6c34\u5e73<\/span><\/span>4<\/span><\/p>\n

4. <\/span>\u6b8b<\/span><\/span><\/strong>\u7559<\/span><\/span><\/strong>\u6eb6\u5242\u7684\u9650\u5ea6<\/span><\/span><\/strong>4<\/span><\/strong><\/h1>\n

4.1 <\/span>\u5e94\u907f\u514d\u7684\u6eb6\u5242<\/span><\/span>4<\/span><\/p>\n

4.2 <\/span>\u5e94\u9650\u5236\u7684\u6eb6\u5242<\/span><\/span>5<\/span><\/p>\n

4.3 <\/span>\u4f4e\u6f5c\u5728\u6bd2\u6027\u7684\u6eb6\u5242<\/span><\/span>6<\/span><\/p>\n

4.4 <\/span>\u6ca1\u6709\u8db3\u591f\u6bd2\u7406\u5b66\u6570\u636e\u7684\u6eb6\u5242<\/span><\/span>7<\/span><\/p>\n

\u8bcd<\/span><\/span><\/strong>\u6c47<\/span><\/span><\/strong>\u8868<\/span><\/span><\/strong>8<\/span><\/strong><\/h1>\n

\u9644\u5f55<\/span><\/span><\/strong> <\/span><\/strong>1<\/span><\/strong>\uff1a<\/span><\/span><\/strong>\u6307<\/span><\/span><\/strong>\u5bfc<\/span><\/span><\/strong>\u539f\u5219\u4e2d\u5305<\/span><\/span><\/strong>\u62ec<\/span><\/span><\/strong>\u7684\u6eb6\u5242\u5217\u8868<\/span><\/span><\/strong>9<\/span><\/strong><\/h1>\n

\u9644\u5f55<\/span><\/span><\/strong> <\/span><\/strong>2<\/span><\/strong>\uff1a<\/span><\/span><\/strong>\u5176<\/span><\/span><\/strong>\u4ed6<\/span><\/span><\/strong>\u80cc\u666f<\/span><\/span><\/strong>13<\/span><\/strong><\/h1>\n

A2.1<\/span>\u73af\u5883\u9886\u57df\u5bf9\u6709\u673a\u6325\u53d1\u6027\u6eb6\u5242\u7684\u76d1\u7ba1<\/span><\/span>13<\/span><\/p>\n

A2.2<\/span>\u836f\u7269\u4e2d\u7684\u6b8b\u7559\u6eb6\u5242<\/span><\/span>13<\/span><\/p>\n

\u9644\u5f55<\/span><\/span><\/strong> <\/span><\/strong>3<\/span><\/strong>\uff1a<\/span><\/span><\/strong>\u5efa<\/span><\/span><\/strong>\u7acb<\/span><\/span><\/strong>\u66b4\u9732\u9650\u5ea6<\/span><\/span><\/strong>\u7684<\/span><\/span><\/strong>\u65b9\u6cd5<\/span><\/span><\/strong>14<\/span><\/strong><\/h1>\n

\u7b2c\u4e8c\u90e8\u5206<\/span><\/span><\/strong>\uff1a<\/span><\/span><\/strong><\/h1>\n

\u56db<\/span><\/span><\/strong>\u6c22<\/span><\/span><\/strong>\u544b\u5583\u7684<\/span><\/span><\/strong> <\/span><\/strong>PDE<\/span><\/strong>17<\/span><\/strong><\/h1>\n

\u7b2c\u4e09\u90e8\u5206<\/span><\/span><\/strong>\uff1a<\/span><\/span><\/strong><\/h1>\n

N-<\/span><\/strong>\u7532\u57fa<\/span><\/span><\/strong>\u5421<\/span><\/span><\/strong>\u54af\u70f7\u916e\uff08<\/span><\/span><\/strong>NMP<\/span><\/strong>\uff09\u7684<\/span><\/span><\/strong> <\/span><\/strong>PDE<\/span><\/strong>19<\/span><\/strong><\/h1>\n

\u7b2c\u56db\u90e8\u5206<\/span><\/span><\/strong>:<\/span><\/strong><\/h1>\n

\u5f02<\/span><\/span><\/strong>\u4e19<\/span><\/span><\/strong>\u57fa\u82ef\u7684<\/span><\/span><\/strong> <\/span><\/strong>PDE<\/span><\/strong>21<\/span><\/strong><\/h1>\n

\u7b2c\u4e94\u90e8\u5206<\/span><\/span><\/strong>:<\/span><\/strong><\/h1>\n

\u4e09<\/span><\/span><\/strong>\u4e59<\/span><\/span><\/strong>\u80fa\u7684<\/span><\/span><\/strong> <\/span><\/strong>PDE<\/span><\/strong> <\/span><\/strong>\u548c\u7532<\/span><\/span><\/strong>\u57fa<\/span><\/span><\/strong>\u5f02\u4e01\u57fa\u916e\u7684<\/span><\/span><\/strong> <\/span><\/strong>PDE<\/span><\/strong>24<\/span><\/strong><\/h1>\n

 <\/span><\/strong><\/p>\n

\u7b2c\u4e00\u90e8\u5206\uff1a<\/span><\/p>\n

\u6742\u8d28\uff1a\u6b8b\u7559\u6eb6\u5242\u7684\u6307\u5bfc\u539f\u5219<\/span><\/p>\n

\u5728 1997 \u5e74 7 \u6708 17 \u65e5\u7684 ICH \u6307\u5bfc\u59d4\u5458\u4f1a\u4f1a\u8bae\u4e0a\u8fdb\u5165 ICH \u8fdb\u7a0b\u7b2c\u56db\u9636\u6bb5\uff0c\u5e76\u5efa\u8bae ICH \u7684<\/span>\u4e09\u65b9\u76d1\u7ba1\u673a\u6784\u91c7\u7eb3\u8be5\u6307\u5bfc\u539f\u5219<\/span><\/p>\n

1. \u5f15\u8a00<\/span><\/p>\n

    \u672c\u6307\u5bfc\u539f\u5219\u65e8\u5728\u5efa\u8bae\u4e3a\u4fdd\u8bc1\u60a3\u8005\u5b89\u5168\u800c\u5e94\u89c4\u5b9a\u7684\u836f\u7269\u4e2d\u6b8b\u7559\u6eb6\u5242\u7684\u53ef\u63a5\u53d7\u91cf\u3002\u672c\u6307<\/span>\u5bfc\u539f\u5219\u5efa\u8bae\u4f7f\u7528\u4f4e\u6bd2\u7684\u6eb6\u5242\uff0c\u5e76\u9610\u8ff0\u4e86\u4e00\u4e9b\u6b8b\u7559\u6eb6\u5242\u5728\u6bd2\u7406\u5b66\u4e0a\u7684\u53ef\u63a5\u53d7\u6c34\u5e73\u3002<\/span><\/p>\n

    \u836f\u7269\u4e2d\u7684\u6b8b\u7559\u6eb6\u5242\u5728\u6b64\u5b9a\u4e49\u4e3a\u5728\u539f\u6599\u836f\u6216\u8f85\u6599\u7684\u751f\u4ea7\u4e2d\u4ee5\u53ca\u5236\u5242\u5236\u5907\u8fc7\u7a0b\u4e2d\u4f7f\u7528<\/span>\u6216\u4ea7\u751f\u7684\u6709\u673a\u6325\u53d1\u6027\u5316\u5408\u7269\u3002\u8fd9\u4e9b\u6eb6\u5242\u5728\u5b9e\u9645\u751f\u4ea7\u6280\u672f\u4e2d\u4e0d\u80fd\u5b8c\u5168\u9664\u53bb\u3002\u9009\u62e9\u9002\u5f53\u7684\u6eb6<\/span>\u5242\u5408\u6210\u539f\u6599\u836f\u53ef\u63d0\u9ad8\u6536\u7387\u6216\u51b3\u5b9a\u836f\u7269\u7684\u6027\u8d28\uff0c\u5982\u6676\u578b\u3001\u7eaf\u5ea6\u548c\u6eb6\u89e3\u5ea6\u3002\u56e0\u6b64\uff0c\u6eb6\u5242\u6709\u65f6<\/span>\u53ef\u80fd\u662f\u5408\u6210\u5de5\u827a\u7684\u5173\u952e\u56e0\u7d20\u3002\u672c\u6307\u5bfc\u539f\u5219\u5e76\u4e0d\u9488\u5bf9\u7279\u610f\u7528\u4f5c\u8f85\u6599\u7684\u6eb6\u5242\uff0c\u4e5f\u4e0d\u9488\u5bf9\u6eb6\u5242<\/span>\u5316\u7269\u3002\u7136\u800c\u8fd9\u4e9b\u5236\u5242\u4e2d\u7684\u6eb6\u5242\u4e5f\u5e94\u8fdb\u884c\u8bc4\u4ef7\uff0c\u5e76\u8bba\u8bc1\u5176\u5408\u7406\u6027\u3002<\/span><\/p>\n

    \u7531\u4e8e\u6b8b\u7559\u6eb6\u5242\u6ca1\u6709\u6cbb\u7597\u76ca\u5904\uff0c\u6545\u5e94\u5c3d\u53ef\u80fd\u9664\u53bb\u6240\u6709\u6b8b\u7559\u6eb6\u5242\uff0c\u4ee5\u7b26\u5408\u5236\u5242\u8d28\u91cf\u6807\u51c6\u3001<\/span>\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff08GMP\uff09\u6216\u5176\u4ed6\u8d28\u91cf\u8981\u6c42\u3002\u5236\u5242\u7684\u6b8b\u7559\u6eb6\u5242\u91cf\u4e0d\u5e94\u9ad8\u4e8e\u5b89\u5168\u6027\u6570\u636e<\/span>\u53ef\u652f\u6301\u7684\u6c34\u5e73\u3002\u9664\u975e\u5728\u98ce\u9669-\u6536\u76ca\u8bc4\u4f30\u4e2d\u5f3a\u6709\u529b\u5730\u8bba\u8bc1\u4e86\u4f7f\u7528\u8fd9\u4e9b\u6eb6\u5242\u7684\u5408\u7406\u6027\uff0c\u5426\u5219<\/span>\u5728\u751f\u4ea7\u539f\u6599\u836f\u3001\u8f85\u6599\u6216\u5236\u5242\u65f6\uff0c\u5e94\u907f\u514d\u4e00\u4e9b\u5df2\u77e5\u4f1a\u5f15\u8d77\u4e0d\u53ef\u63a5\u53d7\u7684\u6bd2\u6027\u7684\u6eb6\u5242\uff081 \u7c7b\uff0c<\/span>\u8868 1\uff09\u3002\u5bf9\u4e8e\u4e00\u4e9b\u6bd2\u6027\u8f83\u4e0d\u4e25\u91cd\u7684\u6eb6\u5242\uff082 \u7c7b\uff0c\u8868 2\uff09\uff0c\u5e94\u8fdb\u884c\u9650\u5236\uff0c\u4ee5\u9632\u6b62\u60a3\u8005\u51fa\u73b0<\/span>\u6f5c\u5728\u7684\u4e0d\u826f\u53cd\u5e94\u3002\u5982\u5207\u5408\u5b9e\u9645\uff0c\u5e94\u5c3d\u53ef\u80fd\u4f7f\u7528\u4f4e\u6bd2\u6eb6\u5242\uff083 \u7c7b\uff0c\u8868 3\uff09\u3002\u9644\u5f55 1 \u4e2d\u5217\u51fa<\/span>\u672c\u6307\u5bfc\u539f\u5219\u6db5\u76d6\u7684\u5168\u90e8\u6eb6\u5242\u3002<\/span><\/p>\n

    \u8868\u4e2d\u6240\u5217\u6eb6\u5242\u5e76\u975e\u8be6\u5c3d\u65e0\u9057\uff0c\u53ef\u4f7f\u7528\u5176\u4ed6\u6eb6\u5242\u5e76\u5728\u65e5\u540e\u8865\u5145\u5230\u8be5\u5217\u8868\u4e2d\u3002\u7b2c 1\u30012 \u7c7b<\/span>\u6eb6\u5242\u7684\u5efa\u8bae\u9650\u5ea6\u6216\u6eb6\u5242\u5206\u7c7b\u53ef\u80fd\u4f1a\u5728\u5f97\u5230\u65b0\u7684\u5b89\u5168\u6027\u6570\u636e\u65f6\u53d8\u66f4\u3002\u542b\u6709\u65b0\u6eb6\u5242\u7684\u65b0\u5236\u5242<\/span>\u5176\u4e0a\u5e02\u7533\u8bf7\u7684\u652f\u6301\u6027\u5b89\u5168\u6027\u6570\u636e\u5e94\u7b26\u5408\u672c\u6307\u5bfc\u539f\u5219\u6216\u539f\u6599\u836f\u6307\u5bfc\u539f\u5219\uff08Q3A\uff0c\u65b0\u539f\u6599\u836f<\/span>\u4e2d\u7684\u6742\u8d28\uff09\u6216\u5236\u5242\u6307\u5bfc\u539f\u5219\uff08Q3B\uff0c\u65b0\u836f\u5236\u5242\u4e2d\u7684\u6742\u8d28\uff09\u4e2d\u6240\u8ff0\u7684\u6742\u8d28\u63a7\u5236\u539f\u5219\uff0c\u6216\u8005<\/span>\u540c\u65f6\u7b26\u5408\u4e0a\u8ff0\u4e09\u8005\u3002<\/span><\/p>\n

2. \u6307\u5bfc\u539f\u5219\u7684\u9002\u7528\u8303\u56f4<\/span><\/p>\n

    \u672c\u6307\u5bfc\u539f\u5219\u7684\u8303\u56f4\u5305\u62ec\u539f\u6599\u836f\u3001\u8f85\u6599\u548c\u5236\u5242\u4e2d\u6240\u542b\u7684\u6b8b\u7559\u6eb6\u5242\u3002\u56e0\u6b64\uff0c\u5f53\u5df2\u77e5\u751f\u4ea7<\/span>\u6216\u7eaf\u5316\u5de5\u827a\u4e2d\u4f1a\u51fa\u73b0\u8fd9\u4e9b\u6eb6\u5242\u65f6\uff0c\u5e94\u8fdb\u884c\u6b8b\u7559\u6eb6\u5242\u68c0\u67e5\u3002\u4e14\u4ec5\u6709\u5fc5\u8981\u5bf9\u539f\u6599\u836f\u3001\u8f85\u6599\u6216<\/span>\u5236\u5242\u7684\u751f\u4ea7\u6216\u7eaf\u5316\u4e2d\u4f7f\u7528\u6216\u4ea7\u751f\u7684\u6eb6\u5242\u8fdb\u884c\u68c0\u67e5\u3002\u751f\u4ea7\u5546\u53ef\u9009\u62e9\u68c0\u9a8c\u5236\u5242\uff0c\u4e5f\u53ef\u6839\u636e\u5236<\/span>\u5242\u751f\u4ea7\u6240\u7528\u7684\u5404\u6210\u5206\u7684\u6b8b\u7559\u6eb6\u5242\u6c34\u5e73\uff0c\u7d2f\u79ef\u8ba1\u7b97\u51fa\u5236\u5242\u4e2d\u6b8b\u7559\u6eb6\u5242\u6574\u4f53\u6c34\u5e73\u3002\u5982\u679c\u7b97\u51fa<\/span>\u7684\u7ed3\u679c\u7b49\u4e8e\u6216\u4f4e\u4e8e\u672c\u6307\u5bfc\u539f\u5219\u5efa\u8bae\u7684\u6c34\u5e73\uff0c\u5219\u4e0d\u9700\u8003\u8651\u5bf9\u5236\u5242\u8fdb\u884c\u8be5\u6b8b\u7559\u6eb6\u5242\u68c0\u67e5\u3002\u4f46<\/span>\u5982\u679c\u8ba1\u7b97\u7ed3\u679c\u9ad8\u4e8e\u5efa\u8bae\u6c34\u5e73\uff0c\u5219\u5e94\u5bf9\u5236\u5242\u8fdb\u884c\u68c0\u9a8c\uff0c\u4ee5\u786e\u5b9a\u5236\u5242\u5de5\u827a\u662f\u5426\u5c06\u6709\u5173\u6eb6\u5242\u7684<\/span>\u91cf\u964d\u81f3\u53ef\u63a5\u53d7\u6c34\u5e73\u3002\u5982\u679c\u5236\u5242\u751f\u4ea7\u4e2d\u7528\u5230\u67d0\u79cd\u6eb6\u5242\uff0c\u4e5f\u5e94\u5bf9\u5236\u5242\u8fdb\u884c\u68c0\u9a8c\u3002<\/span><\/p>\n

    \u672c\u6307\u5bfc\u539f<\/span>\u5219\u4e0d\u9002\u7528\u4e8e\u4e34\u5e8a\u7814\u7a76\u5f00\u53d1\u9636\u6bb5\u6240\u4f7f\u7528\u65b0\u539f\u6599\u836f\u3001\u8f85\u6599\u548c\u5236\u5242\uff0c\u4e5f\u4e0d\u9002\u7528\u4e8e<\/span>\u5df2\u4e0a\u5e02\u7684\u5236\u5242\u3002<\/span><\/p>\n

    \u672c\u6307\u5bfc\u539f\u5219\u9002\u7528\u4e8e\u6240\u6709\u5242\u578b\u548c\u7ed9\u836f\u9014\u5f84\u3002\u5728\u7279\u5b9a\u60c5\u51b5\u4e0b\uff0c\u5982\u77ed\u671f\uff08\u5982 30 \u5929\u6216\u66f4\u77ed\uff09<\/span>\u4f7f\u7528\u6216\u5c40\u90e8\u4f7f\u7528\u65f6\uff0c\u5141\u8bb8\u5b58\u5728\u66f4\u9ad8\u7684\u6b8b\u7559\u6eb6\u5242\u6c34\u5e73\u3002\u5e94\u6839\u636e\u4e0d\u540c\u60c5\u51b5\u8bba\u8bc1\u8fd9\u4e9b\u6eb6\u5242\u6c34\u5e73<\/span>\u7684\u5408\u7406\u6027\u3002<\/span>\u6709\u5173\u6b8b\u7559\u6eb6\u5242\u7684\u5176\u4ed6\u80cc\u666f\u8d44\u6599\uff0c\u8bf7\u53c2\u89c1\u9644\u5f55 2\u3002<\/mpcpc><\/span><\/p>\n

3. \u901a\u5219<\/span><\/p>\n

3.1 \u57fa\u4e8e\u98ce\u9669\u8bc4\u4f30\u7684\u6b8b\u7559\u6eb6\u5242\u7684\u5206\u7c7b<\/span><\/p>\n

   \u201c\u53ef\u8010\u53d7\u7684\u65e5\u6444\u5165\u91cf\u201d\uff08TDI\uff09\u662f\u56fd\u9645\u5316\u5b66\u54c1\u5b89\u5168\u65b9\u6848\uff08IPCS\uff09\u7528\u4e8e\u9610\u8ff0\u6bd2\u6027\u5316\u5408<\/span>\u7269\u66b4\u9732\u9650\u5ea6\u7684\u672f\u8bed\uff0c\u201c\u53ef\u63a5\u53d7\u7684\u65e5\u6444\u5165\u91cf\u201d\uff08ADI\uff09\u662f\u4e16\u754c\u536b\u751f\u7ec4\u7ec7\uff08WHO\uff09\u53ca\u4e00\u4e9b<\/span>\u56fd\u5bb6\u548c\u56fd\u9645\u536b\u751f\u7ec4\u7ec7\u6240\u7528\u7684\u672f\u8bed\u3002\u5728\u672c\u6307\u5bfc\u539f\u5219\u4e2d\uff0c\u5c06\u65b0\u672f\u8bed\u201c\u6bcf\u65e5\u5141\u8bb8\u66b4\u9732\u91cf\u201d<\/span>\uff08PDE\uff09\u5b9a\u4e49\u4e3a\u836f\u5b66\u4e0a\u53ef\u63a5\u53d7\u7684\u6b8b\u7559\u6eb6\u5242\u6444\u5165\u91cf\uff0c\u4ee5\u907f\u514d\u4e0e\u540c\u4e00\u7269\u8d28\u7684 ADI \u6df7\u6dc6\u3002<\/span><\/p>\n

    \u5c06\u672c\u6307\u5bfc\u539f\u5219\u4e2d\u8bc4\u4ef7\u7684\u6b8b\u7559\u6eb6\u5242\u6309\u901a\u7528\u540d\u548c\u7ed3\u6784\u5217\u4e8e\u9644\u5f55 1\u3002\u8bc4\u4ef7\u4e86\u5176\u5bf9\u4eba\u4f53\u5065\u5eb7<\/span>\u7684\u6f5c\u5728\u5371\u5bb3\uff0c\u5e76\u5c06\u5176\u5206\u4e3a\u4ee5\u4e0b\u4e09\u7c7b\uff1a<\/span><\/p>\n

1 \u7c7b\u6eb6\u5242\uff1a\u5e94\u907f\u514d\u7684\u6eb6\u5242<\/span><\/p>\n

\u5df2\u77e5\u7684\u4eba\u4f53\u81f4\u764c\u7269\uff0c\u5f3a\u7591\u4f3c\u4eba\u4f53\u81f4\u764c\u7269\uff0c\u4ee5\u53ca\u73af\u5883\u5371\u5bb3\u7269\u3002<\/span><\/p>\n

2 \u7c7b\u6eb6\u5242\uff1a\u5e94\u9650\u5236\u7684\u6eb6\u5242<\/span><\/p>\n

\u975e\u9057\u4f20\u6bd2\u6027\u52a8\u7269\u81f4\u764c\u7269\u8d28\uff0c\u6216\u53ef\u80fd\u5bfc\u81f4\u5176\u4ed6\u4e0d\u53ef\u9006\u6bd2\u6027\u5982\u795e\u7ecf\u6bd2\u6027\u6216\u81f4\u7578\u6027\u7684\u6eb6<\/span>\u5242\u3002<\/span>\u53ef\u80fd\u6709\u5176\u4ed6\u4e25\u91cd\u4f46\u53ef\u9006\u7684\u6bd2\u6027\u7684\u6eb6\u5242\u3002<\/span><\/p>\n

3 \u7c7b\u6eb6\u5242\uff1a\u4f4e\u6f5c\u5728\u6bd2\u6027\u7684\u6eb6\u5242<\/span><\/p>\n

\u5bf9\u4eba\u4f53\u4f4e\u6f5c\u5728\u6bd2\u6027\u7684\u6eb6\u5242\uff0c\u65e0\u987b\u5236\u5b9a\u57fa\u4e8e\u5065\u5eb7\u7684\u66b4\u9732\u9650\u5ea6\u30023 \u7c7b\u6eb6\u5242\u7684 PDE \u4e3a\u6bcf<\/span>\u5929 50 mg \u6216 50 mg \u4ee5\u4e0a\u3002<\/span><\/p>\n

3.2 \u5efa\u7acb\u66b4\u9732\u9650\u5ea6\u7684\u65b9\u6cd5<\/span><\/p>\n

\u7528\u4e8e\u5efa\u7acb\u6b8b\u7559\u6eb6\u5242\u7684\u201c\u6bcf\u65e5\u5141\u8bb8\u66b4\u9732\u91cf\u201d\uff08PDE\uff09\u7684\u65b9\u6cd5\u89c1\u9644\u5f55 3\u3002\u7528\u4e8e\u5efa\u7acb\u9650\u5ea6<\/span>\u7684\u6bd2\u7406\u5b66\u6570\u636e\u603b\u7ed3\u53c2\u89c1 Pharmeuropa \u7b2c 9 \u5377\u7b2c 1 \u589e\u8865\u7248\uff0c1997 \u5e74 4 \u6708\u3002<\/span><\/p>\n

3.3 2 \u7c7b\u6eb6\u5242\u9650\u5ea6\u7684\u8868\u793a\u65b9\u6cd5<\/span><\/p>\n

\u5236\u5b9a 2 \u7c7b\u6eb6\u5242\u7684\u9650\u5ea6\u65f6\u6709\u4e24\u79cd\u9009\u62e9\u3002<\/span><\/p>\n

\u65b9\u6cd5 1\uff1a\u53ef\u4ee5\u4f7f\u7528\u8868 2 \u4e2d\u5217\u51fa\u7684\u6d53\u5ea6\u9650\u5ea6\uff08ppm\uff09\u3002\u5047\u5b9a\u67d0\u5236\u5242\u7684\u65e5\u7ed9\u836f\u91cf\u4e3a 10 g\uff0c<\/span>\u7528\u4ee5\u4e0b\u516c\u5f0f\uff081\uff09\u8ba1\u7b97\u3002<\/span><\/p>\n

\"ICH<\/p>\n

    \u8ba4\u4e3a\u8fd9\u4e9b\u9650\u5ea6\u9002\u7528\u4e8e\u6240\u6709\u539f\u6599\u836f\u3001\u8f85\u6599\u548c\u5236\u5242\u3002\u56e0\u6b64\uff0c\u82e5\u65e5\u6444\u5165\u603b\u91cf\u672a\u77e5\u6216\u672a\u5b9a\uff0c<\/span>\u53ef\u91c7\u7528\u8fd9\u79cd\u65b9\u6cd5\u3002\u82e5\u5904\u65b9\u4e2d\u7684\u6240\u6709\u8f85\u6599\u53ca\u539f\u6599\u836f\u90fd\u7b26\u5408\u65b9\u6cd5 1 \u7684\u9650\u5ea6\uff0c\u5219\u8fd9\u4e9b\u7ec4\u5206\u53ef\u6309<\/span>\u4efb\u610f\u6bd4\u4f8b\u4f7f\u7528\u3002\u53ea\u8981\u65e5\u6444\u5165\u603b\u91cf\u4e0d\u8d85\u8fc7 10 g\uff0c\u5c31\u65e0\u987b\u8fdb\u4e00\u6b65\u8ba1\u7b97\u3002\u82e5\u5236\u5242\u7684\u7ed9\u836f\u5242\u91cf\u8d85<\/span>\u8fc7 10 g\/\u5929\uff0c\u5219\u5e94\u6309\u65b9\u6cd5 2 \u8003\u8651\u3002<\/span><\/p>\n

    \u65b9\u6cd5 2\uff1a\u8ba4\u4e3a\u5236\u5242\u7684\u5404\u79cd\u6210\u5206\u4e0d\u5fc5\u90fd\u7b26\u5408\u65b9\u6cd5 1 \u7684\u9650\u5ea6\u3002\u53ef\u7528\u8868 2 \u4e2d\u6ce8\u660e\u7684PDE<\/span>\uff08mg\/\u5929\uff09\u3001\u5df2\u77e5\u6700\u5927\u65e5\u6444\u5165\u603b\u91cf\u548c\u516c\u5f0f\uff081\uff09\u6765\u786e\u5b9a\u5236\u5242\u4e2d\u5141\u8bb8\u7684\u6b8b\u7559\u6eb6\u5242\u7684\u6d53\u5ea6\u3002\u5728<\/span>\u8bc1\u660e\u5df2\u5c3d\u529b\u964d\u4f4e\u8be5\u6b8b\u7559\u6eb6\u5242\u81f3\u5b9e\u9645\u53ef\u8fbe\u5230\u7684\u6700\u4f4e\u6c34\u5e73\u7684\u524d\u63d0\u4e0b\uff0c\u53ef\u63a5\u53d7\u8fd9\u4e9b\u8ba1\u7b97\u6240\u5f97\u9650<\/span>\u5ea6\u3002\u8fd9\u4e9b\u9650\u5ea6\u5728\u5206\u6790\u7cbe\u5bc6\u5ea6\u3001\u751f\u4ea7\u80fd\u529b\u548c\u751f\u4ea7\u5de5\u827a\u7684\u5408\u7406\u53d8\u5f02\u65b9\u9762\u5e94\u73b0\u5b9e\u53ef\u884c\uff0c\u5e76\u5e94\u53cd<\/span>\u6620\u5f53\u524d\u7684\u751f\u4ea7\u6280\u672f\u6c34\u5e73\u3002<\/span><\/p>\n

    \u5e94\u7528\u65b9\u6cd5 2 \u65f6\u53ef\u5c06\u5236\u5242\u5404\u6210\u5206\u6240\u542b\u7684\u6b8b\u7559\u6eb6\u5242\u7d2f\u52a0\u3002\u6bcf\u5929\u7684\u6eb6\u5242\u603b\u91cf\u5e94\u4f4e\u4e8e PDE<\/span>\u7ed9\u5b9a\u7684\u503c\u3002<\/span>\u4e0b\u9762\u4e3e\u4f8b\u8bf4\u660e\u5982\u4f55\u5c06\u65b9\u6cd5 l \u548c 2 \u5e94\u7528\u4e8e\u5236\u5242\u4e2d\u7684\u4e59\u8148\u3002\u4e59\u8148\u7684\u6bcf\u65e5\u5141\u8bb8\u66b4\u9732\u91cf\u662f<\/span>4.1 mg\/\u5929\uff0c\u56e0\u6b64\u65b9\u6cd5 1 \u9650\u5ea6\u662f 410 ppm\u3002\u5236\u5242\u7684\u65e5\u6700\u5927\u7ed9\u836f\u91cf\u662f 5.0 g\uff0c\u542b\u4e24\u79cd\u8f85\u6599\u3002\u5236<\/span>\u5242\u4e2d\u7684\u6210\u5206\u548c\u7b97\u51fa\u7684\u6700\u5927\u4e59\u8148\u6b8b\u7559\u91cf\u89c1\u4e0b\u8868\u3002<\/span><\/p>\n

\"ICH<\/p>\n

    \u5728\u8be5\u793a\u4f8b\u4e2d\uff0c\u6839\u636e\u7d2f\u52a0\u7ed3\u679c\uff0c\u8be5\u5236\u5242\u65e2\u4e0d\u7b26\u5408\u65b9\u6cd5 1 \u4e5f\u4e0d\u7b26\u5408\u65b9\u6cd5 2 \u9650\u5ea6\u3002\u751f\u4ea7\u5546<\/span>\u53ef\u5bf9\u5236\u5242\u8fdb\u884c\u68c0\u6d4b\uff0c\u786e\u5b9a\u5904\u65b9\u5de5\u827a\u80fd\u5426\u964d\u4f4e\u4e59\u8148\u7684\u6c34\u5e73\u3002\u5982\u679c\u5728\u5236\u5242\u8fc7\u7a0b\u4e2d\u4e0d\u80fd\u5c06\u4e59\u8148<\/span>\u6c34\u5e73\u964d\u81f3\u5141\u8bb8\u9650\u5ea6\uff0c\u5236\u5242\u751f\u4ea7\u5546\u5e94\u91c7\u53d6\u5176\u4ed6\u63aa\u65bd\u6765\u964d\u4f4e\u5236\u5242\u7684\u4e59\u8148\u542b\u91cf\u3002\u82e5\u6240\u6709\u63aa\u65bd\u5747<\/span>\u4e0d\u80fd\u964d\u4f4e\u6b8b\u7559\u6eb6\u5242\u7684\u6c34\u5e73\uff0c\u5728\u7279\u6b8a\u60c5\u51b5\u4e0b\uff0c\u751f\u4ea7\u5546\u53ef\u63d0\u4f9b\u5de5\u4f5c\u603b\u7ed3\u62a5\u544a\uff0c\u8bf4\u660e\u4e3a\u5c06\u6b8b\u7559<\/span>\u6eb6\u5242\u964d\u4f4e\u5230\u7b26\u5408\u6307\u5bfc\u539f\u5219\u503c\u6240\u4f5c\u7684\u52aa\u529b\uff0c\u63d0\u4f9b\u98ce\u9669-\u6536\u76ca\u5206\u6790\uff0c\u4e3a\u5141\u8bb8\u4f7f\u7528\u6b8b\u7559\u6eb6\u5242\u91cf<\/span>\u8f83\u9ad8\u7684\u5236\u5242\u63d0\u4f9b\u652f\u6301\u3002<\/span><\/p>\n

3.4 \u5206\u6790\u65b9\u6cd5<\/span><\/p>\n

    \u6b8b\u7559\u6eb6\u5242\u901a\u5e38\u7528\u8272\u8c31\u6280\u672f\uff08\u5982\u6c14\u76f8\u8272\u8c31\u6cd5\uff09\u6d4b\u5b9a\u3002\u5982\u53ef\u80fd\uff0c\u5e94\u91c7\u7528\u836f\u5178\u89c4\u5b9a\u7684\u7edf\u4e00<\/span>\u6b8b\u7559\u6eb6\u5242\u6d4b\u5b9a\u65b9\u6cd5\u3002\u751f\u4ea7\u5546\u4e5f\u53ef\u6839\u636e\u7279\u5b9a\u7533\u8bf7\u81ea\u7531\u9009\u62e9\u9002\u5b9c\u7684\u7ecf\u9a8c\u8bc1\u7684\u5206\u6790\u65b9\u6cd5\u3002\u82e5\u4ec5<\/span>\u5b58\u5728 3 \u7c7b\u6eb6\u5242\uff0c\u53ef\u7528\u975e\u4e13\u5c5e\u6027\u7684\u65b9\u6cd5\u5982\u5e72\u71e5\u5931\u91cd\u6765\u68c0\u67e5\u3002<\/span><\/p>\n

\u6b8b\u7559\u6eb6\u5242\u7684\u65b9\u6cd5\u5b66\u9a8c\u8bc1\u5e94\u9075\u5faa ICH \u6307\u5bfc\u539f\u5219\uff1a\u300a\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u300b\u6b63\u6587\u53ca\u589e\u8865\u90e8\u5206\u3002<\/span><\/p>\n

3.5 \u6b8b\u7559\u6eb6\u5242\u7684\u62a5\u544a\u6c34\u5e73<\/span><\/p>\n

    \u5236\u5242\u751f\u4ea7\u5546\u9700\u8981\u4e86\u89e3\u539f\u6599\u836f\u548c\u8f85\u6599\u6b8b\u7559\u6eb6\u5242\u7684\u67d0\u4e9b\u4fe1\u606f\uff0c\u4ee5\u7b26\u5408\u672c\u6307\u5bfc\u539f\u5219\u7684\u6807<\/span>\u51c6\u3002\u4ee5\u4e0b\u9610\u8ff0\u4e86\u8fd9\u4e9b\u4fe1\u606f\uff08\u5e94\u7531\u539f\u6599\u836f\u6216\u8f85\u6599\u4f9b\u5e94\u5546\u63d0\u4f9b\u7ed9\u5236\u5242\u751f\u4ea7\u5546\uff09\u53ef\u63a5\u53d7\u7684\u4f8b\u5b50<\/span><\/p>\n

    \u4f9b\u5e94\u5546\u53ef\u89c6\u60c5\u51b5\u9009\u62e9\u4ee5\u4e0b\u4e00\u9879\uff1a<\/span><\/p>\n

\uf09f \u4ec5\u53ef\u80fd\u5b58\u5728 3 \u7c7b\u6eb6\u5242\u3002\u5e72\u71e5\u5931\u91cd\u5c0f\u4e8e 0.5 %\u3002<\/span><\/p>\n

\uf09f \u4ec5\u53ef\u80fd\u5b58\u5728 2 \u7c7b\u6eb6\u5242\uff0cX\u3001Y\u2026\u2026\u3002\u5168\u90e8\u4f4e\u4e8e\u65b9\u6cd5 1 \u7684\u9650\u5ea6\u3002\uff08\u8fd9\u91cc\u4f9b\u5e94\u5546\u53ef\u5c06<\/span><\/p>\n

2 \u7c7b\u6eb6\u5242\u7528 X\u3001Y\u2026\u2026\u6765\u8868\u793a\uff09<\/span><\/p>\n

\uf09f \u4ec5\u53ef\u80fd\u5b58\u5728 2 \u7c7b\u6eb6\u5242 X\u3001Y\u2026\u2026\u548c 3 \u7c7b\u6eb6\u5242\u3002\u6b8b\u7559\u7684 2 \u7c7b\u6eb6\u5242\u4f4e\u4e8e\u65b9\u6cd5 1 \u7684\u9650<\/span>\u5ea6\uff0c\u6b8b\u7559\u7684 3 \u7c7b\u6eb6\u5242\u4f4e\u4e8e 0.5 %<\/span>\u5982\u679c\u53ef\u80fd\u5b58\u5728 1 \u7c7b\u6eb6\u5242\uff0c\u5e94\u8fdb\u884c\u9274\u5b9a\u5e76\u5b9a\u91cf\u3002<\/span>\u201c\u53ef\u80fd\u5b58\u5728\u201d\u7cfb\u6307\u7528\u4e8e\u5de5\u827a\u6700\u540e\u4e00\u6b65\uff0c\u4ee5\u53ca\u7528\u4e8e\u8f83\u524d\u51e0\u6b65\u751f\u4ea7\u5de5\u827a\u3001\u7528\u7ecf\u9a8c\u8bc1\u7684\u5de5<\/span>\u827a\u4e0d\u80fd\u4e00\u81f4\u5730\u9664\u5c3d\u7684\u6eb6\u5242\u3002<\/span><\/p>\n

\u5982\u679c 2 \u7c7b\u6eb6\u5242\u9ad8\u4e8e\u65b9\u6cd5 1 \u7684\u9650\u5ea6\u6216 3 \u7c7b\u6eb6\u5242\u9ad8\u4e8e 0.5 %\uff0c\u5e94\u5bf9\u5176\u8fdb\u884c\u9274\u5b9a\u548c\u5b9a\u91cf\u3002<\/span><\/p>\n

4. \u6b8b\u7559\u6eb6\u5242\u7684\u9650\u5ea6<\/span><\/p>\n

4.1 \u5e94\u907f\u514d\u7684\u6eb6\u5242<\/span><\/p>\n

    \u7531\u4e8e 1 \u7c7b\u6eb6\u5242\u5177\u6709\u4e0d\u53ef\u63a5\u53d7\u7684\u6bd2\u6027\u6216\u5bf9\u73af\u5883\u9020\u6210\u5371\u5bb3\uff0c\u539f\u6599\u836f\u3001\u8f85\u6599\u53ca\u5236\u5242\u751f\u4ea7\u4e2d<\/span>\u4e0d\u5e94\u4f7f\u7528\u8be5\u7c7b\u6eb6\u5242\u3002\u4f46\u662f\uff0c\u4e3a\u4e86\u751f\u4ea7\u4e00\u79cd\u6709\u663e\u8457\u6cbb\u7597\u4f18\u52bf\u7684\u5236\u5242\u800c\u4e0d\u5f97\u4e0d\u4f7f\u7528\u65f6\uff0c\u9664\u975e<\/span>\u7ecf\u8fc7\u8bba\u8bc1\uff0c\u5426\u5219\u5e94\u6309\u8868 1 \u8fdb\u884c\u63a7\u5236\u30021,1,1-\u4e09\u6c2f\u4e59\u70f7\u56e0\u5371\u5bb3\u73af\u5883\u800c\u5217\u5165\u8868 1\uff0c\u5176\u9650\u5ea6<\/span>1500ppm \u662f\u57fa\u4e8e\u5b89\u5168\u6027\u6570\u636e\u800c\u5b9a\u7684\u3002<\/span><\/p>\n

\"ICH<\/p>\n

\"ICH<\/p>\n

4.2 \u5e94\u9650\u5236\u7684\u6eb6\u5242<\/span><\/p>\n

\u7531\u4e8e\u88682\u6240\u5217\u6eb6\u5242\u7684\u56fa\u6709\u6bd2\u6027\uff0c\u5e94\u9650\u5236\u5176\u5728\u5236\u5242\u4e2d\u7684\u4f7f\u7528\u3002\u89c4\u5b9aPDE\u7ea6\u4e3a0.1 mg\/\u5929\uff0c<\/span>\u6d53\u5ea6\u7ea6 10 ppm\u3002\u6240\u5217\u503c\u5e76\u4e0d\u53cd\u6620\u6d4b\u5b9a\u65b9\u6cd5\u6240\u5fc5\u9700\u7684\u5206\u6790\u7cbe\u5bc6\u5ea6\u3002\u7cbe\u5bc6\u5ea6\u7684\u6d4b\u5b9a\u5e94\u4f5c\u4e3a<\/span>\u65b9\u6cd5\u5b66\u9a8c\u8bc1\u7684\u4e00\u90e8\u5206\u3002<\/span><\/p>\n


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

\"ICH<\/p>\n

\"ICH<\/p>\n

4.3 \u4f4e\u6f5c\u5728\u6bd2\u6027\u7684\u6eb6\u5242<\/span><\/p>\n

    3 \u7c7b\u6eb6\u5242\uff08\u89c1\u8868 3\uff09\u53ef\u89c6\u4e3a\u4f4e\u6bd2\u3001\u5bf9\u4eba\u7c7b\u5065\u5eb7\u5371\u5bb3\u98ce\u9669\u8f83\u4f4e\u7684\u6eb6\u5242\u30023 \u7c7b\u6eb6\u5242\u4e0d\u5305<\/span>\u62ec\u836f\u5b66\u5e38\u89c1\u6c34\u5e73\u5bf9\u4eba\u7c7b\u5065\u5eb7\u6709\u5371\u5bb3\u7684\u6eb6\u5242\u3002\u7136\u800c\uff0c\u8bb8\u591a 3 \u7c7b\u6eb6\u5242\u6ca1\u6709\u957f\u671f\u6bd2\u6027\u6216\u81f4\u764c\u6027<\/span>\u7814\u7a76\u3002\u73b0\u6709\u6570\u636e\u8868\u660e\uff0c\u5176\u5728\u6025\u6027\u6216\u77ed\u671f\u7814\u7a76\u4e2d\u6bd2\u6027\u8f83\u5c0f\uff0c\u9057\u4f20\u6bd2\u6027\u7814\u7a76\u7ed3\u679c\u5448\u9634\u6027\u3002\u56e0<\/span>\u6b64\u8ba4\u4e3a\u6bcf\u65e5 50 mg \u6216\u66f4\u5c11\u91cf\uff08\u7528\u65b9\u6cd5 1 \u8ba1\u7b97\u65f6\uff0c\u5bf9\u5e94\u4e8e 5000 ppm \u6216 0.5 %\uff09\u65f6\u65e0\u987b\u8bba<\/span>\u8bc1\u5373\u53ef\u63a5\u53d7\u3002\u5982\u7b26\u5408\u751f\u4ea7\u80fd\u529b\u548c GMP \u7684\u5b9e\u9645\u60c5\u51b5\uff0c\u4e5f\u53ef\u63a5\u53d7\u66f4\u5927\u7684\u6b8b\u7559\u91cf\u3002<\/span><\/p>\n


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

\"ICH<\/p>\n

4.4 \u6ca1\u6709\u8db3\u591f\u6bd2\u7406\u5b66\u6570\u636e\u7684\u6eb6\u5242<\/span><\/p>\n

\u751f\u4ea7\u5546\u5728\u8f85\u6599\u3001\u539f\u6599\u836f\u548c\u5236\u5242\u751f\u4ea7\u4e2d\u8fd8\u53ef\u80fd\u4f1a\u91c7\u7528\u4ee5\u4e0b\u6eb6\u5242\uff08\u8868 4\uff09\u3002\u4f46\u5c1a\u65e0\u8db3\u591f<\/span>\u7684\u6bd2\u7406\u5b66\u6570\u636e\uff0c\u6545\u65e0 PDE \u503c\u3002\u751f\u4ea7\u5546\u5e94\u8bba\u8bc1\u8fd9\u4e9b\u6eb6\u5242\u5728\u5236\u5242\u4e2d\u7684\u6b8b\u7559\u91cf\u7684\u5408\u7406\u6027\u3002<\/span><\/p>\n


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

\"ICH<\/p>\n

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

\"ICH<\/p>\n


<\/p>\n

\"ICH<\/p>\n

\"ICH<\/p>\n

\"ICH<\/p>\n

\"ICH<\/p>\n

\"ICH<\/p>\n

\"ICH<\/p>\n

\"ICH<\/p>\n

\"ICH<\/p>\n

\"ICH<\/p>\n

\"ICH<\/p>\n

\"ICH<\/p>\n

\"ICH<\/p>\n

\n

\uff08\u672a\u5b8c\u5f85\u7eed\uff09<\/span><\/p>\n

<\/mpcps><\/section>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"

\u4eba\u7528\u836f\u54c1\u6ce8\u518c\u6280\u672f\u8981\u6c42\u56fd\u9645\u534f\u8c03\u4f1a   ICH \u534f\u8c03\u6307\u5bfc\u539f\u5219   \u6742\u8d28\uff1a\u6b8b\u7559\u6eb6\u5242\u7684\u6307\u5bfc\u539f\u5219 Q […]<\/p>\n","protected":false},"author":1,"featured_media":80512,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[2],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/80511"}],"collection":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/comments?post=80511"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/80511\/revisions"}],"predecessor-version":[{"id":80534,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/80511\/revisions\/80534"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/80512"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=80511"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=80511"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=80511"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}