关于我国中西药复方制剂科学监管的思考  

Scientific supervision of compound preparation of traditional Chinese medicine and chemical drug

作　　者：于江泳[1,2] 余伯阳[1] 钱忠直[2] 

机构地区：[1]中国药科大学,江苏南京210009 [2]国家药典委员会,北京100061

出　　处：《中国中药杂志》2011年第11期1542-1546,共5页China Journal of Chinese Materia Medica

基　　金：国家"十一五"科技支撑计划项目(2006BAI21B08-13)

摘　　要：中西药复方制剂在我国临床上的应用由来已久。笔者结合工作实际,对比我国不同时期关于中西药复方制剂的药品监管规定,对中西药复方制剂药品监管的历史沿革和现状进行总结和分析,探讨存在的问题和不足,提出有关对策和建议,以便加强对中西药复方制剂的科学监管。The application of the compound preparation of traditional Chinese medicine（TCM） and chemical drug in clinical has a long history.Drug regulatory requirements of the compound preparation of TCM and chemical drug in various periods were compared and analyzed,and the history and status of the way of scientific supervision of this preparation were summarized.This paper discussed the problems and deficiencies of the compound preparation of TCM and chemical drug,and put forward countermeasures and suggestions about to strengthen the scientific supervision of the compound preparation of TCM and chemical drug.

关 键 词：中西药复方制剂 药品标准 药品监管 

分 类 号：R942[医药卫生—药剂学]