{"id":122229,"date":"2020-02-20T14:15:43","date_gmt":"2020-04-21T00:58:41","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/122229\/"},"modified":"2020-04-21T08:58:46","modified_gmt":"2020-04-21T00:58:46","slug":"d2b2cb3734","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/122229\/","title":{"rendered":"\u200b\u745e\u8212\u4f10\u4ed6\u6c40\u9499\u7247\u4f53\u5185\u5916\u4e00\u81f4\u6027\u8bc4\u4ef7\u7814\u7a76"},"content":{"rendered":"
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\u836f\u5b66\u4e0e\u4e34\u5e8a\u7814\u7a76 2019 Dec;27(6)<\/span><\/strong><\/p>\n

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\"\u200b\u745e\u8212\u4f10\u4ed6\u6c40\u9499\u7247\u4f53\u5185\u5916\u4e00\u81f4\u6027\u8bc4\u4ef7\u7814\u7a76\"<\/p>\n
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\u6458\u8981<\/strong><\/p>\n<\/section>\n

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\u7ed3\u8bba\uff1a<\/strong><\/p>\n

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\u5173\u952e\u8bcd<\/strong><\/p>\n<\/section>\n

\"\u200b\u745e\u8212\u4f10\u4ed6\u6c40\u9499\u7247\u4f53\u5185\u5916\u4e00\u81f4\u6027\u8bc4\u4ef7\u7814\u7a76\"<\/section>\n

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\u6b63\u6587<\/strong><\/p>\n<\/section>\n<\/td>\n


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\u672c\u6587\u91c7\u7528\u7684GastroPlus<\/span>TM<\/span><\/sup>\u8f6f\u4ef6\u5185\u7f6e\u4e86\u72ec\u6709\u7684\u9ad8\u7ea7\u623f\u5ba4\u5438\u6536\u4e0e\u8f6c\u8fd0\u6a21\u578b\uff08advanced compartmental absorption and transit model\uff0cACAT\uff09\uff0c\u5b83\u6309\u751f\u7406\u5b66\u7279\u5f81\u5c06\u80c3\u80a0\u9053\u5206\u4e3a 9 \u4e2a\u623f\u5ba4\uff0c\u8003\u8651\u4e86\u836f\u7269\u5728\u80c3\u80a0\u9053\u4e2d\u7684 6 \u79cd\u72b6\u6001\uff0c\u53ef\u4ee5\u6784\u5efa\u836f\u7269\u7279\u5f02\u6027\u80c3\u80a0\u9053\u5438\u6536\u6a21\u578b[2\uff0c3]\u3002<\/p>\n

\u5176\u57fa\u4e8e\u751f\u7406\u5b66\u7684\u836f\u4ee3\u52a8\u529b\u5b66\uff08physiologically based pharmacokinetic\uff0cPBPK\uff09 \u6a21 \u578b \u8003 \u8651\u4e86\u89e3\u5256\u5b66\u548c\u751f\u7406\u5b66\u4ee5\u53ca\u836f\u7269\u548c\u5236\u5242\u7684\u7269\u7406\u5316\u5b66\u6027\u8d28\uff0c\u63cf\u8ff0\u4e86\u836f\u7269\u5438\u6536\u3001\u5206\u5e03\u3001\u4ee3\u8c22\u548c\u6392\u6cc4\u7684\u52a8\u529b\u5b66\u8fc7\u7a0b[4\uff0c5]\u3002<\/p>\n

\u5c06\u836f\u7269\u7684\u7406\u5316\u6027\u8d28\u53c2\u6570\u8f93\u5165\u5230 ACAT \u6a21\u578b\u7528\u4e8e\u8868\u5f81\u836f\u7269\u7684\u80c3\u80a0\u9053\u5438\u6536\u548c\u8f6c\u8fd0 \uff0c\u5efa \u7acb \u836f \u7269 \u7684PBPK \u6a21\u578b\u7528\u4e8e\u8868\u5f81\u836f\u7269\u7684\u5904\u7f6e\u8fc7\u7a0b\uff0c\u5c06\u836f\u7269\u7684\u4f53\u5916\u6eb6\u51fa\u66f2\u7ebf\u5bfc\u5165\u5230\u8f6f\u4ef6\u4e2d\uff0c\u4ee5\u8bc4\u4f30\u5236\u5242\u7684\u6eb6\u51fa\u884c\u4e3a\u5bf9\u836f\u7269\u4f53\u5185\u8fc7\u7a0b\u7684\u5f71\u54cd\uff1b\u56e0\u6b64\uff0c\u7ed3\u5408\u4f53\u5916\u6eb6\u51fa\u66f2\u7ebf\u76f8\u4f3c\u6027\u8bc4\u4ef7\uff0c\u540c\u65f6\u91c7\u7528\u8ba1\u7b97\u673a\u8f6f\u4ef6\u6a21\u62df\u6280\u672f\u7684\u5efa\u6a21\uff0c\u53ef\u4ee5\u6a21\u62df\u836f\u7269\u5728\u4f53\u5185\u7684\u8fc7\u7a0b[6]\u3002<\/p>\n

\u745e\u8212 \u4f10 \u4ed6 \u6c40 \u9499\uff08Rosuvastatin Calcium\uff09\u4e3a 3-\u7f9f \u57fa-3-\u7532\u57fa\u620a\u4e8c\u9170\u8f85\u9176 A\uff08HMG-CoA\uff09\u8fd8 \u539f \u9176 \u6291 \u5236\u5242\uff0c\u7531\u65e5\u672c\u76d0\u91ce\u4e49\u5236\u836f\u682a\u5f0f\u4f1a\u793e\u4e8e 20 \u4e16\u7eaa 80 \u5e74\u4ee3\u672b\u5408\u6210\uff0c\u540e\u7531\u82f1\u56fd\u963f\u65af\u5229\u5eb7\u516c\u53f8\u5f00\u53d1\u7814\u5236\uff0c\u4e34\u5e8a\u7528\u4e8e\u8c03\u8282\u8840\u8102\u3002<\/p>\n

\u56fd\u5185\u5df2\u6709\u591a\u4e2a\u5382\u5bb6\u5bf9\u745e\u8212\u4f10\u4ed6\u6c40\u9499\u7247\u8fdb\u884c\u4eff\u5236[7-9]\u3002<\/p>\n

\u4ece\u4f53\u5916\u6eb6\u51fa\u66f2\u7ebf\u7814\u7a76\u548c\u4f53\u5185\u751f\u7269\u7b49\u6548\u6027\u8bc4\u4ef7\u4e24\u4e2a\u65b9\u9762\u7cfb\u7edf\u8bc4\u4ef7\u56fd\u4ea7\u745e\u8212\u4f10\u4ed6\u6c40\u9499\u7247\uff0c\u5173\u4e8e\u8fd9\u65b9\u9762\u7684\u7814\u7a76\uff0c\u5c1a\u672a\u89c1\u6587\u732e\u62a5\u9053\u3002<\/p>\n

\u672c\u7814\u7a76\u7ed3\u5408\u745e\u8212\u4f10\u4ed6\u6c40\u9499\u7684 BCS \u7279\u6027\uff0c\u4f7f\u7528\u4f53\u5916\u6eb6\u51fa\u66f2\u7ebf\u548cGastroPlus<\/span>TM<\/span><\/sup>\u8bc4\u4f30\u745e\u8212\u4f10\u4ed6\u6c40\u9499\u7247\u56fd\u4ea7\u4eff\u5236\u5236\u5242\u4e0e\u53c2\u6bd4\u5236\u5242\u7684\u751f\u7269\u7b49\u6548\u6027\uff0c\u5e76\u4e0e\u4e34\u5e8a\u8bd5\u9a8c\u7ed3\u679c\u5bf9\u6bd4\uff0c\u9a8c\u8bc1\u6a21\u62df BE \u7684\u53ef\u884c\u6027\uff0c\u4ee5\u53ca\u8f6f\u4ef6\u8bc4\u4f30\u7684\u53ef\u9760\u6027\uff0c\u4e3a\u4eff\u5236\u836f\u7684\u4e00\u81f4\u6027\u8bc4\u4ef7\u63d0\u4f9b\u53c2\u8003\u3002 <\/p>\n

\u5185\u5bb9\u7531\u5c0f\u7f16\u67e5\u9605\u6587\u732e\u9009\u53d6\uff0c\u6392\u7248\u4e0e\u7f16\u8f91\u4e3a\u539f\u521b\u3002\u5982\u8f6c\u8f7d\uff0c\u8bf7\u5c0a\u91cd\u52b3\u52a8\u6210\u679c\uff0c\u6ce8\u660e\u6765\u6e90\u4e8e\u516c\u4f17\u53f7\u3002<\/p>\n<\/section>\n

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

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\u4eea\u5668\u4e0e\u836f\u54c1\u3001\u8bd5\u5242<\/strong><\/p>\n<\/section>\n<\/section>\n

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_<\/text><\/svg><\/section>\n<\/section>\n<\/section>\n<\/section>\n
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1.1 \u4eea\u5668<\/strong><\/p>\n<\/section>\n

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Sciex API 5000 \u4e09\u91cd\u56db\u7ea7\u6746\u8d28\u8c31\u4eea \uff08\u914d\u6709 ESI\u6e90\u53ca Analyst \u5b9a\u91cf\u5904\u7406\u8f6f\u4ef6\uff0c\u7f8e\u56fd Sciex \u516c\u53f8\uff09\uff1b\u5c9b\u6d25LC20 \u9ad8\u76f8\u6db2\u76f8 \u8272 \u8c31 \u4eea\uff08SPD-M20A\uff0c\u65e5 \u672c Shimadzu\u516c\u53f8\uff09\uff1bAT7 smart \u81ea\u52a8\u6eb6\u51fa\u4eea\uff08\u745e\u58eb Sotax \u516c\u53f8\uff09\uff1bZKT-18F \u771f\u7a7a\u8131\u6c14\u673a \uff08\u5929\u6d25\u5929\u5927\u5929\u53d1\u79d1\u6280\u6709\u9650\u516c\u53f8\uff09\uff1bXSE205 \u5341\u4e07\u5206\u4e4b\u4e00\u7535\u5b50\u5929\u5e73\uff08\u745e\u58eb\u6885\u7279\u52d2-\u6258\u5229\u591a\u516c\u53f8\uff09\uff1bSeven Excellence \u591a\u53c2\u6570\u6d4b\u5b9a\u4eea \uff08\u745e\u58eb\u6885\u7279\u52d2-\u6258\u5229\u591a\u516c\u53f8\uff09\uff1b0.45 \u03bcm \u9488\u5934\u6ee4\u819c \uff08PES \u548c\u5c3c\u9f99\uff0c\u4e0a\u6d77\u5b89\u8c31\u5b9e\u9a8c\u79d1\u6280\u80a1\u4efd\u6709\u9650\u516c\u53f8\uff09\u3002GastroPlus<\/span>TM<\/span><\/sup>\uff08\u7248 \u672c 9.5.0004\uff0cSimulations Plus\uff0cInc.\uff0cLancaster\uff0cCA\uff0cUSA\uff09\u3002<\/p>\n<\/section>\n

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1.2 <\/strong>\u836f\u54c1\u4e0e\u8bd5\u5242<\/strong><\/p>\n<\/section>\n

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\u53c2\u6bd4\u5236\u5242\uff08R\uff09\u745e\u8212\u4f10\u4ed6\u6c40\u9499\u7247\uff08\u89c4\u683c 10 mg\uff0c\u6279 \u53f7 131343\u3001131347\u3001131358\uff0cAstraZeneca UK Limited \u516c\u53f8\uff09\uff1b\u4eff\u5236\u5236\u5242\uff08T\uff09\uff08\u89c4\u683c 10 mg\uff0c\u6279\u53f7 171701\u3001170702\u3001170703\uff0cA \u5236\u836f\u516c\u53f8\uff09\uff1b\u745e\u8212\u4f10\u4ed6\u6c40\u9499\u5bf9\u7167\u54c1\uff08\u7eaf\u5ea6 97.6%\uff0c\u6279\u53f7 101028-201202\uff0c\u4e2d\u56fd\u98df\u54c1\u836f \u54c1\u68c0\u5b9a\u7814\u7a76\u9662\uff09\uff1b\u745e\u8212\u4f10\u4ed6\u6c40\u9499-d6\uff08\u7eaf\u5ea6 98.65%\uff0c\u6279\u53f72-WEN-131-1\uff0c\u52a0\u62ff\u5927 TRC \u516c\u53f8\uff09\u3002<\/p>\n

\u76d0\u9178\u3001\u6c22\u6c27\u5316\u94a0\u3001\u67e0\u6aac\u9178\u4e09\u94a0\u4e8c\u6c34\u5408\u7269\u3001\u67e0\u6aac\u9178\u4e00\u6c34\u5408\u7269\u3001\u4e59\u9178\u94a0\u3001\u51b0\u918b\u9178\u3001\u78f7\u9178\u5747\u4e3a\u5206\u6790\u7eaf\uff08\u56fd\u836f\u96c6\u56e2\u5316\u5b66\u8bd5\u5242\u6709\u9650\u516c\u53f8\uff09\uff1b\u4e59\u8148\u3001\u7532\u9187\uff08\u8272\u8c31\u7eaf\uff0c\u5fb7\u56fdMerck KGaA \u516c\u53f8\uff09\uff1b\u7532\u9178 \uff08\u8272\u8c31\u7eaf\uff0c\u7f8e\u56fd AnaquaChemical \u516c\u53f8\uff09\uff1b\u6eb6\u51fa\u4ecb\u8d28\u8bd5\u9a8c\u7528\u6c34\uff1a\u8d85\u7eaf\u6c34\uff0c\u5747\u91c7\u7528\u8131\u6c14\u88c5\u7f6e\u7ecf 40 \u2103\u8131\u6c14 30 min \u540e\u7acb\u5373\u4f7f\u7528\u3002<\/p>\n<\/section>\n

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

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\u65b9\u6cd5<\/strong><\/p>\n<\/section>\n<\/section>\n

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2.1 \u4f53\u5916\u6eb6\u51fa\u66f2\u7ebf\u76f8\u4f3c\u6027\u8bc4\u4ef7<\/strong><\/p>\n<\/section>\n

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2.1.1 pH-\u6eb6\u89e3\u5ea6\u66f2\u7ebf\u7684\u6d4b\u5b9a <\/p>\n<\/section>\n

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\u5c06\u8fc7\u91cf\u7684\u745e\u8212\u4f10\u4ed6\u6c40\u9499\u5206\u522b\u52a0\u5165 pH \u503c\u4e3a 1.0\u30012.0\u30013.0\u30014.0\u30015.0\u30016.0\u30017.0\u30018.0 \u7684\u7f13\u51b2\u6db2\u4e2d\uff0c\u5728 37 \u2103\u632f\u6447 24 h\uff0c\u4f7f\u6210\u9971\u548c\u6eb6\u6db2\uff0c\u6ee4\u8fc7\uff0c\u53d6\u7eed\u6ee4\u6db2\u9002\u91cf\uff0c\u7528 25%\u4e59\u8148\u9002\u5b9c\u500d\u6570\u7a00\u91ca\u540e\u91c7\u7528 HPLC \u6cd5[10]\u6d4b\u5b9a\u5cf0\u9762\u79ef\uff0c\u6309\u5916\u6807\u6cd5\u8ba1\u7b97\u6eb6\u6db2\u4e2d\u745e\u8212\u4f10\u4ed6\u6c40\u7684\u542b\u91cf\uff0c\u4ece\u800c\u786e\u5b9a\u5728\u4e0d\u540c pH \u503c\u7f13\u51b2\u6db2\u4e2d\u745e\u8212\u4f10\u4ed6\u6c40\u7684\u9971\u548c\u6eb6\u89e3\u5ea6\u3002<\/p>\n

\u5f53\u91ca\u653e\u4ecb\u8d28\u7684\u4f53\u79ef\u4e3a\u836f\u7269\u9971\u548c\u6eb6\u6db2\u6240\u9700\u4ecb\u8d28\u4f53\u79ef\u7684\u81f3\u5c11 3 \u500d\u91cf\u65f6\uff0c\u8ba4\u4e3a\u6ee1\u8db3\u6f0f\u69fd\u6761\u4ef6[11]\uff0c\u53ef\u4f5c\u4e3a\u4f53\u5916\u6eb6\u51fa\u76f8\u4f3c\u6027\u8bc4\u4ef7\u7684\u4ecb\u8d28\u3002<\/p>\n<\/section>\n

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2.1.2 \u4f53 \u5916 \u6eb6 \u51fa \u6d4b \u8bd5 <\/p>\n<\/section>\n<\/section>\n

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\u6bd4\u8f83\u8fdb\u53e3\u6ce8\u518c\u6807\u51c6\uff08JX20030283\uff09[12]\uff0c\u745e\u8212\u4f10\u4ed6\u6c40\u9499\u7247\u7684\u6eb6\u51fa\u5ea6\u68c0\u67e5\u9879\u4e0b\u6eb6\u51fa\u4ecb\u8d28\uff08pH 6.6 \u67b8\u6a7c\u9178\u76d0\u7f13\u51b2\u6db2\uff09\u3001\u5065\u5eb7\u4eba\u4f53\u80c3\u4e2d\u751f\u7406\u6db2 pH\uff080.1 mol\u00b7L<\/span>-1<\/span><\/sup>\u76d0\u9178\u6eb6\u6db2\uff09\u4ee5\u53ca\u201c\u666e\u901a\u53e3\u670d\u56fa\u4f53\u5236\u5242\u6eb6\u51fa\u66f2\u7ebf\u6d4b\u5b9a\u4e0e\u6bd4\u8f83\u6307\u5bfc\u539f\u5219\u201d[10] \u63a8\u8350\u7684\u6eb6\u51fa\u4ecb\u8d28\uff08pH 4.5\uff09\u3002<\/p>\n

\u53c2\u7167\u201c\u666e\u901a\u53e3\u670d\u56fa\u4f53\u5236\u5242\u6eb6\u51fa\u5ea6\u8bd5\u9a8c\u6280\u672f\u6307\u5bfc\u539f\u5219\u201d[13]\uff0c\u6700\u7ec8\u9009\u62e9 0.1 mol\u00b7L<\/span>-1<\/span><\/sup>\u76d0\u9178\uff08pH 1.0\uff09\u3001pH 4.5 \u918b\u9178\u76d0\u7f13\u51b2\u6db2\u3001pH 6.6 \u67b8\u6a7c\u9178\u76d0\u7f13\u51b2\u6db2\u4f5c\u4e3a\u6eb6\u51fa\u4ecb\u8d28\uff0c\u5bf9\u4e24\u5236\u5242\u8fdb\u884c\u6eb6\u51fa\u66f2\u7ebf\u7814\u7a76\u3002<\/p>\n

\u53d6\u4eff\u5236\u5236\u5242\uff08T\uff09\u548c\u53c2\u6bd4\u5236\u5242\uff08R\uff09\u5404 3 \u6279\uff08n=12\uff09\uff0c\u7167\u6eb6\u51fa\u5ea6\u4e0e\u91ca\u653e\u5ea6\u6d4b\u5b9a\u6cd5\uff08\u300a\u4e2d\u56fd\u836f\u5178\u300b2015 \u5e74\u7248\u901a\u5219 0931 \u7b2c\u4e8c\u6cd5\uff09\u5206\u522b\u4ee5 3 \u79cd\u4ecb\u8d28 900 mL \u4e3a\u6eb6\u51fa\u4ecb\u8d28\uff0c\u8f6c\u901f\u4e3a 50 r\u00b7min-1\uff0c\u4f9d\u6cd5\u64cd\u4f5c\uff0c\u5728 5\u300110\u300120\u300130\u300145\u300160 min \u65f6\uff0c\u5206\u522b\u53d6\u6837 10 mL \u5e76\u53ca\u65f6\u8865\u6db2\u3002<\/p>\n

\u5c06\u53d6\u51fa\u7684\u6eb6\u6db2\u6ee4\u8fc7\uff0c\u53d6\u7eed\u6ee4\u6db2\u4f5c\u4e3a\u4f9b\u8bd5\u54c1\u6eb6\u6db2\uff1b\u53e6\u7cbe\u5bc6\u79f0\u53d6\u745e\u8212\u4f10\u4ed6\u6c40\u9499\u5bf9\u7167\u54c1\u9002\u91cf\uff0c\u52a0\u6eb6\u51fa\u4ecb\u8d28\u5e76\u5b9a\u91cf\u7a00\u91ca\u5236\u6210\u6bcf\u6beb\u5347\u4e2d\u7ea6\u542b 10 \u03bcg \u7684\u6eb6\u6db2\u4f5c\u4e3a\u5bf9\u7167\u54c1\u6eb6\u6db2\uff0c\u53c2\u7167\u745e\u8212\u4f10\u4ed6\u6c40\u9499\u7247\u8fdb\u53e3\u6ce8\u518c\u6807\u51c6\uff08JX20030283\uff09[12]\u6eb6\u51fa\u5ea6\u9879\u4e0b\u7684\u8272\u8c31\u6761\u4ef6\u6d4b\u5b9a\uff0c\u8272\u8c31\u6761\u4ef6\u4e3a\uff1a\u8272\u8c31\u67f1\uff1aWaters X-Bridge C18\uff084.6 mm \u00d7 150 mm\uff0c3.5 \u03bcm\uff09\uff1b\u6d41\u52a8\u76f8\uff1a\u78f7\u9178-\u6c34-\u4e59\u8148\uff081\u2236600\u2236400\uff09\uff1b\u68c0\u6d4b\u6ce2\u957f\uff1a242 nm\uff1b\u67f1\u6e29\uff1a30 \u2103\uff1b\u6d41\u901f\uff1a1.0 mL\u00b7min-1\uff1b\u8fdb\u6837\u91cf\uff1a10 \u03bcL\u3002<\/p>\n

\u5178\u578b\u8272\u8c31\u56fe\u5982\u56fe 1 \u6240\u793a\u3002<\/p>\n

\"\u200b\u745e\u8212\u4f10\u4ed6\u6c40\u9499\u7247\u4f53\u5185\u5916\u4e00\u81f4\u6027\u8bc4\u4ef7\u7814\u7a76\"<\/p>\n<\/section>\n

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2.1.3 \u6570\u636e\u5206\u6790 <\/p>\n<\/section>\n

\n

\u5f53\u4eff\u5236\u5236\u5242\u548c\u53c2\u6bd4\u5236\u5242\u5728 15 min\u65f6\u7684\u5e73\u5747\u6eb6\u51fa\u91cf\u5747\u4e0d\u4f4e\u4e8e 85\uff05\u65f6\uff0c\u8ba4\u4e3a\u4e24\u8005\u7684\u6eb6\u51fa\u66f2\u7ebf\u76f8\u4f3c\uff1b\u5426\u5219\uff0c\u7528\u76f8\u4f3c\u56e0\u5b50\uff08f2\uff09\u6cd5\u6bd4\u8f83\u6eb6\u51fa\u66f2\u7ebf\u76f8\u4f3c\u6027[14]\u3002<\/p>\n

\u5f53 f2 \u503c\u4e0d\u5c0f\u4e8e 50 \u65f6\uff0c\u8ba4\u4e3a\u4e24\u6761\u6eb6\u51fa\u66f2\u7ebf\u76f8\u4f3c\uff0c\u5426\u5219\u8ba4\u4e3a\u4e0d\u76f8\u4f3c[14\uff0c15]\u3002\u4ee5\u4e0b\u7b49\u5f0f\u5b9a\u4e49 f2\uff1a<\/p>\n

\"\u200b\u745e\u8212\u4f10\u4ed6\u6c40\u9499\u7247\u4f53\u5185\u5916\u4e00\u81f4\u6027\u8bc4\u4ef7\u7814\u7a76\"<\/p>\n

\u5176\u4e2d Rt \u548c Tt \u8868\u793a\u5728\u65f6\u95f4\u70b9\uff08t\uff09\u7684\u53c2\u6bd4\u548c\u4eff\u5236\u5236\u5242\u7684\u5e73\u5747\u6eb6\u51fa\u767e\u5206\u6570\uff0cn \u662f\u6bd4\u8f83\u5e73\u5747\u6eb6\u51fa\u65f6\u95f4\u70b9\u7684\u6570\u91cf\u3002<\/p>\n<\/section>\n

\n

2.2 \u4f53\u5185\u836f\u4ee3\u52a8\u529b\u5b66\u7814\u7a76<\/strong><\/p>\n<\/section>\n

\n

2.2.1 \u7814\u7a76\u5bf9\u8c61 <\/p>\n<\/section>\n

\n

\u4f9d\u636e CFDA \u6700\u65b0\u9881\u5e03\u7684\u201c\u751f\u7269\u7b49\u6548\u6027\u6307\u5357\u201d\u5bf9\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u5165\u7ec4\u53d7\u8bd5\u8005\u6027\u522b\u7684\u5efa\u8bae\uff1a\u7814\u7a76\u5c06\u62df\u7528\u4e8e\u4e24\u79cd\u6027\u522b\u7684\u4eba\u7fa4\uff1b\u4e14 FDA \u5173\u4e8e\u745e\u8212 \u4f10 \u4ed6 \u6c40 \u9499 \u7684 Clinical Pharmacology Biopharmaceutics Review \u4e2d\u4e00\u5219\u751f\u7269\u7b49\u6548\u6027\u8bd5\u9a8c\u6240\u7528\u53d7\u8bd5\u8005\u4f8b\u6570\u4e3a 31 \u4f8b\uff0c\u53e6\u4e00\u5219\u4e3a 32 \u4f8b\u3002<\/p>\n

\u53c2\u8003\u4ee5\u4e0a\u60c5\u51b5\uff0c\u8bd5\u9a8c\u62df\u5165\u7ec4 30 \u4f8b\u5065\u5eb7\u53d7\u8bd5\u8005\uff0c\u5b9e\u9645\u5165\u7ec4 28 \u4f8b\uff0c\u7537\u6027 18\u4f8b\uff0c\u5973\u6027 10 \u4f8b\uff0c20~43 \u5468\u5c81\uff0c\u4f53\u91cd\u4e0d\u4f4e\u4e8e 50 kg\uff0c\u4f53\u91cd\u6307\u6570\uff08BMI\uff09\u5728 19.0~26.0 kg\u00b7m<\/span>-1<\/span><\/sup>\uff0c\u65e0\u5438\u70df\u3001\u55dc\u9152\u53f2\uff0c\u5168\u9762\u4f53\u68c0\u5404\u9879\u6307\u6807\u5747\u6b63\u5e38\u3002<\/p>\n

\u53d7\u8bd5\u8005\u8bd5\u9a8c\u5f00\u59cb\u524d 3 \u4e2a\u6708\u5185\u672a\u53c2\u52a0\u5176\u5b83\u4efb\u4f55\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u4e14 6 \u5468\u5185\u672a\u670d\u7528\u4efb\u4f55\u836f\u7269\u3002\u53d7\u8bd5\u8005\u672c\u4eba\u7b7e\u7f72\u77e5\u60c5\u540c\u610f\u4e66\uff0c\u5e76\u7ecf\u6d59\u6c5f\u5927\u5b66\u533b\u5b66\u9662\u9644\u5c5e\u7b2c\u4e8c\u533b\u9662\u4eba\u4f53\u7814\u7a76\u4f26\u7406\u59d4\u5458\u4f1a\u5ba1\u6279\u540c\u610f\u3002\u53d7\u8bd5\u8005\u968f\u673a\u5206\u4e3a 2 \u7ec4\uff0c\u7981\u98df 10~12 h \u540e\uff0c\u7a7a\u8179\u53e3\u670d \u4eff \u5236 \u5236 \u5242 \uff08\u6279 \u53f7 170701\uff09 \u6216 \u53c2 \u6bd4 \u5236 \u5242 \uff08\u6279 \u53f7131343\uff091 \u7247\uff0c\u7528 250 mL \u6e29\u5f00\u6c34\u541e\u670d\u836f\u7269\uff0c\u53d7\u8bd5\u8005\u53e3\u670d\u836f\u7269\u524d 0 h\uff08\u670d\u836f\u524d 0.5 h \u5185\uff09\u548c\u670d\u836f\u540e 0.25\u30010.5\u30011.0\u30012.0\u30013.0\u30014.0\u30015.0\u30016.0\u30018.0\u300110.0\u300112.0\u300116.0\u300124.0\u300136.0\u300148.0\u300172.0 h \u5206\u522b\u4e8e\u8098\u9759\u8109\u53d6\u8840\u7ea6 2.5 mL\uff0c\u5206\u522b\u7f6e\u4e8e\u542b EDTA-2K \u6297\u51dd\u8bd5\u7ba1\u4e2d\uff0c\u8bd5\u7ba1\u63d0\u524d\u7f6e\u4e8e\u51b0\u4e0a\u9884\u51b7\u3002<\/p>\n

4 \u2103\u30013 000 r\u00b7min<\/span>-1<\/span><\/sup>\u79bb\u5fc3 10 min\u3002<\/p>\n

\u5438\u53d6\u4e0a\u5c42\u8840\u6d46\uff0c-80 \u2103\u4fdd\u5b58\uff0c\u4f9b\u8840\u836f\u6d53\u5ea6\u6d4b\u5b9a\u7528\u3002<\/p>\n

\u5185\u5bb9\u7531\u5c0f\u7f16\u67e5\u9605\u6587\u732e\u9009\u53d6\uff0c\u6392\u7248\u4e0e\u7f16\u8f91\u4e3a\u539f\u521b\u3002\u5982\u8f6c\u8f7d\uff0c\u8bf7\u5c0a\u91cd\u52b3\u52a8\u6210\u679c\uff0c\u6ce8\u660e\u6765\u6e90\u4e8e\u516c\u4f17\u53f7\u3002<\/p>\n<\/section>\n

\n

2.2.2 \u5206\u6790\u65b9\u6cd5<\/p>\n<\/section>\n

\n

\u4ee5\u745e\u8212\u4f10\u4ed6\u6c40\u9499-d6<\/span> <\/span>\u4f5c\u4e3a\u5185\u6807\uff0c100 \u03bcL \u8840\u6d46\u6837\u54c1\u7ecf\u7532\u9187\u6c89\u6dc0\u86cb\u767d\uff0c\u91c7\u7528\u7ecf\u8fc7\u9a8c\u8bc1\u7684\u8d85\u9ad8\u6548\u6db2\u76f8\u8272\u8c31-\u4e32\u8054\u8d28\u8c31\uff08UPLC-MS\/MS\uff09\u65b9\u6cd5\u68c0\u6d4b\u8840\u6d46\u6837\u672c\u4e2d\u745e\u8212\u4f10\u4ed6\u6c40\u7684\u6d53\u5ea6\u3002<\/p>\n

\u8272\u8c31\u6761\u4ef6\uff1a\u8272\u8c31\u67f1\uff1aSunFire<\/span>TM<\/span><\/sup>C18<\/span>\uff082.1 mm\u00d750 mm\uff0c3.5 \u03bcm\uff09\uff1b\u6d41\u52a8\u76f8 A\uff1a0.1%\u7532\u9178\u6c34\u6eb6\u6db2\uff0cB\uff1a0.1%\u7532\u9178\u4e59\u8148\u6eb6\u6db2 [\u68af\u5ea6\uff1a0~2 min \uff0835% B~70% B\uff09\uff1b2.05~3.50 min\uff0895% B~95% B\uff09\uff1b3.55~5 min\uff0835% B~35% B\uff09]\uff1b\u6d41\u901f\uff1a0.6 mL\u00b7min-1\uff1b\u67f1\u6e29\uff1a40 \u2103\uff1b\u8fdb\u6837\u91cf\uff1a10 \u03bcL\u3002<\/p>\n

\u8d28\u8c31\u6761\u4ef6\uff1a\u91c7\u7528\u5927\u6c14\u538b\u7535\u55b7\u96fe\u79bb\u5b50\u6e90\uff08ESI<\/span>+<\/span><\/sup>\uff09\uff1b\u6b63\u79bb\u5b50\u6a21\u5f0f\uff0c\u9009\u62e9\u591a\u53cd\u5e94\u79bb\u5b50\u76d1\u6d4b\uff08MRM\uff09\uff0c\u7528\u4e8e\u5b9a\u91cf\u7684\u79bb\u5b50\u53cd\u5e94\u4e3a\uff1a\u745e\u8212\u4f10\u4ed6\u6c40\u9009\u62e9\u6027\u53cd\u5e94\u76d1\u6d4b\uff1am\/z482.2\u2192m\/z 258.2\uff0c\u745e\u8212\u4f10\u4ed6\u6c40-d6 \u9009\u62e9\u6027\u53cd\u5e94\u76d1\u6d4b\uff1am\/z 488.2\u2192m\/z 264.2\u3002<\/p>\n<\/section>\n

\n

2.2.3 \u6570\u636e\u7edf\u8ba1\u5206\u6790 <\/p>\n<\/section>\n

\n

\u4f7f \u7528 Phoenix WinNonlinVersion 7.0 \u4ee5\u975e\u623f\u5ba4\u6a21\u578b\u8fdb\u884c PK \u5206\u6790\uff0c\u836f\u4ee3\u52a8\u529b\u5b66 \u53c2 \u6570 \u5305 \u62ec \uff1aCmax<\/span>\u3001AUC0 -t<\/span>\u3001AUC0 -\u221e<\/span>\u3001Tmax<\/span>\u3002<\/p>\n

\u4f7f \u7528 SASVersion 9.2 \u5bf9\u4e3b\u8981\u836f \u52a8 \u5b66 \u53c2 \u6570 Cmax<\/span>\u3001AUC0-t<\/span>\u3001AUC0-\u221e<\/span>\u7ecf\u5bf9\u6570\u8f6c\u6362\u540e\u8fdb\u884c\u65b9\u5dee\u5206\u6790\u53ca\u53cc\u5355\u4fa7 t \u68c0\u9a8c\uff0c\u5e76\u8ba1\u7b97 90%\u7f6e\u4fe1\u533a\u95f4\uff0c\u8003\u5bdf\u4eff\u5236\u5236\u5242\u4e0e\u53c2\u6bd4\u5236\u5242\u7684\u751f\u7269\u7b49\u6548\u6027\uff0c\u5982\u679c Cmax<\/span>\u3001AUC0-t<\/span> <\/span>\u548c AUC0-\u221e<\/span> <\/span>\u7684\u51e0\u4f55\u5e73\u5747\u6bd4\uff08\u4eff\u5236\/\u53c2\u6bd4\uff09 \u7684 90\uff05\u7f6e\u4fe1\u533a\u95f4\u5728 80.00\uff05~125.00\uff05\uff0c\u5219\u8ba4\u4e3a\u4e24\u5236\u5242\u751f\u7269\u7b49\u6548[16]\u3002<\/p>\n

\u76f8\u5bf9\u751f\u7269\u5229\u7528\u5ea6\u7684\u8ba1\u7b97\u516c\u5f0f\u4e3a\uff1a<\/p>\n

\"\u200b\u745e\u8212\u4f10\u4ed6\u6c40\u9499\u7247\u4f53\u5185\u5916\u4e00\u81f4\u6027\u8bc4\u4ef7\u7814\u7a76\"<\/p>\n

\uff08AUC0-t<\/span>\uff09T \u4e3a\u4eff\u5236\u5236\u5242\u7684 AUC0-t<\/span>\uff0c\uff08AUC0-t<\/span>\uff09R \u4e3a\u53c2\u6bd4\u5236\u5242\u7684 AUC0-t<\/span>\u3002<\/p>\n<\/section>\n

\n

2.3 \u7fa4\u4f53\u836f\u4ee3\u52a8\u529b\u5b66\u6a21\u62df<\/strong><\/p>\n<\/section>\n

\n

\u5229\u7528GastroPlus<\/span>TM<\/span><\/sup>\u6a21\u62df\u8f6f\u4ef6\u6784\u5efa\u865a\u62df\u7fa4\u4f53 \uff08n=28\uff0c20~50 \u5c81\uff0c\u5065\u5eb7\u4e2d\u56fd\u4eba\uff0c\u7537\u6027\u548c\u5973\u6027\u5747 50\uff05\uff09\u6a21\u62df\u5355\u6b21\u53e3\u670d\u6bcf\u79cd\u745e\u8212\u4f10\u4ed6\u6c40\u9499\u7247\u7684\u4f53\u5185\u836f\u4ee3\u52a8\u529b\u5b66\u3002<\/p>\n

\u6a21\u578b\u5efa\u7acb\u53c2\u6570\u89c1\u8868 1\u3002<\/p>\n

\"\u200b\u745e\u8212\u4f10\u4ed6\u6c40\u9499\u7247\u4f53\u5185\u5916\u4e00\u81f4\u6027\u8bc4\u4ef7\u7814\u7a76\"<\/p>\n

\u8ba1\u7b97\u6bcf\u4e2a\u865a\u62df\u53d7\u8bd5\u8005\u7684 Cmax<\/span>\u3001 Tmax<\/span>\u3001AUC0-\u221e<\/span> <\/span>\u548c AUC0-t<\/span>\u3002<\/p>\n

\u62a5\u544a\u4e2d\u4f4d\u6570\u548c\u76f4\u63a5\u91c7\u7528 5%\u548c95%\u7684\u7ed3\u679c\u8868\u793a 90\uff05\u7684\u7f6e\u4fe1\u533a\u95f4\u3002<\/p>\n<\/section>\n

\n
\n
\n
\n
\n

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

\n
\n

\u7ed3\u679c<\/strong><\/p>\n<\/section>\n<\/section>\n

\n
_<\/text><\/svg><\/section>\n<\/section>\n<\/section>\n<\/section>\n
\n
\n

3.1 pH-\u6eb6\u89e3\u5ea6\u66f2\u7ebf\u7684\u6d4b\u5b9a<\/strong><\/p>\n<\/section>\n<\/section>\n

\n

\u745e\u8212\u4f10\u4ed6\u6c40\u9499\u5728\u4e0d\u540c pH \u7f13\u51b2\u6db2\u4e2d\u7684\u6eb6\u89e3\u5ea6\u66f2\u7ebf\u89c1\u56fe 2\u3002<\/p>\n

\"\u200b\u745e\u8212\u4f10\u4ed6\u6c40\u9499\u7247\u4f53\u5185\u5916\u4e00\u81f4\u6027\u8bc4\u4ef7\u7814\u7a76\"<\/p>\n

\u968f\u7740 pH \u589e\u52a0\uff0c\u6eb6\u89e3\u5ea6\u5148\u4e0a\u5347\u540e\u4e0b\u964d\u3002<\/p>\n

\u836f\u7269\u5728 \u5404 \u79cd pH \u6761\u4ef6\u4e0b\u7684\u6eb6\u89e3\u5ea6\u5747\u5927\u4e8e 0.041 7 mg\u00b7mL<\/span>-1<\/span><\/sup>\uff08\u4ee5\u745e\u8212\u4f10\u4ed6\u6c40 10 mg \u8ba1\uff09\uff0c\u6ee1\u8db3\u6f0f\u69fd\u6761\u4ef6\uff0c\u5404\u4ecb\u8d28\u5747\u53ef\u4f5c\u4e3a\u745e\u8212\u4f10\u4ed6\u6c40\u9499\u7247\u7684\u6eb6\u51fa\u4ecb\u8d28\u3002<\/p>\n<\/section>\n

\n

3.2 \u4f53\u5916\u6eb6\u51fa\u6d4b\u8bd5<\/strong><\/p>\n<\/section>\n

\n

\u4eff\u5236\u5236\u5242\uff08T\uff09\u548c\u53c2\u6bd4\u5236\u5242\uff08R\uff09\u5728 3 \u79cd\u6eb6\u51fa\u4ecb\u8d28\u4e2d\u7684\u6eb6\u51fa\u66f2\u7ebf\u5982\u56fe 3 \u6240\u793a\u3002<\/p>\n

\"\u200b\u745e\u8212\u4f10\u4ed6\u6c40\u9499\u7247\u4f53\u5185\u5916\u4e00\u81f4\u6027\u8bc4\u4ef7\u7814\u7a76\"<\/p>\n

\u6570\u636e\u8868\u793a\u4e3a x\u00b1s\uff08n=12\uff09\u3002<\/p>\n<\/section>\n

\n

3.2.1 \u76d0\u9178\uff08pH 1.0\uff09\u6eb6\u6db2\u4e2d\u7684\u6eb6\u51fa\u66f2\u7ebf\u76f8\u4f3c\u6027\u8bc4\u4ef7<\/p>\n<\/section>\n

\n

3 \u6279\u53c2\u6bd4\u5236\u5242\u5728 15 min \u65f6\u7684\u5e73\u5747\u7d2f\u79ef\u6eb6\u51fa\u91cf\u5747\u5927\u4e8e 85%\uff0c3 \u6279\u4eff\u5236\u5236\u5242\u5728 15 min \u65f6\u7684\u5e73\u5747\u7d2f\u79ef\u6eb6\u51fa\u91cf\u5c0f\u4e8e 85\uff05\uff08\u56fe 3-A\uff09\uff0c\u56e0\u6b64\u8ba1\u7b97 f2 \u56e0\u5b50\u8bc4\u4ef7\u4eff\u5236\u5236\u5242\u4e0e\u53c2\u6bd4\u5236\u5242\u4f53\u5916\u6eb6\u51fa\u76f8\u4f3c\u6027 \u3002<\/p>\n

\u9664 \u4eff \u5236 \u54c1 \u6279 \u53f7170703 \u7684 f2 \u56e0\u5b50\u4e3a 49\uff0c\u5176\u4ed6 2 \u4e2a\u4eff\u5236\u54c1\u6279\u53f7\u7684 f2\u56e0\u5b50\u5747\u5927\u4e8e 50\uff08\u89c1\u8868 2\uff09\uff0c\u8ba4\u4e3a\u4eff\u5236\u5236\u5242\u4e0e\u53c2\u6bd4\u5236\u5242\u5728\u8be5\u4ecb\u8d28\u4e2d\u7684\u4f53\u5916\u6eb6\u51fa\u66f2\u7ebf\u57fa\u672c\u76f8\u4f3c\u3002<\/p>\n

\"\u200b\u745e\u8212\u4f10\u4ed6\u6c40\u9499\u7247\u4f53\u5185\u5916\u4e00\u81f4\u6027\u8bc4\u4ef7\u7814\u7a76\"<\/p>\n<\/section>\n

\n

3.2.2 \u918b\u9178\u76d0\u7f13\u51b2\u6db2\uff08pH 4.5\uff09\u4e2d\u7684\u6eb6\u51fa\u66f2\u7ebf\u76f8\u4f3c\u6027\u8bc4\u4ef7 <\/p>\n<\/section>\n

\n

3 \u6279\u53c2\u6bd4\u5236\u5242\u5728 15 min \u65f6\u7684\u5e73\u5747\u7d2f\u79ef\u6eb6\u51fa\u91cf\u5747\u5c0f\u4e8e 85\uff05\uff0c\u4eff\u5236\u5236\u5242\u5747\u4e0d\u4f4e\u4e8e 85\uff05\uff08\u56fe 3-B\uff09\u3002<\/p>\n

\u7ecf\u8ba1\u7b97 f2 \u56e0\u5b50\u5747\u5c0f\u4e8e 50\uff08\u89c1\u8868 3\uff09\uff0c\u8bf4\u660e\u4eff\u5236\u5236\u5242\u4e0e\u53c2\u6bd4\u5236\u5242\u7684\u4f53\u5916\u6eb6\u51fa\u66f2\u7ebf\u4e0d\u76f8\u4f3c\u3002<\/p>\n

\"\u200b\u745e\u8212\u4f10\u4ed6\u6c40\u9499\u7247\u4f53\u5185\u5916\u4e00\u81f4\u6027\u8bc4\u4ef7\u7814\u7a76\"<\/p>\n<\/section>\n

\n

3.2.3 \u67b8\u6a7c\u9178\u76d0\u7f13\u51b2\u6db2\uff08pH 6.6\uff09\u4e2d\u7684\u6eb6\u51fa\u66f2\u7ebf\u76f8\u4f3c\u6027\u8bc4\u4ef7 <\/p>\n<\/section>\n

\n

\u867d\u7136\u53c2\u6bd4\u5236\u5242\u7684\u6eb6\u51fa\u901f\u7387\u8f83\u4eff\u5236\u5236\u5242\u7a0d\u6162\uff0c\u4f46 15 min \u51e0\u4e4e\u5b8c\u5168\u6eb6\u51fa\uff08>85\uff05\uff09\uff08\u89c1\u56fe 3-C\uff09\u3002\u4eff\u5236\u5236\u5242\u4e0e\u53c2\u6bd4\u5236\u5242\u7684\u4f53\u5916\u6eb6\u51fa\u66f2\u7ebf\u76f8\u4f3c\u3002<\/p>\n<\/section>\n

\n

3.3 \u4f53\u5185\u836f\u4ee3\u52a8\u529b\u5b66\u7814\u7a76<\/strong><\/p>\n<\/section>\n

\n
\n

28 \u4f8b\u5065\u5eb7\u53d7\u8bd5\u8005\u5355\u6b21\u53e3\u670d\u745e\u8212\u4f10\u4ed6\u6c40\u9499\u724710 mg\uff0c\u4eff\u5236\u5236\u5242\u548c\u53c2\u6bd4\u5236\u5242\u5e73\u5747\u8840\u836f\u6d53\u5ea6-\u65f6\u95f4\u66f2\u7ebf\u89c1\u56fe 4\uff0c\u4e24\u8005\u53d8\u5316\u8d8b\u52bf\u57fa\u672c\u4e00\u81f4\u3002<\/p>\n

\"\u200b\u745e\u8212\u4f10\u4ed6\u6c40\u9499\u7247\u4f53\u5185\u5916\u4e00\u81f4\u6027\u8bc4\u4ef7\u7814\u7a76\"<\/p>\n

\u751f\u7269\u7b49\u6548\u6027\u5206\u6790\u7ed3 \u679c \u89c1 \u8868 4\uff0c\u4eff\u5236\u5236\u5242\u7684\u76f8\u5bf9\u751f\u7269\u5229\u7528\u5ea6 F \u4e3a95.65%\u00b117.62%\uff08AUC0-t<\/span>\uff09\u3002<\/p>\n

\"\u200b\u745e\u8212\u4f10\u4ed6\u6c40\u9499\u7247\u4f53\u5185\u5916\u4e00\u81f4\u6027\u8bc4\u4ef7\u7814\u7a76\"<\/p>\n

Cmax<\/span> <\/span>\u7684\u51e0\u4f55\u5747\u503c\u6bd4\u7684 90%CI \u4e3a 84.09% ~104.70% \uff0cAUC0 -t<\/span> <\/span>\u7684 \u51e0 \u4f55 \u5747 \u503c \u6bd4 \u768490% CI \u4e3a 88.32%~103.58%\uff0cAUC0-\u221e<\/span> <\/span>\u7684\u51e0\u4f55\u5747\u503c\u6bd4\u7684 90% CI \u4e3a 94.17%~105.28%\uff0c\u5747\u5728 80%~125%\u7684\u8303\u56f4\u5185\uff0c\u4e24\u5236\u5242\u65e0\u7edf\u8ba1\u5b66\u5dee\u5f02\uff0c\u5177\u6709\u751f\u7269\u7b49\u6548\u6027\u3002<\/p>\n

\u5185\u5bb9\u7531\u5c0f\u7f16\u67e5\u9605\u6587\u732e\u9009\u53d6\uff0c\u6392\u7248\u4e0e\u7f16\u8f91\u4e3a\u539f\u521b\u3002\u5982\u8f6c\u8f7d\uff0c\u8bf7\u5c0a\u91cd\u52b3\u52a8\u6210\u679c\uff0c\u6ce8\u660e\u6765\u6e90\u4e8e\u516c\u4f17\u53f7\u3002<\/p>\n<\/section>\n<\/section>\n

\n

3.4 \u7fa4\u4f53\u836f\u4ee3\u52a8\u529b\u5b66\u6a21\u62df<\/strong><\/p>\n<\/section>\n

\n

\u56fe 5 \u663e\u793a\u4e86\u53c2\u6bd4\u5236\u5242\u548c\u4eff\u5236\u5236\u5242\u5728\u865a\u62df\u7684 28\u540d\u5065\u5eb7\u6210\u5e74\u4e2d\u56fd\u4eba\u4e2d\u7684\u7fa4\u4f53\u836f\u4ee3\u52a8\u529b\u5b66\u7814\u7a76\u7ed3\u679c\uff0c\u70b9\u4ee3\u8868\u5b9e\u6d4b\u7684\u5e73\u5747\u8840\u836f\u6d53\u5ea6\uff0c\u7ebf\u4ee3\u8868\u9884\u6d4b\u7684\u5e73\u5747\u8840\u836f\u6d53\u5ea6\u3002<\/p>\n

\"\u200b\u745e\u8212\u4f10\u4ed6\u6c40\u9499\u7247\u4f53\u5185\u5916\u4e00\u81f4\u6027\u8bc4\u4ef7\u7814\u7a76\"<\/p>\n

\u4e24\u5236\u5242\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570\u7684\u9884\u6d4b\u503c\u548c\u5b9e\u6d4b\u503c\u89c1\u8868 5\u3002<\/p>\n

\"\u200b\u745e\u8212\u4f10\u4ed6\u6c40\u9499\u7247\u4f53\u5185\u5916\u4e00\u81f4\u6027\u8bc4\u4ef7\u7814\u7a76\"<\/p>\n

\u4e3b\u8981\u836f\u4ee3\u52a8\u529b\u5b66\u53c2\u6570 Cmax \u548c AUC \u7684\u9884\u6d4b\u8bef\u5dee \uff08\uff05PE\uff09 \u4e0d\u5927\u4e8e 10\uff05\uff1bTmax \u7684\uff05PE \u7a0d\u9ad8\uff0c\u4f46\u5c0f\u4e8e20%\uff0c\u4e14\u53c2\u6bd4\u5236\u5242\u8bf4\u660e\u4e66\u62a5\u544a\u4e86\u5355\u6b21\u53e3\u670d 10 mg \u745e\u8212\u4f10\u4ed6\u6c40\u9499\u7247\u540e Tmax \u7684\u4e2d\u4f4d\u503c\u4e3a 2.5~5 h\uff0c\u6a21\u62df\u503c\u5206\u522b\u4e3a 3.24\uff08R\uff09\u548c 3.25\uff08T\uff09\uff0c\u4ecd\u53ef\u63a5\u53d7[17]\u3002<\/p>\n

\u7efc\u4e0a\uff0c\u8ba4\u4e3aGastroPlus<\/span>TM<\/span><\/sup>\u5efa\u7acb\u7684\u7fa4\u4f53\u836f\u4ee3\u52a8\u529b\u5b66\u6a21\u578b\u8f83\u4e3a\u5408\u7406\u7684\u63cf\u8ff0\u4e86\u5355\u6b21\u53e3\u670d\u745e\u8212\u4f10\u4ed6\u6c40\u9499\u7247\u7684\u836f\u4ee3\u52a8\u529b\u5b66\u7279\u5f81\u3002\u865a\u62df BE \u7ed3\u679c\u663e\u793a Cmax \u7684\u51e0\u4f55\u5747\u503c\u6bd4\uff08T\/R\uff09\u7684 90\uff05 CI \u4e3a 86.44%~112.44%\uff0cAUC0-t\u7684\u51e0\u4f55\u5747\u503c\u6bd4\u7684 90% CI \u4e3a 91.36%~118.80%\uff0cAUC0-\u221e\u7684\u51e0\u4f55\u5747\u503c\u6bd4\u7684 90% CI \u4e3a 91.35%~118.80%\uff0c\u5747\u572880%~125%\u7684\u8303\u56f4\u5185\uff0c\u4e24\u5236\u5242\u5177\u6709\u751f\u7269\u7b49\u6548\u6027\u3002<\/p>\n<\/section>\n

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

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\u8ba8\u8bba<\/strong><\/p>\n<\/section>\n<\/section>\n

\n
_<\/text><\/svg><\/section>\n<\/section>\n<\/section>\n<\/section>\n
\n

\u745e\u8212\u4f10\u4ed6\u6c40\u9499\u5728 pH 1.0 \u76d0\u9178\u6eb6\u6db2\u4e2d\u4e0d\u7a33\u5b9a\uff0c\u964d\u89e3\u4ea7\u751f\u6742\u8d28 B\u3001D \u53ca\u5c11\u91cf\u672a\u77e5\u6742\u8d28\uff0c\u5728\u6b64\u4ecb\u8d28\u4e2d\u7684\u6eb6\u51fa\u66f2\u7ebf\uff0c\u5747\u4ee5\u4e3b\u5cf0\u548c\u9178\u964d\u89e3\u4ea7\u7269\u7684\u5cf0\u9762\u79ef\u548c\u8ba1\u7b97[18]\u3002<\/p>\n

\u7ecf\u8bd5\u9a8c\u8003\u5bdf\uff0c\u6742\u8d28 B \u7684\u76f8\u5bf9\u6821\u6b63\u56e0\u5b50\u4e3a 1.0\uff0c\u6742\u8d28 D \u4e3a 0.9\uff0c\u5728 0.9~1.1 \u8303\u56f4\u5185\uff0c\u4e14\u4eff\u5236\u836f\u548c\u53c2\u6bd4\u5236\u5242\u964d\u89e3\u7a0b\u5ea6\u5dee\u5f02\u4e0d\u5927\uff08\u89c1\u8868 6\uff09\u3002<\/p>\n

\"\u200b\u745e\u8212\u4f10\u4ed6\u6c40\u9499\u7247\u4f53\u5185\u5916\u4e00\u81f4\u6027\u8bc4\u4ef7\u7814\u7a76\"<\/p>\n

\u56e0\u6b64\uff0c\u91c7\u7528\u4e0a\u8ff0\u6587\u732e\u65b9\u6cd5\u8ba1\u7b97\u745e\u8212\u4f10\u4ed6\u6c40\u9499\u5728 pH 1.0 \u76d0\u9178\u6eb6\u6db2\u4e2d\u7684\u6eb6\u51fa\u66f2\u7ebf\uff0c\u66f4\u79d1\u5b66\u5408\u7406\u3002<\/p>\n

\u5728 pH 4.5 \u918b\u9178\u76d0\u7f13\u51b2\u6db2\u4e2d\uff0c\u4eff\u5236\u5236\u5242\u4e0e\u53c2\u6bd4\u5236\u5242\u7684\u6eb6\u51fa\u66f2\u7ebf\u4e0d\u76f8\u4f3c\uff0c\u539f\u56e0\u53ef\u80fd\u662f\u53c2\u6bd4\u5236\u5242\u4e2d\u542b\u6709\u78b1\u6027\u8f85\u6599\u78f7\u9178\u9499\uff0c\u5bf9\u5236\u5242\u6eb6\u51fa\u6709\u6240\u5f71\u54cd\u3002<\/p>\n

\u865a\u62df BE \u8bd5\u9a8c\u548c\u4e34\u5e8a BE \u8bd5\u9a8c\u7ed3\u679c\u5747\u8868\u660e\u4eff\u5236\u5236\u5242\u4e0e\u53c2\u6bd4\u5236\u5242\u751f\u7269\u7b49\u6548\uff0c\u4e14\u4eff\u5236\u5236\u5242\u5df2\u901a\u8fc7\u4e00\u81f4\u6027\u8bc4\u4ef7\u3002<\/p>\n

\u7efc\u4e0a\u8ba4\u4e3a\uff0c\u4eff\u5236\u5236\u5242\u5728 pH 4.5 \u7684\u918b\u9178\u76d0\u7f13\u51b2\u6db2\u4e2d\u7684\u6eb6\u51fa\u901f\u7387\u4e0e\u53c2\u6bd4\u5236\u5242\u4e0d\u76f8\u4f3c\uff0c\u5bf9\u836f\u7269\u7684\u4f53\u5185 PK \u5f71\u54cd\u4e0d\u5927\uff0c\u4ec5\u4ec5\u901a\u8fc7\u4f53\u5916\u6eb6\u51fa\u66f2\u7ebf\u76f8\u4f3c\u6027\u8bc4\u4ef7\u4e0d\u80fd\u51c6\u786e\u53cd\u6620\u745e\u8212\u4f10\u4ed6\u6c40\u9499\u7247\u7684\u4f53\u5185\u8fc7\u7a0b\u3002<\/p>\n

\u53c2\u6bd4\u5236\u5242\u5728 pH 1.0 \u7684\u76d0\u9178\u6eb6\u6db2\u4e2d\u7684\u6eb6\u51fa\u901f\u7387\u5feb\u4e8e\u4eff\u5236\u5236\u5242\uff0c\u800c\u5728 pH 4.5 \u548c pH 6.6 \u7684\u4ecb\u8d28\u4e2d\u7684\u6eb6\u51fa\u901f\u7387\u6162\u4e8e\u4eff\u5236\u5236\u5242\uff0c\u53ef\u80fd\u662f\u7531\u4e8e\u4eff\u5236\u5236\u5242\u7684\u5305\u8863\u5c42\u4e0e\u8f85\u6599\u53ca\u751f\u4ea7\u5de5\u827a\u4e0e\u53c2\u6bd4\u5236\u5242\u4e0d\u4e00\u81f4\u5bfc\u81f4\u7684\u3002<\/p>\n

\u7531\u4e8e\u4e34\u5e8a BE \u8bd5\u9a8c\u7ed3\u679c\u663e\u793a\u4e24\u5236\u5242\u5404 PK \u53c2\u6570\u4e0d\u5b58\u5728\u663e\u8457\u5dee\u5f02\uff0c\u8bf4\u660e\u5236\u5242\u7ecf\u80c3\u80a0\u9053\u5230\u8fbe\u5438\u6536\u90e8\u4f4d\u65f6\uff0c\u836f\u7269\u5df2\u57fa\u672c\u5b8c\u5168\u6eb6\u51fa\uff0c\u6eb6\u51fa\u901f\u7387\u7684\u5dee\u5f02\u88ab\u5747\u4e00\u5316\u3002<\/p>\n

\u5bf9\u6bd4\u5b9e\u6d4b\u7684\u548c\u6a21\u62df\u7684\u836f\u4ee3\u52a8\u529b\u5b66\u66f2\u7ebf\uff0c\u8f6f\u4ef6\u5728\u5438\u6536\u76f8\u62df\u5408\u826f\u597d\uff1b\u5728\u6d88\u9664\u76f8\uff0c\u6a21\u62df\u6bd4\u5b9e\u6d4b\u7684\u6d88\u9664\u7a0d\u6162\uff0c\u53ef\u80fd\u662f\u7531\u4e8e\u6a21\u578b\u5efa\u7acb\u6240\u7528\u7684\u6e05\u9664\u7387\u548c\u5206\u5e03\u5bb9\u79ef\u7b49\u6570\u636e\u662f\u57fa\u4e8e\u767d\u79cd\u4eba\u7684\u9759\u8109\u6ef4\u6ce8\u6570\u636e\u8ba1\u7b97\u5f97\u5230\uff0c\u4e0e\u4e2d\u56fd\u4eba\u5b58\u5728\u5dee\u5f02\u5bfc\u81f4\u7684\u3002<\/p>\n

\u5c3d\u7ba1\u865a\u62df BE \u548c\u5b9e\u9645\u4e34\u5e8a\u8bd5\u9a8c\u7684\u836f\u52a8\u5b66\u53c2\u6570\u5b58\u5728\u4e00\u5b9a\u5dee\u5f02\uff0c\u4f46\u7ed3\u679c\u5747\u663e\u793a\u4eff\u5236\u54c1\u4e0e\u53c2\u6bd4\u54c1\u751f\u7269\u7b49\u6548\u3002<\/p>\n

\u865a\u62df BE \u8bd5\u9a8c\u4e3a\u4eff\u5236\u836f\u4e00\u81f4\u6027\u8bc4\u4ef7\u5de5\u4f5c\u7684\u4e34\u5e8a\u524d\u7814\u7a76\u63d0\u4f9b\u4e86\u4e00\u79cd\u65b0\u7684\u601d\u8def\uff0c\u5373\u4f53\u5916-PK \u5efa\u6a21-\u4f53\u5185\u7814\u7a76\u3002<\/p>\n

\u4e3a\u5236\u5242\u5904\u65b9\u7b5b\u9009\u548c BE\u4e34\u5e8a\u8bd5\u9a8c\u8bbe\u8ba1\u63d0\u4f9b\u6307\u5bfc\uff0c\u964d\u4f4e\u5236\u5242\u751f\u7269\u4e0d\u7b49\u6548\u98ce\u9669\uff0c\u7f29\u77ed\u836f\u7269\u7684\u7814\u53d1\u5468\u671f\u3002<\/p>\n

GastroPlus<\/span>TM<\/span><\/sup>\u7b49\u8ba1\u7b97\u673a\u6a21\u62df\u6280\u672f\u53ef\u7528\u4e8e\u4eff\u5236\u836f\u4e00\u81f4\u6027\u8bc4\u4ef7\u7814\u7a76\u4e2d\u3002<\/p>\n<\/section>\n

\n
\"\u200b\u745e\u8212\u4f10\u4ed6\u6c40\u9499\u7247\u4f53\u5185\u5916\u4e00\u81f4\u6027\u8bc4\u4ef7\u7814\u7a76\"<\/p>\n
\n

\u53c2\u8003\u6587\u732e<\/strong><\/p>\n<\/section>\n

\"\u200b\u745e\u8212\u4f10\u4ed6\u6c40\u9499\u7247\u4f53\u5185\u5916\u4e00\u81f4\u6027\u8bc4\u4ef7\u7814\u7a76\"<\/section>\n

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\u8be6\u89c1 \u836f\u5b66\u4e0e\u4e34\u5e8a\u7814\u7a76 2019 Dec;27(6)<\/p>\n<\/section>\n

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\u514d\u8d23\u58f0\u660e<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\u672c\u516c\u4f17\u53f7\u53d1\u5e03\u7684\u6587\u7ae0\u5747\u4e3a\u4fc3\u8fdb\u5236\u836f\u754c\u540c\u884c\u7684\u4ea4\u6d41\u4e0e\u5b66\u4e60\uff1b\u672a\u7528\u4e8e\u4efb\u4f55\u5546\u4e1a\u7528\u9014\u3002\u6211\u4eec\u5c0a\u91cd\u539f\u521b\u4f5c\u54c1\u3002\u9009\u53d6\u7684\u6587\u7ae0\u5df2\u660e\u786e\u6ce8\u660e\u6765\u6e90\u548c\u4f5c\u8005\uff0c\u7248\u6743\u5f52\u539f\u4f5c\u8005\u6240\u6709\uff0c\u5982\u6d89\u53ca\u4fb5\u6743\u6216\u5176\u4ed6\u95ee\u9898\uff0c\u8bf7\u8054\u7cfb\u6211\u4eec\u8fdb\u884c\u5220\u9664\u3002<\/strong><\/p>\n

\u5185\u5bb9\u7531\u5c0f\u7f16\u67e5\u9605\u6587\u732e\u9009\u53d6\uff0c\u6392\u7248\u4e0e\u7f16\u8f91\u4e3a\u539f\u521b\u3002\u5982\u8f6c\u8f7d\uff0c\u8bf7\u5c0a\u91cd\u52b3\u52a8\u6210\u679c\uff0c\u6ce8\u660e\u6765\u6e90\u4e8e\u516c\u4f17\u53f7\u3002<\/p>\n

\u6587\u7ae0\u5185\u5bb9\u4e3a\u4f5c\u8005\u89c2\u70b9\uff0c\u4e0d\u4ee3\u8868\u672c\u516c\u4f17\u53f7\u7acb\u573a\u3002<\/p>\n<\/section>\n


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

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