[关键词]
[摘要]
中药质量标志物是中药质量控制的新概念,反映了中药质量本质的科学内涵。 该新概念提出以来,我国中药行业开展了广泛的研究,形成丰硕的研究成果,但是,迄今尚未提出中药质量标志物发现和确定的技术规范。 中华中医药学会立项制订《中药质量标志物研究技术指南》, 意在明确质量标志物发现和确定的原则、研究路径、技术方法。 本指南制定集合了起草单位各团队中药质量标志物研究工作,并结合公开发表的中药质量标志物文献调研结果,经过多个学科专家充分讨论后形成共识,同时广泛征求来自大专院校、科研院所、检验检测机构及中药生产企业的多学科专家意见,保证了指南的实用性、规范性、科学性及可行性。
[Key word]
[Abstract]
Quality markers (Q-Markers) of traditional Chinese medicine (TCM) represent a novel concept in TCM quality control, reflecting the scientific essence of TCM quality. Since its introduction, extensive research has been conducted in China's TCM industry, yielding substantial outcomes. However, standardized technical specifications for the discovery and determination of Q-Markers have yet to be established. The Technical Guide for Research on Quality Markers of Traditional Chinese Medicine, initiated by the China Association of Chinese Medicine (CACM), aims to define principles, research pathways, and technical methods for identifying and validating Q-Markers. This guideline consolidates research efforts from drafting teams, integrates literature reviews on Q-Markers, and incorporates multidisciplinary expert consensus through extensive discussions and consultations with academia, research institutions, testing agencies, and TCM manufacturers, ensuring its practicality, standardization, scientificity, and feasibility.
[中图分类号]
R28
[基金项目]
国家自然科学基金区域联合基金项目(U21A20406);安徽省科技重大专项资助(202303a07020007)