中药质量标志物的概念、核心理论与研究方法

The concept, core theory and research methods of Chinese medicine quality markers

中药质量标志物(Q-marker)是中药质量控制的新概念,自2016年提出后,得到全国业内人士的广泛支持和积极参与,极大地推动了中药质量标志物研究,丰富了质量标志物的研究方法和实验证据。为了进一步提升质量标志物研究水平、规范研究模式、提供理论指导,本文提出中药质量标志物核心理论和研究方法。解析了中药质量标志物的定义和科学内涵,并从质量标志物的"有效性"、"特有性"、"传递与溯源"、"配伍环境"以及"可测性"等五个方面概要阐述了质量标志物的核心理论和研究方法,以期为中药质量标志物研究提供有益的理论和方法指导。

Q-marker is a new concept of quality control for traditional Chinese medicine.Since its introduc‐tion in 2016,it has received extensive support and participation from researchers and manufactures of the entire industry.In order to establishing the research level of quality markers,normative research model,we review the proposed core theory and research methods of Chinese medicine quality markers.The definition and scientific connotation of Chinese medicine quality markers are analyzed.The core theories and research methods of quality markers are summarized from five aspects:'effectiveness','specificity','transfer and traceability','compatibility environment'and'measurability'of quality markers.This paper aims to provide useful theoretical and method‐ological guidance for studying Chinese medicine quality markers.