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\u5728\u533b\u836f\u5de5\u4e1a\u9886\u57df\uff0c1-\u8418\u4e59\u916e<\/strong>\u4f5c\u4e3a\u4e00\u79cd\u91cd\u8981\u7684\u533b\u836f\u4e2d\u95f4\u4f53<\/strong>\uff0c\u5728\u6709\u673a\u5408\u6210<\/strong>\u4e2d\u5c55\u73b0\u51fa\u5353\u8d8a\u7684\u5e94\u7528\u4ef7\u503c\u3002\u5176\u72ec\u7279\u7684\u5316\u5b66\u7ed3\u6784\u548c\u53cd\u5e94\u6d3b\u6027\u4f7f\u5176\u6210\u4e3a\u591a\u79cd\u836f\u7269\u6d3b\u6027\u6210\u5206\uff08API\uff09\u5408\u6210\u7684\u5173\u952e\u539f\u6599\u3002\u968f\u7740\u5168\u7403\u533b\u836f\u5e02\u573a\u7684\u5feb\u901f\u589e\u957f\uff0c1-\u8418\u4e59\u916e<\/strong>\u7684\u9700\u6c42\u6301\u7eed\u6500\u5347\u3002\u672c\u6587\u5c06\u6df1\u5165\u63a2\u8ba81-\u8418\u4e59\u916e<\/strong>\u7684\u5316\u5b66\u7279\u6027\u3001\u5728\u533b\u836f\u5408\u6210\u4e2d\u7684\u5177\u4f53\u5e94\u7528\u3001\u4f18\u52bf\u4e0e\u6ce8\u610f\u4e8b\u9879\uff0c\u4ee5\u53ca\u5176\u5728\u533b\u836f\u884c\u4e1a\u7684\u672a\u6765\u524d\u666f\u3002\u5982\u679c\u60a8\u6b63\u5728\u5bfb\u627e\u9ad8\u54c1\u8d28\u7684\u533b\u836f\u4e2d\u95f4\u4f53<\/strong>\u4f9b\u5e94\u5546\uff0c\u6b22\u8fce\u5173\u6ce8\u6211\u4eec\u7684\u4ea7\u54c1\u4e0e\u6280\u672f\u52a8\u6001\u3002<\/p>\n\n\n\n

\u4ea7\u54c1\u7b80\u4ecb<\/strong><\/p>\n\n\n\n

1-<\/strong>\u8418\u4e59\u916e<\/strong>\uff08\u82f1\u6587\u540d\uff1a1-(Naphthalen-1-yl)ethanone\uff09\uff0c\u53c8\u79f01-\u4e59\u9170\u8418\uff0c\u662f\u4e00\u79cd\u91cd\u8981\u7684\u82b3\u9999\u916e\u7c7b\u5316\u5408\u7269\uff0c\u5e7f\u6cdb\u5e94\u7528\u4e8e\u6709\u673a\u5408\u6210<\/strong>\u548c\u533b\u836f\u4e2d\u95f4\u4f53<\/strong>\u9886\u57df\u3002\u5176\u5206\u5b50\u5f0f\u4e3aC\u2081\u2082H\u2081\u2080O\uff0c\u5206\u5b50\u91cf\u4e3a170.21 g\/mol\uff0cCAS\u53f7\u4e3a941-98-0\uff0c\u4fbf\u4e8e\u5168\u7403\u5316\u5b66\u54c1\u6570\u636e\u5e93\u7684\u8bc6\u522b\u4e0e\u7ba1\u7406\u3002\u4f5c\u4e3a\u4e00\u79cd\u529f\u80fd\u6027\u4e2d\u95f4\u4f53\uff0c1-\u8418\u4e59\u916e<\/strong>\u4ee5\u5176\u7a33\u5b9a\u7684\u5316\u5b66\u6027\u8d28\u548c\u591a\u6837\u7684\u53cd\u5e94\u9014\u5f84\u53d7\u5230\u533b\u836f\u884c\u4e1a\u7684\u9752\u7750\u3002<\/p>\n\n\n\n

\u4ece\u5316\u5b66\u6027\u8d28\u6765\u770b\uff0c1-\u8418\u4e59\u916e<\/strong>\u662f\u4e00\u79cd\u5f31\u6781\u6027\u5316\u5408\u7269\uff0c\u53ef\u6eb6\u4e8e\u4e59\u9187\u3001\u4e59\u919a\u548c\u82ef\u7b49\u6709\u673a\u6eb6\u5242\uff0c\u5fae\u6eb6\u4e8e\u6c34\u3002\u5176\u916e\u57fa\u5177\u6709\u8f83\u9ad8\u7684\u4eb2\u7535\u6027\uff0c\u80fd\u591f\u53c2\u4e0e\u4eb2\u6838\u52a0\u6210\u3001\u8fd8\u539f\u548c\u6c27\u5316\u7b49\u53cd\u5e94\uff0c\u4e3a\u836f\u7269\u5206\u5b50\u529f\u80fd\u5316\u63d0\u4f9b\u7075\u6d3b\u6027\u3002\u7194\u70b9\u7ea6\u4e3a33-35\u00b0C\uff0c\u6cb8\u70b9\u4e3a302\u00b0C\uff08760 mmHg\uff09\uff0c\u5bc6\u5ea6\u4e3a1.12 g\/mL\uff0825\u00b0C\uff09\uff0c\u5728\u5e38\u6e29\u4e0b\u4e3a\u6d45\u9ec4\u8272\u81f3\u65e0\u8272\u6db2\u4f53\u6216\u4f4e\u7194\u70b9\u56fa\u4f53\uff0c\u4fbf\u4e8e\u5de5\u4e1a\u50a8\u5b58\u548c\u64cd\u4f5c\u3002<\/p>\n\n\n\n

\u5916\u89c2\u4e0a\uff0c1-\u8418\u4e59\u916e<\/strong>\u901a\u5e38\u4e3a\u6d45\u9ec4\u8272\u900f\u660e\u6db2\u4f53\u6216\u6676\u4f53\uff0c\u7eaf\u5ea6\u4e00\u822c\u63a7\u5236\u572898%\u4ee5\u4e0a\uff0c\u533b\u836f\u7ea7\u4ea7\u54c1\u53ef\u8fbe99.5%\u3002\u9ad8\u7eaf\u5ea6\u662f1-\u8418\u4e59\u916e<\/strong>\u5728\u533b\u836f\u5408\u6210\u4e2d\u7684\u5173\u952e\u4f18\u52bf\uff0c\u53ef\u663e\u8457\u51cf\u5c11\u526f\u4ea7\u7269\uff0c\u63d0\u9ad8\u836f\u7269\u5408\u6210\u7684\u6536\u7387\u548c\u8d28\u91cf\u3002\u6211\u4eec\u516c\u53f8\u91c7\u7528\u5148\u8fdb\u7684\u84b8\u998f\u4e0e\u91cd\u7ed3\u6676\u5de5\u827a\uff0c\u786e\u4fdd\u4ea7\u54c1\u6742\u8d28\u542b\u91cf\u4f4e\u4e8e0.3%\uff0c\u7b26\u5408GMP\uff08\u826f\u597d\u751f\u4ea7\u89c4\u8303\uff09\u548cICH Q3D\uff08\u5143\u7d20\u6742\u8d28\u6307\u5357\uff09\u6807\u51c6\uff0c\u4e3a\u9ad8\u6807\u51c6\u533b\u836f\u751f\u4ea7\u63d0\u4f9b\u53ef\u9760\u539f\u6599\u3002<\/p>\n\n\n\n

\u53c2\u6570<\/strong><\/td>\u63cf\u8ff0<\/strong><\/td><\/tr><\/thead>
\u5206\u5b50\u5f0f<\/strong><\/td>C\u2081\u2082H\u2081\u2080O<\/td><\/tr>
CAS<\/strong>\u53f7<\/strong><\/td>941-98-0<\/td><\/tr>
\u5916\u89c2<\/strong><\/td>\u6d45\u9ec4\u8272\u6db2\u4f53\u6216\u6676\u4f53<\/td><\/tr>
\u7eaf\u5ea6<\/strong><\/td>\u226598%\uff08\u5de5\u4e1a\u7ea7\uff09<\/td><\/tr>
\u7194\u70b9<\/strong><\/td>33-35\u00b0C<\/td><\/tr>
\u6cb8\u70b9<\/strong><\/td>302\u00b0C\uff08760 mmHg\uff09<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

\u8fd9\u4e9b\u7279\u6027\u5960\u5b9a\u4e861-\u8418\u4e59\u916e<\/strong>\u4f5c\u4e3a\u533b\u836f\u4e2d\u95f4\u4f53<\/strong>\u7684\u6838\u5fc3\u5730\u4f4d\uff0c\u4e3a\u590d\u6742\u836f\u7269\u5206\u5b50\u5408\u6210\u63d0\u4f9b\u4e86\u575a\u5b9e\u57fa\u7840\u3002<\/p>\n\n\n\n

\u533b\u836f\u5408\u6210\u5e94\u7528<\/strong><\/p>\n\n\n\n

\u5728\u6709\u673a\u5408\u6210<\/strong>\u9886\u57df\uff0c1-\u8418\u4e59\u916e<\/strong>\u56e0\u5176\u82b3\u9999\u8418\u73af\u548c\u6d3b\u6027\u916e\u57fa\uff0c\u6210\u4e3a\u5408\u6210\u591a\u79cd\u836f\u7269\u6d3b\u6027\u6210\u5206\uff08API\uff09\u7684\u5173\u952e\u4e2d\u95f4\u4f53\u3002\u5b83\u5e7f\u6cdb\u5e94\u7528\u4e8e\u6297\u708e\u836f\u3001\u6297\u764c\u836f\u548c\u795e\u7ecf\u7cfb\u7edf\u836f\u7269\u7684\u5408\u6210\uff0c\u5177\u4f53\u4f53\u73b0\u5728\u4ee5\u4e0b\u51e0\u4e2a\u65b9\u9762\uff1a<\/p>\n\n\n\n

    \n
  1. \u6297\u708e\u836f\u7269\u5408\u6210<\/strong>\uff1a1-\u8418\u4e59\u916e<\/strong>\u53ef\u4f5c\u4e3a\u8d77\u59cb\u539f\u6599\uff0c\u901a\u8fc7\u916e\u57fa\u7684\u4eb2\u6838\u52a0\u6210\u53cd\u5e94\u751f\u6210\u4ef2\u9187\u6216\u80fa\u7c7b\u884d\u751f\u7269\u3002\u4f8b\u5982\uff0c\u5728\u975e\u753e\u4f53\u6297\u708e\u836f\uff08NSAIDs\uff09\u5982\u8418\u666e\u751f\uff08Naproxen\uff09\u7684\u5408\u6210\u4e2d\uff0c1-\u8418\u4e59\u916e<\/strong>\u7ecf\u8fd8\u539f\u548c\u70f7\u57fa\u5316\u53cd\u5e94\uff0c\u751f\u6210\u5173\u952e\u7684\u624b\u6027\u4e2d\u95f4\u4f53\uff0c\u4ea7\u7387\u53ef\u8fbe80%\u4ee5\u4e0a\u3002\u5176\u8418\u73af\u7ed3\u6784\u8d4b\u4e88\u836f\u7269\u4f18\u5f02\u7684\u4ee3\u8c22\u7a33\u5b9a\u6027\u548c\u751f\u7269\u5229\u7528\u5ea6\u3002<\/li>\n\n\n\n
  2. \u6297\u764c\u836f\u7269\u5f00\u53d1<\/strong>\uff1a1-\u8418\u4e59\u916e<\/strong>\u5728\u9776\u5411\u6297\u764c\u836f\u7269\u7684\u5408\u6210\u4e2d\u8868\u73b0\u51fa\u8272\u3002\u901a\u8fc7\u916e\u57fa\u7684\u7f29\u5408\u53cd\u5e94\uff0c\u53ef\u5408\u6210\u542b\u8418\u73af\u7684\u6742\u73af\u5316\u5408\u7269\uff0c\u5982\u55b9\u5549\u6216\u5432\u54da\u884d\u751f\u7269\uff0c\u8fd9\u4e9b\u5316\u5408\u7269\u5e38\u7528\u4e8e\u9776\u5411\u916a\u6c28\u9178\u6fc0\u9176\u6291\u5236\u5242\u7684\u5f00\u53d1\u3002\u4f8b\u5982\uff0c\u67d0\u6297\u764c\u836f\u7269\u5019\u9009\u7269\uff08\u516c\u5f00\u6587\u732e\u7f16\u53f7\uff1aCN108530382A\uff09\u4ee51-\u8418\u4e59\u916e<\/strong>\u4e3a\u539f\u6599\uff0c\u901a\u8fc7\u591a\u6b65\u5408\u6210\u5236\u5907\u4e86EGFR\u6291\u5236\u5242\uff0c\u6291\u5236\u7387\u8fbe90%\u3002<\/li>\n\n\n\n
  3. \u795e\u7ecf\u7cfb\u7edf\u836f\u7269<\/strong>\uff1a1-\u8418\u4e59\u916e<\/strong>\u7684\u916e\u57fa\u53ef\u901a\u8fc7\u8fd8\u539f\u80fa\u5316\u53cd\u5e94\uff0c\u751f\u6210\u542b\u8418\u73af\u7684\u80fa\u7c7b\u5316\u5408\u7269\uff0c\u7528\u4e8e\u6297\u6291\u90c1\u6216\u6297\u5e15\u91d1\u68ee\u836f\u7269\u7684\u5408\u6210\u3002\u4f8b\u5982\uff0c\u5176\u884d\u751f\u7269\u53ef\u4f5c\u4e3a\u591a\u5df4\u80fa\u53d7\u4f53\u6fc0\u52a8\u5242\u7684\u524d\u4f53\uff0c\u5e94\u7528\u4e8e\u5e15\u91d1\u68ee\u75c5\u6cbb\u7597\u836f\u7269\u7684\u7814\u53d1\uff0c\u53cd\u5e94\u9009\u62e9\u6027\u9ad8\u8fbe95%\u3002<\/li>\n<\/ol>\n\n\n\n

    \u5728\u5b9e\u9645\u751f\u4ea7\u4e2d\uff0c1-\u8418\u4e59\u916e<\/strong>\u7684\u8418\u73af\u7ed3\u6784\u589e\u5f3a\u4e86\u836f\u7269\u5206\u5b50\u7684\u758f\u6c34\u6027\uff0c\u6709\u52a9\u4e8e\u63d0\u9ad8\u836f\u7269\u900f\u8fc7\u7ec6\u80de\u819c\u7684\u80fd\u529b\u3002\u540c\u65f6\uff0c\u5176\u916e\u57fa\u7684\u5316\u5b66\u591a\u6837\u6027\u652f\u6301\u591a\u6b65\u5408\u6210\u7684\u9ad8\u6548\u63a8\u8fdb\u3002\u4f8b\u5982\uff0c\u5728\u67d0\u6297\u708e\u836f\u7684\u5de5\u4e1a\u5316\u751f\u4ea7\u4e2d\uff0c1-\u8418\u4e59\u916e<\/strong>\u7684\u5f15\u5165\u4f7f\u53cd\u5e94\u6b65\u9aa4\u4ece5\u6b65\u51cf\u5c11\u52303\u6b65\uff0c\u6574\u4f53\u6536\u7387\u63d0\u534715%\u3002<\/p>\n\n\n\n

    \u4f18\u52bf\u4e0e\u6ce8\u610f\u4e8b\u9879<\/strong><\/p>\n\n\n\n

    1-<\/strong>\u8418\u4e59\u916e<\/strong>\u5728\u533b\u836f\u5408\u6210\u4e2d\u7684\u4f18\u52bf\u663e\u8457\uff0c\u4e3b\u8981\u4f53\u73b0\u5728\u4ee5\u4e0b\u51e0\u4e2a\u65b9\u9762\uff1a<\/p>\n\n\n\n

      \n
    • \u9ad8\u7eaf\u5ea6<\/strong>\uff1a\u7eaf\u5ea6\u8fbe99%\u4ee5\u4e0a\u76841-\u8418\u4e59\u916e<\/strong>\u53ef\u51cf\u5c11\u526f\u53cd\u5e94\uff0c\u786e\u4fdd\u836f\u7269\u5408\u6210\u7684\u8d28\u91cf\u548c\u4e00\u81f4\u6027\uff0c\u7b26\u5408USP\u548cEP\u836f\u5178\u6807\u51c6\u3002<\/li>\n\n\n\n
    • \u53cd\u5e94\u6d3b\u6027\u5f3a<\/strong>\uff1a\u916e\u57fa\u7684\u9ad8\u4eb2\u7535\u6027\u652f\u6301\u591a\u79cd\u529f\u80fd\u5316\u53cd\u5e94\uff0c\u5982\u4eb2\u6838\u52a0\u6210\u3001\u6c27\u5316\u548c\u7f29\u5408\uff0c\u53cd\u5e94\u6548\u7387\u6bd4\u82ef\u4e59\u916e\u7c7b\u4e2d\u95f4\u4f53\u9ad820%-30%\u3002<\/li>\n\n\n\n
    • \u7ed3\u6784\u7a33\u5b9a\u6027<\/strong>\uff1a\u8418\u73af\u7684\u5171\u8f6d\u4f53\u7cfb\u589e\u5f3a\u4e86\u4e2d\u95f4\u4f53\u7684\u5316\u5b66\u7a33\u5b9a\u6027\uff0c\u964d\u4f4e\u4e86\u836f\u7269\u5408\u6210\u4e2d\u7684\u964d\u89e3\u98ce\u9669\u3002<\/li>\n\n\n\n
    • \u7eff\u8272\u5de5\u827a\u517c\u5bb9\u6027<\/strong>\uff1a\u6211\u4eec\u516c\u53f8\u76841-\u8418\u4e59\u916e<\/strong>\u91c7\u7528\u50ac\u5316\u52a0\u6c22\u5de5\u827a\u751f\u4ea7\uff0c\u5e9f\u6db2\u6392\u653e\u91cf\u964d\u4f4e35%\uff0c\u7b26\u5408\u7eff\u8272\u5316\u5b66\u539f\u5219\u548cREACH\u6cd5\u89c4\u3002<\/li>\n<\/ul>\n\n\n\n

      \u4f7f\u75281-\u8418\u4e59\u916e<\/strong>\u65f6\u9700\u6ce8\u610f\u4ee5\u4e0b\u4e8b\u9879\uff1a<\/p>\n\n\n\n

        \n
      • \u5b89\u5168\u6027<\/strong>\uff1a1-\u8418\u4e59\u916e<\/strong>\u53ef\u80fd\u5bf9\u76ae\u80a4\u548c\u773c\u775b\u6709\u8f7b\u5fae\u523a\u6fc0\u6027\uff0c\u64cd\u4f5c\u65f6\u9700\u4f69\u6234\u9632\u62a4\u88c5\u5907\uff0c\u5e76\u786e\u4fdd\u901a\u98ce\u826f\u597d\u3002<\/li>\n\n\n\n
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      • \u6cd5\u89c4\u5408\u89c4<\/strong>\uff1a\u533b\u836f\u7ea7\u4ea7\u54c1\u9700\u4e25\u683c\u9075\u5b88ICH Q3C\uff08\u6b8b\u7559\u6eb6\u5242\u6307\u5357\uff09\u548cGMP\u8981\u6c42\uff0c\u786e\u4fdd\u6742\u8d28\u63a7\u5236\u5728ppm\u7ea7\u3002<\/li>\n<\/ul>\n\n\n\n

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