中药饮片质量控制标准研究与展望  

Research and Prospect on Quality Control Standard of Traditional Chinese Medicine Decoction Pieces

作　　者：薛蓉 戴衍朋[2] 王彬[1] 张伟[1,3] 李林 季德[1] 苏联麟[1] 张村 陆兔林[1] XUE Rong;DAI Yan-peng;WANG Bin;ZHANG Wei;LI Lin;JI De;SU Lian-lin;ZHANG Cun;LU Tu-lin(College of Pharmacy,Nanjing University of Chinese Medicine;Shandong Academy of Chinese Medicine;College of Pharmacy,Anhui University of Chinese Medicine;Institute of Chinese Materia Medica,China Academy of Chinese Medical Sciences)

机构地区：[1]南京中医药大学药学院 [2]山东省中医药研究院 [3]安徽中医药大学药学院 [4]中国中医科学院中药研究所

出　　处：《中国食品药品监管》2022年第11期32-41,共10页China Food & Drug Administration Magazine

基　　金：国家重点研发计划(2018YFC1707000)。

摘　　要：中药饮片作为中医临床用药的基本形式,是中医药传承发展的重要组成部分。随着现代科技的不断发展,中药饮片质量控制从传统外观性状向内在质量转变,中药饮片标准与监管逐步完善。但中药饮片的质量控制仍存在诸多问题,生产过程控制标准仍需完善规范、质量评价标准的科学性有待提升、相应监管政策与措施需要进一步优化。针对上述问题,本文提出应基于中药饮片全产业链生产过程控制技术规范、饮片质量控制及等级标准、饮片溯源系统、饮片监管等多方位加强中药饮片质量控制,逐步推进中药饮片科学规范化管理,提升中药饮片质量整体控制水平,促进中医药健康产业的发展。As the basic form of traditional Chinese medicine(TCM)clinical medication,decoction pieces are important parts of the inheritance and development of Traditional Chinese medicine.With the continuous development of modern science and technology,the quality control of TCM decoction pieces has changed from traditional appearance to internal quality,and the standards and supervision of these decoction pieces have been gradually improved.However,there are still many problems in the quality control of TCM decoction pieces:the control standards of the manufacturing process still need to be improved;the quality evaluation standards need to be raised scientifically;and the corresponding regulatory policies and measures need to be further perfected.In view of the above problems,it is proposed that the quality control should be strengthened based on the control of the manufacturing process of the whole industrial chain of TCM decoction pieces,including technical specifications,quality control,grade standards,traceability system and supervision of them.This will help gradually promote the scientific and standardized management of TCM decoction pieces,improve the overall quality control level of TCM decoction pieces,and promote the development of TCM health industry.

关 键 词：中药饮片 质量控制 生产技术规范 饮片产业链 饮片监管 

分 类 号：R288[医药卫生—中药学]