搜狐首页 财经 法医秦明2

手机搜狐

SOHU.COM

华海药业关于缬沙坦原料药杂质的认知说明

近期,华海药业缬沙坦原料药杂质事件在网络上炒得沸沸扬扬,众说纷纭。这个杂质到底是什么?对人体影响如何?华海药业在其官方平台发布了《关于N-亚硝基二甲胺(NDMA)的认知说明》,现转载如下,供大家了解。

一、概述

N-亚硝基二甲胺,又称N-二甲基亚硝胺,英文简称NDMA,分子式C2H6N2O,分子量74.08,黄色液体,可溶于水、乙醇、乙醚、二氯甲烷,由二甲胺与亚硝酸盐在酸性条件下反应而生成。该物质在环境中广泛存在,日常生活中每人日均摄入量为0.16~134μg [IARC关于人类致癌风险评估的专著17: 125-76 (1978)]。

世界卫生组织(WHO)所属机构国际癌症研究机构(IARC)2017年10月27日公布的致癌物清单,将 NDMA 归为 2A 类致癌物质。2A 类是指在动物实验中有相应数据支持,但对人类致癌性证据有限的物质。与NDMA同属于2A类物质的共有81种,包括油炸食品中普遍存在的丙烯酰胺、温度高于65度的饮料、红肉等物质。此外,昼夜节律打乱的轮班工作也属于2A类致癌风险行为。虽然在非常高剂量的动物研究中发现NDMA可增加癌症的发生率,但该杂质对人体的影响尚无充分数据支持。

各国监管部门评估意见

2.1 美国FDA官方公告

“Update [07/27/2018] On July 13th, FDA announced a recall of certain batches of valsartan tablets because of an impurity, a chemical known as N-nitrosodimethylamine (NDMA). Valsartan is a medication commonly used to treat high blood pressure and heart failure.”

更新[07/27/2018] 7月13日,美国食品药品监督管理局宣布召回某些批次的缬沙坦片,这是由于一个名为N-亚硝基二甲胺(NDMA)的化学物质。缬沙坦是一种常用于治疗高血压和心力衰竭的药物。

“NDMA has been found to increase the occurrence of cancer in animal studies. These animal studies were done using amounts of NDMA much higher than the impurity levels in recalled valsartan batches. Based on these animal studies, the U.S. Environmental Protection Agency considers NDMA a probable human carcinogen—a chemical that can increase the risk of cancer in humans. NDMA is found in some water supplies and in some foods . Consuming up to 96 nanograms NDMA/day is considered reasonably safe for human ingestion . It is estimated that over the course of a person’s lifetime, consuming this amount of NDMA would result in less than one additional case of cancer for every 100,000 people. To put this in context, currently one out of every three people in the US will experience cancer in their lifetime.”

精选