《国家基本药物目录》中中成药品种的质量标准现状及发展趋势分析  

Current Situation and Trends of Quality Standard for Chinese Patent Medicine Types Included in National Essential Medicine List

作　　者：曹骋[1] 刘梦楚 汪杰[2] 邹晓红[1] 

机构地区：[1]广州中医药大学中药学院,广州510006 [2]三亚市中医院药剂科,海南三亚572000

出　　处：《中国药房》2017年第9期1153-1155,共3页China Pharmacy

基　　金：国家卫计委药政司委托课题(2015)

摘　　要：目的:评价我国2012年版《国家基本药物目录》收录的中成药品种的质量标准整体水平,为下一版《国家基本药物目录》中成药品种的遴选提供参考依据。方法:检索国内外中成药相关国家标准,收集其质量标准中的关键信息,建立中成药质量标准数据库并进行数据分析。结果与结论:2012年版《国家基本药物目录》共收载371个中药制剂,其中267个制剂被2015年版《中国药典》(一部)收载,执行药典标准,占总数的71.97%,该类制剂质量标准体系健全,质量控制项多,检测手段丰富,同时加强了安全性控制技术;尚有104个中药制剂的质量标准是执行的非药典标准,占总数的28.03%,其中18个中药制剂执行《中华人民共和国卫生部药品标准·中药成方制剂》,6个中药制剂执行《国家中成药标准汇编》,均属于较早期的质量标准,存在鉴别项、含量测定项缺失,鉴别药味数少,含量测定指标成分少等问题,其制剂质量标准有待提高。OBJECTIVE：To evaluate the level of quality standard for Chinese patent medicine types included in National Essen-tial Medicine List（2012 edition）,and to provide reference for the selection of Chinese patent medicine types in the next edition of National Essential Medicine List. METHODS：By retrieving the relevant national standards of Chinese patent medicine,collecting the key information about their quality standard,database establishment and data analysis were conducted for quality standard of Chinese patent medicine. RESULTS＆CONCLUSIONS：There were 371 preparations included in the 2012 edition of National Essen-tial Medicine List. Among them,267 preparations were included in part I of Chinese Pharmacopoeia（2015 edition）;71.97% car-ried out pharmacopoeia quality standard. The quality standard system was perfect;the quality control items and the detection meth-ods were abundant;and the safety control technology was strengthened. The quality standard of 104 TCM preparations carried out non-pharmacopoeia standards,accounting for 28.03% of the total;among which,the quality standard for 18 TCM preparations were from Medicine Standard of Ministry of Public Health of Peoples Republic of China·Preparation Containing Traditional Chi-nese Medicine;the quality standard for 6 TCM preparations came from National Standards Compilation for Chinese Patent Medi-cines;both were relatively early quality standards. There are some problems,such as absence of identification and content determi-nation,few ingredient for identification,few index and components for measurement. The quality standards of preparations are to be improved.

关 键 词：国家基本药物 质量标准 中成药 

分 类 号：R95[医药卫生—药学]