中药形成产业链长且行业跨度大，横跨一、二、三产业，药物成分经过多环节的传递与变化，最终体内的效应成分与原料药中原有成分的构成已大不相同，因此，中药质量控制应着眼于中药形成的全过程，而中药质量标志物（quality marker，Q-Marker）的应用价值在于建立全程质量控制体系。针对目前中药质量研究存在的问题，提出“以中药Q-Marker为核心，从质量要素的传递与溯源”的基本研究模式，以中药形成的全过程及质量要素的传递规律为基础，为经典名方的质量控制及中药大品种质量标准的提升提供了新的思路和视角，有利于提升中药产品质量，为中药标准化建设提供新的思路，促进中药产业的健康发展。

Traditional Chinese medicine formation has a long industrial chain, and spans across the primary, secondary and tertiary industries. Pharmaceutical ingredients are transferred and changed in multiple stages, resulting in the composition of effective components in the body is greatly different from that of original components in raw materials. Therefore, quality control should focus on the formation process of traditional Chinese medicine, and the application value of quality markers lies in the establishment of whole process quality control system. In view of current problems existing in quality research of traditional Chinese medicine, a research model of “taking quality markers as the core, from the transitivity and traceability of quality elements” is proposed in this paper. Based on the formation process and quality elements transitivity of traditional Chinese medicine, it provides a new idea and perspective for quality control of classical famous prescriptions and quality standards improvement of large varieties of traditional Chinese medicine. It will help to improve the quality of traditional Chinese medicine products and promote standardization construction and healthy development of traditional Chinese medicine.

R283;R284

国家自然科学基金资助项目（81830111）；国家重大新药创制科技专项（2018ZX09721004-006）；“中医药现代化研究”重点专项（2019YFC1711200）；天津市自然科学基金资助项目（19JCQNJC12700）