中药饮片质量标志物（ Q-Marker）研究策略

中药饮片作为中药产业链的中间环节，具有承前启后的作用，为了保证其质量可控，引入反映中药临床安全性、有效性的质量标志物（quality marker,Q-Marker）概念，建立中药饮片专属性质量控制与评价体系。中药Q-Marker在药材、制剂等方面已有较多研究，饮片的Q-Marker研究亦逐渐引起重视，但尚缺乏对饮片质量的专属性系统研究。对中药饮片质量的影响因素以及中药饮片Q-Marker在物质基础识别、药理药效、性味归经、炮制机制、质量评价与控制等方面的研究进展进行梳理，形成以炮制机制和复方配伍为关键点的中药饮片Q-Marker研究策略，以期为中药饮片Q-Marker研究提供理论依据，提高中药饮片质量控制水平。

Research strategy on quality marker (Q-Marker) of traditional Chinese medicine decoction pieces

In order to control the quality of Chinese herbal pieces which play a role of connecting the past and the future, as the intermediate link of traditional Chinese medicine (TCM) industry chain, the concept of quality marker (Q-Marker) reflecting the safety and effectiveness of TCM was applied to establish the quality control and evaluation system for traditional Chinese medicine decoction pieces. Q-Marker of TCM has been widely used in the study of Chinese medicinal materials and TCM preparation, but the specific research on the quality of traditional Chinese medicine decoction pieces is lacking. By summarizing the influence factors, the application of Q-Marker in the substance basis identification, medicinal effect, flavor and meridian tropism, processing mechanism and quality evaluation and control, the research strategy with processing mechanism and formulation composition as the key points was proposed, which is to provide theoretical foundation for Q-Marker and improve quality control level of traditional Chinese medicine decoction pieces.