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致癌杂质 cancer-causing impurity

Updated: 2018-08-10

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A pharmaceutical company in Zhejiang has reported finding an impurity that can cause cancer in a drug it makes as an ingredient for blood pressure medications, the State Drug Administration said on Sunday. The products have been recalled.
国家药品监督管理局29日称,浙江一家制药公司报告其生产的一款降压药原料药被发现含有致癌杂质。该产品已被召回。

根据欧盟药品管理局发布的公告,浙江华海药业生产的原料药缬沙坦(valsartan)中被检测出含有一种叫做"N-亚硝基二甲胺"(NDMA)的可致癌杂质(carcinogenic/cancer-causing impurity)。缬沙坦被广泛用于高血压(hypertension, high blood pressure)的治疗,正常情况下不该含有这种杂质(valasartan normally contains no such contaminant)。据称,N-亚硝基二甲胺可损害肝脏及肾脏,对动物有明确致癌性,但几乎没有证据表明其对人类也有致癌性(there is little evidence showing it causes cancer in humans)。一些腌制食物(salted foods)中也含有N-亚硝基二甲胺。

7月29日,国家药监局回应称,国内涉及使用华海药业缬沙坦原料药的共有6家药企(pharmaceutical company),一家生产的胶囊未出厂,剩余5家均已召回相关产品(recall the involved products)。国家卫生健康委员会7月30日发出通知,要求各级各类医疗机构不得使用涉及召回的含华海药业缬沙坦原料药药品,可以使用含其他药企生产的缬沙坦的药品(use drugs containing other makers' valsartan)或者为患者开具其他药物(prescribe different drugs for patients)。

[相关词汇]
重要原料 key ingredient
生产工艺 manufacturing techniques
一级致癌物 level 1 carcinogen
加工肉制品 processed meat

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