Yang Wenzhi, Zhang Yibei, Wu Wanying, Huang Luqi, Guo Dean, Liu Changxiao
National Engineering Laboratory for Standardization of Traditional Chinese Medicine, Shanghai Institute of Materia Medica, Shanghai 201203, China.
Research Center for Chinese Medicinal Resources, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Acta Pharm Sin B. 2017 Jul;7(4):439-446. doi: 10.1016/j.apsb.2017.04.012. Epub 2017 May 23.
Traditional Chinese medicine (TCM) has played a pivotal role in maintaining the health of Chinese people and is now gaining increasing acceptance around the global scope. However, TCM is confronting more and more concerns with respect to its quality. The intrinsic "multicomponent and multitarget" feature of TCM necessitates the establishment of a unique quality and bioactivity evaluation system, which is different from that of the Western medicine. However, TCM is investigated essentially as "herbal medicine" or "natural product", and the pharmacopoeia quality monographs are actually chemical-markers-based, which can ensure the consistency only in the assigned chemical markers, but, to some extent, have deviated from the basic TCM theory. A concept of "quality marker" (Q-marker), following the "property-effect-component" theory, is proposed. The establishment of Q-marker integrates multidisciplinary technologies like natural products chemistry, analytical chemistry, bionics, chemometrics, pharmacology, systems biology, and pharmacodynamics, etc. Q-marker-based fingerprint and multicomponent determination conduce to the construction of more scientific quality control system of TCM. This review delineates the background, definition, and properties of Q-marker, and the associated technologies applied for its establishment. Strategies and approaches for establishing Q-marker-based TCM quality control system are presented and highlighted with a few TCM examples.
传统中药（TCM）在中国人民的健康维护中发挥了关键作用，如今在全球范围内越来越受到认可。然而，中药的质量正面临越来越多的关注。中药固有的“多成分、多靶点”特性使得有必要建立一个不同于西药的独特质量和生物活性评价体系。然而，中药本质上是作为“草药”或“天然产物”来研究的，药典质量专论实际上是以化学标志物为基础的，这只能确保指定化学标志物的一致性，但在一定程度上偏离了基本的中医理论。遵循“性-效-成分”理论，提出了“质量标志物”（Q-标志物）的概念。Q-标志物的建立整合了天然产物化学、分析化学、仿生学、化学计量学、药理学、系统生物学和药效学等多学科技术。基于Q-标志物的指纹图谱和多成分测定有助于构建更科学的中药质量控制体系。本文综述阐述了Q-标志物的背景、定义和性质，以及用于其建立的相关技术。文中通过一些中药实例介绍并强调了建立基于Q-标志物的中药质量控制体系的策略和方法。
