{"id":53301,"date":"2018-09-28T01:00:00","date_gmt":"2018-09-30T01:43:10","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/09\/30\/%e8%8d%af%e7%89%a9%e5%88%86%e6%9e%90%e7%9a%84%e6%96%b9%e6%b3%95%e5%ad%a6%e9%aa%8c%e8%af%81%e6%89%80%e8%a6%81%e5%81%9a%e5%88%b0%e7%9a%84%e4%ba%8b%e9%a1%b9\/"},"modified":"2018-09-30T09:43:11","modified_gmt":"2018-09-30T01:43:11","slug":"%e8%8d%af%e7%89%a9%e5%88%86%e6%9e%90%e7%9a%84%e6%96%b9%e6%b3%95%e5%ad%a6%e9%aa%8c%e8%af%81%e6%89%80%e8%a6%81%e5%81%9a%e5%88%b0%e7%9a%84%e4%ba%8b%e9%a1%b9","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/53301\/","title":{"rendered":"\u836f\u7269\u5206\u6790\u7684\u65b9\u6cd5\u5b66\u9a8c\u8bc1\u6240\u8981\u505a\u5230\u7684\u4e8b\u9879"},"content":{"rendered":"
\n

\u70b9\u51fb\u4e0a\u65b9\u7684 \u884c\u821fDrug \u25b2 \u6dfb\u52a0\u5173\u6ce8<\/span><\/span><\/p>\n


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

\u65b0\u836f\u7533\u62a5\u65f6\uff0c\u836f\u54c1\u8d28\u91cf\u6807\u51c6\u4e2d\u5206\u6790\u65b9\u6cd5\u5fc5\u987b\u9a8c\u8bc1\uff1b\u836f\u7269\u751f\u4ea7\u5de5\u827a\u53d8\u66f4\u3001\u5236\u5242\u7684\u7ec4\u5206\u53d8\u66f4\u3001\u539f\u5206\u6790\u65b9\u6cd5\u8fdb\u884c\u4fee\u8ba2\u65f6\uff0c\u5219\u8d28\u91cf\u6807\u51c6\u5206\u6790\u65b9\u6cd5\u5fc5\u987b\u8fdb\u884c\u9a8c\u8bc1\uff1b<\/span>\u836f\u7269\u5206\u6790\u68c0\u9a8c\u65f6\u836f\u54c1\u751f\u4ea7\u7684GMP\u7684\u836f\u7269\u5206\u6790\u7684\u65b9\u6cd5\u5b66\u9a8c\u8bc1\uff0c\u662f\u4fdd\u8bc1\u836f\u7269\u5206\u6790\u7ed3\u679c\u51c6\u786e\u6027\u7684\u524d\u63d0\u548c\u57fa\u7840\uff0c\u4e5f\u662f\u5b9e\u73b0\u836f\u7269\u5206\u6790\u68c0\u6d4bGMP\u7684\u5fc5\u7136\u8981\u7d20\u3002<\/span><\/p>\n


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

    \u6784\u6210\u836f\u7269\u5206\u6790\u4e2d\u7684\u68c0\u6d4b\u65b9\u6cd5\u9a8c\u8bc1\uff0c\u8fd9\u8981\u6d89\u53ca\u5230\u4ee5\u4e0b\u4e9b\u65b9\u9762\u7684\u5185\u5bb9\uff1a<\/span><\/p>\n


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

1<\/span>\u3001\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u6210\u529f\u7684\u524d\u63d0\u6761\u4ef6\uff1a<\/span><\/span><\/strong><\/span>
<\/span><\/strong>\uff081\uff09\u4eea\u5668\u5df2\u7ecf\u786e\u8ba4\u3001\u6821\u6b63\u5e76\u5728\u6709\u6548\u671f\u5185 \uff082\uff09\u7ecf\u8fc7\u57f9\u8bad\u7684\u4eba\u5458\uff083\uff09\u53ef\u9760\u7a33\u5b9a\u7684\u5bf9\u7167\u54c1
\uff084\uff09\u53ef\u9760\u7a33\u5b9a\u7684\u5b9e\u9a8c\u8bd5\u5242 \uff085\uff09\u786e\u8ba4\u53d7\u8bd5\u6eb6\u6db2\u7684\u7a33\u5b9a\u6027\uff0c\u5728\u89c4\u5b9a\u65f6\u95f4\u5185\u65e0\u964d\u89e3\u3002<\/span><\/span><\/p>\n


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

2\u3001\u5206\u6790\u65b9\u6cd5\u5b66\u9a8c\u8bc1\u6240\u8981\u6c42\u9a8c\u8bc1\u7684\u5185\u5bb9\uff1a<\/span><\/strong><\/p>\n

\uff081\uff09\u542b\u91cf\u7684\u6d4b\u5b9a \uff082\uff09\u6742\u8d28\u7684\u542b\u91cf\u6d4b\u5b9a \uff083\uff09\u836f\u7269\u7684\u5b9a\u6027\u9274\u5b9a \uff084\uff09\u836f\u7269\u7684\u542b\u91cf\u5747\u5300\u5ea6\u6d4b\u5b9a \uff085\uff09\u836f\u7269\u7684\u5fae\u751f\u7269\u68c0\u6d4b \uff086\uff09\u836f\u7269\u7684\u7ec6\u83cc\u5185\u6bd2\u7d20\u7684\u68c0\u6d4b<\/span><\/p>\n

 <\/span><\/p>\n

\u9a8c\u8bc1\u5185\u5bb9\uff1a<\/span><\/span><\/strong><\/p>\n

<\/span><\/span><\/strong>
<\/strong><\/span>\u51c6\u786e\u5ea6\uff1a<\/span><\/strong>\u51c6\u786e\u5ea6\u662f\u6307\u7528\u8be5\u65b9\u6cd5\u6d4b\u5b9a\u7684\u7ed3\u679c\u4e0e\u771f\u5b9e\u503c\u6216\u53c2\u8003\u503c\u63a5\u8fd1\u7684\u7a0b\u5ea6\uff0c\u7528\u767e\u5206\u56de\u6536\u7387\u8868\u793a\u3002
\u6d4b\u5b9a\u56de\u6536\u7387R\uff08recovery\uff09\u7684\u5177\u4f53\u65b9\u6cd5\u53ef\u91c7\u7528\u52a0\u6837\u56de\u6536\u8bd5\u9a8c\u6cd5\u6765\u8fdb\u884c\u6d4b\u5b9a\u3002\u52a0\u6837\u56de\u6536\u8bd5\u9a8c\u5df2\u51c6\u786e\u6d4b\u5b9a\u836f\u7269\u542b\u91cfP\u7684\u771f\u5b9e\u6837\u54c1+\u5df2\u77e5\u91cfA\u7684\u5bf9\u7167\u54c1\uff08\u6216\u6807\u51c6\u54c1\uff09\u6d4b\u5b9a\uff0c\u6d4b\u5b9a\u503c\u4e3aM\u3002\u6570\u636e\u8981\u6c42:\u89c4\u5b9a\u7684\u8303\u56f4\u5185\uff0c\u81f3\u5c11\u75289\u6b21\u6d4b\u5b9a\u7ed3\u679c\u8bc4\u4ef7\uff0c\u5982\u5236\u5907\u9ad8\u3001\u4e2d\u3001\u4f4e\u4e09\u4e2a\u4e0d\u540c\u6d53\u5ea6\u6837\u54c1\u5404\u6d4b\u4e09\u6b21<\/span><\/span><\/p>\n


\u7cbe\u5bc6\u5ea6\uff1a<\/strong>\uff08\u91cd\u590d\u6027\u3001\u4e2d\u95f4\u7cbe\u5bc6\u5ea6\u548c\u91cd\u73b0\u6027\u7cbe\u5bc6\u5ea6\u662f\u6307\u5728\u89c4\u5b9a\u6761\u4ef6\u4e0b\uff0c\u540c\u4e00\u4e2a\u5747\u5300\u6837\u54c1\uff0c\u7ecf\u591a\u6b21\u53d6\u6837\u6d4b\u5b9a\u6240\u5f97\u7ed3\u679c\u4e4b\u95f4\u7684\u63a5\u8fd1\u7a0b\u5ea6\u3002\u7528\u504f\u5dee\uff08d\uff09\u3001\u6807\u51c6\u504f\u5dee(SD)\u3001\u76f8\u5bf9\u6807\u51c6\u504f\u5dee(RSD)\uff08\u53d8\u5f02\u7cfb\u6570\uff0cCV\uff09\u8868\u793a\u3002<\/span><\/span><\/p>\n

  \uff081\uff09\u91cd\u590d\u6027(repeatability):\u5728\u76f8\u540c\u6761\u4ef6\u4e0b\uff0c\u7531\u540c\u4e00\u4e2a\u5206\u6790\u4eba\u5458\u6d4b\u5b9a\u6240\u5f97\u7ed3\u679c\u7684\u7cbe\u5bc6\u5ea6\uff1b\u5728\u89c4\u5b9a\u7684\u8303\u56f4\u5185\uff0c\u81f3\u5c11\u75289\u6b21\u6d4b\u5b9a\u7ed3\u679c\u8bc4\u4ef7\uff0c\u5982\u5236\u5907\u4e09\u4e2a\u4e0d\u540c\u6d53\u5ea6\u6837\u54c1\u5404\u6d4b\u4e09\u6b21\u6216\u628a\u88ab\u6d4b\u7269\u6d53\u5ea6\u5f53\u4f5c100%\uff0c\u81f3\u5c11\u6d4b6\u6b21\u8fdb\u884c\u8bc4\u4ef7
 \uff082\uff09\u4e2d\u95f4\u7cbe\u5bc6\u5ea6\u540c\u4e00\u5b9e\u9a8c\u5ba4\uff0c\u4e0d\u540c\u65f6\u95f4\u7531\u4e0d\u540c\u5206\u6790\u4eba\u5458\u7528\u4e0d\u540c\u8bbe\u5907\u6240\u5f97\u7ed3\u679c\u7684\u7cbe\u5bc6\u5ea6
 \uff083\uff09\u91cd\u73b0\u6027(reproducibility)\u4e0d\u540c\u5b9e\u9a8c\u5ba4\uff0c\u4e0d\u540c\u5206\u6790\u4eba\u5458\u6d4b\u5b9a\u7ed3\u679c\u7684\u7cbe\u5bc6\u5ea6
 \uff084\uff09\u6570\u636e\u8981\u6c42\uff1a\u9700\u62a5\u544aSD\uff0cRSD\u548c\u53ef\u4fe1\u9650\u3002<\/span><\/p>\n


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

\u4e13\u5c5e\u6027\uff1a<\/span><\/strong> \u6307\u6709\u5176\u4ed6\u6210\u5206\uff08\u6742\u8d28\u3001\u964d\u89e3\u7269\u3001\u8f85\u6599\u7b49\uff09\u53ef\u80fd\u5b58\u5728\u60c5\u51b5\u4e0b\u91c7\u7528\u7684\u65b9\u6cd5\u80fd\u51c6\u786e\u6d4b\u5b9a\u51fa\u88ab\u6d4b\u7269\u7684\u7279\u6027\uff0c\u80fd\u53cd\u6620\u8be5\u65b9\u6cd5\u5728\u6709\u5171\u5b58\u7269\u65f6\u5bf9\u4f9b\u8bd5\u7269\u51c6\u786e\u800c\u4e13\u5c5e\u7684\u6d4b\u5b9a\u80fd\u529b\uff0c\u662f\u6307\u8be5\u6cd5\u7528\u4e8e\u590d\u6742\u6837\u54c1\u5206\u6790\u65f6\u662f\u5426\u53d7\u5230\u76f8\u4e92\u5e72\u6270\u7a0b\u5ea6\u7684\u5ea6\u91cf
<\/span>\u2022<\/span> \u901a\u5e38\u901a\u8fc7\u5206\u6790\u542b\u6709\u52a0\u4e86\u6742\u8d28\u3001\u964d\u89e3\u4ea7\u7269\u3001\u6709\u5173\u5316\u5b66\u7269\u8d28\u6216\u5b89\u6170\u5242\u6210\u5206\u7684\u6837\u54c1\uff0c\u5c06\u6240\u83b7\u5206\u6790\u7ed3\u679c\u4e0e\u672a\u52a0\u524d\u8ff0\u6210\u5206\u4e4b\u6837\u54c1\u7684\u6d4b\u8bd5\u7ed3\u679c\u8fdb\u884c\u6bd4\u8f83\uff0c\u4e24\u7ec4\u6d4b\u8bd5\u7ed3\u679c\u4e4b\u5dee\u5373\u4e13\u5c5e\u6027<\/span><\/span><\/p>\n

\u2022<\/span>\u9274\u522b\u53cd\u5e94—\u5e94\u80fd\u4e0e\u53ef\u80fd\u5171\u5b58\u7684\u7269\u8d28\u6216\u7ed3\u6784\u76f8\u4f3c\u5316\u5408\u7269\u533a\u522b\uff0c\u4e0d\u542b\u88ab\u5206\u6790\u7684\u6837\u54c1\uff0c\u4ee5\u53ca\u7ed3\u6784\u76f8\u4f3c\u6216\u7ec4\u5206\u4e2d\u7684\u6709\u5173\u5316\u5408\u7269\uff0c\u5747\u5e94\u5448\u8d1f\u53cd\u5e94
<\/span>\u2022<\/span>\u542b\u91cf\u6d4b\u5b9a\u548c\u6742\u8d28\u6d4b\u5b9a—\u8272\u8c31\u6cd5\u548c\u5176\u4ed6\u65b9\u6cd5\uff0c\u5e94\u9644\u4ee3\u8868\u6027\u56fe\u8c31\uff0c\u4ea6\u8bf4\u660e\u4e13\u5c5e\u6027\u3002\u56fe\u4e2d\u5e94\u6807\u660e\u5404\u7ec4\u4efd\u7684\u4f4d\u7f6e\uff0c\u8272\u8c31\u6cd5\u4e2d\u7684\u5206\u79bb\u5ea6\u5e94\u7b26\u5408\u8981\u6c42
<\/span>\u2022<\/span>\u6742\u8d28\u53ef\u83b7\u5f97\u7684\u60c5\u51b5\u4e0b\uff0c\u5bf9\u4e8e\u542b\u91cf\u6d4b\u5b9a\uff0c\u8bd5\u6837\u4e2d\u53ef\u52a0\u5165\u6742\u8d28\u6216\u8f85\u6599\uff0c\u8003\u5bdf\u6d4b\u8bd5\u7ed3\u679c\u662f\u5426\u53d7\u5e72\u6270\uff1b\u5bf9\u4e8e\u6742\u8d28\u6d4b\u5b9a\uff0c\u4e5f\u53ef\u5411\u8bd5\u6837\u4e2d\u52a0\u5165\u4e00\u5b9a\u91cf\u7684\u6742\u8d28\uff0c\u8003\u5bdf\u6742\u8d28\u95f4\u662f\u5426\u5f97\u5230\u5206\u79bb<\/span><\/span><\/p>\n


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

\u68c0\u6d4b\u9650\uff1a<\/span><\/strong> \u68c0\u6d4b\u9650\u7cfb\u6307\u8bd5\u6837\u5728\u786e\u5b9a\u7684\u5b9e\u9a8c\u6761\u4ef6\u4e0b\uff0c\u88ab\u6d4b\u7269\u80fd\u88ab\u68c0\u6d4b\u51fa\u7684\u6700\u4f4e\u6d53\u5ea6\u6216\u542b\u91cf\u3002\u5b83\u662f\u9650\u5ea6\u68c0\u9a8c\u6548\u80fd\u6307\u6807\uff0c\u65e0\u9700\u5b9a\u91cf\u6d4b\u5b9a\uff0c\u53ea\u8981\u6307\u51fa\u9ad8\u4e8e\u6216\u4f4e\u4e8e\u8be5\u89c4\u5b9a\u6d53\u5ea6\u5373\u53ef\u3002<\/span><\/span><\/p>\n

\u2022<\/span>\u975e\u4eea\u5668\u5206\u6790\u76ee\u89c6\u6cd5\uff1a\u7528\u5df2\u77e5\u6d53\u5ea6\u7684\u88ab\u6d4b\u7269\uff0c\u8bd5\u9a8c\u51fa\u80fd\u88ab\u53ef\u9760\u5730\u68c0\u6d4b\u51fa\u7684\u6700\u4f4e\u6d53\u5ea6\u6216\u91cf
<\/span>\u2022<\/span>\u4fe1\u566a\u6bd4\u6cd5:\u7528\u4e8e\u80fd\u663e\u793a\u57fa\u7ebf\u566a\u97f3\u7684\u5206\u6790\u65b9\u6cd5\uff08\u4eea\u5668\u5206\u6790\u65b9\u6cd5\uff09\uff0c\u662f\u628a\u5df2\u77e5\u4f4e\u6d53\u5ea6\u8bd5\u6837\u6d4b\u51fa\u7684\u4fe1\u53f7\u4e0e\u7a7a\u767d\u6837\u54c1\u6d4b\u51fa\u7684\u4fe1\u53f7\u8fdb\u884c\u6bd4\u8f83\uff0c\u7b97\u51fa\u80fd\u88ab\u53ef\u9760\u5730\u68c0\u6d4b\u51fa\u7684\u6700\u4f4e\u6d53\u5ea6\u6216\u91cf\u3002\u4e00\u822c\u4ee5\u4fe1\u566a\u6bd43\u22361\u62162\u22361\u65f6\u7684\u76f8\u5e94\u6d53\u5ea6\u6216\u6ce8\u5165\u4eea\u5668\u7684\u91cf\u786e\u5b9a\u68c0\u6d4b\u9650
<\/span>\u2022<\/span>\u4e5f\u53ef\u91c7\u7528\u6807\u51c6\u5dee\u6cd5\uff1a<\/span>\u7a7a\u767d\u503c\uff1d0\u65f6<\/span><\/strong>\uff1b\u2460\u6d4b\u5b9a\u80cc\u666f10\u6b21\u4ee5\u4e0a\uff0c\u6c42\u51fa\u6807\u51c6\u5dee\u03c3
\u2461\u5c06\u03c3\u4e58\u4ee5\u4e09\u500d\uff1b\u2462\u5728\u5de5\u4f5c\u66f2\u7ebf\u4e0a\u6c42\u51fa3\u03c3\u76f8\u5bf9\u5e94\u7684\u6d53\u5ea6X\uff0c\u5373\u4e3a\u65b9\u6cd5\u7684\u68c0\u51fa\u503c\uff1b\u7a7a\u767d\u503c\u4e0d\u7b49\u4e8e0<\/strong>\uff1b\u2460\u6d4b\u5b9a\u80cc\u666f10\u6b21\u4ee5\u4e0a\uff0c\u6c42\u51fa\u6807\u51c6\u5dee\u03c3\uff1b\u2461\u5c06\u03c3\u4e58\u4ee5\u4e09\u500d\uff1b\u2462\u5728\u5de5\u4f5c\u66f2\u7ebf\u4e0a\u6c42\u51fa3\u03c3\u76f8\u5bf9\u5e94\u7684\u6d53\u5ea6X\uff1b\u2463\u5c06\u6c42\u5f97\u7684\u5bf9\u5e94\u6d53\u5ea6\u503c\u52a0\u4e0a\u7a7a\u767d\u503c\u5373\u5f97\u8be5\u65b9\u6cd5\u7684\u68c0\u51fa\u9650<\/span><\/span><\/p>\n


<\/p>\n

\u5b9a\u91cf\u9650\uff1a<\/span><\/span><\/strong><\/p>\n

\u6307\u6837\u54c1\u4e2d\u88ab\u6d4b\u7269\u80fd\u88ab\u5b9a\u91cf\u6d4b\u5b9a\u7684\u6700\u4f4e\u91cf\uff0c\u7ed3\u679c\u5e94\u5177\u6709\u4e00\u5b9a\u51c6\u786e\u5ea6\u548c\u7cbe\u5bc6\u5ea6\u8981\u6c42
<\/span>\u2022<\/span>\u5e38\u7528\u4fe1\u566a\u6bd4\u6cd5\u786e\u5b9a\u5b9a\u91cf\u9650\uff0c\u4e00\u822c\u4ee5\u4fe1\u566a\u6bd4\uff08S\/N\uff09\u4e3a10\u22361\u65f6\u76f8\u5e94\u7684\u6d53\u5ea6\u6216\u6ce8\u5165\u4eea\u5668\u7684\u91cf\u8fdb\u884c\u786e\u5b9a\uff0c\u4e5f\u53ef\u7528\u4eea\u5668\u6240\u6d4b\u7a7a\u767d\u80cc\u666f\u54cd\u5e94\u6807\u51c6\u5dee\uff08SD\uff09\u768410\u500d\u4e3a\u4f30\u8ba1\u503c\uff0c\u518d\u7ecf\u8bd5\u9a8c\u786e\u5b9a\u65b9\u6cd5\u7684\u5b9e\u9645\u6d4b\u5b9a\u4e0b\u9650<\/span><\/span><\/p>\n


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

\u7ebf\u6027\uff1a<\/span><\/span><\/strong><\/span>\u5728\u8bbe\u8ba1\u7684\u8303\u56f4\u5185\uff0c\u6d4b\u8bd5\u7ed3\u679c\u4e0e\u8bd5\u6837\u4e2d\u88ab\u6d4b\u7269\u6d53\u5ea6\u76f4\u63a5\u5448\u6b63\u6bd4\u5173\u7cfb\u7684\u7a0b\u5ea6\u3002\u7ebf\u5f62\u901a\u5e38\u7528\u6700\u5c0f\u4e8c\u4e58\u6cd5\u5904\u7406\u6570\u636e\u6c42\u5f97\u56de\u5f52\u66f2\u7ebf\u7684\u659c\u7387\uff08Slope\uff09\u6765\u8868\u793a\u3002\u6570\u636e\u8981\u6c42\uff1a\u81f3\u5c11\u9700\u8981\u4e94\u4e2a\u6d53\u5ea6\u8003\u5bdf\u7ebf\u5f62\uff0c\u9700\u63d0\u4f9b\u76f8\u5173\u7cfb\u6570\u3001y\u622a\u8ddd\uff08\u662f\u68c0\u5b9a\u7684\u53ef\u80fd\u504f\u5dee\uff09\u3001\u56de\u5f52\u659c\u7387\u53ca\u65b9\u5dee\u7b49\u53c2\u6570\uff0c\u5e94\u5217\u51fa\u56de\u5f52\u65b9\u7a0b\u6570\u548c\u7ebf\u6027\u56fe<\/span><\/span><\/p>\n


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

\u6ce8\u610f\uff1a<\/span><\/strong>\u505a\u7ebf\u6027\u65f6\uff0c\u5e94\u6ce8\u610f\u5c3d\u91cf\u505a\u7684\u70b9\u591a\u4e00\u70b9\u3001\u7ebf\u6027\u6d53\u5ea6\u8303\u56f4\u5bbd\u4e00\u70b9\uff0c\u8fd9\u6837\u505a\u7684\u597d\u5904\u662f\uff1a\u5f53\u4f60\u5728\u51c6\u786e\u5ea6\u8003\u5bdf\u65f6\uff0c\u4f60\u505a\u7684\u56de\u6536\u7387\u8003\u5bdf\u7684\u6d53\u5ea6\u5c31\u5927\u4e9b\uff0c\u914d\u5236\u6eb6\u6db2\u65f6\u5c31\u5bb9\u6613\u64cd\u4f5c\u4e9b\uff0c\u5426\u8005\uff0c\u5728\u4f60\u505a\u7ebf\u6027\u8003\u5bdf\u65f6\uff0c\u4f60\u505a\u7684\u7ebf\u6027\u6d53\u5ea6\u8303\u56f4\u4e0d\u5bbd\uff0c\u90a3\u4e48\u4f60\u5728\u8003\u5bdf\u56de\u6536\u7387\u65f6\uff0c\u4f60\u91c7\u7528\u52a0\u5165\u6cd5\u8003\u5bdf\u65f6\u7684\u6d53\u5ea6\u53d8\u5316\u8303\u56f4\u4e0d\u5bbd\uff0c\u64cd\u4f5c\u6d53\u5ea6\u5f88\u96be\u63a7\u5236\uff0c\u9020\u6210\u5b9e\u9645\u64cd\u4f5c\u56f0\u96be\u3002\u6211\u78b0\u5230\u4e00\u4e2a\u5728\u505a\u65b9\u6cd5\u5b66\u7814\u7a76\u7684\u4eba\uff0c\u7531\u4e8e\u5979\u5728\u8003\u5bdf\u7ebf\u6027\u65f6\uff0c\u505a\u7684\u7ebf\u6027\u6d53\u5ea6\u4e0d\u5927\uff0c\u5728\u505a\u56de\u6536\u7387\u65f6\uff0c\u52a0\u5165\u540e\u7684\u91cf\u9020\u6210\u56de\u6536\u7387\u6d53\u5ea6\u8d85\u51fa\u7ebf\u6027\u8003\u5bdf\u8303\u56f4\u7684\u6d53\u5ea6\uff0c\u6211\u8bf4\u90a3\u6837\u662f\u4e0d\u884c\u7684\u3002\u56e0\u4e3a\u5728\u505a\u5206\u6790\u8ba1\u7b97\u65f6\u53c8\u6070\u6070\u7528\u4e86\u7ebf\u6027\u5173\u7cfb\u6765\u8ba1\u7b97\uff0c\u7ed3\u679c\u80af\u5b9a\u662f\u503c\u5f97\u6000\u7591\uff0c\u7ed3\u679c\u662f\u4e0d\u80fd\u4ee4\u4eba\u80af\u5b9a\u7684\uff01\uff08\u8fd9\u662f\u7ecf\u9a8c\u603b\u7ed3\uff09<\/span><\/span><\/p>\n


<\/span><\/span>\u8303\u56f4\uff1a<\/span><\/strong>\u6307\u8fbe\u5230\u4e00\u5b9a\u7cbe\u5bc6\u5ea6\u3001\u51c6\u786e\u5ea6\u548c\u7ebf\u6027\u7684\u6761\u4ef6\u4e0b\uff0c\u6d4b\u8bd5\u65b9\u6cd5\u9002\u7528\u7684\u9ad8\u3001\u4f4e\u9650\u6d53\u5ea6\u6216\u91cf\u7684\u533a\u95f4\u3002\u8303\u56f4\u5e94\u6839\u636e\u5206\u6790\u65b9\u6cd5\u7684\u5177\u4f53\u5e94\u7528\u548c\u7ebf\u6027\u3001\u51c6\u786e\u5ea6\u3001\u7cbe\u5bc6\u5ea6\u7ed3\u679c\u548c\u8981\u6c42\u786e\u5b9a\u3002
<\/span>\u2022<\/span>\u539f\u6599\u836f\u548c\u5236\u5242\u542b\u91cf\u6d4b\u5b9a\u8303\u56f4\u4e3a80%-120%\uff1b\u5236\u5242\u542b\u91cf\u5747\u5300\u5ea6\u8303\u56f4\u4e3a70%-130%\uff1b\u6742\u8d28\u6d4b\u5b9a\u5e94\u4e3a\u88ab\u6d4b\u6742\u8d28\u6c47\u62a5\u503c\u5230\u9650\u5ea6\u7684120%\uff1b\u6eb6\u51fa\u5ea6\u5e94\u4e3a\u6d4b\u5b9a\u8303\u56f4\u7684\u00b120%\uff0c\u5982\u89c4\u5b9a\u4e86\u9650\u5ea6\u8303\u56f4\uff0c\u5e94\u4e3a\u4e0b\u9650\u7684-20%\u81f3\u4e0a\u9650\u7684+20%\uff0c\u4f8b\u5982\u7f13\u91ca\u72471h<20%,7h>70%,\u5219\u9a8c\u8bc1\u8303\u56f4\u5b9a\u4e3a0-90%\u3002<\/span><\/span><\/p>\n


\u8010\u7528\u6027\uff1a<\/strong>\u6307\u6d4b\u5b9a\u6761\u4ef6\u7a0d\u6709\u53d8\u52a8\u65f6\uff0c\u7ed3\u679c\u4e0d\u53d7\u5f71\u54cd\u7684\u627f\u53d7\u7a0b\u5ea6\uff0c\u4e3a\u5e38\u89c4\u68c0\u9a8c\u63d0\u4f9b\u4f9d\u636e\u3002\u662f\u8861\u91cf\u5b9e\u9a8c\u5ba4\u548c\u5de5\u4f5c\u4eba\u5458\u4e4b\u95f4\u5728\u6b63\u5e38\u60c5\u51b5\u4e0b\u5b9e\u9a8c\u7ed3\u679c\u91cd\u73b0\u6027\u7684\u5c3a\u5ea6;\u5982\u679c\u65b9\u6cd5\u6613\u53d7\u5230\u5206\u6790\u6761\u4ef6\u7684\u5f71\u54cd\uff0c\u6216\u8981\u6c42\u82db\u523b\uff0c\u5e94\u6ce8\u660e\u3002\u5178\u578b\u7684\u53d8\u52a8\u5305\u62ec\uff1a\u5206\u6790\u6eb6\u6db2\u7684\u7a33\u5b9a\u6027\uff0c\u63d0\u53d6\u65f6\u95f4\u7b49\u3002<\/span><\/span><\/p>\n


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

\u836f\u7269\u5206\u6790\u7684\u65b9\u6cd5\u5b66\u9a8c\u8bc1\u4e8b\u9879<\/span><\/strong><\/p>\n

\u542b\u91cf\u6d4b\u5b9a\u65b9\u6cd5\u9a8c\u8bc1\u7684\u63a5\u6536\u6807\u51c6<\/span><\/p>\n

*<\/span>\u5bb9\u91cf\u5206\u6790\u6cd5\uff1a\u7528\u539f\u6599\u836f\u7cbe\u5236\u54c1<\/span>(<\/span>\u542b\u91cf<\/span>>99.5<\/span>\uff05<\/span>)<\/span>\u6216\u5bf9\u7167\u54c1\u8003\u5bdf\u65b9\u6cd5\u7684\u7cbe\u5bc6\u5ea6\uff0c\u76f8\u5bf9\u6807\u51c6\u5dee\u4e00\u822c\u5e94\u4e0d\u5927\u4e8e<\/span>0.2<\/span>\uff05\uff1b\u8fdb\u884c\u56de\u6536\u7387\u8bd5\u9a8c\u3002\u56de\u6536\u7387\u4e00\u822c\u5728<\/span>99.7<\/span>\uff5e<\/span>100.3<\/span>\uff05\u4e4b\u95f4<\/span><\/span><\/p>\n

*UV<\/span>\u6cd5\uff1a\u7528\u9002\u5f53\u6d53\u5ea6\u7684\u7cbe\u5236\u54c1\u8fdb\u884c\u6d4b\u5b9a\uff0c\u5176<\/span>RSD<\/span>\u4e00\u822c\u4e0d\u5927\u4e8e<\/span>1<\/span>\uff05\u3002\u5236\u5242\u7684\u6d4b\u5b9a\uff0c\u56de\u6536\u7387\u4e00\u822c\u5e94\u5728<\/span>98<\/span>\uff05\uff5e<\/span>102<\/span>\uff05\u4e4b\u95f4\uff1b\u7ebf\u6027\uff1a\u5438\u5149\u5ea6<\/span>A<\/span>\u4e00\u822c\u5728<\/span>0.2<\/span>\uff5e<\/span>0.7<\/span>\uff0c\u6d53\u5ea6\u70b9<\/span>n<\/span>\uff1d<\/span>5<\/span>\u3002\u7528\u6d53\u5ea6<\/span>c<\/span>\u5bf9<\/span>A<\/span>\u4f5c\u7ebf\u6027\u56de\u5f52\u5904\u7406\uff0c\u5f97\u4e00\u76f4\u7ebf\u65b9\u7a0b\uff0c<\/span>r<\/span>\u5e94\u8fbe\u5230<\/span>0.9999(n<\/span>\uff1d<\/span>5)<\/span>\uff0c\u65b9\u7a0b\u7684\u622a\u8ddd\u5e94\u8fd1\u4e8e\u96f6\u542b\u91cf\u6d4b\u5b9a\u65b9\u6cd5\u9a8c\u8bc1\u7684\u63a5\u6536\u6807\u51c6<\/span><\/span><\/p>\n

*HPLC<\/span>\u6cd5\uff1a<\/span><\/span><\/p>\n

*<\/span>\u8981\u6c42<\/span>RSD<2<\/span>\uff05\uff0c\u56de\u6536\u7387<\/span>98<\/span>\uff05\uff5e<\/span>102<\/span>\uff05\u4e4b\u95f4\u3002<\/span><\/span><\/p>\n

*<\/span>\u7ebf\u6027\u8303\u56f4\uff1a\u7528\u7cbe\u5236\u54c1\u914d\u5236\u4e00\u7cfb\u5217\u6807\u51c6\u6eb6\u6db2\uff0c\u6d53\u5ea6\u70b9<\/span>n<\/span>\u5e94\u4e3a<\/span>5<\/span>\uff5e<\/span>7<\/span>\uff0c\u7528\u6d53\u5ea6<\/span>c<\/span>\u5bf9\u5cf0\u9ad8<\/span>h<\/span>\u6216\u88ab\u6d4b\u7269\u7684\u54cd\u5e94\u503c\u4e4b\u6bd4\u8fdb\u884c\u56de\u5f52\u5904\u7406\uff0c\u5efa\u7acb\u56de\u5f52\u65b9\u7a0b\uff0c<\/span>r<\/span>\u5e94\u5927\u4e8e<\/span>0.999<\/span>\uff0c\u622a\u8ddd\u5e94\u8d8b\u4e8e\u96f6<\/span><\/span><\/p>\n

 <\/span><\/p>\n

\u5206\u6790\u65b9\u6cd5\u9a8c\u8bc1\u6b65\u9aa4\uff1a<\/span><\/p>\n

*<\/span>\u9a8c\u8bc1\u65b9\u6848\u7684\u5236\u8ba2<\/span><\/span><\/p>\n

*<\/span>\u9a8c\u8bc1\u76ee\u7684\u3001\u65b9\u6cd5\u6539\u8fdb\u80cc\u666f\u3001<\/span><\/span><\/p>\n

*<\/span>\u63d0\u4f9b\u7684\u539f\u6599\u836f\u548c\u4ea7\u54c1\u3001\u4eea\u5668\u6982\u8981\u3001\u8bd5\u5242\u3001\u5bf9\u7167\u54c1<\/span><\/span><\/p>\n

*<\/span>\u5f85\u9a8c\u8bc1\u7684\u65b9\u6cd5\uff0c\u9879\u76ee\uff0c\u5408\u683c\u6807\u51c6<\/span><\/span><\/p>\n

*<\/span>\u5b9e\u65bd\u4eba\u5458\u7684\u57f9\u8bad<\/span><\/span><\/p>\n

*<\/span>\u53c2\u8003\u6587\u732e<\/span><\/span><\/p>\n

*<\/span>\u9a8c\u8bc1\u7684\u5b9e\u65bd<\/span><\/span><\/p>\n

*<\/span>\u6536\u96c6\u5b8c\u6574\u7684\u9a8c\u8bc1\u8fc7\u7a0b\u8bb0\u5f55\u548c\u539f\u59cb\u56fe\u8c31<\/span><\/span><\/p>\n

*<\/span>\u590d\u6838<\/span><\/span><\/p>\n

*<\/span>\u9a8c\u8bc1\u62a5\u544a<\/span><\/span><\/p>\n

*<\/span>\u8bc4\u4ef7\u8be5\u65b9\u6cd5\u662f\u5426\u901a\u8fc7\u9a8c\u8bc1<\/span><\/span><\/p>\n

\u65b9\u6cd5\u786e\u8ba4\u548c\u65b9\u6cd5\u8f6c\u79fb<\/span><\/p>\n

*<\/span>\u5bf9\u65b0\u4ea7\u54c1\u7684\u65b9\u6cd5\u9a8c\u8bc1\u901a\u5e38\u5728\u4ea7\u54c1\u5f00\u53d1\u9636\u6bb5\u5b8c\u6210\uff1b\u5927\u89c4\u6a21\u751f\u4ea7\u540e\u7684\u9a8c\u8bc1\u901a\u5e38\u5305\u62ec\u65b9\u6cd5\u786e\u8ba4\u548c\u65b9\u6cd5\u8f6c\u79fb<\/span><\/span><\/p>\n

*<\/span>\u5206\u6790\u65b9\u6cd5\u786e\u8ba4\u662f\u6307\u5f53\u56fd\u5bb6\u6807\u51c6\u6216\u836f\u5178\u6807\u51c6\u62df\u53d8\u5316\u6216\u5df2\u7ecf\u53d8\u5316\u65f6\u5728\u672c\u5b9e\u9a8c\u5ba4\u8fdb\u884c\u7684\u5bf9\u6240\u6d89\u53ca\u4ea7\u54c1\u662f\u5426\u9002\u7528\u7684\u786e\u8ba4\u5b9e\u9a8c<\/span><\/span><\/p>\n

*<\/span>\u786e\u8ba4\u4e4b\u524d\u5e94\u5bf9\u65b0\u65e7\u65b9\u6cd5\u8fdb\u884c\u6838\u5bf9\uff0c\u6807\u660e\u6240\u6709\u53d8\u66f4\u7ec6\u8282<\/span><\/span><\/p>\n

*<\/span>\u68c0\u9a8c\u6837\u54c1\u7684\u4fe1\u606f\uff08\u6279\u53f7\u3001\u89c4\u683c<\/span>),<\/span>\u53d8\u66f4\u9879\u76ee\u7684\u63a5\u6536\u6807\u51c6<\/span><\/span><\/p>\n

*<\/span>\u786e\u8ba4\u8bd5\u9a8c\u7684\u6837\u54c1\u901a\u5e38\u5305\u62ec\u6b63\u5e38\u4ea7\u54c1\u3001\u7a33\u5b9a\u6027\u4ea7\u54c1<\/span><\/span><\/p>\n

*<\/span>\u65b9\u6cd5\u8f6c\u79fb\u6307\u68c0\u9a8c\u65b9\u6cd5\u7531\u8f6c\u79fb\u65b9\u8f6c\u79fb\u81f3\u63a5\u6536\u65b9\u65f6\u8fdb\u884c\u7684\u5b9e\u9a8c\u3002<\/span><\/span><\/p>\n

 *<\/span>\u6d41\u52a8\u76f8<\/span>PH<\/span>\uff08<\/span>\u00b10.5)<\/span><\/span><\/p>\n

 *<\/span>\u6d41\u52a8\u76f8\u7ec4\u6210<\/span>(<\/span>\u6709\u673a\u76f8<\/span>\u00b15%<\/span>\uff09<\/span><\/span><\/p>\n

 *<\/span>\u8272\u8c31\u67f1\uff08\u540c\u4e00\u5382\u5bb6\u7684\u4e09\u4e2a\u6279\u53f7\uff0c\u6216\u4e24\u4e2a\u4e0d\u540c\u5382\u5bb6\uff08\u540c\u56fa\u5b9a\u76f8\u548c\u586b\u5145\u7269\uff0c\u5c3a\u5bf8\uff09<\/span><\/span><\/p>\n

 *<\/span>\u6e29\u5ea6\uff08<\/span>20-25C)<\/span>\u548c\u6d41\u901f<\/span>(\u00b110%<\/span>\uff09<\/span><\/span><\/p>\n

 *<\/span>\u68c0\u6d4b\u6ce2\u957f<\/span>(\u00b15nm)<\/span><\/span><\/p>\n

\u68c0\u9a8c\u9879\u76ee\u548c\u9a8c\u8bc1\u5185\u5bb9\u603b\u7ed3<\/span><\/p>\n

*<\/span>\u9274\u522b\u8bd5\u9a8c\u9664\u4e13\u5c5e\u6027\u3001\u8010\u7528\u6027\u5916\uff0c\u5176\u5b83\u90fd\u4e0d\u8981\u6c42\u3002<\/span><\/span><\/p>\n

*<\/span>\u6742\u8d28\u7684\u9650\u5ea6\u68c0\u67e5\u9664\u4e13\u5c5e\u6027\u3001\u68c0\u6d4b\u9650\u3001\u8010\u7528\u6027\u5916\uff0c\u5176\u5b83\u90fd\u4e0d\u8981\u6c42<\/span><\/span><\/p>\n

*<\/span>\u6742\u8d28\u7684\u5b9a\u91cf\u6d4b\u5b9a\u9664\u68c0\u6d4b\u9650\u5916\uff0c\u5176\u5b83\u90fd\u8981\u6c42\u3002<\/span><\/span><\/p>\n

*<\/span>\u542b\u91cf\u6d4b\u5b9a\u53ca\u6eb6\u51fa\u91cf\u6d4b\u5b9a\u9664\u68c0\u6d4b\u9650\u3001\u5b9a\u91cf\u9650\u5916\uff0c\u5176\u5b83\u90fd\u8981\u6c42<\/span><\/span><\/p>\n


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


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