基于中药属性和作用特点的中药质量标志物研究与质量评价路径

中药质量是中药产业的生命线,但目前中药质量研究上存在诸多问题,在一定程度上制约了中药产业的健康发展。针对目前中药质量研究存在的问题,在系统分析和论述中药的基本属性和临床作用特点的基础上,以质量标志物核心概念为统领,结合研究实践,从质量要素的传递与溯源、化学成分与"药性"及"药效"两方面传统功效的关联关系、基于植物亲缘学及生源途径的成分特有性分析等角度,提出中药质量标志物研究的思路、方法与研究路径。最后,建立中药质量评价与控制的新的集成模式。

Method of quality marker research and quality evaluation of Chinese materia medica based on drug properties and effect characteristics

The quality of Chinese materia medica (CMM) is the lifeline of Chinese medicine industry. However, many problems are still found in the quality study on CMM, which restricts the healthy development of Chinese medicine industry to a certain extent. Aiming at the problems existing in the quality research on CMM, the research idea, method and approach of quality marker research and quality evaluation of CMM were put forward based on systematic analysis and discussion on the basic properties and clinical features of CMM according to the core concept of quality marker and the combination of research practice, from the perspective of transmission and traceability of quality elements, the relationship between chemical composition and traditional efficacy containing "drug property" and "drug function", composition analysis of endemicity based on pharmacophylogenetic study and biosynthetic approach. Finally, a new integrated mode of CMM quality evaluation and control was established.