中药质量标志物（Q-marker）是近年来提出的中药质量评价与质量控制的核心概念，自提出后我国科技工作者广泛开展了中药质量标志物的相关研究，但迄今为止，大多数研究仍仅限于单味药材和饮片的质量标志物研究，尚不能全面反映质量标志物概念的所用要素。基于中药质量标志物的定义和基本要求，从质量传递与溯源、成分特有性、成分的有效性、成分可测性以及复方配伍环境5方面，系统论述了中药质量标志物的5要素的科学内涵及其发现和确定的原则、思路和方法，提出基于"五原则"的复方中药质量标志物研究和发现的路径，并以代表性的研究实例，为中药质量标志物的研究和发现提供系统的研究思路和范例。

Q-marker of Chinese materia medica (CMM) is a latest proposed core concept of CMM quality evaluation and quality control. A wide range of relevant researches on the Q-marker have been carried out by science and technology workers since the concept was put forward. However, to date, most studies are still limited to Q-marker studies of single herbs and pieces and cannot fully reflect all the elements of the concept of Q-marker. In this paper, the scientific connotation of five elements and the principles, ideas and approaches for the discovery and determination of CMM Q-marker were systemically discussed from the perspectives of quality transmissibility and traceability, ingredient specificity, component validity, component measurability, and formula compatibility environment. Moreover, research approaches of Q-marker of CMM formula based on "five principles" were proposed. The examples of representative researches provide a systematic research idea and reference for the research and discovery of CMM Q-marker.

国家自然科学基金重点项目资助（81430096）；国家中药标准化项目资助（ZYBZH-C-AH-02）