从牛黄解毒片(丸)看含砷中成药的安全性问题  

Safety issues of traditional Chinese medical preparations containing arsenic substances:review starting from Niuhuang Jiedu Pian(Wan)

作　　者：张力[1] 高思华 周超凡[3] 林瑞超[4] 柳长华[3] 

机构地区：[1]国家食品药品监督管理局药品评价中心,北京100061 [2]国家中医药管理局科技教育司,北京100026 [3]中国中医科学院,北京100700 [4]中国药品生物制品检定所,北京100050

出　　处：《中国中药杂志》2006年第23期2010-2013,共4页China Journal of Chinese Materia Medica

摘　　要：针对牛黄解毒片(丸)的安全性问题,通过考证牛黄解毒丸源流和品种演变情况,分析雄黄功效历史的沿革、毒性和用法用量的记载,提出导致牛黄解毒片(丸)及含砷成方制剂的安全性相关因素,并对如何加强该类成方制剂的监督管理提出建议。By comprehensively reviewing the origin and history of Niuhuang Jiedu Wan and its ＂derivatives＂, we studied the clinical records of realgar, investigated its clinical usage, dosage, efficacy, and toxicity in the literatures. We pinpointed the factors that might be associated with safety problems of Niuhuang Jiedu Pian （Wan） and other traditional Chinese medicine （TCM） preparations containing arsenic substances. In this article we also put forward suggestions for strengthening the surveillance and administration of similar TCM preparations.

关 键 词：牛黄解毒片(丸) 砷 雄黄 不良反应 监督管理 

分 类 号：R286[医药卫生—中药学]