{"id":11373,"date":"2018-07-20T01:00:00","date_gmt":"2018-07-30T04:04:29","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/07\/30\/%e3%80%90%e5%b9%b2%e8%b4%a7%e3%80%91%e4%bb%bf%e5%88%b6%e8%8d%af%e6%a0%bc%e5%88%97%e5%8d%ab%e7%9a%84%e7%a0%94%e7%a9%b6%e5%bc%80%e5%8f%91%e6%8a%80%e6%9c%af%e6%96%b9%e6%a1%88\/"},"modified":"2018-07-30T12:04:30","modified_gmt":"2018-07-30T04:04:30","slug":"%e3%80%90%e5%b9%b2%e8%b4%a7%e3%80%91%e4%bb%bf%e5%88%b6%e8%8d%af%e6%a0%bc%e5%88%97%e5%8d%ab%e7%9a%84%e7%a0%94%e7%a9%b6%e5%bc%80%e5%8f%91%e6%8a%80%e6%9c%af%e6%96%b9%e6%a1%88","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/11373\/","title":{"rendered":"\u3010\u5e72\u8d27\u3011\u4eff\u5236\u836f\u201c\u683c\u5217\u536b\u201d\u7684\u7814\u7a76\u5f00\u53d1\u6280\u672f\u65b9\u6848"},"content":{"rendered":"
\n

\"\u3010\u5e72\u8d27\u3011\u4eff\u5236\u836f\u201c\u683c\u5217\u536b\u201d\u7684\u7814\u7a76\u5f00\u53d1\u6280\u672f\u65b9\u6848\"<\/p>\n

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1<\/section>\n
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\u80cc\u666f\u4ecb\u7ecd                         <\/strong><\/span><\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n


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

\u7532\u78fa\u9178\u4f0a\u9a6c\u66ff\u5c3c\uff08<\/span>Imatinib mesylate<\/span>\uff09\u7531\u8bfa\u534e\uff08<\/span>Novartis<\/span>\uff09\u7814\u53d1\uff0c<\/span>2001<\/span>\u5e74<\/span>2<\/span>\u6708\uff0c\u8bfa\u534e\u516c\u53f8\u5411\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u7ba1\u7406\u5c40\uff08<\/span>FDA<\/span>\uff09\u9012\u4ea4\u4e86\u4e0a\u5e02\u7533\u8bf7\uff1b<\/span>2001<\/span>\u5e74<\/span>5<\/span>\u6708\uff0c\u7f8e\u56fd<\/span>FDA<\/span>\u4ec5\u7528<\/span>2<\/span>\u4e2a\u534a\u6708\u7684\u65f6\u95f4\u5c31\u52a0\u901f\u6279\u51c6\u4e86\u8be5\u7533\u8bf7<\/span>\u3002\u4e4b\u540e\uff0c\u4e8e<\/span>2001<\/span>\u5e74<\/span>11<\/span>\u6708\u5728\u6b27\u76df\u83b7\u5f97\u6279\u51c6\u4e0a\u5e02\uff0c<\/span>2002<\/span>\u5e74<\/span>4<\/span>\u6708\u5728\u4e2d\u56fd\u83b7\u5f97\u6279\u51c6\u4e0a\u5e02\uff0c<\/span>2005<\/span>\u5e74<\/span>3<\/span>\u6708\u5728\u65e5\u672c\u83b7\u5f97\u6279\u51c6\u4e0a\u5e02\u3002\u683c\u5217\u536b\u4e3a\u7532\u78fa\u9178\u4f0a\u9a6c\u66ff\u5c3c\u5728\u4e2d\u56fd\u7684\u5546\u54c1\u540d\uff0c\u5728\u7f8e\u56fd\u4e3a<\/span>\u201cGleevec\u201d<\/span>\uff0c\u5728\u6b27\u6d32\u4e3a<\/span>\u201cGlivec\u201d<\/span>\u3002<\/span><\/span><\/p>\n

\u9002\u5e94\u75c7\uff1a<\/span><\/strong>2001\u5e74<\/span>5\u6708\uff0c\u7f8e\u56fd<\/span>FDA\u4ec5\u7528<\/span>2\u4e2a\u534a\u6708\u7684\u65f6\u95f4\u5c31\u52a0\u901f\u6279\u51c6\u4e86\u4f0a\u9a6c\u66ff\u5c3c\u7528\u4e8e\u6cbb\u7597\u665a\u671f\u8d39\u57ce\u67d3\u8272\u4f53\u9633\u6027\u7684\u6162\u6027\u7c92\u7ec6\u80de\u6027\u767d\u8840\u75c5<\/span>(CML)\uff1b<\/span>2002\u5e74<\/span>2\u6708\uff0c<\/span>FDA\u901a\u8fc7\u52a0\u901f\u6279\u51c6\u9014\u5f84\u6279\u51c6\u4f0a\u9a6c\u66ff\u5c3c\u6cbb\u7597\u665a\u671f\u6216\u8f6c\u79fb\u80c3\u80a0\u9053\u95f4\u8d28\u7ec6\u80de\u80bf\u7624<\/span>(GIST)\uff0c\u540c\u671f\u4e5f\u5f88\u5feb\u88ab\u6b27\u76df\u4e13\u5229\u836f\u54c1\u8bc4\u5ba1\u59d4\u5458\u4f1a<\/span>(CPMP)\u6279\u51c6\uff1b<\/span>2003\u5e74<\/span>3\u6708\uff0c<\/span>FDA\u6279\u51c6\u7532\u78fa\u9178\u4f0a\u9a6c\u66ff\u5c3c\u7528\u4e8e<\/span>CML\u7684\u4e00\u7ebf\u6cbb\u7597\uff1b<\/span>2003\u5e74<\/span>5\u6708\uff0c<\/span>FDA\u6279\u51c6\u7532\u78fa\u9178\u4f0a\u9a6c\u66ff\u5c3c\u6cbb\u7597<\/span>Ph\u67d3\u8272\u4f53\u9633\u6027\u7684\u513f\u7ae5<\/span>CML\u60a3\u8005\uff1b<\/span>2006\u5e74\uff0c\u7f8e\u56fd<\/span>FDA\u6279\u51c6\u7532\u78fa\u9178\u4f0a\u9a6c\u66ff\u5c3c\u7528\u4e8e\u6cbb\u7597<\/span>Ph\u67d3\u8272\u4f53\u9633\u6027\u7684\u6025\u6027\u6dcb\u5df4\u7ec6\u80de\u767d\u8840\u75c5<\/span>(ALL)\u60a3\u8005\uff0c\u4e14\u7532\u78fa\u9178\u4f0a\u9a6c\u66ff\u5c3c\u8054\u5408\u5316\u7597\u9042\u6210\u4e3a<\/span>Ph\u67d3\u8272\u4f53\u9633\u6027<\/span>ALL\u7684\u4e00\u7ebf\u6cbb\u7597\u65b9\u6848\uff1b<\/span>2008\u5e74\uff0c<\/span>FDA\u53c8\u901a\u8fc7\u52a0\u901f\u6279\u51c6\u9014\u5f84\u6279\u51c6\u5176\u7528\u4e8e\u6709\u53ef\u80fd\u6839\u6cbb\u6027\u5207\u9664\u4f46\u590d\u53d1\u5371\u9669\u589e\u52a0\u7684<\/span>GIST\u80bf\u7624\u75c5\u4eba\uff1b<\/span>2011\u5e74\uff0c\u83b7\u5f97\u7f8e\u56fd\u548c\u6b27\u76df\u6279\u51c6\u5176\u6cbb\u7597\u6025\u6027\u6dcb\u5df4\u7ec6\u80de\u767d\u8840\u75c5\u513f\u79d1\u60a3\u8005\u3002<\/span><\/span><\/p>\n

\u4e13\u5229\uff1a<\/span><\/strong>\u5316\u5408\u7269\u4e13\u5229\u5df2\u4e8e<\/span>2013\u5e74\u8fc7\u671f\uff0c\u6676\u578b\u4e13\u5229\u5230\u671f\u65e5\u4e3a<\/span>2018\u5e74<\/span>7\u6708<\/span>16\u65e5\uff0c\u5236\u5242\u4e13\u5229\u5728\u56fd\u5185\u5df2\u88ab\u9a73\u56de\u3002<\/span> <\/span>\u5efa\u8bae\u672c\u9879\u76ee\u5f00\u53d1\u9009\u62e9\u4e0e\u539f\u7814\u4e00\u81f4\u7684\u6676\u578b\u8fdb\u884c\u5f00\u53d1\uff0c\u964d\u4f4e\u4f53\u5185<\/span>BE\u98ce\u9669\u3002<\/span><\/span>                         <\/strong><\/p>\n

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2<\/section>\n
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\u5236\u5242\u5f00\u53d1                        <\/strong><\/strong><\/strong><\/span><\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

                                                  <\/p>\n

2.1 \u53c2\u6bd4\u5236\u5242\u7684\u9009\u62e9<\/strong><\/span><\/p>\n

\u6839\u636e<\/span>CFDA\u9881\u5e03\u7684\u4eff\u5236\u836f\u53c2\u6bd4\u5236\u5242\u76ee\u5f55\uff08\u7b2c\u516b\u6279\uff09\uff0c\u53ef\u6839\u636e\u4eff\u5236\u836f\u5242\u578b\u9009\u62e9\u539f\u7814\u8fdb\u53e3\u7684\u7532\u78fa\u9178\u4f0a\u9a6c\u66ff\u5c3c\u80f6\u56ca\uff08\u89c4\u683c<\/span>0.1g\uff0c\u6ce8\u518c\u8bc1\u53f7<\/span>H20150294\uff09\u6216\u7532\u78fa\u9178\u4f0a\u9a6c\u66ff\u5c3c\u7247\uff08\u89c4\u683c<\/span>0.1g\u3001<\/span>0.4g\uff0c\u6ce8\u518c\u8bc1\u53f7<\/span>H20150112\u3001<\/span>H20150298\uff09\u4f5c\u4e3a\u53c2\u6bd4\u5236\u5242\u3002<\/span><\/span><\/p>\n

2.2 <\/span><\/strong>\u836f\u7269\u4fe1\u606f<\/span><\/strong><\/span><\/p>\n

API \u7532\u78fa\u9178\u4f0a\u9a6c\u66ff\u5c3c<\/span><\/p>\n

\"\u3010\u5e72\u8d27\u3011\u4eff\u5236\u836f\u201c\u683c\u5217\u536b\u201d\u7684\u7814\u7a76\u5f00\u53d1\u6280\u672f\u65b9\u6848\"<\/p>\n

\u5316\u5b66\u540d\uff1a<\/span>4-[(4-<\/span>\u7532\u57fa<\/span>-1-<\/span>\u54cc\u55ea<\/span>)<\/span>\u7532\u57fa<\/span>]-N-[4-<\/span>\u7532\u57fa<\/span>-3-[[4-(3-<\/span>\u5421\u5576<\/span>)-2-<\/span>\u5627\u5576<\/span>]<\/span>\u6c28\u57fa<\/span>]<\/span>\u82ef\u57fa<\/span>]-<\/span>\u82ef\u80fa\u7532\u78fa\u9178\u76d0<\/span><\/span><\/p>\n

\u5206\u5b50\u5f0f\uff1a<\/span>C29<\/sub>H31<\/sub>N7<\/sub>O\u30fbCH4<\/sub>O3<\/sub>S<\/span><\/span><\/p>\n

\u5206\u5b50\u91cf\uff1a<\/span>589.71<\/span><\/span><\/p>\n

CAS<\/span>\u7f16\u53f7\uff1a<\/span>220127-57-1<\/span><\/span><\/p>\n

\u7406\u5316\u6027\u8d28<\/span><\/strong><\/span><\/p>\n

\u5916\u89c2<\/span>\/<\/span>\u6027\u80fd\uff1a\u767d\u8272\u81f3\u6d45\u9ec4\u8272\u6216\u6d45\u68d5\u8272\u7ed3\u6676\u6027\u7c89\u672b<\/span><\/span><\/p>\n

\u7194\u70b9\uff1a<\/span>210 <\/span><\/span>\uff5e<\/span> <\/span>220\u2103<\/span><\/span><\/p>\n

\u9178\u78b1\u89e3\u79bb\u5e38\u6570\uff1a<\/span>pKa1 <\/span><\/span>\uff1d<\/span> <\/span>7.8<\/span>\u3001<\/span> <\/span>pKa2 <\/span><\/span>\uff1d<\/span> <\/span>3.8<\/span>\u3001<\/span> <\/span>pKa3 <\/span><\/span>\uff1d<\/span> <\/span>3.3 <\/span><\/span>\uff08\u6eb6\u5242\uff1a<\/span>1,4-<\/span>\u4e8c\u6076\u70f7<\/span>\/<\/span>\u6c34\u6df7\u5408\u7269\uff09<\/span><\/span><\/p>\n

\u6eb6\u89e3\u6027\uff1a\u6613\u6eb6\u4e8e\u6c34\uff0c\u6613\u6eb6\u6216\u5fae\u6eb6\u4e8e\u4e8c\u7532\u4e9a\u781c\u3001\u7532\u9187\u548c\u4e59\u9187\uff08<\/span>95\uff09\uff0c\u96be\u6eb6\u4e8e\u5176\u4ed6\u975e\u6781\u6027\u6eb6\u5242\uff08\u5982\u6b63\u8f9b\u9187\uff0c\u4e19\u916e\u548c\u4e59\u8148\uff09\u3002\u6eb6\u89e3\u6027\u5b58\u5728<\/span>pH\u4f9d\u8d56\u6027\uff0c\u5728<\/span>pH\u5c0f\u4e8e\u7b49\u4e8e<\/span>5.5\u7684\u7f13\u51b2\u6db2\u4e2d\u6613\u6eb6\uff0c\u5728\u4e2d\u6027<\/span>\/\u78b1\u6027\u73af\u5883\u4e2d\u6781\u5fae\u6eb6\u89e3\u751a\u81f3\u51e0\u4e4e\u4e0d\u6eb6<\/span><\/span><\/p>\n

\u5728\u5404\u79cd\u6eb6\u5242\u4e2d\u7684\u6eb6\u89e3\u5ea6<\/span>(w\/v\uff05\uff0c<\/span>23 <\/span>\uff5e<\/span> <\/span>25\u2103)<\/span><\/p>\n\n\n\n\n\n\n\n\n\n\n\n
\n

\u6eb6\u5242\u540d\u79f0<\/span><\/p>\n<\/td>\n

\n

\u6eb6\u89e3\u5ea6<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u6c34<\/span><\/p>\n<\/td>\n

\n

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

\n

\u7532\u9187<\/span><\/p>\n<\/td>\n

\n

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

\n

\u4e59\u9187\uff08<\/span>95\uff09<\/span><\/span><\/p>\n<\/td>\n

\n

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

\n

\u4e59\u8148<\/span><\/p>\n<\/td>\n

\n

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

\n

1-\u8f9b\u9187<\/span><\/span><\/p>\n<\/td>\n

\n

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

\n

\u78f7\u9178\u76d0\u7f13\u51b2\u6db2<\/span>pH 5.5<\/span><\/p>\n<\/td>\n

\n

\u2267<\/span>10<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u78f7\u9178\u76d0\u7f13\u51b2\u6db2<\/span>pH 6.0<\/span><\/p>\n<\/td>\n

\n

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

\n

\u78f7\u9178\u76d0\u7f13\u51b2\u6db2<\/span>pH 8.0<\/span><\/p>\n<\/td>\n

\n

<0.001<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\u5438\u6e7f\u6027\uff1a\u5728<\/span>25\u2103<\/span>\uff0c<\/span>75<\/span>\uff05<\/span>RH<\/span>\u6761\u4ef6\u4e0b\u50a8\u5b58<\/span>7<\/span>\u5929\u672a\u89c2\u5bdf\u5230\u5438\u6e7f\u6027\u3002<\/span><\/span><\/p>\n

\u5206\u914d\u7cfb\u6570\uff1a<\/span>D <\/span><\/span>\uff1c<\/span> <\/span>0.01<\/span>\uff08<\/span>1-<\/span>\u8f9b\u9187<\/span>\/0.1mol\/L<\/span>\u76d0\u9178\uff09\uff0c<\/span>D <\/span><\/span>\uff1e<\/span> <\/span>100<\/span>\uff08<\/span>1-<\/span>\u8f9b\u9187<\/span>\/pH6.8<\/span>\u78f7\u9178\u76d0\u7f13\u51b2\u6db2\u3002<\/span><\/span><\/p>\n

\u7a33\u5b9a\u6027\uff1a\u5728\u957f\u671f\u7a33\u5b9a\u6027\u6761\u4ef6\u4e0b\uff08\u6e29\u5ea6<\/span>25\u2103\uff64<\/span>\u6e7f\u5ea6<\/span>60%<\/span>\uff09<\/span>36<\/span>\u6708\u3001\u52a0\u901f\u7a33\u5b9a\u6027\u6761\u4ef6\uff08\u6e29\u5ea6<\/span>40\u2103\uff64<\/span>\u6e7f\u5ea6<\/span>75%<\/span>\uff09<\/span>6<\/span>\u6708\u6761\u4ef6\u4e0b\u6837\u54c1\u5747\u4fdd\u6301\u7a33\u5b9a\u3002<\/span><\/span><\/p>\n

\u751f\u7269\u5b66\u7279\u6027<\/span><\/strong><\/span><\/p>\n

\u672c\u54c1\u53e3\u670d\u7ed9\u836f\u540e\u5438\u6536\u826f\u597d\uff0c\u5728<\/span>2-4\u5c0f\u65f6\u540e\u51fa\u73b0\u6700\u5927\u8840\u836f\u6d53\u5ea6\uff08<\/span>Cmax\uff09\u3002\u5e73\u5747\u7edd\u5bf9\u751f\u7269\u5229\u7528\u5ea6\u4e3a<\/span>98%\uff0c\u53e3\u670d\u540e\u8840\u6d46\u4e2d\u4f0a\u9a6c\u66ff\u5c3c<\/span>AUC\u7684\u53d8\u5f02\u7cfb\u6570\u6ce2\u52a8\u5728<\/strong><\/span>40<\/strong>\uff5e<\/span><\/strong>60%<\/strong>\u4e4b\u95f4<\/span><\/strong>\u3002\u4e0e\u7a7a\u8179\u65f6\u6bd4\u8f83\uff0c\u9ad8\u8102\u996e\u98df\u540e\u672c\u836f\u5438\u6536\u7387\u6709\u8f7b\u5fae\u964d\u4f4e\uff08<\/span>Cmax\u51cf\u5c11<\/span>11%\uff0c<\/span>tmax\u5ef6\u540e<\/span>1.5\u5c0f\u65f6\uff09\uff0c<\/span>AUC\u7565\u6709\u51cf\u5c0f\uff08<\/span>7.4%\uff09\u3002<\/span><\/span><\/p>\n

\u4f0a\u9a6c\u66ff\u5c3c\u53ca\u5176\u4e3b\u8981\u6d3b\u6027\u4ee3\u8c22\u7269<\/span>N-\u53bb\u7532\u57fa\u5316\u54cc\u55ea\u884d\u751f\u7269\u7684\u8840\u6d46\u6d88\u9664\u534a\u8870\u671f\u5206\u522b\u4e3a\u7ea6<\/span>18\u5c0f\u65f6\u548c<\/span>40\u5c0f\u65f6\uff0c\u8be5\u4ee3\u8c22\u7269\u7684\u8840\u6d46<\/span>AUC\u662f\u539f\u836f\u7532\u78fa\u9178\u4f0a\u9a6c\u66ff\u5c3c<\/span>AUC\u7684<\/span>16%\u3002\u4f0a\u9a6c\u66ff\u5c3c\u7ea6<\/span>81\uff05\u7684\u5242\u91cf\u5728<\/span>7\u5929\u5185\u6d88\u9664\uff0c\u5176\u4e2d\u4ece\u7caa\u4fbf\u4e2d\u6392\u6cc4<\/span>68%\uff0c\u4ece\u5c3f\u6db2\u4e2d\u6392\u6cc4<\/span>13%\uff0c\u4e3b\u8981\u4ee5\u4ee3\u8c22\u7269\u7684\u5f62\u5f0f\u6392\u6cc4\uff0c\u4ec5\u6709<\/span>25\uff05\u4e3a\u539f\u5f62\u3002<\/span><\/span><\/p>\n

\u52a8\u7269\u4f53\u5185\u7814\u7a76\u53d1\u73b0\u4f0a\u9a6c\u66ff\u5c3c\u5b58\u5728\u7ea6<\/span>3.4%\u809d\u80a0\u5faa\u73af\u3002<\/span><\/span><\/p>\n

2.3 <\/span><\/strong>\u53c2\u6bd4\u5236\u5242<\/span><\/strong><\/span><\/p>\n

2.3.1 <\/span><\/strong>\u53c2\u6bd4\u5236\u5242\u5904\u65b9<\/span><\/strong><\/span><\/p>\n

PMDA<\/span>\uff1a\u4e8c\u6c27\u5316\u7845\uff0c\u4ea4\u8054\u805a\u7ef4\u916e\uff0c\u786c\u8102\u9178\u9541\uff0c\u5fae\u6676\u7ea4\u7ef4\u7d20\uff0c\u7f9f\u4e19\u7532\u7ea4\u7ef4\u7d20\uff0c\u4e09\u6c27\u5316\u4e8c\u94c1\uff0c\u805a\u4e59\u4e8c\u9187\uff0c\u6ed1\u77f3\u7c89\u3002<\/span><\/span><\/p>\n

FDA<\/span>\uff1a\u80f6\u6001\u4e8c\u6c27\u5316\u7845\uff0c\u4ea4\u8054\u805a\u7ef4\u916e\uff0c\u7f9f\u4e19\u7532\u7ea4\u7ef4\u7d20\uff0c\u786c\u8102\u9178\u9541\uff0c\u5fae\u6676\u7ea4\u7ef4\u7d20\u3002<\/span><\/span><\/p>\n

\u7247\u5242\u5305\u8863\u6750\u6599\uff1a\u7ea2\u6c27\u5316\u94c1\uff0c\u9ec4\u6c27\u5316\u94c1\uff0c\u7f9f\u4e19\u7532\u7ea4\u7ef4\u7d20\uff0c\u805a\u4e59\u4e8c\u9187\uff0c\u6ed1\u77f3\u7c89\u3002<\/span><\/p>\n

2.3.2 <\/span><\/strong>\u5236\u5242\u5916\u89c2<\/span><\/strong><\/span><\/p>\n

100 mg\u7247\u5242\uff08\u74f6\u88c5\uff09\uff1a\u6df1\u9ec4\u8272\u81f3\u68d5\u9ec4\u8272\u53cc\u51f8\u7684\u8584\u819c\u8863\u7247\uff0c\u5706\u5f62\uff0c\u9664\u53bb\u5305\u8863\u540e\u663e\u767d\u8272\u81f3\u6de1\u9ec4\u8272\u3002\u4e00\u4fa7\u523b\u6709<\/span>\u201cNVR\u201d\uff0c\u53e6\u4e00\u4fa7\u6709\u523b\u75d5\uff0c\u4e14\u523b\u6709<\/span>\u201cSA\u201d\u3002<\/span><\/span><\/p>\n

PMDA\u516c\u5e03\uff1a<\/span><\/span><\/p>\n

\"\u3010\u5e72\u8d27\u3011\u4eff\u5236\u836f\u201c\u683c\u5217\u536b\u201d\u7684\u7814\u7a76\u5f00\u53d1\u6280\u672f\u65b9\u6848\"<\/p>\n

\u4e13\u5229\u516c\u5e03\uff1a<\/span><\/p>\n

\"\u3010\u5e72\u8d27\u3011\u4eff\u5236\u836f\u201c\u683c\u5217\u536b\u201d\u7684\u7814\u7a76\u5f00\u53d1\u6280\u672f\u65b9\u6848\"<\/p>\n

400 mg<\/span>\u7247\u5242\uff08\u74f6\u88c5\uff09\uff1a\u6df1\u9ec4\u8272\u81f3\u68d5\u9ec4\u8272\u53cc\u51f8\u7684\u8584\u819c\u8863\u7247\uff0c\u692d\u5706\u5f62\uff0c\u9664\u53bb\u5305\u8863\u540e\u663e\u767d\u8272\u81f3\u6de1\u9ec4\u8272\u3002\u4e00\u4fa7\u523b\u6709<\/span>\u201c400\u201d<\/span>\uff0c\u53e6\u4e00\u4fa7\u6709\u523b\u75d5\uff0c\u4e14\u523b\u75d5\u4e24\u8fb9\u5747\u523b\u6709<\/span>\u201cSL\u201d<\/span>\u3002<\/span>
<\/span><\/p>\n

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

1<\/strong>\uff09\u6eb6\u51fa\u65b9\u6cd5<\/span><\/strong><\/span><\/p>\n

FDA<\/span>\uff1a\u6eb6\u51fa\u4ecb\u8d28\uff1a<\/span>1000 ml 0.1 N HCl<\/span>\uff0c\u6eb6\u51fa\u65b9\u6cd5\uff1a\u6d46\u6cd5\uff0c<\/span>50 rpm<\/span>\u63a8\u8350\u91c7\u6837\u65f6\u95f4\uff1a<\/span>5,10,15,20<\/span>\u548c<\/span>30 min\u3002<\/span><\/span><\/p>\n

PMDA<\/span>\uff1a\u6eb6\u51fa\u4ecb\u8d28\uff1a<\/span>1000 ml 0.1 N HCl<\/span>\uff0c\u6eb6\u51fa\u65b9\u6cd5\uff1a\u6d46\u6cd5\uff0c<\/span>50 rpm\u3002<\/span><\/span><\/p>\n

2<\/strong>\uff09\u5236\u5242\u542b\u91cf\u6d4b\u5b9a\u65b9\u6cd5<\/span><\/strong><\/span><\/p>\n

\u91c7\u7528\u9ad8\u6548\u6db2\u76f8\u8272\u8c31\u6cd5\u6d4b\u5b9a\u7532\u78fa\u9178\u4f0a\u9a6c\u66ff\u5c3c\u7247\u7684\u542b\u91cf\u3002<\/span><\/p>\n

\u8272\u8c31\u67f1\uff1a<\/span>C18(250 x 4.6 mm, 5\u03bcm)<\/span>\uff1b<\/span><\/span><\/p>\n

\u6d41\u52a8\u76f8\uff1a<\/span>1%<\/span>\u918b\u9178\u94f5\u2236\u4e59\u8148<\/span>=77<\/span>\u2236<\/span>23(v\/v)<\/span>\uff1b<\/span><\/span><\/p>\n

\u6d41\u901f\uff1a<\/span>0.7 mL\u00b7min-1<\/sup><\/span>\uff1b<\/span><\/span><\/p>\n

\u68c0\u6d4b\u6ce2\u957f\uff1a<\/span>254 nm\uff1b<\/span><\/span><\/p>\n

\u8fdb\u6837\u91cf\uff1a<\/span>20 \u03bcL<\/span>\u3002<\/span><\/span><\/p>\n

3<\/strong>\uff09\u6709\u5173\u7269\u8d28\u542b\u91cf\u6d4b\u5b9a<\/span><\/strong><\/span><\/p>\n

\u91c7\u7528\u9ad8\u6548\u6db2\u76f8\u8272\u8c31\u6cd5\u6d4b\u5b9a\u7532\u78fa\u9178\u4f0a\u9a6c\u66ff\u5c3c\u7247\u7684\u6709\u5173\u7269\u8d28\u3002<\/span><\/p>\n

\u8272\u8c31\u67f1\uff1a<\/span>C18(250 x 4.6 mm, 5\u03bcm)<\/span>\uff1b<\/span><\/span><\/p>\n

\u67f1\u6e29\uff1a<\/span>35\u2103\uff1b<\/span><\/span><\/p>\n

\u6d41\u52a8\u76f8\uff1a\u6d41\u52a8\u76f8<\/span>A<\/span>\uff1a\u79f0\u53d6<\/span>2.3 g<\/span>\u8f9b\u70f7\u78fa\u9178\u94a0\u6eb6\u4e8e<\/span>700 ml<\/span>\u6c34\u4e2d\uff0c\u5e76\u52a0\u5165<\/span>300 ml<\/span>\u4e59\u8148\u53ca<\/span>1.2 ml<\/span>\u7a00\u78f7\u9178\uff1b\u6d41\u52a8\u76f8<\/span>B<\/span>\uff1a\u79f0\u53d6<\/span>2.3 g<\/span>\u8f9b\u70f7\u78fa\u9178\u94a0\u6eb6\u4e8e<\/span>100 ml<\/span>\u6c34\u4e2d\uff0c\u5e76\u52a0\u5165<\/span>900 ml<\/span>\u4e59\u8148\u53ca<\/span>1.2 ml<\/span>\u7a00\u78f7\u9178\uff1b<\/span><\/span><\/p>\n\n\n\n\n\n
\n

\u65f6\u95f4\uff08<\/span>min\uff09<\/span><\/span><\/p>\n<\/td>\n

\n

\u6d41\u52a8\u76f8<\/span>A\uff08<\/span>V\/V\uff09<\/span><\/span><\/p>\n<\/td>\n

\n

\u6d41\u52a8\u76f8<\/span>B\uff08<\/span>V\/V\uff09<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

0-16<\/span><\/p>\n<\/td>\n

\n

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

\n

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

\n

16-30<\/span><\/p>\n<\/td>\n

\n

98\u219250<\/span><\/p>\n<\/td>\n

\n

2\u219250<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\u6d41\u901f\uff1a<\/span>2.3 ml\/min<\/span>\uff1b<\/span><\/span><\/p>\n

\u68c0\u6d4b\u6ce2\u957f\uff1a<\/span>267 nm<\/span>\uff1b<\/span><\/span><\/p>\n

\u8fdb\u6837\u91cf\uff1a<\/span>10 \u03bcl<\/span><\/span><\/p>\n

2.5 <\/span><\/strong>\u6280\u672f\u96be\u5ea6<\/span><\/strong><\/span><\/p>\n

1<\/span>\uff09\u7c92\u5f84\uff1a\u836f\u7269\u4e3a<\/span>BCS2<\/span>\u7c7b\uff0c\u7c92\u5f84\u4f1a\u5f71\u54cd\u836f\u7269\u4f53\u5185\u6eb6\u51fa\u4e0e\u5438\u6536\uff0c\u9700\u8981\u5bf9\u53c2\u6bd4\u5236\u5242\u7c92\u5f84\u8fdb\u884c\u53cd\u5411\u89e3\u6790\uff0c\u5e76\u5728\u4f53\u5916\u6eb6\u51fa\u7b5b\u9009\u5177\u6709\u533a\u5206\u529b\u7684\u4ecb\u8d28\u3002<\/span><\/span><\/p>\n

2\uff09\u6eb6\u51fa\u66f2\u7ebf\u62df\u5408\uff1a\u836f\u7269\u6eb6\u89e3\u5ea6\u5b58\u5728<\/span>pH\u4f9d\u8d56\u6027\uff0c\u6676\u5f62<\/span>\/\u6676\u578b\u90fd\u4f1a\u5f71\u54cd\u836f\u7269\u7684\u6eb6\u51fa\u901f\u5ea6\uff0c\u9700\u4f18\u5316\u5904\u65b9\u63a7\u5236\u6eb6\u51fa\u66f2\u7ebf\u3002<\/span><\/span><\/p>\n

3<\/span>\uff09\u5236\u5242\u5de5\u827a\uff1a\u539f\u6599\u836f\u5728\u5904\u65b9\u5360\u6bd4\u5927\uff0c\u53ef\u80fd\u5b58\u5728\u6d41\u52a8\u6027\u95ee\u9898\uff0c\u6e7f\u6cd5\u5236\u7c92\u7684\u5185\u5916\u52a0\u8f85\u6599\u91cf\u9700\u8981\u8fdb\u884c\u5bf9\u6bd4\u7814\u7a76\uff0c\u5df2\u83b7\u5f97\u4e0e\u53c2\u6bd4\u8f83\u76f8\u4f3c\u7684\u6eb6\u51fa\u72b6\u6001\u3002<\/span><\/span><\/p>\n

\u9644\uff1a\u65e5\u672c\u4eff\u5236\u836f\u6eb6\u51fa\u66f2\u7ebf\u56fe<\/span><\/p>\n

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

2.6 <\/span><\/strong>\u5f00\u53d1\u65b9\u6848<\/span><\/strong><\/span><\/p>\n

1\uff09  <\/span><\/span><\/strong>\u53c2\u6bd4\u5236\u5242\u89e3\u6790<\/span><\/strong><\/span><\/p>\n

\u6839\u636e\u53c2\u6bd4\u5236\u5242\u4e34\u5e8a\u9002\u5e94\u75c7\u3001\u60a3\u8005\u4eba\u7fa4\u3001\u539f\u6599\u836f\u6027\u8d28\u4ee5\u53ca\u4ea7\u54c1\u7279\u6027\uff0c\u5236\u5b9a\u76ee\u6807\u4ea7\u54c1\u7684\u8d28\u91cf\u6982\u51b5\uff08<\/span>QTPP<\/span>\uff09\uff1b\u5b9e\u9645\u7814\u53d1\u4e2d\uff0c\u53ef\u57fa\u4e8e<\/span>RLD<\/span>\u7684\u4e34\u5e8a\u836f\u52a8\u5b66\u53c2\u6570\u3001\u4f53\u5916\u6eb6\u51fa\u548c\u7406\u5316\u6027\u8d28\u6765\u786e\u5b9a<\/span>QTPP<\/span>\u3002<\/span><\/span><\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\n

\u76ee\u6807\u4ea7\u54c1\u8d28\u91cf\u6982\u51b5<\/span><\/strong><\/span><\/p>\n<\/td>\n

\n

\u76ee\u6807<\/span><\/p>\n<\/td>\n

\n

\u5408\u7406\u6027\u8bf4\u660e<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

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

\n

\u7247\u5242<\/span><\/p>\n<\/td>\n

\n

\u4e0e\u539f\u7814<\/span><\/strong>BE<\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u5242\u578b\u8bbe\u8ba1<\/span><\/p>\n<\/td>\n

\n

\u901f\u91ca<\/span><\/p>\n<\/td>\n

\n

\u6eb6\u51fa\u66f2\u7ebf\u8981\u6c42\uff1a\u4e0e\u539f\u7814\u4e00\u81f4<\/span><\/strong><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u7ed9\u836f\u9014\u5f84<\/span><\/p>\n<\/td>\n

\n

\u53e3\u670d<\/span><\/p>\n<\/td>\n

\n

\u836f\u5b66\u7b49\u6548\uff1a\u4e0e\u539f\u7814\u4e00\u81f4<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u89c4\u683c<\/span><\/p>\n<\/td>\n

\n

100\/400mg  <\/span><\/p>\n<\/td>\n

\n

\u836f\u5b66\u7b49\u6548\uff1a\u4e0e\u539f\u7814\u4e00\u81f4<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u5305\u88c5<\/span><\/p>\n<\/td>\n

\n

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

\n

\u7a33\u5b9a\u6027\u4e0e\u8fd0\u8f93\u4fdd\u8bc1\u5b8c\u6574\u6027\u8981\u6c42<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u836f\u54c1\u8d28\u91cf\u5c5e\u6027<\/span><\/p>\n<\/td>\n

\n

\u7269\u7406\u5c5e\u6027<\/span>–\u5916\u89c2\u3001\u5927\u5c0f\u7b49<\/span><\/span><\/p>\n<\/td>\n

\n

\u836f\u5b66\u7b49\u6548\u8981\u6c42\uff1a\u5fc5\u987b\u7b26\u5408\u836f\u5178\u6216\u5176\u4ed6\u76f8\u5e94\u7684\u8d28\u91cf\u6807\u51c6<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u9274\u522b<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u542b\u91cf<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u542b\u91cf\u5747\u5300\u5ea6<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u964d\u89e3\u4ea7\u7269<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u6b8b\u4f59\u6eb6\u5242<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u6eb6\u51fa\u5ea6<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u6c34\u5206<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u5fae\u751f\u7269<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u7a33\u5b9a\u6027\uff0c\u6709\u6548\u671f<\/span><\/p>\n<\/td>\n

\n

36 <\/span>\u6708<\/span><\/span><\/p>\n<\/td>\n

\n

\u836f\u5b66\u7b49\u6548\uff1a\u4e0e\u539f\u7814\u4e00\u81f4<\/span><\/p>\n<\/td>\n<\/tr>\n<\/thead>\n<\/table>\n

\u9488\u5bf9\u8be5\u9879\u76ee\uff0c\u53c2\u6bd4\u5236\u5242\u7814\u7a76\u5982\u4e0b\u8868\uff1a<\/span><\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\n

\u53c2\u6bd4\u5236\u5242\u7814\u7a76\u5185\u5bb9<\/span><\/p>\n<\/td>\n

\n

\u5907\u6ce8<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u7269\u7406\u7279\u6027<\/span><\/p>\n<\/td>\n

\n

\u6c34\u5206<\/span><\/p>\n<\/td>\n

\n

\u89c6\u586b\u5145\u91cd\u91cf\u800c\u5b9a\uff0c\u5982\u586b\u5145\u91cf\u5c0f\uff08\u5c0f\u4e8e<\/span>100mg\uff09\uff0c\u9700\u589e\u52a0\u81f3<\/span>1g\u8fdb\u884c\u7814\u7a76\u3002<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u7247\u91cd\u3001\u539a\u5ea6\u3001\u91cd\u91cf\u3001\u5305\u8863\u589e\u91cd<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u5904\u65b9\u5206\u6790<\/span><\/p>\n<\/td>\n

\n

\u4e0d\u6eb6\u6027\u8f85\u6599<\/span><\/p>\n

\u6c34\u6eb6\u6027\u8f85\u6599\u91cd\u91cf<\/span><\/p>\n<\/td>\n

\n

\u91cd\u91cf\u6cd5<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u4e8c\u6c27\u5316\u7845\u542b\u91cf<\/span><\/p>\n<\/td>\n


<\/td>\n<\/tr>\n
\n

\u8f85\u6599\u6027\u8d28<\/span>–\u5f62\u6001\u4e0e\u5927\u5c0f<\/span><\/span><\/p>\n<\/td>\n

\n

\u663e\u5fae\u955c\u89c2\u6d4b\uff0c\u63a8\u6d4b\u539f\u6599\u7c92\u5f84\u3001\u8f85\u6599\u578b\u53f7\u53ca\u53ef\u80fd\u7684\u5de5\u827a\u3002<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

API\u7c92\u5f84\u4e0e\u5f62\u6001<\/span><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

\u6676\u578b<\/span><\/p>\n<\/td>\n

\n

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

\n

\u6eb6\u51fa\u5ea6\u7814\u7a76<\/span><\/p>\n<\/td>\n

\n

RLD\u5728\u8d28\u91cf\u6807\u51c6\u4e2d\u6eb6\u51fa\u5ea6\u66f2\u7ebf<\/span> <\/span>pH 1.0<\/span><\/p>\n<\/td>\n


<\/td>\n<\/tr>\n
\n

RLD\u5728\u4e0d\u540c\u4ecb\u8d28\u6eb6\u51fa\u5ea6\u66f2\u7ebf<\/span>(\u76d0\u9178\u3001<\/span>pH   3\/4.0\u3001<\/span>pH6.8\u3001\u6c34<\/span>)<\/span><\/p>\n<\/td>\n


<\/td>\n<\/tr>\n
\n

\u5176\u4ed6\u53ef\u80fd\u9700\u8981\u8bc4\u4f30\u7684\u4ecb\u8d28<\/span><\/p>\n<\/td>\n


<\/td>\n<\/tr>\n
\n

\u8d28\u91cf\u5bf9\u6bd4<\/span><\/p>\n<\/td>\n

\n

\u5f71\u54cd\u56e0\u7d20\u3001\u52a0\u901f\u9884\u5b9e\u9a8c<\/span><\/p>\n<\/td>\n


<\/td>\n<\/tr>\n<\/thead>\n<\/table>\n

2\uff09<\/strong>\u5904\u65b9\u524d\u7814\u7a76<\/span><\/strong>
<\/span><\/p>\n

–API\u9971\u548c\u6eb6\u89e3\u5ea6\uff1a<\/span>0.1M\u76d0\u9178\u3001<\/span>0.01M\u76d0\u9178\u3001<\/span>pH4.0\u3001<\/span>pH6.8\u7f13\u51b2\u6db2\uff0c\u4e3a\u6eb6\u51fa\u4ecb\u8d28\u9009\u62e9\u63d0\u4f9b\u4f9d\u636e\u3002<\/span><\/span><\/p>\n

—\u836f\u7269\u5728\u5404\u79cd\u6eb6\u51fa\u4ecb\u8d28\u7a33\u5b9a\u6027\u4e0e\u6ee4\u819c\u5438\u9644\u6027\uff1a\u4e3a\u6eb6\u51fa\u5b9e\u9a8c\u53d6\u6837\u4e0e\u68c0\u6d4b\u63d0\u4f9b\u4f9d\u636e\u3002<\/span><\/span><\/p>\n

—\u539f\u8f85\u6599\u76f8\u5bb9\u6027\uff1a\u4e3a\u8f85\u6599\u7b5b\u9009\u63d0\u4f9b\u4f9d\u636e\u3002<\/span><\/span><\/p>\n

—\u539f\u6599\u836f\u6676\u578b\u3001\u6676\u7656\u5bf9\u6eb6\u51fa\u901f\u5ea6\u7684\u5f71\u54cd\u3002<\/span><\/span><\/p>\n

3\uff09<\/strong>\u5904\u65b9\u5de5\u827a\u7814\u7a76<\/span><\/strong><\/span><\/p>\n

—\u539f\u6599\u7c92\u5f84\u5bf9\u6eb6\u51fa\u7684\u5f71\u54cd\u3002<\/span><\/span><\/p>\n

—\u586b\u5145\u5242\u3001\u5d29\u89e3\u5242\u7b49\u7528\u91cf\u7b5b\u9009\uff1a\u8bc4\u4ef7\u6307\u6807<\/span>–\u6eb6\u51fa\u66f2\u7ebf\u62df\u5408<\/span>f2\u3002<\/span><\/span><\/p>\n

—\u5de5\u827a\u7814\u7a76\uff1a\u4e3b\u8981\u5bf9\u6e7f\u6cd5\u5236\u7c92\u901f\u5ea6\u65f6<\/span>\/\u95f4\u3001\u8f85\u6599\u52a0\u5165\u987a\u5e8f<\/span>\/\u6bd4\u4f8b\u3001\u603b\u6df7\u65f6\u95f4\u3001\u538b\u7247\u786c\u5ea6\u3001\u5305\u8863\u589e\u91cd\u7b49\u5bf9\u6eb6\u51fa\u66f2\u7ebf\u7684\u5f71\u54cd\uff0c\u786e\u8ba4\u5173\u952e\u5de5\u827a\u53c2\u6570\u3002<\/span><\/span><\/p>\n

4\uff09<\/strong>\u7a33\u5b9a\u6027\u7814\u7a76<\/span><\/strong><\/span><\/p>\n

—\u5c0f\u8bd5\u5904\u65b9\u786e\u8ba4\u6279\u4e0e\u53c2\u6bd4\u5236\u5242\u521d\u6b65\u5f71\u54cd\u56e0\u7d20\u4e0e\u52a0\u901f\u8bd5\u9a8c\uff1a\u521d\u6b65\u786e\u8ba4\u5305\u6750\u548c\u5904\u65b9\u5de5\u827a\u7a33\u5b9a\u6027\u3002<\/span><\/span><\/p>\n

—\u751f\u4ea7\u9884\u653e\u5927\u6279\u6b21\u5f71\u54cd\u56e0\u7d20\u8bd5\u9a8c\uff1a\u786e\u8ba4\u751f\u4ea7\u653e\u5927\u5de5\u827a\u53ef\u884c\u6027\u3002<\/span><\/span><\/p>\n

—\u8fde\u7eed<\/span>3\u6279\u751f\u4ea7\u6279\u4e0e\u53c2\u6bd4\u5236\u5242\u7684\u7a33\u5b9a\u6027\u5bf9\u6bd4\u7814\u7a76\uff1a\u52a0\u901f<\/span>6\u6708\u4e0e\u957f\u671f<\/span>36\u6708\u7a33\u5b9a\u6027\u5bf9\u6bd4\uff0c\u5236\u5b9a\u4ea7\u54c1\u6709\u6548\u671f\u3002<\/span><\/span><\/p>\n


<\/p>\n

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3<\/section>\n
<\/section>\n
\u4e34\u5e8a\u7814\u7a76                         <\/strong><\/strong><\/strong><\/strong><\/span><\/section>\n<\/section>\n<\/section>\n

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

\u5b9e\u9a8c\u8bbe\u8ba1\uff1a\u53cc\u4ea4\u53c9\uff0c\u8fdb\u98df<\/span><\/p>\n

\u7ed9\u836f\u5242\u91cf\uff1a<\/span>400 mg<\/span><\/p>\n

\u5b9e\u9a8c\u5bf9\u8c61\uff1a\u5df2\u7a33\u5b9a\u670d\u7528\u7532\u78fa\u9178\u4f0a\u9a6c\u66ff\u5c3c\uff0c\u5242\u91cf\u4e3a<\/span>400 mg\u7684\u60a3\u8005\u3002<\/strong><\/span><\/span><\/p>\n

\u8865\u5145\u8bf4\u660e\uff1a\u8fdb\u884c\u60a3\u8005\u62db\u52df\u5de5\u4f5c\u65f6\u5e94\u9488\u5bf9\u7ed9\u836f\u5242\u91cf\u4e3a<\/span>400 mg\u7684\u60a3\u8005\uff0c\u5982\u60a3\u6709\u80c3\u80a0\u9053\u95f4\u8d28\u7624\uff08<\/span>GIST\uff09\u7684\u60a3\u8005\u548c\u5904\u4e8e\u6162\u6027\u7c92\u7ec6\u80de\u767d\u8840\u75c5\uff08<\/span>CML\uff09\u524d\u4e09\u4e2a\u6708\u6cbb\u7597\u671f\u7684\u60a3\u8005\uff1b\u5bf9\u6240\u62db\u52df\u60a3\u8005\u8fdb\u884c\u809d\u6bd2\u6027\u7b5b\u9009\uff0c\u5e76\u5728\u4e34\u5e8a\u5b9e\u9a8c\u8fc7\u7a0b\u4e2d\u5bf9\u809d\u6bd2\u6027\u8fdb\u884c\u76d1\u6d4b\uff1b\u670d\u7528<\/span>CYP3A4\u6291\u5236\u5242\u53ca\u8bf1\u5bfc\u5242\u836f\u7269\u7684\u60a3\u8005\u4e0d\u5e94\u53c2\u4e0e\u6b64\u4e34\u5e8a\u5b9e\u9a8c\u3002<\/span><\/span><\/p>\n

\u8fdb\u98df\u5e94\u4e3a\u6e05\u6de1\u7684\u65e9\u9910\uff0c\u5e94\u5728\u7814\u7a76\u65b9\u6848\u4e2d\u660e\u786e\u6807\u6ce8\uff0c\u5305\u62ec\u5361\u8def\u91cc\u53ca\u98df\u7269\u6210\u5206\u3002<\/span><\/p>\n

\u4f53\u5185\u5b9e\u9a8c\u8c41\u514d\u8981\u6c42\uff1a\u5f53\u6ee1\u8db3<\/span>1\uff09<\/span>400 mg\u5242\u91cf\u5177\u6709\u53ef\u63a5\u53d7\u7684\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\uff1b<\/span>2\uff09<\/span>100 mg\u5242\u91cf\u7ec4\u4e0e<\/span>400 mg\u5242\u91cf\u7ec4\u5904\u65b9\u6bd4\u4f8b\u76f8\u4f3c\u53ca\uff1b<\/span>3\uff09<\/span>100 mg\u5242\u91cf\u7ec4\u4e0e<\/span>400 mg\u5242\u91cf\u7ec4\u5747\u6709\u53ef\u63a5\u53d7\u7684\u4f53\u5916\u6eb6\u51fa\u5b9e\u9a8c\u65f6\uff0c<\/span>100 mg\u5242\u91cf\u53ef\u8c41\u514d\u4f53\u5185\u5b9e\u9a8c\u3002<\/span><\/span><\/p>\n

\u7efc\u4e0a\u6240\u8ff0<\/span><\/strong>\uff0c\u7532\u78fa\u9178\u4f0a\u9a6c\u66ff\u5c3c\u5236\u5242\u4e3a\u901f\u91ca\u5236\u5242\uff0c<\/span>BCS\u5206\u7c7b\u4e3a<\/span>2\u7c7b\uff0c\u836f\u7269\u6eb6\u89e3\u5ea6\u5b58\u5728<\/span>pH\u4f9d\u8d56\u6027\uff0c\u7c92\u5f84\u548c\u5904\u65b9\u5de5\u827a\u5747\u4f1a\u5f71\u54cd\u4f53\u5185\u91ca\u653e\u548c\u5438\u6536\uff0c\u4e14<\/span>AUC\u53d8\u5f02\u7cfb\u6570\u8d85\u8fc7<\/span>30%\u3002\u56e0\u6b64\uff0c\u5728\u4eff\u5236\u836f\u7684\u5f00\u53d1\u4e2d\uff0c\u539f\u6599\u836f\u6676\u578b<\/span>\/\u7c92\u5f84\u7a33\u5b9a\u6027\uff0c\u4ee5\u53ca\u4e34\u5e8a\u8bd5\u9a8c\u63a7\u5236\u662f\u6210\u529f\u7684\u91cd\u8981\u4fdd\u969c\u3002<\/span><\/span><\/p>\n

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\u672c\u6587\u4f5c\u8005\uff1a\u5f90\u9e4f\u98de\uff0c\u73b0\u4efb\u804c\u4e8e\u535a\u5fd7\u7814\u65b0\u3002\u535a\u5fd7\u7814\u65b0\u4e13\u6ce8\u4e8e\u836f\u7269\u5168\u6d41\u7a0b\u7814\u53d1\u670d\u52a1\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n


<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n
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\u5fc5\u987b\u8981\u8d5e\u4e00\u4e2a\uff01\uff01<\/section>\n<\/section>\n<\/section>\n<\/section>\n
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\u59cb\u53d1\u4e8e\u5fae\u4fe1\u516c\u4f17\u53f7\uff1a <\/p>\n<\/blockquote>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

1 \u80cc\u666f\u4ecb\u7ecd               […]<\/p>\n","protected":false},"author":1,"featured_media":11374,"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\/11373"}],"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=11373"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/11373\/revisions"}],"predecessor-version":[{"id":11380,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/11373\/revisions\/11380"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/11374"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=11373"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=11373"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=11373"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}