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从牛黄解毒片(丸)看含砷中成药的安全性问题
引用本文:张力,高思华,周超凡,林瑞超,柳长华.从牛黄解毒片(丸)看含砷中成药的安全性问题[J].中国中药杂志,2006,31(23):2010-2013.
作者姓名:张力  高思华  周超凡  林瑞超  柳长华
作者单位: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
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。

关 键 词:牛黄解毒片(丸)      雄黄  不良反应  监督管理
文章编号:1001-5302(2006)23-2010-04
收稿时间:2006-08-15
修稿时间:2006-08-15

Safety issues of traditional Chinese medical preparations containing arsenic substances: review starting from Niuhuang Jiedu Pian (Wan)
ZHANG Li ;GAO Si-hua;ZHOU Chao-fan;LIN Rui-chao ;LIU Chang-hua.Safety issues of traditional Chinese medical preparations containing arsenic substances: review starting from Niuhuang Jiedu Pian (Wan)[J].China Journal of Chinese Materia Medica,2006,31(23):2010-2013.
Authors:ZHANG Li ;GAO Si-hua;ZHOU Chao-fan;LIN Rui-chao ;LIU Chang-hua
Institution:1. Center or Drug reevaluation, State Food and Drug Administration, Beijing 100061, China; 2. Department of Science and educaton, State Administration of Traditional Chinese Medicine of China, Beijing 100026, China; 3. China Academy of Chinese Medical Sciences, Belling 100700 , China ; 4. National Institute for the control of Pharmaceutical and Biological Products , Beijing 100050, China
Abstract: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.
Keywords:Niuhuang jiedu Pian (Wan)  arsenic  realgar  adverse reaction  surveillance and administration
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