National Chinmedomics Research Center, Sino-America Chinmedomics Technology Collaboration Center, National TCM Key Laboratory of Serum Pharmacochemistry, Metabolomics Laboratory, Department of Pharmaceutical Analysis, Heilongjiang University of Chinese Medicine, Heping Road 24, Harbin, China.
National Chinmedomics Research Center, Sino-America Chinmedomics Technology Collaboration Center, National TCM Key Laboratory of Serum Pharmacochemistry, Metabolomics Laboratory, Department of Pharmaceutical Analysis, Heilongjiang University of Chinese Medicine, Heping Road 24, Harbin, China; State Key Laboratory of Quality Research in Chinese Medicine, Macau University of Science and Technology, Avenida Wai Long, Taipa, Macau; National Engineering Laboratory for the Development of Southwestern Endangered Medicinal Materials, Guangxi Botanical Garden of Medicinal Plant, Nanning, Guangxi, China.
Phytomedicine. 2020 Feb;67:153165. doi: 10.1016/j.phymed.2019.153165. Epub 2019 Dec 30.
Quality control of traditional Chinese medicine (TCM) is the basis of clinical efficacy. Due to the complexity of TCM, it is difficult to unify the quality control, and hinders the further implementation of the quality standardization of TCM. As a new concept, quality-marker (Q-marker) plays a powerful role in promoting the standardization of quality control system of TCM.
HYPOTHESIS/PURPOSE: The present review aims to provide reference and scientific basis for further development of Q-marker and assist standardization of quality control of TCM.
Extensive search of various documents and electronic databases such as Pubmed, Royal Society of Chemistry, Science Direct, Springer, Web of Science, and Wiley, etc., were used to search scientific contributions. Other online academic libraries, e.g. Google Scholars, Scopus and national pharmacology literature were also been employed to learn more relevant information about Q-marker.
Q-markers play vital role in promoting the standardization of quality control of TCM. The factors that affect the quality of TCM, the advantages and disadvantages of the analytical techniques commonly used in Q-marker research were reviewed, as well as the systematic research strategies, which were verified by practices.
The proposal of Q-marker not only provided a new perspective to break through the bottleneck of current quality control, but also can be used in the evaluation of pharmacological efficiency, therapeutic discovery, toxicology, etc. In addition, the Q-marker analysis strategies summarized in this paper is helpful to standardize the quality control of TCM and promote the internationalization of TCM.
中药（TCM）的质量控制是临床疗效的基础。由于 TCM 的复杂性，难以统一质量控制，这阻碍了 TCM 质量标准化的进一步实施。作为一个新概念，质量标志物（Q-marker）在促进 TCM 质量控制系统标准化方面发挥着强大的作用。
假设/目的：本综述旨在为 Q-marker 的进一步发展提供参考和科学依据，并有助于 TCM 质量控制的标准化。
广泛搜索各种文献和电子数据库，如 Pubmed、英国皇家化学学会、Science Direct、施普林格、Web of Science 和 Wiley 等，以搜索科学贡献。还利用其他在线学术图书馆，如 Google Scholar、Scopus 和国家药理学文献，了解更多关于 Q-marker 的相关信息。
Q-marker 在促进 TCM 质量控制的标准化方面发挥着重要作用。综述了影响 TCM 质量的因素、Q-marker 研究中常用分析技术的优缺点，以及通过实践验证的系统研究策略。
Q-marker 的提出不仅为突破当前质量控制的瓶颈提供了新的视角，而且可用于评估药效、治疗发现、毒理学等。此外，本文总结的 Q-marker 分析策略有助于规范 TCM 的质量控制，促进 TCM 的国际化。
