含毒性药材中药制剂的风险管理  

Risk Management of Chinese Medicine Preparations Containing Toxic Herbs

作　　者：翟永松[1] 叶华[2] 王满元[1] 李朝霞[1] 马莉[1] 龚慕辛[1] 

机构地区：[1]首都医科大学中医药学院,北京100069 [2]中央民族大学管理学院,北京100081

出　　处：《中国实验方剂学杂志》2012年第16期347-349,共3页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：北京市教育委员会科技创新平台专项经费资助(PXM2011 014226 07 000049)

摘　　要：目的:研究含毒性药材中药制剂存在的风险并为构建风险管理体系提出相应建议。方法:统计《中国药典》2010年版一部中的含毒性药材中药制剂,检索和查阅相关文献、法律法规、药品标准、标签和说明书,分析其中存在的缺陷,探讨可能造成此类制剂风险的问题。结果:建议完善相关法规,对此类制剂进行再评价,加强毒性物质基础研究,完善药品标准、标签和说明书。结论:风险管理对于含毒性药材中药制剂的用药安全十分重要,要从管理和专业技术两方面着手构建并完善风险管理体系。Objective： To study potential risk of Chinese medicine preparations containing toxic herbs and offer suggestion about risk management system. Method： Based on Statistics of Chinese medicine preparations containing toxic herbs in Chinese Pharmacopoeia （2010）, related literature, regulations, drug standard, the statements of drug labels and instructions were searched. The insufficient causes were analysed and the potential risk was investigated. Result ： To ensure the safety of drug usage for the people, risk management system should be set up by improving the related laws, evaluating these drugs with Pattern Recognition, researching on toxic substances, perfecting quality standard, instruction and labte, etc. Conclusion： It is very important to construct and perfect risk management system for Chinese medicine preparations containing toxic herbs by management means and technical means.

关 键 词：毒性药材 中药制剂 风险管理 

分 类 号：R284.1[医药卫生—中药学]