OBJECTIVE: To evaluate the level of quality standard for Chinese patent medicine types included in National Essential 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 Essential Medicine List. Among them, 267 preparations were included in part I of Chinese Pharmacopoeia (2015 edition); 71.97% carried out pharmacopoeia quality standard. The quality standard system was perfect; the quality control items and the detection methods 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 Chinese Medicine; the quality standard for 6 TCM preparations came from National Standards Compilation for Chinese Patent Medicines; both were relatively early quality standards. There are some problems, such as absence of identification and content determination, 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
Keywords
National essential medicinesQuality standardChinese patent medicine