BACKGROUND 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. METHODS 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. RESULTS 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. CONCLUSION 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.

中文翻译：

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中药质量标志物发现和验证的分析策略。

背景技术中药（TCM）的质量控制是临床疗效的基础。由于中药的复杂性，难以统一质量控制，阻碍了中药质量标准化的进一步实施。质量标记（Q-marker）作为一个新概念，在促进中药质量控制体系标准化方面发挥着强大的作用。假设/目的 本综述旨在为进一步开发Q-marker提供参考和科学依据，并协助中药质量控制的标准化。方法 广泛搜索各种文献和电子数据库，如 Pubmed、皇家化学学会、Science Direct、Springer、Web of Science 和 Wiley 等，用于搜索科学贡献。其他在线学术图书馆，例如 Google Scholar，Scopus和国家药理学文献也被用来了解更多关于Q-marker的相关信息。结果Q-markers在促进中药质量控制标准化方面发挥着至关重要的作用。综述了影响中药质量的因素、Q-marker研究中常用的分析技术的优缺点以及系统的研究策略，并得到实践验证。结论 Q-marker的提出不仅为突破目前质量控制的瓶颈提供了新的视角，而且可用于药效评价、治疗发现、毒理学等方面。