摘要
中药饮片的炮制作为中药体系十分重要的一环,对保障患者生命健康有着极大的作用,但其监管目前仍存监管不全面、监管手段单一等问题,有关立法也缺乏针对性,甚至存在标准混乱、不统一的情况,对饮片质量的保障造成了极大隐患。基于此现象,应当尽快收集汇总现有法律法规,依据科学标准统一定制监管评价体系,建立饮片追溯体系,并对毒性药材、炮制辅料进一步完善规定、构建动态GMP认证,为我国中医药体系的发展奠定坚实的基础和保障。
The production of Chinese medicine decoction pieces is a very important part of the Chinese medicine system,and it has a great effect on the protection of patients′life and health.However,its supervision still has problems such as incomplete supervision and single supervision means.The relevant legislation is also lack of pertinence and even standards.The situation of chaos and inconsistency has caused great hidden dangers to the quality of the pieces.Based on this phenomenon,we should collect and summarize existing laws and regulations as soon as possible,and uniformly customize the regulatory evaluation system according to scientific standards,establish a traceability system for decoction pieces,further improve the regulations on toxic medicines and processing accessories,and construct dynamic GMP certification,which is the development of Chinese medicine system.Laying a solid foundation and guarantee is very important.
作者
朱钟锐
李筱永
Zhu Zhongrui;Li Xiaoyong(School of Medical Humanities , Capital Medical University , Beijing 100069)
出处
《中国卫生法制》
2019年第5期27-30,共4页
China Health Law
基金
2018年国家中医药管理局委托项目:放管服背景下加强中医药服务事中事后监管相关法律问题研究(2018SK000272)
关键词
饮片炮制
监管问题
饮片追溯体系
毒性药材
炮制辅料
Pieces of concoction
Regulatory issues
Pieces traceability system
Toxic herbs
Processing accessories
