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

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.