{"id":33244,"date":"2018-12-25T00:04:33","date_gmt":"2018-12-24T16:04:33","guid":{"rendered":"https:\/\/case.ntu.edu.tw\/blog\/?p=33244"},"modified":"2018-12-21T10:44:26","modified_gmt":"2018-12-21T02:44:26","slug":"%e5%be%ae%e9%87%8f%e8%87%b4%e7%99%8c%e6%88%90%e5%88%86%e8%ae%93%e3%80%8c%e9%99%8d%e8%a1%80%e5%a3%93%e8%97%a5%e3%80%8d%e5%a3%9e%e4%ba%86%e4%b8%80%e9%8d%8b%e7%b2%a5","status":"publish","type":"post","link":"https:\/\/case.ntu.edu.tw\/blog\/?p=33244","title":{"rendered":"\u5fae\u91cf\u81f4\u764c\u6210\u5206\u8b93\u300c\u964d\u8840\u58d3\u85e5\u300d\u58de\u4e86\u4e00\u934b\u7ca5"},"content":{"rendered":"

\u25a0\u4e00\u7c92\u8001\u9f20\u5c4e\uff0c\u58de\u4e86\u4e00\u934b\u7ca5\u3002\u9019\u53e5\u8a71\u7528\u4f86\u63cf\u8ff0\u964d\u8840\u58d3\u85e5\u542b\u6709\u81f4\u764c\u6210\u5206\u7684\u4e8b\u4ef6\uff0c\u771f\u7684\u662f\u904e\u65bc\u5beb\u5be6\u8207\u8cbc\u5207\u3002\u5230\u5e95\u8ab0\u662f\u8001\u9f20\u5c4e\uff1f\u5f15\u767c\u4e86\u9019\u5834\u964d\u8840\u58d3\u85e5\u4e0b\u67b6\u98a8\u66b4\uff0c\u5c31\u8b93\u6211\u5011\u7e7c\u7e8c\u770b\u4e0b\u53bb\u3002<\/strong><\/span><\/p>\n

\"\"
\u5716\u7247\u4f86\u6e90 pixabay.com\/<\/figcaption><\/figure>\n

\u64b0\u6587\uff5c\u694a\u671d\u5091<\/strong><\/p>\n

\u25cf\u964d\u8840\u58d3\u85e5 valsartan <\/strong>\u7684<\/strong>\u843d\u96e3\u8a18<\/strong><\/span><\/p>\n

\u4e0b\u67b6\u964d\u8840\u58d3\u85e5\u7684\u4e00\u865f\u82e6\u4e3b\u5728 2018 \u5e74 7 \u6708\u63ed\u66c9\uff0c\u85e5\u540d\u70ba\u300cvalsartan\u300d\uff0c\u5176\u70ba\u4e00\u7a2e\u5e38\u7528\u4f86\u6cbb\u7642\u9ad8\u8840\u58d3\u53ca\u5fc3\u81df\u8870\u7aed\u7684\u85e5\u7269\u3002\u6b64\u85e5\u7269\u662f\u4e00\u7a2e\u8840\u7ba1\u6536\u7e2e\u7d20\u53d7\u9ad4\u963b\u65b7\u5291 (angiotensin receptor blocker, ARB)\uff0c\u4e3b\u8981\u4f5c\u7528\u6a5f\u8f49\u662f\u6291\u5236\u8840\u7ba1\u6536\u7e2e\u7d20\u2161 (angiotensin \u2161) \u7684\u4f5c\u7528\uff0c\u4ee5\u53ca\u6e1b\u5c11\u814e\u4e0a\u817a\u76ae\u8cea\u5206\u6ccc\u7684\u919b\u56fa\u916e (aldosterone)\u3002\u4e00\u9023\u5e7e\u500b\u5c08\u6709\u540d\u8a5e\uff0c\u770b\u8d77\u4f86\u4f3c\u4e4e\u6709\u9ede\u8907\u96dc\uff0c\u4e0d\u904e\u6211\u5011\u53ef\u4ee5\u5f88\u7c21\u55ae\u7684\u6982\u5ff5\u5316\u4e26\u7406\u89e3\u70ba\uff0c\u5c31\u662f valsartan \u4e3b\u8981\u80fd\u5920\u963b\u65b7\u9ad4\u5167\u6703\u8b93\u8840\u58d3\u5347\u9ad8\u7684\u5169\u689d\u6fc0\u7d20\u8def\u5f91\u800c\u5df2\u3002<\/p>\n

Valsartan \u5176\u5be6\u662f\u500b\u5df2\u5728\u81e8\u5e8a\u9ad8\u8840\u58d3\u6cbb\u7642\u4e0a\u6253\u6efe\u8a31\u4e45\u7684\u8001\u9762\u5b54\uff0c\u65e9\u5728 1996 \u5e74\u5df2\u9996\u6b21\u5728\u5fb7\u570b\u4e0a\u5e02\uff0c\u76f4\u5230 2012 \u5e74\u539f\u5ee0\u7684\u5c08\u5229\u5230\u671f\u5f8c\uff0c\u5176\u4ed6\u8a31\u591a\u85e5\u5ee0\u624d\u80fd\u958b\u59cb\u751f\u7522 valsartan \u7684\u5b78\u540d\u85e5\uff0c\u800c\u6240\u8b02\u5b78\u540d\u85e5\u662f\u6307\u539f\u5ee0\u85e5\u5c08\u5229\u904e\u671f\u5f8c\u53ef\u4ee5\u4eff\u88fd\u76f8\u540c\u7684\u5316\u5b78\u5206\u5b50\u7d50\u69cb\u3002\u9020\u6210 valsartan \u5728 2018 \u5e74 7 \u6708\u53f0\u7063\u4e0b\u67b6\u56de\u6536\u7684\u539f\u56e0\uff0c\u51fa\u5728\u53f0\u7063\u88fd\u9020\u5b78\u540d\u85e5\u7684\u85e5\u5ee0\u8cfc\u8cb7\u4e26\u4f7f\u7528\u4e86\u6709\u554f\u984c\u7684 valsartan \u539f\u6599\u85e5 (\u85e5\u54c1\u9700\u8981\u7528\u5230\u7684\u4e3b\u6210\u5206)\uff0c\u800c\u6b64\u539f\u6599\u85e5\u662f\u7531\u4e2d\u570b\u7684\u88fd\u85e5\u516c\u53f8\u6240\u751f\u7522\uff0c\u5176\u542b\u6709\u4e00\u7a2e\u540d\u70ba\u300cN-\u4e9e\u785d\u57fa\u4e8c\u7532\u80fa (N-Nitrosodimethylamine, NDMA)\u300d\u7684\u81f4\u764c\u6210\u5206\u3002<\/p>\n

\u25cf\u53d7\u5230\u6c60\u9b5a\u4e4b\u6b83<\/strong>\u7684<\/strong>\u964d\u8840\u58d3\u85e5 irbesartan<\/strong><\/span><\/p>\n

\u518d\u4f86\u8ac7\u8ac7\u6700\u8fd1 (2018 \u5e74 11 \u6708) \u88ab\u4e0b\u67b6\u7684\u4e8c\u865f\u82e6\u4e3b\uff0c\u85e5\u540d\u70ba\u300cirbesartan<\/strong>\u300d\u3002\u5404\u4f4d\u770b\u5b98\u5011\u7b49\u7b49\u554a\u2026\u9019\u540d\u5b57\u600e\u9ebc\u4f3c\u66fe\u76f8\u8b58\uff1f\u7684\u78ba\u4e0d\u662f\u4f60\u773c\u82b1\uff0c\u6b64\u85e5\u7269\u8207\u524d\u6587\u7684\u300cvalsartan<\/strong>\u300d\u90fd\u6709\u76f8\u540c\u7684\u300c-sartan<\/strong>\u300d\u5b57\u5c3e\uff0c\u8070\u660e\u5982\u4f60\u518d\u4ee5\u6b64\u985e\u63a8\uff0c\u6c92\u932f\u4e8c\u865f\u82e6\u4e3b\u4e00\u6a23\u662f\u5c6c\u65bcARB \u964d\u8840\u58d3\u85e5\uff0c\u5169\u8005\u7684\u5316\u5b78\u7d50\u69cb\u5f0f\u4e5f\u5f88\u76f8\u4f3c (\u4e0b\u5716)\u3002<\/p>\n

\u540c\u6a23\u5730\u7576 irbesartan \u5c08\u5229\u5230\u671f\u5f8c\uff0c\u4e5f\u6709\u8a31\u591a\u85e5\u5ee0\u958b\u59cb\u4eff\u88fd\u5176\u5b78\u540d\u85e5\uff0c\u4e0d\u904e\u53ef\u5148\u5225\u6025\u8457\u6253\u81c9\u4e2d\u570b\uff0c\u9019\u6b21\u767c\u73fe\u539f\u6599\u85e5\u51fa\u554f\u984c\u7684\u662f\u5370\u5ea6\u88fd\u85e5\u516c\u53f8\uff0c\u5728 irbesartan \u7684\u539f\u6599\u85e5\u4e2d\u542b\u6709\u4e00\u7a2e\u540d\u70ba\u300cN-\u4e9e\u785d\u57fa\u4e8c\u4e59\u80fa (N-Nitrosodiethylamine, NDEA)\u300d\u7684\u81f4\u764c\u6210\u5206\u3002\u7528\u4e0d\u8457\u6211\u591a\u8aaa\uff0c\u773c\u5c16\u7684\u4f60\u60f3\u5fc5\u4e5f\u5df2\u767c\u73fe\u8ddf\u4e0a\u8ff0\u63d0\u5230\u7684\u81f4\u764c\u6210\u5206 NDMA \u53ea\u5dee\u4e86\u4e00\u500b\u5b57\u6bcd\uff0c\u5169\u7a2e\u81f4\u764c\u6210\u5206\u7684\u5316\u5b78\u7d50\u69cb\u5f0f\u4e5f\u662f\u5341\u5206\u76f8\u4f3c (\u4e0b\u5716)\u3002\u770b\u5230\u9019\u88e1\uff0c\u9084\u7528\u4e0d\u8457\u67ef\u5357\u51fa\u4f86\u63a8\u7406\uff0c\u6211\u5011\u53ef\u4ee5\u5408\u7406\u7684\u61f7\u7591\uff0c\u9019\u985e ARB \u964d\u8840\u58d3\u85e5\u5728\u4e0d\u540c\u85e5\u5ee0\u7684\u751f\u7522\u88fd\u7a0b\u4e2d\uff0c\u67d0\u4e9b\u6b65\u9a5f\u7684\u300c\u5171\u901a\u6027\u300d\u6703\u5c0e\u81f4\u6b98\u7559\u81f4\u764c\u7684\u4e9e\u785d\u57fa\u5316\u5408\u7269\u3002<\/p>\n

\"\"<\/p>\n

\u25cf\u85e5\u54c1\u76e3\u7ba1\u6a5f\u69cb\u61c9\u5f9e\u6e90\u982d\u56b4\u683c\u628a\u95dc\u624d\u80fd\u672a\u96e8\u7da2\u7e46<\/strong><\/span><\/p>\n

\u6b50\u7f8e\u7684\u85e5\u54c1\u76e3\u7ba1\u6a5f\u69cb\u61f7\u7591\u6b64\u4e8b\u4ef6\u7684\u300c\u5171\u901a\u6027\u300d\uff0c\u5728\u65bc\u85e5\u7269\u7d50\u69cb\u5177\u6709\u5982\u4e0a\u5716\u7d05\u5708\u8655\u6240\u793a\uff0c\u7531 4 \u500b\u6c2e (N) \u7d44\u6210\u7a31\u70ba\u56db\u5511 (tetrazole) \u7684\u74b0\u5316\u7d50\u69cb\uff0c\u5177\u6709\u6b64\u7d50\u69cb\u7684\u5176\u4ed6 ARB \u964d\u8840\u58d3\u85e5\u9084\u5305\u542b losartan\u3001candesartan \u53caolmesartan\uff0c\u662f\u8ab0\u9084\u6703\u88ab\u81f4\u764c\u6210\u5206\u6383\u5230\u98b1\u98a8\u5c3e\uff0c\u9084\u6709\u5f85\u5f8c\u7e8c\u8abf\u67e5\u3002\u53e6\u4e00\u500b\u7591\u9ede\u662f\uff0c\u9019\u9ebc\u6b77\u53f2\u60a0\u4e45\u7684\u85e5\u7269\u70ba\u4f55\u81f4\u764c\u6210\u5206\u554f\u984c\u5230\u73fe\u5728\u624d\u7206\u767c\uff1f\u76ee\u524d\u7684\u63a8\u6e2c\u662f\u9019\u4e9b\u539f\u6599\u85e5\u5ee0\u70ba\u4e86\u512a\u5316\u88fd\u7a0b\u7684\u76ee\u7684\uff0c\u66f4\u63db\u4e86\u4e00\u7a2e\u6eb6\u5291\uff0c\u624d\u9020\u6210\u51fa\u4e4e\u9810\u671f\u7684\u81f4\u764c\u4e0d\u7d14\u7269\u3002\u7136\u800c\uff0c\u8b93\u4eba\u6176\u5e78\u7684\u662f\uff0c\u85e5\u7269\u88fd\u7a0b\u6539\u8b8a\u5fc5\u9808\u5148\u7d93\u904e\u76f8\u95dc\u4e3b\u7ba1\u55ae\u4f4d\u6838\u51c6\uff0c\u53f0\u7063\u5728 2017 \u5e74\u624d\u6838\u51c6\u8b8a\u66f4\uff0c\u5f71\u97ff\u6642\u9593\u4e0d\u9577\u3002\u53e6\u5916\uff0c\u6839\u64da\u4e39\u9ea5\u7684\u7814\u7a76\u8abf\u67e5\uff0c\u670d\u7528\u88ab NDMA \u6c61\u67d3\u7684 valsartan \u85e5\u7269\uff0c\u5171\u6709 3,450 \u540d\u60a3\u8005\u5e73\u5747\u8ffd\u8e64 4.6 \u5e74\uff0c\u5728\u300c\u77ed\u671f\u300d\u5167\u4e0d\u6703\u589e\u52a0\u60a3\u8005\u7684\u81f4\u764c\u98a8\u96aa\u3002<\/p>\n

\u7f8e\u570b\u98df\u54c1\u53ca\u85e5\u7269\u7ba1\u7406\u5c40 (FDA) \u53ca\u570b\u969b\u91ab\u85e5\u6cd5\u898f\u5354\u5408\u6703 (ICH) \u5c0d NDMA \u7684\u9650\u503c\u70ba 0.3 ppm\uff0c\u53ef\u8b6c\u5982\u70ba 1 \u516c\u65a4\u7684\u7ca5\u4e2d\u6709\u8d85\u904e 0.3 \u6beb\u514b (mg) \u7684\u8001\u9f20\u5c4e\u5c31\u4e0d\u5408\u683c\u3002\u4e0d\u904e\u5176\u5be6\u65e5\u5e38\u751f\u6d3b\u4e2d\u7684\u9183\u88fd\u98df\u54c1\u5c31\u542b\u6709\u5fae\u91cf NDMA\uff0c\u4f8b\u5982\uff1a1 \u516c\u65a4\u7684\u57f9\u6839\u5c31\u53ef\u542b\u6709\u7d04 0.6 \u5fae\u514b (\u00b5g) \u7684 NDMA\u3002\u6240\u4ee5\u7f8e\u570b FDA \u4e5f\u5ba3\u5c0e\uff0c\u670d\u7528\u5230\u542b\u81f4\u764c\u6210\u5206\u964d\u8840\u58d3\u85e5\u7684\u60a3\u8005\uff0c\u4e0d\u8981\u904e\u65bc\u64d4\u5fc3\uff0c\u56e0\u70ba\u4efb\u610f\u505c\u85e5\u9020\u6210\u9ad8\u8840\u58d3\u63a7\u5236\u4e0d\u826f\uff0c\u6bd4\u8d77\u5403\u5230\u5fae\u91cf\u81f4\u764c\u6210\u5206\u66f4\u5371\u96aa\u3002<\/p>\n

\u7d50\u8a9e\uff0c\u773e\u751f\u754f\u679c\uff0c\u83e9\u85a9\u754f\u56e0\u3002\u4e00\u822c\u6c11\u773e\u5c0d\u85e5\u7269\u542b\u6709\u81f4\u764c\u6210\u5206\u611f\u5230\u6050\u614c\uff0c\u5341\u5206\u5408\u4e4e\u60c5\u7406\uff0c\u4f46\u662f\u85e5\u54c1\u76e3\u7ba1\u6a5f\u69cb\u662f\u5426\u80fd\u64d4\u4efb\u597d\u82b8\u82b8\u773e\u751f\u7684\u83e9\u85a9\u89d2\u8272\uff0c\u627e\u51fa\u85e5\u54c1\u88ab\u81f4\u764c\u6210\u5206\u6c59\u67d3\u7684\u6839\u672c\u539f\u56e0 (root cause)\uff1f\u66f4\u91cd\u8981\u7684\u662f\u5c0d\u65bc\u6e90\u982d\u85e5\u5ee0\u7684\u8b8a\u66f4\u88fd\u7a0b\uff0c\u61c9\u8a72\u8981\u66f4\u56b4\u683c\u7684\u628a\u95dc\uff0c\u65bc\u5176\u4e8b\u5f8c\u5f4c\u88dc\u4e0b\u67b6\u56de\u6536\u53d7\u5f71\u97ff\u7684\u85e5\u54c1\uff0c\u4e0d\u5982\u5228\u6839\u554f\u5e95\u627e\u51fa\u89e3\u6c7a\u4e4b\u9053\uff0c\u624d\u80fd\u5fb9\u5e95\u675c\u7d55\u985e\u4f3c\u7684\u554f\u984c\u518d\u6b21\u4e0a\u6f14\u3002<\/p>\n

 <\/p>\n

\u53c3\u8003\u8cc7\u6599\uff1a<\/strong><\/p>\n

    \n
  1. Wikipedia\u2013Valsartan<\/a><\/li>\n
  2. \u98df\u54c1\u85e5\u7269\u7ba1\u7406\u7f72\uff0c07.2018\uff0c\u98df\u85e5\u7f72\u8abf\u67e5\u4f7f\u7528\u4e2d\u570b\u5927\u9678\u6d59\u6c5f\u83ef\u6d77\u88fd\u85e5\u516c\u53f8valsartan\u539f\u6599\u85e5\u4e4b\u7570\u5e38\u4e8b\u4ef6\u8aaa\u660e<\/a><\/li>\n
  3. Wikipedia\u2013Irbesartan<\/a><\/li>\n
  4. \u98df\u54c1\u85e5\u7269\u7ba1\u7406\u7f72\uff0c11.2018\uff0c\u98df\u85e5\u7f72\u8abf\u67e5\u4f7f\u7528\u5370\u5ea6Aurboindo Pharma Limited\u516c\u53f8Irbesartan\u539f\u6599\u85e5\u4e4b\u7570\u5e38\u4e8b\u4ef6\u8aaa\u660e<\/a><\/li>\n
  5. PharmTech, 26.09.2018, After Valsartan Recalls, Regulators Grapple with Nitrosamine Contamination in APIs<\/a>.<\/li>\n
  6. ECA Academy, 26.07.2018, Valsartan: what caused the contamination?<\/a><\/li>\n
  7. \u4e2d\u592e\u901a\u8a0a\u793e\uff0c07.2018\uff0c\u4e2d\u88fd\u964d\u8840\u58d3\u85e5\u6050\u81f4\u764c \u98df\u85e5\u7f72\uff1a\u88fd\u7a0b\u6539\u8b8a\u60f9\u798d<\/a><\/li>\n
  8. Potteg\u00e5rd A, et al. BMJ. 2018;362:k3851. Use of N-nitrosodimethylamine (NDMA) contaminated valsartan products and risk of cancer: Danish nationwide cohort study.<\/a><\/li>\n
  9. UFDA, GC\/MS Headspace Method for Detection of NDMA in Valsartan Drug Substance<\/a>.<\/li>\n
  10. FDA updates on angiotensin II receptor blocker (ARB) recalls<\/a>.<\/li>\n<\/ol>\n

    \"\u52a0\u5165\u597d\u53cb\"<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

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