{"id":98727,"date":"2019-04-15T00:00:50","date_gmt":"2019-05-17T08:16:26","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/98727\/"},"modified":"2019-05-17T16:16:29","modified_gmt":"2019-05-17T08:16:29","slug":"ec8d061d0d","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/98727\/","title":{"rendered":"\u3010\u6848\u4f8b\u63ed\u79d8\u3011 \u4f7f\u7528DDDplus\u8f6f\u4ef6\u6a21\u62df\u4f53\u5916\u6eb6\u51fa\u884c\u4e3a"},"content":{"rendered":"
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\u6765\u6e90\uff1a<\/strong><\/span>\u516c\u4f17\u53f7<\/strong><\/span><\/p>\n

\u4f5c\u8005\uff1a<\/strong><\/span>\u987e\u5ddd\u6c5f<\/strong><\/span>
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\n
\n

\u66fe\u7ecf\u63a8\u9001\u8fc7\uff1a<\/strong><\/p>\n

\u3010\u7b2c\u5341\u5b63\u7fa4\u53cb\u4f1a\u4e13\u9898\u3011\u91c7\u7528\u5efa\u6a21\u4e0e\u6a21\u62df\u8fdb\u884c\u5236\u5242\u5f00\u53d1\u4e0e\u51b3\u7b56\u6307\u5bfc<\/a><\/strong><\/p>\n

\u3010\u6848\u4f8b\u63ed\u79d8\u3011\u57fa\u4e8e\u673a\u68b0\u80a0\u80c3\u6a21\u62df\u548c\u4eba\u5de5\u795e\u7ecf\u7f51\u7edc\u7684\u4f53\u5916-\u8ba1\u7b97\u673a\u6a21\u62df-\u4f53\u5185\u836f\u7269\u5438\u6536\u6a21\u578b\u5f00\u53d1\uff1a\u785d\u82ef\u5730\u5e73\u6e17\u900f\u7f13\u91ca\u7247\u6848\u4f8b\u7814\u7a76<\/a><\/strong>
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\u3010\u5efa\u6a21\u6a21\u62df\u3011\u4f7f\u7528\u52a8\u6001\u80c3\u6a21\u578b\u7814\u7a76\u5728\u7981\u98df\u548c\u975e\u7981\u98df\u60c5\u51b5\u4e0b\u805a\u5408\u7269\u542b\u91cf\u4f4e\u7684\u4eb2\u6c34\u57fa\u8d28\u9aa8\u67b6\u5236\u5242\u7684\u53cd\u5e94<\/a><\/strong>
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 \u591a\u7bc7\u5efa\u6a21\u6a21\u62df\u7684\u6587\u7ae0\u4e0e<\/strong>\u540c\u884c\u5206\u4eab\u3002<\/strong>
<\/p>\n

\u672c\u6587\u51fa\u5904\u89c1\u4e0b\u9762\u622a\u56fe\uff1a<\/strong><\/span>
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\"\u3010\u6848\u4f8b\u63ed\u79d8\u3011<\/p>\n


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

\"\u3010\u6848\u4f8b\u63ed\u79d8\u3011<\/p>\n

    <\/span>
<\/p>\n

\u4f7f\u7528<\/span>DDDplus\u8f6f\u4ef6\u6a21\u62df\u4f53\u5916\u6eb6\u51fa\u884c\u4e3a<\/span><\/strong><\/span><\/p>\n

  <\/p>\n

[\u6458\u8981<\/span>] <\/span><\/span><\/strong>\u6eb6\u51fa\u5ea6\u6d4b\u8bd5\u662f\u8bb8\u591a\u5242\u578b\uff08\u5305\u62ec\u7247\u5242\u548c\u80f6\u56ca\uff09\u7684\u6027\u80fd\u6d4b\u8bd5\u3002<\/span><\/p>\n

\u672c\u7814\u7a76\u7684\u76ee\u7684\u662f\u8bc4\u4f30\u8ba1\u7b97\u673a\u6a21\u62df\u662f\u5426\u53ef\u4ee5\u9884\u6d4b\u4e24\u79cd\u6a21\u578b\u836f\u7269\u7684\u4f53\u5916\u6eb6\u51fa\u5ea6\uff0c\u800c\u8fd9\u4e24\u79cd\u4e0d\u540c\u836f\u7269\u7684\u6eb6\u51fa\u6570\u636e\u53ef\u4ee5\u83b7\u5f97\u3002\u4f7f\u7528\u516c\u5e03\u7684\u5b5f\u9c81\u53f8\u7279\u94a0\u548c\u683c\u5217\u672c\u8132\u6eb6\u51fa\u6570\u636e\u7528\u4e8e\u6a21\u62df\u3002\u8bc4\u4f30\u4e86\u4e0d\u540c\u7684\u836f\u5178\u548c\u751f\u7269\u6eb6\u51fa\u5ea6\u68c0\u6d4b\u4ecb\u8d28\uff0c\u4f53\u79ef\u548c\u8f6c\u901f\u3002\u53e6\u5916\uff0c\u4f7f\u7528\u8fd9\u4e9b\u7f13\u51b2\u6db2\u8bc4\u4f30\u4e00\u4e2a<\/span>pH\u503c\u53d8\u5316\u65b9\u6848\u3002<\/span> <\/span>DDDPlus\u21223\uff0c<\/span>Beta\u7248\uff08<\/span>Simulation Plus\uff0c<\/span>Inc\u3002\uff09\u7528\u4e8e\u6a21\u62df\u4f53\u5916\u6eb6\u51fa\u6570\u636e\u3002\u5c06\u6a21\u62df\u6570\u636e\u4e0e\u4f53\u5916\u6570\u636e\u8fdb\u884c\u6bd4\u8f83\u3002\u4f7f\u7528\u9884\u6d4b\u6570\u636e\u548c\u89c2\u5bdf\u6570\u636e\u4e4b\u95f4\u7684\u56de\u5f52\u7cfb\u6570\u6765\u8bc4\u4f30\u6a21\u62df\u3002\u5b5f\u9c81\u53f8\u7279\u94a0\u7edf\u8ba1\u5206\u6790\u663e\u793a\uff0c\u9664\u4e00\u79cd\u7f13\u51b2\u6db2\u5916\uff0c\u6240\u6709\u6848\u4f8b\u7684\u4f53\u5916\u91ca\u653e\u6570\u636e\u4e0e\u9884\u6d4b\u6570\u636e\u4e4b\u95f4\u5b58\u5728\u663e\u8457\u76f8\u5173\u6027\u3002\u4f7f\u7528\u5355\u4e00<\/span>pH\u6761\u4ef6\uff0c\u683c\u5217\u672c\u8132\u5728\u5b9e\u9a8c\u6570\u636e\u4e0e\u9884\u6d4b\u6570\u636e\u4e4b\u95f4\u5b58\u5728\u663e\u8457\u76f8\u5173\u6027\u3002\u4f7f\u7528\u52a8\u6001<\/span>pH\u65b9\u6848\uff0c\u5bf9\u4e8e\u4e00\u79cd\u751f\u7269\u6eb6\u51fa\u5ea6\u4ecb\u8d28\u662f\u663e\u8457\u76f8\u5173\u6027\u3002\u6a21\u62df\u663e\u793a\u4f53\u5916\u836f\u7269\u91ca\u653e\u90fd\u5bf9\u6eb6\u89e3\u5ea6\u6548\u5e94\u654f\u611f\uff0c\u8fd9\u8bc1\u5b9e\u4e86\u5b83\u4eec\u7684<\/span>BCS\u5f52\u5c5e<\/span> <\/span>II\u7c7b\u3002\u4f7f\u7528<\/span>DDDPlus\u7684\u4f53\u5916\u91ca\u653e\u7684\u8ba1\u7b97\u673a\u6a21\u62df\u5177\u6709\u5728\u836f\u7269\u5f00\u53d1\u8fc7\u7a0b\u7684\u65e9\u671f\u9636\u6bb5\u4f30\u8ba1\u4f53\u5185\u6eb6\u51fa\u7684\u6f5c\u529b\u3002\u8fd9\u53ef\u80fd\u7528\u4e8e\u9009\u62e9\u6700\u5408\u9002\u7684\u6eb6\u51fa\u6761\u4ef6\uff0c\u4ee5\u5efa\u7acb<\/span>IVIVC\u5e76\u5f00\u53d1\u751f\u7269\u6eb6\u51fa\u5ea6\u76f8\u5173\u7684\u4f53\u5916\u6027\u80fd\u6d4b\u8bd5\uff0c\u4ee5\u901a\u8fc7\u8bbe\u8ba1\u7a7a\u95f4\u6355\u83b7\u8d28\u91cf\u63a7\u5236\u8fc7\u7a0b\u4e2d\u7684\u5173\u952e\u4ea7\u54c1\u5c5e\u6027\u3002<\/span><\/span><\/p>\n

\u5173\u952e\u8bcd<\/span><\/strong>\uff1a\u751f\u7269\u6eb6\u51fa\u5ea6\u4ecb\u8d28\uff1b<\/span>DDDPlus, <\/span>\u6eb6\u51fa\u6d4b\u8bd5<\/span>; QbD\uff1b<\/span>QC<\/span><\/p>\n

\u4ecb\u7ecd<\/span><\/strong><\/p>\n

\u836f\u7269\u5438\u6536\u53d6\u51b3\u4e8e\u751f\u7406\u56e0\u7d20\u548c\u836f\u7269\u6eb6\u89e3\u5e76\u88ab\u5438\u6536\u7684\u7406\u5316\u6027\u8d28\u3002\u5242\u578b\u7684\u6eb6\u51fa\u53d6\u51b3\u4e8e\u7ed9\u836f\u540e\uff0c\u836f\u7269\u672c\u8eab\u7684\u6eb6\u89e3\u5ea6\u548c\u5242\u578b\u7684\u91ca\u653e\u6a21\u5f0f\uff08<\/sup><\/span>1<\/sup>\uff09<\/span><\/sup>\u3002\u836f\u7269\u7684\u6eb6\u89e3\u5ea6\u53d6\u51b3\u4e8e\u8bb8\u591a\u56e0\u7d20\uff0c\u6bd4\u5982\u5206\u5b50\u91cf\uff0c\u4eb2\u8102\u6027\uff0c\u6676\u4f53\u6216\u975e\u6676\u6001\u548c<\/span>pKa\uff08<\/span><\/sup>2-4<\/sup>\uff09<\/span><\/sup>\u3002\u7814\u7a76\u8868\u660e\uff0c\u836f\u7269\u5dee\u7684\u6eb6\u89e3\u5ea6\u53ef\u80fd\u5bfc\u81f4\u836f\u7269\u5438\u6536\u6709\u9650\uff0c\u4f46\u53ea\u8981\u6eb6\u51fa\u673a\u7406\u80fd\u88ab\u6478\u900f\uff0c\u914d\u65b9\u5de5\u827a\u53ef\u4ee5\u514b\u670d\u8fd9\u4e9b\u95ee\u9898\uff08<\/sup><\/span>5-8<\/sup>\uff09<\/span><\/sup>\u3002\u751f\u7269\u836f\u5242\u5b66\u5206\u7c7b\u7cfb\u7edf\uff08<\/span>BCS\uff09\u6839\u636e\u836f\u7269\u7684\u6eb6\u89e3\u5ea6\u548c\u6e17\u900f\u6027\u5bf9\u836f\u7269\u8fdb\u884c\u5206\u7c7b\uff0c\u5206\u4e3a\u56db\u4e2a\u7c7b\u522b\u3002<\/span>1\u7c7b\u548c<\/span>3\u7c7b\u836f\u7269\u6eb6\u89e3\u5ea6\u9ad8\uff0c\u800c<\/span>2\u7c7b\u548c<\/span>4\u7c7b\u7684\u6eb6\u89e3\u5ea6\u8f83\u4f4e\uff08<\/sup><\/span>8<\/sup>\uff09<\/span><\/sup>\u3002<\/span><\/span><\/p>\n

\u836f\u7269\u6eb6\u51fa\u8bd5\u9a8c\u7528\u4e8e\u836f\u7269\u5f00\u53d1\u7684\u65e9\u671f\u548c\u540e\u671f\uff0c\u7528\u4e8e\u8bb8\u591a\u5242\u578b\uff0c\u5305\u62ec\u7247\u5242\u548c\u80f6\u56ca\uff08<\/sup><\/span>9<\/sup>\uff09<\/span><\/sup>\u3002\u5728\u65e9\u671f\u836f\u7269\u5f00\u53d1\u9636\u6bb5\uff0c\u6eb6\u51fa\u5ea6\u6d4b\u8bd5\u6709\u52a9\u4e8e\u7814\u7a76\u4eba\u5458\u627e\u5230\u6700\u4f73\u914d\u65b9\uff0c\u4ee5\u4f7f\u53e3\u670d\u5242\u578b\u7684\u4f53\u5916\u884c\u4e3a\u8fbe\u5230\u6240\u9700\u7684\u5c5e\u6027\uff08<\/sup><\/span>1,6-8,10<\/sup>\uff09<\/span><\/sup>\u3002\u4e4b\u540e\uff0c\u6eb6\u51fa\u66f2\u7ebf\u53ef\u7528\u4e8e\u5efa\u7acb\u4f53\u5916<\/span>\/\u4f53\u5185\u76f8\u5173\u6027\uff08<\/span>IVIVC\uff09\uff0c\u8fd9\u53ef\u4ee5\u51cf\u5c11\u5bf9\u6602\u8d35\u7684\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u7684\u9700\u6c42\uff08<\/sup><\/span>6,11<\/sup>\uff09<\/span><\/sup>\u3002<\/span><\/span><\/p>\n

\u5728\u836f\u7269\u5f00\u53d1\u7684\u6700\u540e\u9636\u6bb5\uff0c\u6eb6\u51fa\u5ea6\u6d4b\u8bd5\u7528\u4e8e\u8d28\u91cf\u63a7\u5236\uff0c\u5373\u6d4b\u8bd5\u6279\u6b21\u95f4\u7684\u4e00\u81f4\u6027\uff0c\u7a33\u5b9a\u6027\uff0c\u4ee5\u53ca\u68c0\u6d4b\u53ef\u80fd\u5bfc\u81f4\u6574\u6279\u4ea7\u54c1\u88ab\u62d2\u7edd\u653e\u884c\u7684\u751f\u4ea7\u7f3a\u9677\u3002\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40\uff08<\/span>FDA\uff09\u8981\u6c42\u6eb6\u51fa\u5ea6\u6d4b\u8bd5\uff0c\u5e76\u5728\u7f8e\u56fd\u836f\u5178\uff08<\/span>USP\uff09\u4e2d\u5217\u4e3a\u4f53\u5916\u6027\u80fd\u6d4b\u8bd5\u3002\u6eb6\u51fa\u8bd5\u9a8c\u5728<\/span>50\u591a\u5e74\u524d\u5f15\u5165<\/span>USP\uff0c\u5e76\u5728<\/span><711>\uff08<\/span><\/sup>6,12,13<\/sup>\uff09\u7ae0\u8282\u4e2d\u8be6\u7ec6\u63cf\u8ff0\u3002<\/span><\/span><\/p>\n

\u65e9\u671f\u9884\u4f30\u6eb6\u51fa\u884c\u4e3a\u548c\u7814\u7a76\u5904\u65b9\u56e0\u7d20\u5bf9\u6eb6\u51fa\u5ea6\u7684\u5f71\u54cd\u5bf9\u4e8e\u836f\u7269\u5904\u65b9\u5f00\u53d1\u81f3\u5173\u91cd\u8981\uff08<\/sup><\/span>1,2,13<\/sup>\uff09<\/span><\/sup>\u3002\u5728\u836f\u7269\u53d1\u73b0\u9636\u6bb5\u4f7f\u7528<\/span>Insilico\u65b9\u6cd5\u6765\u9884\u4f30\u836f\u7269\u6eb6\u51fa\u53ef\u4ee5\u51cf\u5c11\u8bb8\u591a\u8bd5\u9a8c\u548c\u6d88\u9664\u9519\u8bef\u5b9e\u9a8c\u5e76\u8282\u7701\u65f6\u95f4\u548c\u91d1\u94b1\uff08<\/sup><\/span>2-5<\/sup>\uff09<\/span><\/sup>\u3002\u672c\u7814\u7a76\u7684\u76ee\u7684\u662f\u8bc4\u4f30\u9884\u6d4b\u4e24\u79cd\u6a21\u578b\u836f\u7269\u4f53\u5916\u6eb6\u51fa\u7684\u8ba1\u7b97\u673a\u6a21\u62df\u6027\u80fd\u3002<\/span><\/span><\/p>\n

\u65b9\u6cd5<\/span>    <\/span><\/p>\n

 <\/span>\u5b5f\u9c81\u53f8\u7279\u3002\u516c\u5e03\u7684\u5b5f\u9c81\u53f8\u7279\u6eb6\u51fa\u6570\u636e\u7528\u4e8e\u6a21\u62df\uff08<\/sup><\/span>14<\/span><\/sup>\uff09<\/span><\/sup>\u3002\u4f53\u5916\u8bd5\u9a8c\u5728<\/span>USP<\/span>\u88c5\u7f6e<\/span>II<\/span>\uff08\u6868\u6cd5\uff09\uff0c\u6e29\u5ea6<\/span>37\u00b10.5\u2103<\/span>\uff0c\u6eb6\u51fa\u676f\u4f53\u79ef<\/span>900mL<\/span>\uff0c\u8f6c\u901f\u4e3a<\/span>75<\/span>\u6216<\/span>100rpm<\/span>\u3002\u4f7f\u7528\u56db\u79cd\u4e0d\u540c\u7684\u751f\u7269\u6eb6\u51fa\u4ecb\u8d28\u8fdb\u884c\u6d4b\u8bd5\uff1a<\/span>USP<\/span>\u6a21\u62df\u80a0\u6db2\uff08<\/span>SIF<\/span>\uff09\uff0c<\/span>pH6.8<\/span>\u7f13\u51b2\u6db2\uff0c\u7a7a\u767d\u7981\u98df\u72b6\u6001\u6a21\u62df\u80a0\u6db2\uff08<\/span>BFaSSIF<\/span>\uff09\u548c\u7981\u98df\u72b6\u6001\u6a21\u62df\u80a0\u6db2\uff08<\/span>FaSSIF<\/span>\uff09\uff08<\/sup><\/span>14<\/span><\/sup>\uff09<\/span><\/sup>\u3002<\/span> <\/span>FaSSIF<\/span>\u7684\u4f7f\u7528\u4f53\u79ef\u4e3a<\/span>500<\/span>\u548c<\/span>900 mL<\/span>\u3002\u7a7a\u767d<\/span>FaSSIF<\/span>\u4e0d\u542b\u5375\u78f7\u8102\u6216\u725b\u78fa\u80c6\u9178\u94a0\u3002\u8868<\/span>I<\/span>\u5217\u51fa\u4e86\u4ecb\u8d28\u7684\u7ec4\u6210\u3002<\/span><\/p>\n

\u8868<\/span>I.\u6a21\u62df\u4e2d\u4f7f\u7528\u7684\u4ecb\u8d28\u7ec4\u6210<\/span><\/span><\/p>\n\n\n\n\n
\n

\u4ecb\u8d28<\/span><\/p>\n<\/td>\n

\n

  USP  SIF<\/span><\/p>\n<\/td>\n

\n

\uff08<\/span>FaSSIF\uff09<\/span><\/span><\/p>\n<\/td>\n

\n

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

\n

\u7ec4\u6210<\/span>14<\/sup><\/span><\/p>\n<\/td>\n

\n

\uff08<\/span>0.023M\uff09\u6c22\u6c27\u5316\u94a0\uff08<\/span>0.005M\uff09\u78f7\u9178\u4e8c\u6c22\u94be<\/span><\/span><\/p>\n<\/td>\n

\n

\uff08<\/span>0.029M\uff09\u78f7\u9178\u4e8c\u6c22\u94a0\uff08<\/span>0.0095M\uff09\u6c22\u6c27\u5316\u94a0\uff08<\/span>0.015M\uff09\u6c2f\u5316\u94a0\uff08<\/span>0.0035M\uff09\u725b\u78fa\u80c6\u9178\u94a0<\/span>.(0.00075M)\u5375\u78f7\u8102<\/span><\/span><\/p>\n<\/td>\n

\n

\u4e0e<\/span>FaSSIF\u76f8\u540c\u7684\u6210\u5206\u4f46\u6ca1\u6709\u80c6\u6c41\u76d0\uff08\u5375\u78f7\u8102\u6216\u725b\u78fa\u80c6\u9178\u94a0\uff09<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\u4f7f\u7528<\/span>DDDPlus TM 3<\/span>\uff08<\/span>Dose Disintegration andDissolution Plus<\/span>\uff09\uff0c<\/span>beta<\/span>\u7248\uff08<\/span>Simulation Plus<\/span>\uff0c<\/span>Inc<\/span>\u3002\uff09\uff0c\u4f7f\u7528\u4e0a\u8ff0\u6eb6\u51fa\u8bd5\u9a8c\u6761\u4ef6\u6a21\u62df\u836f\u7269\u7684\u4f53\u5916\u91ca\u653e\u3002<\/span> <\/span>DDDPlus\u2122<\/span>\u662f\u4e00\u79cd\u8ba1\u7b97\u673a\u7a0b\u5e8f\uff0c\u7528\u4e8e\u5efa\u6a21\u548c\u6a21\u62df\u6d3b\u6027\u836f\u7269\u6210\u5206\uff08<\/span>API<\/span>\uff09\u6216\u5176\u5236\u5242\u7684\u4f53\u5916\u6eb6\u51fa\u5ea6\u3002\u8be5\u8f6f\u4ef6\u6709\u4e09\u4e2a\u4e3b\u8981\u9009\u9879\u5361\uff1a\u914d\u65b9\uff0c\u5b9e\u9a8c\u8bbe\u7f6e\u548c\u6a21\u62df\u3002\u5728\u914d\u65b9\u9009\u9879\u5361\u4e2d\uff0c\u836f\u7269\u7684\u7269\u7406\u5316\u5b66\u53c2\u6570\u7528\u4e8e\u5b9a\u4e49\u6a21\u62df\u7684\u5173\u952e\u53c2\u6570\uff0c\u5982\u8868<\/span>II<\/span>\u6240\u793a\u3002<\/span><\/span><\/p>\n

                          <\/span><\/span>\u8868<\/span>II<\/span>\u7528\u4e8e\u6a21\u62df\u7684\u8f93\u5165\u6570\u636e<\/span><\/span><\/p>\n\n\n\n\n\n\n\n\n\n\n
\n

\u836f\u7269<\/span><\/p>\n<\/td>\n

\n

\u683c\u5217\u82ef\u8132<\/span><\/p>\n<\/td>\n

\n

\u5b5f\u9c81\u65af\u7279<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u5242\u91cf\uff08<\/span>mg<\/span>\uff09<\/span><\/span><\/p>\n<\/td>\n

\n

3.5(15)<\/sup><\/span><\/p>\n<\/td>\n

\n

10(14)<\/sup><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u5242\u578b<\/span><\/p>\n<\/td>\n

\n

\u901f\u91ca\uff08<\/sup><\/span>15<\/span><\/sup>\uff09<\/span><\/sup><\/span><\/p>\n<\/td>\n

\n

\u901f\u91ca\uff08<\/sup><\/span>14<\/span><\/sup>\uff09<\/span><\/sup><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u6eb6\u89e3\u5ea6\uff08<\/span>mg\/ml<\/span>\uff09<\/span><\/span><\/p>\n<\/td>\n

\n

0.043(pH 7.4) <\/span>(15)<\/sup><\/span><\/p>\n<\/td>\n

\n

0.0007 (pH 6.5) <\/span>(16)<\/sup><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u5e73\u5747\u7c92\u5b50\u534a\u5f84<\/span>(<\/span>\u03bc<\/span>m)<\/span><\/span><\/p>\n<\/td>\n

\n

6.28 <\/span>(15)<\/sup><\/span><\/p>\n<\/td>\n

\n

6.572 <\/span>(14)<\/sup><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u9897\u7c92\u5bc6\u5ea6\uff08<\/span>g\/ml<\/span>\uff09<\/span><\/span><\/p>\n<\/td>\n

\n

1.38<\/span>\uff08<\/span><\/sup>15<\/span><\/sup>\uff09<\/span><\/sup><\/span><\/p>\n<\/td>\n

\n

1.2<\/span>\uff08<\/span>ADMET <\/span><\/span>\u9ed8\u8ba4\u8bbe\u7f6e\uff09<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u6269\u6563\u7cfb\u6570\uff08<\/span>cm2<\/sup>\/s<\/span>\u25ca<\/span>10-5<\/sup><\/span>\uff09<\/span><\/span><\/p>\n<\/td>\n

\n

0.5878(15)<\/sup><\/span><\/p>\n<\/td>\n

\n

0.54(ADMET 5)<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

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

\n

5.5,(ADMET  5)11.62,10.64<\/span><\/p>\n<\/td>\n

\n

2.8,5.7(16)<\/sup><\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/span><\/p>\n

\u5728\u5b9e\u9a8c\u8bbe\u7f6e\u9009\u9879\u5361\u4e2d\uff0c\u6307\u5b9a\u4e86\u88c5\u7f6e\u7c7b\u578b\uff0c\u4eea\u5668\u901f\u5ea6\uff0c\u4ecb\u8d28\u4f53\u79ef\u548c\u4ecb\u8d28\u7c7b\u578b\u3002\u5728\u672c\u7814\u7a76\u4e2d\uff0c\u4e3a\u6bcf\u79cd\u4ecb\u8d28\u751f\u6210\u4e86\u5355\u72ec\u7684\u6570\u636e\u5e93\u8bb0\u5f55\u3002\u5728\u7a7a\u767d<\/span>FaSSIF\u4e2d\uff0c\u5375\u78f7\u8102\u548c\u725b\u78fa\u80c6\u9178\u94a0\u7684\u6eb6\u89e3\u5ea6\u589e\u5f3a\u56e0\u5b50\uff08<\/span>SEF\uff09\u8bbe\u5b9a\u4e3a<\/span>1\uff0c\u56e0\u4e3a\u8be5\u57f9\u517b\u57fa\u4e0d\u542b\u589e\u6eb6\u5242\u3002\u5728<\/span>75rpm\u7684<\/span>500mL FaSSIF\u4e2d\uff0c\u4f18\u5316\u4e86<\/span>SEF\uff0c\u56e0\u6b64\u8f6f\u4ef6\u6a21\u578b\u62df\u5408\u4e86\u5b9e\u9a8c\u6570\u636e\uff1a\u5375\u78f7\u8102<\/span>SEF = 36702.14; <\/span>\u725b\u78fa\u80c6\u9178\u94a0<\/span>SEF = 96200.54\u3002\u5728\u5269\u4f59\u7684<\/span>FaSSIF\u4ecb\u8d28\u4e2d\u4f7f\u7528\u76f8\u540c\u7684<\/span>SEF\u503c\uff08<\/span>500mL\uff0c<\/span>100rpm\uff0c<\/span>900mL\uff0c<\/span>75rpm\uff09\u3002\u6240\u7528<\/span>API\u5b9e\u9a8c\u6570\u636e\u7684\u7c92\u5ea6\u5206\u5e03\u5217\u4e8e\u56fe<\/span>1.\u8be5\u5206\u5e03\u7528\u4f5c<\/span>DDDPlus TM\u4e2d\u7684\u8f93\u5165\u53c2\u6570\u4ee5\u8fdb\u884c\u6a21\u62df\u3002<\/span><\/span><\/p>\n

\u683c\u5217\u672c\u8132\u3002\u516c\u5e03\u7684\u683c\u5217\u672c\u8132\u4f53\u5916\u6eb6\u51fa\u6570\u636e\u7528\u4e8e\u6a21\u62df\uff08<\/sup><\/span>15,16<\/sup>\uff09<\/span><\/sup>\u3002\u4e3a\u4e86\u672c\u6b21\u7814\u7a76\u7684\u76ee\u7684\uff0c\u9009\u62e9\u4e86\u8be5\u7814\u7a76\u7684\u53c2\u6bd4\u4ea7\u54c1\uff0c\u56e0\u4e3a\u53ef\u4ee5\u5f97\u5230\u8be5\u4ea7\u54c1\u7684\u66f4\u591a\u4fe1\u606f\u3002\u672c\u7814\u7a76\u5728\u4e09\u79cd\u4e0d\u540c\u4ecb\u8d28\u4e2d\u8fdb\u884c\uff1a<\/span>SIF\uff0c<\/span>BFaSSIF\u548c<\/span>FaSSIF\uff0c\u4f7f\u7528<\/span>USP\u88c5\u7f6e<\/span>II\uff08\u6868\u6cd5\uff09\u3002\u5b9e\u9a8c\u6761\u4ef6<\/span>37\u00b10.5\u2103\uff0c<\/span>900mL\uff0c<\/span>75rpm\uff0c\u5355\u4e00\u4ecb\u8d28<\/span>pH6.5\uff0c\u52a8\u6001<\/span>pH\u8303\u56f4\u4ecb\u8d28<\/span>pH6.0,6.5,7.0,7.5\u548c<\/span>5.0\u3002\u968f\u7740\u65f6\u95f4\u6539\u53d8<\/span>pH\u6761\u4ef6\u4ee5\u6a21\u62df\u5242\u578b\u7684\u80a0\u9053\u7a7f\u8d8a\u3002\u5982\u8868<\/span>III\u6240\u793a\uff0c<\/span>FaSSIF\u542b\u6709<\/span>3mM\u725b\u78fa\u80c6\u9178\u94a0\u548c<\/span>0.75mM\u5375\u78f7\u8102\u3002\u5728\u5b9e\u9a8c\u7814\u7a76\u4e2d\uff0c\u4f7f\u7528\u4e86\u4e24\u79cd\u5316\u5b66\u7eaf\u7684\u725b\u78fa\u80c6\u9178\u94a0\u548c\u5375\u78f7\u8102\uff1a\u4f4e\u8d28\u91cf\uff08\u7c97\u725b\u78fa\u80c6\u9178\u94a0\u548c<\/span>60\uff05\u5375\u78f7\u8102\uff09\u548c\u9ad8\u8d28\u91cf\uff08<\/span>97\uff05\u725b\u78fa\u80c6\u9178\u94a0\u548c<\/span>99\uff05\u5375\u78f7\u8102\uff09\u3002\u5728\u8be5\u6a21\u62df\u7a0b\u5e8f\u4e2d\uff0c\u6ca1\u6709\u53ef\u7528\u4e8e\u6539\u53d8\u725b\u78fa\u80c6\u9178\u94a0\u548c\u5375\u78f7\u8102\u7684\u5316\u5b66\u7eaf\u7684\u9009\u9879\u3002\u56e0\u6b64\uff0c\u4f30\u7b97<\/span>LQ FaSSIF\u548c<\/span>HQ FaSSIF\u4e2d\u6eb6\u51fa\u5ea6\u7684\u8f93\u5165\u662f\u76f8\u540c\u7684\u3002<\/span><\/span><\/p>\n

\u4f7f\u7528\u914d\u65b9\u9009\u9879\uff08\u8868<\/span>II<\/span>\uff09\u4e0e\u5b5f\u9c81\u53f8\u7279\u94a0\u76f8\u540c\u7684\u65b9\u5f0f\u5e94\u7528\u8f93\u5165\u53c2\u6570\u3002\u6839\u636e\u7814\u7a76\uff08<\/sup><\/span>15,16<\/sup>\uff09<\/span><\/sup>\u7684\u89c4\u5b9a\u4f7f\u7528\u7279\u5b9a\u7684\u88c5\u7f6e\u578b\u53f7\uff0c\u88c5\u7f6e\u901f\u5ea6\uff0c\u4ecb\u8d28\u4f53\u79ef\u548c\u4ecb\u8d28\u7c7b\u578b\u3002\u5728\u7a7a\u767d<\/span>FaSSIF<\/span>\u4e2d\uff0c\u5375\u78f7\u8102\u548c\u725b\u78fa\u80c6\u9178\u94a0\u7684\u6eb6\u89e3\u5ea6\u589e\u5f3a\u56e0\u5b50\uff08<\/span>SEF<\/span>\uff09\u7b49\u4e8e<\/span>1; <\/span><\/span>\u7136\u800c\uff0c\u5728<\/span>FaSSIF<\/span>\u4e2d\uff0c<\/span>SEF<\/span>\u9488\u5bf9\u4f4e\u8d28\u91cf\u7684<\/span>FaSSIF<\/span>\u8fdb\u884c\u4e86\u4f18\u5316\uff0c\u52a8\u6001<\/span>pH<\/span>\u53d8\u5316\u65b9\u6848\u5982\u4e0b\uff1a\u5375\u78f7\u8102<\/span>SEF = 1374.91; <\/span><\/span>\u725b\u78fa\u80c6\u9178\u94a0<\/span>SEF = 96200.54<\/span>\u3002\u5c06\u76f8\u540c\u7684\u503c\u5e94\u7528\u4e8e\u5269\u4f59\u7684<\/span>FaSSIF<\/span>\u4ecb\u8d28\u3002\u4e3a\u4e86\u6a21\u62df\u6052\u5b9a\u7684<\/span>pH<\/span>\u6761\u4ef6\uff0c\u5728\u6574\u4e2a\u6a21\u62df\u8fc7\u7a0b\u4e2d\u5c06\u5b9e\u9a8c\u9636\u6bb5\u8bbe\u5b9a\u4e3a<\/span>pH6.5<\/span>\u3002\u4e3a\u4e86\u6a21\u62df\u52a8\u6001<\/span>pH<\/span>\u53d8\u5316\u65b9\u6848\uff0c\u5c06\u5b9e\u9a8c\u9636\u6bb5\u5206\u6210<\/span>5<\/span>\u4e2a\u9636\u6bb5\u4ee5\u4ee3\u8868\u4e94\u79cd\u4e0d\u540c\u7684<\/span>pH<\/span>\u503c\uff08<\/span>6.0,6.5,7.0,7.5<\/span>\u548c<\/span>5.0<\/span>\uff09\uff0c\u5982\u8868<\/span>III<\/span>\u6240\u793a\u3002<\/span>
<\/p>\n

\u8fd0\u884c\u6a21\u62df\u540e\uff0c\u8ba1\u7b97\u9884\u6d4b\u6570\u636e\u548c\u89c2\u5bdf\u6570\u636e\u4e4b\u95f4\u7684\u56de\u5f52\u7cfb\u6570\uff0c\u4f7f\u7528\u7edf\u8ba1\u7a0b\u5e8f<\/span>SPSS 17\u8bc4\u4f30\u6a21\u62df\u7684\u9884\u6d4b\u80fd\u529b\u3002<\/span><\/span><\/p>\n

\u7ed3\u679c<\/span><\/p>\n

\u5b5f\u9c81\u53f8\u7279\u94a0\u3002\u7edf\u8ba1\u5206\u6790\u663e\u793a\uff0c\u9664<\/span>BFaSSIF\u5916\uff0c\u6240\u6709\u6848\u4f8b\u7684\u4f53\u5916\u91ca\u653e\u6570\u636e\u4e0e\u9884\u6d4b\u91ca\u653e\u6570\u636e\u4e4b\u95f4\u5b58\u5728\u76f8\u5173\u6027\u3002\u56fe<\/span>2\u548c<\/span>3\u4ee5\u53ca\u8868<\/span>IV\u663e\u793a\u4e86\u76f8\u5173\u6027\u3002\u5728\u5b9e\u9a8c\u7814\u7a76\u4e2d\uff0c<\/span>BFaSSIF\u6d4b\u5f97\u7684\u836f\u7269\u91ca\u653e\u4e3a\u96f6\uff0c\u9884\u6d4b\u6570\u636e\u4e3a<\/span>5.9\uff05<\/span>; <\/span>\u56e0\u6b64\uff0c\u6ca1\u6709\u53d1\u73b0\u8fd9\u79cd\u4ecb\u8d28\u7684\u76f8\u5173\u6027\u3002\u5b9e\u9a8c\u6570\u636e\u4e2d\u7684\u4f53\u5916\u91ca\u653e\u548c\u5305\u62ec<\/span>P\u503c\u7684\u9884\u6d4b\u503c\u4e4b\u95f4\u7684\u76f8\u5173\u6027\u5217\u4e8e\u8868<\/span>IV\u4e2d\u3002<\/span><\/span><\/p>\n


<\/p>\n


    <\/span><\/p>\n

\"\u3010\u6848\u4f8b\u63ed\u79d8\u3011<\/p>\n


<\/p>\n

\u56fe<\/span>1.\u5b5f\u9c81\u53f8\u7279\u94a0\u7684\u7c92\u5ea6\u5206\u5e03\u6a21\u62df\uff08\u9009\u81ea<\/span>Okumu et al.2008<\/span>\uff08<\/span><\/sup>14<\/sup>\uff09<\/span><\/sup>\uff09<\/span><\/span><\/p>\n

\"\u3010\u6848\u4f8b\u63ed\u79d8\u3011<\/p>\n

\u56fe<\/span>2.\u4f7f\u7528<\/span>USP\u88c5\u7f6e<\/span>II 900ml 75rpm<\/span>\uff0c<\/span>37<\/span>\u00b0C\u5b9e\u9a8c\u6761\u4ef6\u4e0b\uff0c\u89c2\u5bdf\u5b5f\u9c81\u53f8\u7279\u94a0\u7684\u4f7f\u7528<\/span>USP\u6a21\u62df\u80a0\u6db2\uff08<\/span>SIF\uff09\u548c\u7a7a\u8179\u7981\u98df\u6a21\u62df\u80a0\u6db2\uff08<\/span>BFaSSIF\uff09\u6eb6\u51fa\u91ca\u653e\u66f2\u7ebf\uff08<\/span>Diss\uff09\u5b9e\u9645\u89c2\u6d4b\u503c\uff08<\/span>obs\uff09\u548c\u9884\u6d4b\u503c\uff08<\/span>pre\uff09\u3002<\/span><\/span><\/p>\n

\u683c\u5217\u672c\u8132\u3002\u5f53\u4f7f\u7528\u5355\u4e00<\/span>pH\u503c\u6761\u4ef6\u65f6\uff0c\u5b9e\u9a8c\u6570\u636e\u4e0e\u9884\u6d4b\u7684\u91ca\u653e\u66f2\u7ebf\u4e4b\u95f4\u5b58\u5728\u7edf\u8ba1\u5b66\u4e0a\u663e\u8457\u76f8\u5173\u6027\uff08\u8868<\/span>IV\uff0c\u56fe<\/span>4\uff09\u3002\u7136\u800c\uff0c\u52a8\u6001<\/span>pH\u503c\u53d8\u5316\u65b9\u6848\u4f7f\u7528<\/span>FaSSIF\u4ecb\u8d28\u663e\u8457\u589e\u52a0\u4e86\u76f8\u5173\u6027\u3002\u5f53\u4f7f\u7528\u4f4e\u8d28\u91cf\u5375\u78f7\u8102\u548c\u725b\u78fa\u80c6\u9178\u94a0\u65f6\uff0c\u53d1\u73b0\u6700\u4f73\u76f8\u5173\u6027\uff0c\u5982\u56fe<\/span>5\u548c\u8868<\/span>IV\u6240\u793a\u3002\u76f8\u53cd\uff0c<\/span>SIF\u548c<\/span>BFaSSIF\u4e2d\u7684\u76f8\u5173\u6027\u4e0d\u663e\u8457\u3002<\/span><\/span><\/p>\n

\u8ba8\u8bba<\/span><\/p>\n

 <\/span><\/p>\n

\u836f\u7269\u5f00\u53d1\u4e2d\u7684\u6a21\u62df\u548c\u8ba1\u7b97\u673a\u5efa\u6a21\u5df2\u7ecf\u5728\u6574\u4e2a\u5236\u836f\u5de5\u4e1a\u4e2d\u83b7\u5f97\u4e86\u5173\u6ce8\u548c\u4e00\u5b9a\u91cd\u8981\u6027\u3002\u5728\u836f\u7269\u5f00\u53d1\u8fc7\u7a0b\u7684\u6240\u6709\u9636\u6bb5\u4e2d\u4f7f\u7528<\/span>slico\u5de5\u5177\uff0c\u4ece\u6d3b\u6027\u5206\u5b50\u7684\u5408\u6210\u5230\u836f\u7269\u9012\u9001\u7cfb\u7edf\u7684\u4f18\u5316\u3002\u8bc4\u4f30\u6b64\u7c7b\u8f6f\u4ef6\u7a0b\u5e8f\u7684\u6027\u80fd\u5bf9\u4e8e\u786e\u5b9a\u5176\u9002\u7528\u6027\u548c\u8ba9\u76d1\u7ba1\u90e8\u95e8\u63a5\u53d7\u81f3\u5173\u91cd\u8981\u3002\u4f8b\u5982\uff0c<\/span>FDA\u62e5\u6709\u4e0d\u540c\u6a21\u62df\u8f6f\u4ef6\u5305\u7684\u8bb8\u53ef\u8bc1\uff0c<\/span>DDDPlus\u2122\u5c31\u662f\u5176\u4e2d\u4e4b\u4e00\u3002<\/span> <\/span>DDDPlus\u2122\u662f\u4e00\u79cd\u5546\u4e1a\u5316\u7a0b\u5e8f\uff0c\u53ef\u4ee5\u4f7f\u7528\u836f\u5178\u88c5\u7f6e\u6a21\u62df\u836f\u7269\u5206\u5b50\u7684\u4f53\u5916\u6eb6\u51fa\uff08<\/sup><\/span>21<\/sup>\uff09<\/span><\/sup>\u3002\u7136\u800c\uff0c\u4ec5\u51ed\u516c\u5e03\u7684\u6709\u9650\u6570\u636e\uff0c\u4e5f\u8bc1\u5b9e\u4e86\u5176\u6027\u80fd\u3002<\/span><\/span><\/p>\n

            <\/span>\u8868<\/span>3  <\/span>\u52a8\u6001<\/span>pH\u503c\u53d8\u5316\u8fc7\u7a0b\u4e2d\u683c\u5217\u672c\u8132\u8f93\u5165\u6570\u636e<\/span><\/span><\/p>\n\n\n\n\n\n\n\n\n
\n

\u5b9e\u9a8c\u9636\u6bb5<\/span><\/p>\n<\/td>\n

\n

\u8d77\u59cb\u65f6\u95f4<\/span><\/p>\n<\/td>\n

\n

\u7ed3\u675f\u65f6\u95f4<\/span><\/p>\n<\/td>\n

\n

\u4ecb\u8d28<\/span>pH<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

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

\n

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

\n

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

\n

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

\n

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

\n

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

\n

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

\n

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

\n

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

\n

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

\n

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

\n

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

\n

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

\n

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

\n

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

\n

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

\n

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

\n

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

\n

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

\n

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

 <\/span><\/p>\n

\u6eb6\u51fa\u5ea6\u6d4b\u8bd5\u662f\u836f\u7269\u5236\u5242\u7684\u6709\u4ef7\u503c\u7684\u6027\u80fd\u6d4b\u8bd5\u3002\u6eb6\u51fa\u5ea6\u6d4b\u8bd5\u5229\u7528\u4e0d\u540c\u7684\u4ecb\u8d28\uff08\u5982\u6c34\uff09\u6216\u66f4\u590d\u6742\u7684\u4ecb\u8d28\uff08\u5982\u751f\u7269\u6eb6\u51fa\u5ea6\u4ecb\u8d28\uff09\u6765\u6d4b\u8bd5\u5242\u578b\u7684\u6027\u80fd\uff08<\/sup><\/span>6,20<\/sup>\uff09<\/span><\/sup>\u3002<\/span><\/span><\/p>\n

\u5b5f\u9c81\u53f8\u7279\u94a0\u662f\u4e00\u79cd\u4eb2\u8102\u6027\u836f\u7269<\/span>; <\/span>\u56e0\u6b64\uff0c\u5728<\/span>FaSSIF\u4ecb\u8d28\u4e2d\u4f7f\u7528\u589e\u6eb6\u5242\u5982\u80c6\u6c41\u9178\u76d0\u53ef\u6539\u5584\u5176\u6eb6\u89e3\u5ea6\u3002\u76f8\u5bf9\u5e94\u5730\uff0c\u8be5\u836f\u7269\u4e0d\u6eb6\u4e8e\u6ca1\u6709\u589e\u6eb6\u5242\u7684\u7a7a\u767d<\/span>-SIF\u3002\u4f7f\u7528<\/span>DDDPlus\u2122\u7684\u9884\u6d4b\u6570\u636e\u9884\u6d4b\u836f\u7269\u5728\u4ecb\u8d28\u4e2d\u6709\u826f\u597d\u4e14\u6709\u9650\u7684\u6eb6\u89e3\u5ea6\uff0c\u8fd9\u8868\u660e\u8be5\u8f6f\u4ef6\u4f7f\u7528\u56fa\u6001\u9884\u6d4b\u6a21\u578b\u3002<\/span> <\/span><\/p>\n

\u5728\u5b9e\u9a8c\u7814\u7a76\u4e2d\uff0c\u5728<\/span>100rpm\uff0c<\/span>FaSSIF-500ml\u4e2d\u53d1\u73b0\u6eb6\u89e3\u836f\u7269\u7684\u767e\u5206\u6bd4\u6700\u9ad8\uff08<\/sup><\/span>14<\/sup>\uff09<\/span><\/sup>\u3002\u8fd9\u4e9b\u5b9e\u9a8c\u6570\u636e\u7528\u4e8e\u5c06\u4f53\u5916\u6eb6\u51fa\u4e0e\u4f7f\u7528<\/span>GastroPlusTM<\/sup>\u7684\u4e34\u5e8a\u7814\u7a76\u4e2d\u89c2\u5bdf\u5230\u7684\u4f53\u5185\u7279\u5f81\u76f8\u5173\u8054\u3002\u8be5\u8f6f\u4ef6\u53ef\u4ee5\u901a\u8fc7\u4f7f\u7528\u836f\u7269\u7406\u5316\u6027\u8d28\u6216\u6eb6\u51fa\u6570\u636e\u6765\u8ba1\u7b97\u8840\u6d46\u6d53\u5ea6\u3002\u5728\u8be5\u7814\u7a76\u4e2d\uff0c\u5728<\/span>FaSSIF-500ml\uff0c<\/span>100rpm\u6761\u4ef6\u4e0b\u663e\u793a\u6700\u4f73\u76f8\u5173\u6027\uff08<\/span>r2<\/sup> <\/span>= 0.83\uff09\u3002\u5728\u76ee\u524d\u7684\u7814\u7a76\u4e2d\uff0c\u89c2\u5bdf\u5230\u7684\u548c\u9884\u6d4b\u7684\u8be5\u4ecb\u8d28\u7684\u4f53\u5916\u6eb6\u51fa\u66f2\u7ebf\u4e4b\u95f4\u7684\u76f8\u5173\u6027\u662f<\/span>r2<\/sup> <\/span>= 0.99\u3002<\/span>DDDPlus\u2122\u80fd\u591f\u6a21\u62df\u836f\u7269\u5728<\/span>FaSSIF\u4e2d\u7684\u4f53\u5916\u6eb6\u51fa\u5ea6\u3002\u7136\u540e\uff0c\u8fd9\u4e9b\u9884\u6d4b\u53ef\u4ee5\u88ab\u5176\u4ed6\u8f6f\u4ef6\u7a0b\u5e8f\uff08\u4f8b\u5982<\/span>Gastroplus\uff09\u7528\u4e8e\u4f30\u8ba1\u65b0\u836f\u7269\u5206\u5b50\u7684\u4f53\u5185\u8868\u73b0\u3002<\/span> <\/span><\/p>\n

\u683c\u5217\u672c\u8132\u662f\u4e00\u79cd\u5f31\u9178\u6027\u836f\u7269\u3002\u5b9e\u9a8c\u6570\u636e\u663e\u793a\uff0c\u589e\u52a0<\/span>pH\u503c\u4f1a\u589e\u52a0\u836f\u7269\u7684\u6eb6\u89e3\u5ea6\uff08<\/sup><\/span>16<\/sup>\uff09<\/span><\/sup>\u3002\u6b64\u5916\uff0c\u5728\u6eb6\u51fa\u4ecb\u8d28\uff08\u4f8b\u5982\u80c6\u6c41\u9178\u76d0\uff09\u4e2d\u4f7f\u7528\u589e\u6eb6\u5242\u589e\u52a0\u4e86\u836f\u7269\u7684\u6eb6\u89e3\u3002\u56e0\u6b64\uff0c\u4f7f\u7528<\/span>DDDPlus\u2122\u5728\u5b9e\u9a8c\u4ecb\u8d28<\/span>LQ-FaSSIF pH 6.5\u6761\u4ef6\u4e0b\u53d1\u73b0\u6eb6\u89e3\u836f\u7269\u7684\u767e\u5206\u6bd4\u6700\u9ad8\u3002<\/span>LQ-FaSSIF\u548c<\/span>HQ-FaSSIF\u7684\u9884\u6d4b\u6eb6\u51fa\u66f2\u7ebf\u4e4b\u95f4\u7684\u56de\u5f52\u7cfb\u6570\u975e\u5e38\u9ad8\uff0c\u5206\u522b\u4e3a<\/span>0.87\u548c<\/span>0.83\u3002\u4f46\u662f\uff0c<\/span>DDDPlus\u2122\u4e0d\u63d0\u4f9b\u6539\u53d8\u5375\u78f7\u8102\u548c\u725b\u78fa\u80c6\u9178\u94a0\u5316\u5b66\u7b49\u7ea7\u7684\u9009\u9879\u3002\u5982<\/span>\u201c\u65b9\u6cd5<\/span>\u201d\u90e8\u5206\u6240\u8ff0\uff0c<\/span>LQ\u548c<\/span>HQ FaSSIF\u4ecb\u8d28\u7684\u8f93\u5165\u503c\u76f8\u540c\uff0c\u4f7f\u7528<\/span>LQ-\u5316\u5b66\u7ea7\u5375\u78f7\u8102\u548c\u725b\u78fa\u80c6\u9178\u94a0\u7ed3\u679c\u8868\u793a\u5728<\/span>DDDPlus\u2122\u8bbe\u7f6e\u4e2d\u3002\u683c\u5217\u672c\u8132\u7684\u5b9e\u9a8c\u6570\u636e\u8868\u660e\uff0c\u4f4e\u8d28\u91cf\u7684<\/span>FaSSIF\u662f\u5efa\u7acb\u4f53\u5185<\/span>\/\u4f53\u5916\u76f8\u5173\u6027\uff08<\/span>IVIVC\uff09\u7684\u6700\u4f73\u4ecb\u8d28\uff0c\u56e0\u6b64\u4ec5\u7528\u4e8e\u672c\u7814\u7a76\uff08<\/sup><\/span>15,16<\/sup>\uff09<\/span><\/sup>\u3002<\/span><\/span><\/p>\n

\"\u3010\u6848\u4f8b\u63ed\u79d8\u3011<\/p>\n


<\/p>\n

          \u56fe<\/span>3 <\/span>\u5b5f\u9c81\u53f8\u7279\u94a0\u4f7f\u7528\u7981\u98df\u72b6\u6001\u6a21\u62df\u80a0\u6db2\uff08<\/span>FaSSIF\uff09\u89c2\u5bdf\uff08<\/span>obs\uff09\u548c\u9884\u6d4b\uff08<\/span>pre\uff09\u6eb6\u51fa\u66f2\u7ebf\uff0c\u6761\u4ef6\u5982\u4e0b\uff1a<\/span>37\u00b0C USP\u88c5\u7f6e<\/span>II\uff0c\u5728<\/span>75rpm\u4e0b<\/span>500mL\uff0c\u5728<\/span>100rpm\u4e0b<\/span>500mL\uff0c\u5728<\/span>75rpm\u4e0b<\/span>900mL<\/span><\/p>\n

Table IV. P valuesand Regression Coefficients for Predicted vs.<\/span><\/p>\n

Experimental Data of Montelukast Sodium and Glyburide<\/span><\/p>\n

\u8868<\/span>IV <\/span>\u5b5f\u9c81\u53f8\u7279\u94a0\u548c\u683c\u5217\u672c\u8132\u7684\u9884\u6d4b\u503c\u4e0e\u5b9e\u9a8c\u6570\u636e\u4e4b\u95f4\u7684<\/span>P\u503c\u548c\u56de\u5f52\u7cfb\u6570<\/span><\/span><\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\n

\u836f\u7269<\/span><\/p>\n<\/td>\n

\n

\u4ecb\u8d28<\/span><\/p>\n<\/td>\n

\n

P <\/span>\u503c<\/span><\/span><\/p>\n<\/td>\n

\n

\u56de\u5f52\u7cfb\u6570<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u5b5f\u9c81\u65af\u7279<\/span><\/p>\n<\/td>\n

\n

USP-SIf<\/span><\/p>\n<\/td>\n

\n

P<0.001<\/span><\/p>\n<\/td>\n

\n

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


<\/td>\n		\n

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

\n

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

\n

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


<\/td>\n		\n

FaSSIS 500ml 75rpm<\/span><\/p>\n<\/td>\n

\n

P<0.001<\/span><\/p>\n<\/td>\n

\n

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


<\/td>\n		\n

FaSSIF 500ml 100rpm<\/span><\/p>\n<\/td>\n

\n

P<0.001<\/span><\/p>\n<\/td>\n

\n

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


<\/td>\n		\n

FaSSIF 900ml 75rpm<\/span><\/p>\n<\/td>\n

\n

P<0.001<\/span><\/p>\n<\/td>\n

\n

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

\n

\u683c\u5217\u82ef\u8132<\/span><\/p>\n<\/td>\n

\n

USP-SIf pH 6.5<\/span><\/p>\n<\/td>\n

\n

P=0.003<\/span><\/p>\n<\/td>\n

\n

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


<\/td>\n		\n

BFaSSIF pH 6.5<\/span><\/p>\n<\/td>\n

\n

P=0.005<\/span><\/p>\n<\/td>\n

\n

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


<\/td>\n		\n

FaSSIF-LQ pH6.5<\/span><\/p>\n<\/td>\n

\n

P<0.001<\/span><\/p>\n<\/td>\n

\n

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


<\/td>\n		\n

FaSSIF-HQ pH6.5<\/span><\/p>\n<\/td>\n

\n

P=0.001<\/span><\/p>\n<\/td>\n

\n

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


<\/td>\n		\n

USP-SIF <\/span>\u52a8\u6001<\/span>pH<\/span><\/p>\n<\/td>\n

\n

P=0.19<\/span><\/p>\n<\/td>\n

\n

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


<\/td>\n		\n

BFaSSIF <\/span>\u52a8\u6001<\/span>pH<\/span><\/p>\n<\/td>\n

\n

P=0.19<\/span><\/p>\n<\/td>\n

\n

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


<\/td>\n		\n

FaSSIF-LQ <\/span>\u52a8\u6001<\/span>pH<\/span><\/p>\n<\/td>\n

\n

P<0.001<\/span><\/p>\n<\/td>\n

\n

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


<\/td>\n		\n

FaSSIF-HQ <\/span>\u52a8\u6001<\/span>pH<\/span><\/p>\n<\/td>\n

\n

P=0.06<\/span><\/p>\n<\/td>\n

\n

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

 <\/span><\/p>\n

\"\u3010\u6848\u4f8b\u63ed\u79d8\u3011<\/p>\n

\u56fe<\/span>4. <\/span>\u683c\u5217\u672c\u8132\u6eb6\u51fa\u91ca\u653e\u66f2\u7ebf\uff08<\/span>Diss\uff09\u5b9e\u9645\u89c2\u6d4b\u503c\uff08<\/span>obs.\uff09\u548c\u9884\u6d4b\u503c\uff08<\/span>pred.\uff09\u4f7f\u7528<\/span>USP\u88c5\u7f6e<\/span>II\uff0c\u6761\u4ef6\uff1a<\/span>37\u2103\uff0c<\/span>900ml\uff0c<\/span>pH6.5\uff0c\u8f6c\u901f<\/span>75\u8f6c<\/span>\/\u5206\u548c\u4ee5\u4e0b\u4ecb\u8d28\uff1a<\/span>USP\u6a21\u62df\u80a0\u6db2\uff08<\/span>USP-SIF\uff09\uff0c<\/span><\/span><\/p>\n

\u7a7a\u767d\u7981\u98df\u72b6\u6001\u6a21\u62df\u80a0\u6db2\uff08<\/span>BFaSSIF\uff09\uff0c\u4f4e\u8d28\u91cf\u7981\u98df\u72b6\u6001\u6a21\u62df\u80a0\u6db2\uff08<\/span>LQ-FaSSIF\uff09\uff0c\u4ee5\u53ca\u9ad8\u8d28\u91cf\u7684\u7981\u98df\u72b6\u6001\u6a21\u62df\u80a0\u6db2\uff08<\/span>HQ-FaSSIF\uff09<\/span><\/span><\/p>\n

\"\u3010\u6848\u4f8b\u63ed\u79d8\u3011<\/p>\n

\u56fe<\/span>5.\u5728\u52a8\u6001<\/span>pH\u53d8\u5316\u8fc7\u7a0b\uff08<\/span>pH 6.0,6.5,7.0,7.5\u548c<\/span>5.0\uff09\u4e2d\u683c\u5217\u672c\u8132\u6eb6\u51fa\u91ca\u653e\u66f2\u7ebf\uff08<\/span>Diss\uff09\u89c2\u6d4b\u503c\uff08<\/span>obs.\uff09\u548c\u9884\u6d4b\u503c\uff08<\/span>pre.\uff09\u4f7f\u7528<\/span>USP\u88c5\u7f6e<\/span>II\uff0c\u6761\u4ef6<\/span>37\u00b0C\uff0c\u4f53\u79ef<\/span>900 ml  <\/span>\u8f6c\u901f<\/span>75\u8f6c<\/span>\/\u5206\u949f\uff0c\u6eb6\u51fa\u4ecb\u8d28\u5305\u62ec\u4ee5\u4e0b\u51e0\u79cd\uff1a<\/span>USP\u6a21\u62df\u80a0\u6db2\uff08<\/span>USP-SIF\uff09\uff0c\u7a7a\u767d\u7981\u98df\u72b6\u6001\u6a21\u62df\u80a0\u6db2\uff08<\/span>BFaSSIF\uff09\uff0c\u4f4e\u8d28\u91cf\u7981\u98df\u72b6\u6001\u6a21\u62df\u80a0\u6db2\uff08<\/span>LQ-FaSSIF\uff09\u548c\u9ad8\u8d28\u91cf\u7981\u98df\u72b6\u6001\u6a21\u62df\u80a0\u6db2\uff08<\/span>HQ-FaSSIF\uff09<\/span><\/span><\/p>\n

\u5728\u8d28\u91cf\u6e90\u4e8e\u8bbe\u8ba1\uff08<\/span>QbD\uff09\u65b9\u6cd5\u4e2d\uff0c\u6eb6\u51fa\u5e94\u7406\u60f3\u5730\u53cd\u6620\u4f53\u5185\u4ea7\u54c1\u6027\u80fd\uff08<\/sup><\/span>17-19<\/sup>\uff09<\/span><\/sup>\u3002\u4ece\u6a21\u62df\u7684\u4f53\u5916\u6eb6\u51fa\u6570\u636e\u5f00\u59cb\uff0c\u4f5c\u4e3a\u8bf8\u5982<\/span>GastroPlusTM<\/sup>\u7684\u4f53\u5185\u9884\u6d4b\u8f6f\u4ef6\u7684\u8f93\u5165\u53ef\u4ee5\u6709\u52a9\u4e8e\u5728\u836f\u7269\u5f00\u53d1\u8fc7\u7a0b\u7684\u540e\u671f\u9636\u6bb5\u5efa\u7acb<\/span>IVIVC\u3002\u914d\u65b9\u79d1\u5b66\u5bb6\u53ef\u4ee5\u4f7f\u7528\u8fd9\u4e9b\u6570\u636e\u8fdb\u884c\u9002\u5f53\u7684\u914d\u65b9\u8bbe\u8ba1\u548c\u6709\u9009\u62e9\u7684\u8fdb\u884c\u751f\u7269\u76f8\u5173\u6027\u80fd\u6d4b\u8bd5\u3002<\/span><\/span><\/p>\n

  \u672c\u7814\u7a76\u4e2d\u7684\u6a21\u62df\u663e\u793a\u4e24\u79cd\u836f\u7269\u7684\u4f53\u5916\u91ca\u653e\u5bf9\u6eb6\u89e3\u5ea6\u6548\u5e94\u654f\u611f\uff0c\u8fd9\u8bc1\u5b9e\u4e86<\/span>API\u7684<\/span>BCS II\u5206\u7c7b\uff08<\/sup><\/span>8<\/sup>\uff09<\/span><\/sup>\u3002\u5f53\u4f53\u5916\u6eb6\u51fa\u4ee3\u8868\u4f53\u5185\u91ca\u653e\u65f6\uff0c\u53ef\u4ee5\u4e3a<\/span>BCS II\u7c7b\u836f\u7269\u5efa\u7acb<\/span>IVIVC\uff08<\/span><\/sup>7,15,16<\/sup>\uff09<\/span><\/sup>\u3002\u4f7f\u7528\u8ba1\u7b97\u673a\u7a0b\u5e8f\u9884\u6d4b\u4f53\u5916\u836f\u7269\u91ca\u653e\u53ef\u4ee5\u5e2e\u52a9\u9009\u62e9\u5408\u9002\u7684<\/span>IVIVC\u6eb6\u51fa\u8bbe\u7f6e\uff0c\u5e76\u4e14\u53ef\u80fd\u5c06\u5173\u952e\u4ea7\u54c1\u5c5e\u6027\u4e0e\u6709\u610f\u4e49\u7684\u8d28\u91cf\u63a7\u5236\u548c\u6027\u80fd\u6d4b\u8bd5\u7a0b\u5e8f\u76f8\u5173\u8054\u8d77\u6765\uff08<\/sup><\/span>20-22<\/sup>\uff09<\/span><\/sup>\u3002\u901a\u8fc7\u6bd4\u8f83\u4f7f\u7528\u5b9e\u9a8c\u7814\u7a76\u7684<\/span>DDDPlus\u2122\u9884\u6d4b\uff0c\u8be5\u7814\u7a76\u8868\u660e<\/span>DDDPlus\u2122\u53ef\u4ee5\u9884\u6d4b\u96be\u6eb6\u6027\u836f\u7269\u5728\u5404\u79cd\u4ecb\u8d28\u548c\u8bbe\u5907\u4e2d\u7684<\/span>API\u6eb6\u51fa\u3002\u80fd\u591f\u9884\u6d4b<\/span>BCS II\u7c7b\u836f\u7269\u7684\u6eb6\u51fa\u66f2\u7ebf\u8868\u660e<\/span>DDDPlus\u2122\u662f\u4f30\u7b97<\/span>API\u6eb6\u51fa\u66f2\u7ebf\u7684\u5408\u9002\u5de5\u5177\uff0c\u5c24\u5176\u662f\u5728\u65e9\u671f\u53d1\u73b0\u9636\u6bb5\u3002<\/span><\/span><\/p>\n

  \u7ed3\u8bba<\/span><\/strong><\/span><\/p>\n

  DDDPlus\u2122\u80fd\u591f\u9884\u6d4b\u4e0d\u540c\u5b9e\u9a8c\u6761\u4ef6\u4e0b\u5b5f\u9c81\u53f8\u7279\u94a0\u548c\u683c\u5217\u672c\u8132\u7684\u4f53\u5916\u91ca\u653e\u7c7b\u578b\u3002\u4f7f\u7528<\/span>DDDPlus <\/span>TM<\/sup>\u7684\u4f53\u5916\u91ca\u653e\u7c7b\u578b\u7684\u8ba1\u7b97\u673a\u6a21\u62df\u5177\u6709\u5728\u836f\u7269\u5f00\u53d1\u8fc7\u7a0b\u7684\u65e9\u671f\u9636\u6bb5\u4f30\u8ba1\u4f53\u5916\u6eb6\u51fa\u884c\u4e3a\u7684\u6f5c\u529b\u3002\u8fd9\u53ef\u4ee5\u7528\u4e8e\u9009\u62e9\u6700\u5408\u9002\u7684\u6eb6\u51fa\u6761\u4ef6\uff0c\u4e00\u65b9\u9762\u5efa\u7acb<\/span>IVIVC\uff0c\u53e6\u4e00\u65b9\u9762\u5f00\u53d1\u751f\u7269\u76f8\u5173\u7684\u4f53\u5916\u6027\u80fd\u6d4b\u8bd5\uff0c\u6355\u83b7\u8d28\u91cf\u6e90\u4e8e\u8bbe\u8ba1\u65b9\u6cd5\u4e2d\u7684\u5173\u952e\u4ea7\u54c1\u5c5e\u6027\u6216\u9002\u5f53\u7684\u8d28\u91cf\u63a7\u5236\u7a0b\u5e8f\u3002<\/span><\/span><\/p>\n

 <\/span><\/p>\n

\u81f4\u8c22<\/span><\/strong><\/p>\n

\u4f5c\u8005\u8981\u611f\u8c22<\/span>Simulation Plus\u548c<\/span>Princess Nora BintAbdulrahman\u5927\u5b66\u7684\u652f\u6301\u3002<\/span><\/span><\/p>\n

 <\/p>\n

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\u6b22\u8fce\u5404\u4f4d\u540c\u884c\u5411\u516c\u4f17\u53f7\u6295\u7a3f\u3002<\/strong>
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\u5fae\u4fe1\u8ba2\u9605\u53f7\u53ef\u4ee5\u7f6e\u9876\u4e86\uff01\u628a\u672c\u53f7\u7f6e\u9876\uff0c\u60f3\u770b\u5c31\u770b\uff0c\u4e0d\u7528\u518d\u5411\u4e0b\u62c9\u4e86\uff01<\/strong><\/p>\n

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\u6295\u7a3f\u8bf7\u8054\u7cfb\u7fa4\u4e3b\uff08\u90ae\u7bb1\uff1a9111628@qq.com\uff09\u6216\u5fae\u4fe1\u7f16\u8f91\uff081642214@qq.com\uff09\u3002<\/span>
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\u8bf7\u6b32\u52a0\u5165\u672c\u7fa4\u540c\u884c\u4ed4\u7ec6\u9605\u8bfb\u672c\u7fa4\u9996\u9875\u4ecb\u7ecd\u4e86\u89e3\u672c\u7fa4\u52a0\u7fa4\u8981\u6c42\u548c\u7fa4\u89c4\u5219\u3002<\/span><\/p>\n

\u67e5\u770b\u4ee5\u524d\u7684\u6587\u7ae0\u8bf7\u5173\u6ce8\u672c\u516c\u4f17\u53f7\u4e4b\u540e\u67e5\u770b\u5386\u53f2\u6d88\u606f\u3002<\/span><\/p>\n

\u2014\u2014\u2014\u2014<\/span><\/p>\n

\"\u3010\u6848\u4f8b\u63ed\u79d8\u3011<\/p>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"

\u6765\u6e90\uff1a\u516c\u4f17\u53f7 \u4f5c\u8005\uff1a\u987e\u5ddd\u6c5f \u66fe\u7ecf\u63a8\u9001\u8fc7\uff1a \u3010\u7b2c\u5341\u5b63\u7fa4\u53cb\u4f1a\u4e13\u9898\u3011\u91c7\u7528\u5efa\u6a21\u4e0e\u6a21\u62df\u8fdb\u884c\u5236\u5242\u5f00\u53d1\u4e0e\u51b3\u7b56\u6307\u5bfc \u3010\u6848\u4f8b\u63ed\u79d8 […]<\/p>\n","protected":false},"author":1,"featured_media":98728,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[1],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/98727"}],"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=98727"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/98727\/revisions"}],"predecessor-version":[{"id":98738,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/98727\/revisions\/98738"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/98728"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=98727"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=98727"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=98727"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}