中药材及饮片质量等级标准研究思路和方法

Research Methods for Quality Grading Standards of Chinese Medicinal Materials and Decoction Pieces

中药质量评价作为保障中药材及饮片质量安全有效的有力手段,对维护人民群众身心健康、促进中药产业高质量发展具有重要意义。长久以来,中药质量多以法定检验标准为准入门槛进行低限控制,质量等级标准缺乏,致使中药质量仅能满足基本要求,而“优质优价”未能得到充分体现,导致“劣币驱逐良币”,市场公平严重受损,这很大程度影响了中药产业高质量发展。因此,开展中药质量优劣评价研究,构建中药质量等级标准体系对于全面落实“四个最严”要求、促进中医药传承创新发展、规范市场秩序、引导产业健康发展具有深远而重大的意义。对中药材质量评价现状进行概述,针对目前中药材质量评价的瓶颈问题,提出符合中医药特点的质量等级标准研究思路,包括关键质量控制指标确立、综合质量评价方法建立、质量等级标准验证等内容,以期为建立中药质量等级评价体系提供参考,助力中药产业高质量发展。

As a powerful method to ensure the quality and safety of Chinese medicinal materials(CMM)and decoction pieces(DP),the quality evaluation of traditional Chinese medicine(TCM)has been of great significance to people′s physical and mental health.For a long time,the quality evaluation of TCM only uses the legal inspection standards for low limit control.As a result,the quality of TCM can only meet the minimum requirements,and the high quality and good price cannot be fully reflected,which seriously damage the market fairness and affect the high-quality development of the TCM industry.Therefore,the research on quality grading of TCM and the establishment of a quality standard system of TCM are of far-reaching significance for fully implementing the most rigorous standards,the strictest supervision,the severest punishment,and the most serious accountability,promoting the inheritance and innovation of TCM,regulating market order,and guiding the healthy development of the industry.The research progress in the quality evaluation of TCM is summarized in this article.In view of the bottlenecks in the quality evaluation of TCM,the research ideas of quality grading standards that conform to the characteristics of TCM are proposed,including identifying key quality control indicators,developing comprehensive quality evaluation methods,and verifying quality grading standards.The article is expected to provide reference for the establishment of the quality grading standards.