Current Situation and Trends of Quality Standard for Chinese Patent Medicine Types Included in National Essential Medicine List
10.6039/j.issn.1001-0408.2017.09.01
- VernacularTitle:《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
- Author:
Cheng CAO
;
Mengchu LIU
;
Jie WANG
;
Xiaohong ZOU
- Keywords:
National essential medicines;
Quality standard;
Chinese patent medicine
- From:
China Pharmacy
2017;28(9):1153-1155
- CountryChina
- Language:Chinese
-
Abstract:
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.
