[关键词]
[摘要]
基于中药质量标志物(quality marker,Q-Marker)理论,结合整合药理学理论,研究丰富Q-Marker发现与评价研究范式,指明关联成分质量属性和生物效应质量属性的Q-Marker是中药关键质量属性(critical quality attributes,CQA)的标志物。明确中药Q-Marker的辨识路径、分析方法及质量标准制定原则,为基于Q-Marker理论的全过程质量评价体系构建与中药质量控制监管提供研究支持。
[Key word]
[Abstract]
Based on the theory of traditional Chinese medicine quality markers (Q-Markers) and the framework of integrative pharmacology, this study enriches the research paradigm for the discovery and evaluation of Q-Markers, and proposes that Q-Markers linking component quality attributes and biological effect quality attributes serve as markers of the critical quality attributes (CQAs) of traditional Chinese medicine. It clarifies the identification pathway, analytical methods, and principles for quality standard establishment of traditional Chinese medicine Q-Markers, providing research support for the construction of a whole-process quality evaluation system based on Q-Marker theory and the supervision of traditional Chinese medicine quality control.
[中图分类号]
R282
[基金项目]
国家重点研发计划项目(2023YFC2308200);国家自然科学基金区域创新发展联合基金项目(U25A20167);中央级公益性科研院所基本科研业务费专项(ZXKT25041)