牛黄解毒片的不良反应与砷相关性分析

目的:分析牛黄解毒片不良反应产生的原因.方法:汇总近年来我院全军不良反应监测中心有关牛黄解毒片不良反应的一般资料以及表现,并分析其原因.结果:通过分析不良反应产生的原因,认为处方中所含矿物药雄黄中的砷引起,牛黄解毒片每克样品中含砷0.076 8 g,是中国药品检验标准操作规范2000年版中砷盐限量的38 400倍.结论:砷在人体内的生物半衰期长,因此提醒在使用时不要过量,乳妇应禁用,避免不合理应用造成对整体人群的伤害.

Correlation of adverse events to arsenic in detoxicating tablets of cow-bezoar

Objective:To identify why the detoxicating tablets of cow-bezoar (Niuhuang Jiedu Pian) causes adverse events. Methods: Based on the AE information in the AE surveillance system of our hospital, the AEs due to the detoxicating tablets of cow-bezoar were analyzed. Results: The AEs resulted from arsenic that was contained in Realgar, one of the components of the tablets. It was found that each gram of the tablet samples contained 0.076 8 g of arsenic, which was equivalent to 38 400 times of the maximal limit of arsenide described in China Guideline of quality control of drugs (2000 version). Conclusion: Attention should be paid not to abuse and overdose the detoxicating tablets of cow-bezoar and not to be taken by nursing women.