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\u4ea7\u54c1\u8bf4\u660e
\n\u76d0\u9178\u66ff\u7f57\u975e\u73ed\u4e00\u6c34\u5408\u7269\uff08Tirofiban Hydrochloride Monohydrate\uff09\u4ea7\u54c1\u8bf4\u660e\u4e66
\n1. \u4ea7\u54c1\u6982\u8ff0\u4e0e\u5316\u5b66\u7279\u6027
\n\u76d0\u9178\u66ff\u7f57\u975e\u73ed\u4e00\u6c34\u5408\u7269\u662f\u4e00\u79cd\u5c0f\u5206\u5b50\u975e\u80bd\u7c7b\u8840\u5c0f\u677f\u7cd6\u86cb\u767dIIb\/IIIa\u53d7\u4f53\u62ee\u6297\u5242\uff0c\u5316\u5b66\u540d\u79f0\u4e3aN-(\u4e01\u57fa\u78fa\u9170\u57fa)-O-[4-(4-\u54cc\u5576\u57fa)\u4e01\u57fa]-L-\u916a\u6c28\u9178\u4e00\u76d0\u9178\u76d0\u4e00\u6c34\u5408\u7269\u3002\u5176\u5206\u5b50\u5f0f\u4e3aC22H39ClN2O6S\uff0c\u5206\u5b50\u91cf\u4e3a495.073\uff0cCAS\u53f7\u4e3a142373-60-2\u3002\u672c\u54c1\u4e3a\u767d\u8272\u81f3\u7c7b\u767d\u8272\u7ed3\u6676\u6027\u7c89\u672b\uff0c\u7eaf\u5ea6\u226596%\uff0c\u6613\u6eb6\u4e8e\u6c34\u548c\u7532\u9187\uff0c\u5728\u751f\u7406pH\u6761\u4ef6\u4e0b\u5448\u5f31\u9178\u6027\u3002
\n2. \u751f\u7269\u5316\u5b66\u529f\u80fd\u4e0e\u91cd\u8981\u6027
\n\u76d0\u9178\u66ff\u7f57\u975e\u73ed\u901a\u8fc7\u9009\u62e9\u6027\u3001\u53ef\u9006\u6027\u7ed3\u5408\u8840\u5c0f\u677f\u8868\u9762\u7684GPIIb\/IIIa\u53d7\u4f53\uff0c\u963b\u65ad\u7ea4\u7ef4\u86cb\u767d\u539f\u4e0e\u53d7\u4f53\u7684\u7ed3\u5408\uff0c\u4ece\u800c\u6291\u5236\u8840\u5c0f\u677f\u805a\u96c6\u3002\u8fd9\u4e00\u673a\u5236\u5728\u6025\u6027\u51a0\u8109\u7efc\u5408\u5f81\uff08ACS\uff09\u548c\u7ecf\u76ae\u51a0\u72b6\u52a8\u8109\u4ecb\u5165\u6cbb\u7597\uff08PCI\uff09\u4e2d\u5177\u6709\u5173\u952e\u4f5c\u7528\uff0c\u53ef\u663e\u8457\u964d\u4f4e\u8840\u6813\u5f62\u6210\u98ce\u9669\uff0c\u662f\u6297\u8840\u5c0f\u677f\u6cbb\u7597\u7684\u91cd\u8981\u836f\u7269\u6210\u5206\u3002
\n3. \u4e3b\u8981\u5e94\u7528\u9886\u57df\u4e0e\u5177\u4f53\u7528\u9014
\n\u672c\u54c1\u4e3b\u8981\u7528\u4e8e\u5236\u5907\u6297\u8840\u6813\u6ce8\u5c04\u5242\uff0c\u9002\u7528\u4e8e\u4ee5\u4e0b\u4e34\u5e8a\u573a\u666f\uff1a
\n– \u4e0d\u7a33\u5b9a\u578b\u5fc3\u7ede\u75db\u548c\u975eST\u6bb5\u62ac\u9ad8\u578b\u5fc3\u808c\u6897\u6b7b\u7684\u6025\u6027\u671f\u6cbb\u7597
\n– PCI\u672f\u4e2d\u7684\u8f85\u52a9\u6297\u51dd\u7ba1\u7406
\n– \u5fc3\u8840\u7ba1\u624b\u672f\u4e2d\u9884\u9632\u8840\u5c0f\u677f\u6d3b\u5316
\n\u5b9e\u9a8c\u5ba4\u7814\u7a76\u4e2d\u4ea6\u7528\u4f5c\u8840\u5c0f\u677f\u529f\u80fd\u7814\u7a76\u7684\u5de5\u5177\u5316\u5408\u7269\u3002
\n4. \u50a8\u5b58\u6761\u4ef6\u4e0e\u4f7f\u7528\u5efa\u8bae
\n\u50a8\u5b58\u4e8e2-8\u2103\u907f\u5149\u5e72\u71e5\u73af\u5883\uff0c\u5f00\u5c01\u540e\u9700\u5145\u6c2e\u5bc6\u5c01\u4fdd\u5b58\u3002\u914d\u5236\u6210\u6eb6\u6db2\u540e\u5e94\u572824\u5c0f\u65f6\u5185\u4f7f\u7528\uff0c\u907f\u514d\u53cd\u590d\u51bb\u878d\u3002\u5b9e\u9a8c\u64cd\u4f5c\u9700\u5728\u65e0\u83cc\u6761\u4ef6\u4e0b\u8fdb\u884c\uff0c\u4e34\u5e8a\u4f7f\u7528\u9700\u4e25\u683c\u9075\u5faa\u533b\u5631\u5242\u91cf\u3002
\n5. \u8d28\u91cf\u63a7\u5236\u4e0e\u5b89\u5168\u4fe1\u606f
\n\u672c\u54c1\u7ecfHPLC\u68c0\u6d4b\u7eaf\u5ea6\u226596%\uff0c\u6b8b\u7559\u6eb6\u5242\u7b26\u5408ICH\u6807\u51c6\u3002\u5b89\u5168\u6570\u636e\uff1a
\n– \u5371\u9669\u4ee3\u7801\uff1aH302\uff08\u541e\u54bd\u6709\u5bb3\uff09
\n– \u9632\u62a4\u63aa\u65bd\uff1a\u64cd\u4f5c\u65f6\u4f69\u6234\u9632\u62a4\u624b\u5957\/\u773c\u955c\uff0c\u907f\u514d\u5438\u5165\u7c89\u5c18
\n– \u6025\u6551\u63aa\u65bd\uff1a\u63a5\u89e6\u76ae\u80a4\u540e\u7acb\u5373\u7528\u80a5\u7682\u6c34\u51b2\u6d17\uff0c\u8bef\u98df\u9700\u5c31\u533b
\n\u5e9f\u5f03\u7269\u5e94\u4f5c\u4e3a\u533b\u836f\u5371\u9669\u54c1\u5904\u7406\u3002
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