{"id":47970,"date":"2026-08-17T09:00:48","date_gmt":"2026-08-17T07:00:48","guid":{"rendered":"https:\/\/kymos.com\/?p=47970"},"modified":"2026-08-17T09:00:48","modified_gmt":"2026-08-17T07:00:48","slug":"%e7%94%9f%e7%89%a9%e5%88%b6%e5%93%81%e7%9a%84%e5%be%ae%e7%94%9f%e7%89%a9%e6%8e%a7%e5%88%b6%ef%bc%9a%e6%a3%80%e6%b5%8b%e7%ad%96%e7%95%a5","status":"publish","type":"post","link":"https:\/\/kymos.com\/zh-hans\/news\/%e7%94%9f%e7%89%a9%e5%88%b6%e5%93%81%e7%9a%84%e5%be%ae%e7%94%9f%e7%89%a9%e6%8e%a7%e5%88%b6%ef%bc%9a%e6%a3%80%e6%b5%8b%e7%ad%96%e7%95%a5\/","title":{"rendered":"\u751f\u7269\u5236\u54c1\u7684\u5fae\u751f\u7269\u63a7\u5236\uff1a\u68c0\u6d4b\u7b56\u7565"},"content":{"rendered":"

\u751f\u7269\u5236\u54c1\u7684\u5fae\u751f\u7269\u5b89\u5168\u6027\u662f\u5f00\u53d1\u3001\u751f\u4ea7\u548c\u6279\u6b21\u653e\u884c\u8fc7\u7a0b\u4e2d\u7684\u5173\u952e\u73af\u8282\u3002\u751f\u7269\u5236\u54c1\u9700\u8981\u4e00\u5957\u5168\u9762\u7684\u68c0\u6d4b\u7b56\u7565\uff0c\u4ee5\u9a8c\u8bc1\u662f\u5426\u5b58\u5728\u5fae\u751f\u7269\u6c61\u67d3\uff0c\u540c\u65f6\u8bc1\u660e\u7b26\u5408\u56fd\u9645\u836f\u5178\u548c\u76d1\u7ba1\u8981\u6c42\u3002 <\/span><\/p>\n

\u4e00\u5957\u5168\u9762\u7684\u5fae\u751f\u7269\u63a7\u5236\u7b56\u7565\u5bf9\u4e8e\u8bc4\u4f30\u4ea7\u54c1\u5f00\u53d1\u548c\u751f\u4ea7\u4e0d\u540c\u9636\u6bb5\u7684\u6f5c\u5728\u6c61\u67d3\u98ce\u9669\u81f3\u5173\u91cd\u8981\u3002\u5728 Kymos \u96c6\u56e2\uff0c\u6211\u4eec\u7ecf\u8fc7 GMP \u8ba4\u8bc1\u7684\u5fae\u751f\u7269\u5b9e\u9a8c\u5ba4\u901a\u8fc7\u4e3a\u751f\u7269\u5236\u54c1\u3001\u7ec6\u80de\u548c\u57fa\u56e0\u7597\u6cd5\u3001\u75ab\u82d7\u4ee5\u53ca\u5176\u4ed6\u65e0\u83cc\u548c\u975e\u65e0\u83cc\u836f\u7269\u4ea7\u54c1\u63d0\u4f9b\u5fae\u751f\u7269\u8d28\u91cf\u63a7\u5236\u670d\u52a1\uff0c\u4e3a\u8fd9\u4e00\u7b56\u7565\u63d0\u4f9b\u652f\u6301\u3002 <\/span><\/p>\n

\u5b8c\u6574\u7684\u65b9\u6cd5 <\/strong><\/span><\/h2>\n

\u4ea7\u54c1\u5b89\u5168\u6027\u4f9d\u8d56\u4e8e\u4e00\u7cfb\u5217\u8bc4\u4f30\u751f\u4ea7\u548c\u8d28\u91cf\u63a7\u5236\u4e0d\u540c\u9636\u6bb5\u6c61\u67d3\u98ce\u9669\u7684\u5206\u6790\u7ec4\u5408\u3002<\/span><\/p>\n

\u8fd9\u4e9b\u5fae\u751f\u7269\u8bc4\u4f30\u901a\u5e38\u4e0e\u7406\u5316\u548c\u5206\u6790\u8d28\u91cf\u63a7\u5236\u68c0\u6d4b\u540c\u65f6\u8fdb\u884c\uff0c\u4e3a\u4ea7\u54c1\u8868\u5f81\u548c\u6279\u6b21\u653e\u884c\u63d0\u4f9b\u7efc\u5408\u65b9\u6cd5\u3002<\/span><\/p>\n

\u5fae\u751f\u7269\u9650\u5ea6\uff08\u751f\u7269\u8d1f\u8f7d\uff09 <\/strong><\/span><\/h2>\n

\uff08\u7b26\u5408 Ph. Eur. 2.6.12\uff1bUSP <1119>\uff09 <\/em><\/span><\/p>\n

\u5fae\u751f\u7269\u9650\u5ea6\u68c0\u6d4b\u7528\u4e8e\u786e\u5b9a\u706d\u83cc\u6216\u65e0\u83cc\u5de5\u827a\u524d\u539f\u6599\u3001API \u6216\u6210\u54c1\u4e2d\u5b58\u5728\u7684\u6d3b\u5fae\u751f\u7269\u603b\u6570\u3002\u8fd9\u662f\u7528\u4e8e\u8bc4\u4f30\u751f\u4ea7\u5de5\u827a\u5fae\u751f\u7269\u72b6\u6001\u7684\u5173\u952e\u8d28\u91cf\u63a7\u5236\u63aa\u65bd\u3002\u5bf9\u5fae\u751f\u7269\u9650\u5ea6\u6c34\u5e73\u7684\u5e38\u89c4\u76d1\u6d4b\u53ef\u786e\u4fdd\u5de5\u827a\u5904\u4e8e\u53d7\u63a7\u72b6\u6001\uff0c\u5e76\u652f\u6301\u706d\u83cc\u7a0b\u5e8f\u7684\u9a8c\u8bc1\u548c\u6301\u7eed\u6709\u6548\u6027\u3002 <\/span><\/p>\n

\u5fae\u751f\u7269\u9650\u5ea6\u68c0\u67e5\uff1aTAMC\u3001TYMC \u548c\u7279\u5b9a\u5fae\u751f\u7269 <\/strong><\/span><\/h2>\n

\uff08\u7b26\u5408 Ph. Eur. 2.6.12\/Ph. Eur. 2.6.13\uff1bUSP <61>\/ USP <62>\uff09 <\/em><\/span><\/p>\n

\u4e0e\u5fae\u751f\u7269\u9650\u5ea6\uff08\u751f\u7269\u8d1f\u8f7d\uff09\u68c0\u6d4b\u4e0d\u540c\uff0c\u5fae\u751f\u7269\u9650\u5ea6\u68c0\u67e5\u7528\u4e8e\u975e\u65e0\u83cc\u836f\u7269\u4ea7\u54c1\uff0c\u4ee5\u8bc4\u4f30\u4ea7\u54c1\u7684\u5fae\u751f\u7269\u8d28\u91cf\uff0c\u5e76\u9a8c\u8bc1\u5fae\u751f\u7269\u6570\u91cf\u662f\u5426\u4fdd\u6301\u5728\u76f8\u5173\u836f\u5178\u89c4\u5b9a\u7684\u53ef\u63a5\u53d7\u9650\u5ea6\u5185\u3002<\/span><\/p>\n

\u68c0\u6d4b\u5305\u62ec\uff1a<\/span><\/p>\n

    \n
  • \u9700\u6c27\u5fae\u751f\u7269\u603b\u6570 (TAMC)\uff1a\u9700\u6c27\u7ec6\u83cc\u8ba1\u6570\u3002<\/span><\/li>\n
  • \u9709\u83cc\u548c\u9175\u6bcd\u83cc\u603b\u6570 (TYMC)\uff1a\u9175\u6bcd\u83cc\u548c\u4e1d\u72b6\u771f\u83cc\u8ba1\u6570\u3002<\/span><\/li>\n
  • \u7279\u5b9a\u5fae\u751f\u7269\u7684\u68c0\u6d4b\uff0c\u5982 \u5927\u80a0\u57c3\u5e0c\u83cc<\/em>\u3001\u94dc\u7eff\u5047\u5355\u80de\u83cc<\/em>\u3001\u91d1\u9ec4\u8272\u8461\u8404\u7403\u83cc<\/em>\u3001\u6c99\u95e8\u6c0f\u83cc<\/em> \u5c5e\u3001\u767d\u8272\u5ff5\u73e0\u83cc<\/em> \u6216\u8010\u80c6\u6c41\u9178\u9769\u5170\u6c0f\u9634\u6027\u83cc\uff0c\u5177\u4f53\u53d6\u51b3\u4e8e\u4ea7\u54c1\u7c7b\u522b\u548c\u7ed9\u836f\u9014\u5f84\u3002<\/span><\/li>\n<\/ul>\n

    \u65e0\u83cc\u68c0\u67e5 <\/strong><\/span><\/h2>\n

    \uff08\u7b26\u5408 Ph. Eur. 2.6.1\uff0cUSP <71>\uff09 <\/em><\/span><\/p>\n

    \u65e0\u83cc\u68c0\u67e5\u786e\u8ba4\u4e86\u9884\u671f\u65e0\u83cc\u7684\u4ea7\u54c1\u4e2d\u4e0d\u5b58\u5728\u6d3b\u5fae\u751f\u7269\u3002\u8be5\u68c0\u67e5\u5728\u4e25\u683c\u63a7\u5236\u7684\u65e0\u83cc\u6761\u4ef6\u4e0b\u8fdb\u884c\uff0c\u662f\u4e00\u9879\u5173\u952e\u7684\u8d28\u91cf\u63a7\u5236\u68c0\u6d4b\uff0c\u4e5f\u662f\u65e0\u83cc\u751f\u7269\u5236\u54c1\u548c\u6ce8\u5c04\u5242\u4ea7\u54c1\u6279\u6b21\u653e\u884c\u7684\u6838\u5fc3\u8981\u6c42\u3002 <\/span><\/p>\n

    \u5bf9\u4e8e\u65e0\u83cc\u4ea7\u54c1\u68c0\u6d4b\uff0c\u6211\u4eec\u7684\u5fae\u751f\u7269\u5b9e\u9a8c\u5ba4\u62e5\u6709\u4e00\u4e2a\u4e13\u95e8\u7684\u6d01\u51c0\u5ba4\uff0c\u914d\u5907\u4e86\u4e24\u53f0 4 \u624b\u5957\u9694\u79bb\u5668\u3001\u4e00\u53f0 Steritest\u00ae Symbio\u00ae \u6cf5\u548c\u4e00\u5957 H\u2082O\u2082 \u751f\u7269\u53bb\u6c61\u7cfb\u7edf\u3002\u8fd9\u79cd\u5148\u8fdb\u7684\u9694\u79bb\u5668\u6280\u672f\u6700\u5927\u9650\u5ea6\u5730\u964d\u4f4e\u4e86\u5916\u90e8\u6c61\u67d3\u98ce\u9669\uff0c\u540c\u65f6\u786e\u4fdd\u6309\u7167\u836f\u5178\u8981\u6c42\u8fdb\u884c\u53ef\u9760\u7684\u65e0\u83cc\u68c0\u67e5\u3002 <\/span><\/p>\n

    \u7ec6\u83cc\u5185\u6bd2\u7d20\u68c0\u67e5 <\/strong><\/span><\/h2>\n

    \uff08\u7b26\u5408 Ph. Eur. 2.6.14\uff1bUSP <85> \u548c <86>\uff09 <\/em><\/span><\/p>\n

    \u6e90\u81ea\u9769\u5170\u6c0f\u9634\u6027\u83cc\u5916\u819c\u7684\u7ec6\u83cc\u5185\u6bd2\u7d20\uff0c\u5373\u4f7f\u5728\u5fae\u751f\u7269\u88ab\u6e05\u9664\u540e\u4ecd\u53ef\u80fd\u5b58\u5728\u3002\u5982\u679c\u65bd\u7528\u4e8e\u60a3\u8005\uff0c\u5185\u6bd2\u7d20\u4f1a\u8bf1\u53d1\u4e25\u91cd\u7684\u81f4\u70ed\u53cd\u5e94\uff0c\u56e0\u6b64\u5176\u68c0\u6d4b\u5bf9\u4e8e\u533b\u7597\u4ea7\u54c1\uff08\u5c24\u5176\u662f\u6ce8\u5c04\u7528\u751f\u7269\u5236\u54c1\uff09\u81f3\u5173\u91cd\u8981\u3002 <\/span><\/p>\n

    \u9009\u62e9\u5408\u9002\u7684\u5185\u6bd2\u7d20\u68c0\u6d4b\u65b9\u6cd5\u53d6\u51b3\u4e8e\u4ea7\u54c1\u7684\u7279\u6027\u548c\u9002\u7528\u8981\u6c42\u3002\u6211\u4eec\u63d0\u4f9b\u591a\u79cd\u7ecf\u8fc7\u9a8c\u8bc1\u7684\u65b9\u6cd5\uff0c\u5305\u62ec\uff1a <\/span><\/p>\n

      \n
    • \u52a8\u529b\u5b66\u663e\u8272 LAL \u6cd5<\/span><\/li>\n
    • \u52a8\u529b\u5b66\u6d4a\u5ea6 LAL \u6cd5<\/span><\/li>\n
    • \u51dd\u80f6\u6cd5<\/span><\/li>\n
    • \u91cd\u7ec4\u7ea7\u8054\u8bd5\u5242\u6cd5 (rCR)<\/span><\/li>\n<\/ul>\n

      \u901a\u8fc7 qPCR \u8fdb\u884c\u652f\u539f\u4f53\u5feb\u901f\u68c0\u6d4b\uff1a\u65e9\u671f\u53d1\u73b0\uff0c\u52a9\u529b\u51b3\u7b56<\/strong><\/p>\n

      \u9664\u4e86\u4f20\u7edf\u7684\u5fae\u751f\u7269\u65b9\u6cd5\u5916\uff0c\u5206\u5b50\u65b9\u6cd5\u53ef\u4ee5\u66f4\u5feb\u5730\u68c0\u6d4b\u7279\u5b9a\u6c61\u67d3\u7269\u3002\u901a\u8fc7 qPCR \u8fdb\u884c\u652f\u539f\u4f53\u5feb\u901f\u68c0\u6d4b\u5bf9\u4e8e\u76d1\u6d4b\u7ec6\u80de\u57f9\u517b\u3001\u7ec6\u80de\u5e93\u3001\u75c5\u6bd2\u8f7d\u4f53\u548c\u5176\u4ed6\u751f\u7269\u5236\u54c1\u7279\u522b\u6709\u4ef7\u503c\uff0c\u80fd\u591f\u5b9e\u73b0\u6c61\u67d3\u7684\u65e9\u671f\u53d1\u73b0\u3002 <\/span><\/p>\n

      \u5728 Kymos\uff0c\u6211\u4eec\u63d0\u4f9b\u7b26\u5408 GLP \u6807\u51c6\u7684\u57fa\u4e8e qPCR \u7684\u652f\u539f\u4f53\u68c0\u6d4b\uff0c\u4ee5\u652f\u6301\u5f00\u53d1\u6d3b\u52a8\u3002<\/span><\/p>\n

      \u4e0e\u4f20\u7edf\u7684\u57f9\u517b\u6cd5\u76f8\u6bd4\uff0cqPCR \u5177\u6709\u4ee5\u4e0b\u4f18\u52bf\uff1a<\/span><\/p>\n

        \n
      • \u5728\u6570\u5c0f\u65f6\u5185\u5373\u53ef\u83b7\u5f97\u7ed3\u679c\uff0c\u800c\u975e\u6570\u5468<\/span><\/li>\n
      • \u9ad8\u5206\u6790\u7075\u654f\u5ea6\u548c\u7279\u5f02\u6027<\/span><\/li>\n
      • \u65e9\u671f\u53d1\u73b0\u6c61\u67d3<\/span><\/li>\n<\/ul>\n

        \u5f53\u524d\u836f\u5178\u6307\u5357\u53cd\u6620\u4e86\u6838\u9178\u6269\u589e\u6280\u672f (NAT)\uff08\u5305\u62ec qPCR\uff09\u65e5\u76ca\u5e7f\u6cdb\u7684\u5e94\u7528\u3002\u4fee\u8ba2\u540e\u7684\u300a\u6b27\u6d32\u836f\u5178\u300b\u7ae0\u8282 \u201c2.6.7 \u652f\u539f\u4f53\u201d<\/em> \u5c06\u7ecf\u8fc7\u9a8c\u8bc1\u7684\u57fa\u4e8e NAT \u7684\u65b9\u6cd5\u7eb3\u5165\u652f\u539f\u4f53\u68c0\u6d4b\u7684\u76d1\u7ba1\u6846\u67b6\uff0c\u800c\u65b0\u7684 \u201cUSP <77> \u652f\u539f\u4f53\u6838\u9178\u6269\u589e\u68c0\u6d4b\u201d<\/em> \u4e3a\u5b9a\u6027 NAT \u65b9\u6cd5\u7684\u9a8c\u8bc1\u548c\u5e94\u7528\u63d0\u4f9b\u4e86\u6307\u5bfc\u3002\u8fd9\u4e9b\u4fee\u8ba2\u7a81\u663e\u4e86\u5728\u9488\u5bf9\u9884\u671f\u7528\u9014\u8fdb\u884c\u9002\u5f53\u9a8c\u8bc1\u540e\uff0c\u57fa\u4e8e PCR \u7684\u6280\u672f\u5728\u652f\u539f\u4f53\u68c0\u6d4b\u4e2d\u65e5\u76ca\u53d7\u5230\u8ba4\u53ef\u3002 <\/span><\/p>\n

        \u751f\u7269\u5236\u54c1\u7efc\u5408 GMP \u5fae\u751f\u7269\u670d\u52a1<\/strong><\/span><\/h2>\n

        \u786e\u4fdd\u751f\u7269\u5236\u54c1\u7684\u5fae\u751f\u7269\u5b89\u5168\u6027\u4e0d\u4ec5\u4ec5\u9700\u8981\u5355\u4e00\u7684\u68c0\u6d4b\u3002\u5fae\u751f\u7269\u548c\u5206\u5b50\u65b9\u6cd5\u7684\u9002\u5f53\u7ec4\u5408\u53d6\u51b3\u4e8e\u4ea7\u54c1\u3001\u751f\u4ea7\u5de5\u827a\u3001\u5f00\u53d1\u9636\u6bb5\u548c\u9002\u7528\u7684\u76d1\u7ba1\u8981\u6c42\u3002 <\/span><\/p>\n

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