摘要
中药饮片组方是中医治病防病的物质基础,中药饮片既用于中医临床配方,又用于中药制剂生产,其质量直接关乎人民群众用药的安全性和有效性。笔者结合近五年市场流通中药饮片的质量问题,以及在药品技术审评过程中有关中药饮片标准的问题进行了详细分析,梳理了中药创新药、古代经典名方中药复方制剂、中药改良型新药及同名同方药、已上市中药制剂用饮片在不同研发阶段的质量要求,为中药饮片质量控制和相关研究提供参考。
The prescription of Chinese herbal decoction pieces is the material basis for the treatment and prevention of diseases.It is used not only in the clinical formulation of traditional Chinese medicine(TCM),but also in the production of TCM.Its quality directly relates to the safety and effectiveness of the medicine used by the people.Combining the quality problems of Chinese herbal decoction pieces in the past five years,this article analyzes the problems related to the standard of Chinese herbal decoction pieces in the process of drug evaluation,and sorts out the basic requirements of Chinese herbal decoction pieces for new TCM,new TCM drug on classic famous prescription,modified new TCM,TCM with same name and prescription,and marketed TCM.It is convenient to strengthen the quality control of Chinese herbal decoction pieces,and provide a useful reference for the quality control of Chinese herbal decoction pieces and related research.
作者
王玲玲
张永文
WANG Ling-ling;ZHANG Yong-wen(Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China;School of Pharmacy, Nanjing University of Chinese Medicine, Nanjing 210023, China)
出处
《南京中医药大学学报》
CAS
CSCD
北大核心
2022年第2期166-171,共6页
Journal of Nanjing University of Traditional Chinese Medicine
关键词
中药饮片
质量标准
中药新药
经典名方
技术要求
Chinese herbal decoction pieces
quality standards
new TCM drug
classic famous prescription
technical requirements
