State Key Laboratory for Quality Research in Chinese Medicine, University of Macau, Macao SAR, China.
National Institutes for Food and Drug Control, Tiantan Xili 2, Beijing 100050, China.
J Pharm Biomed Anal. 2018 Jan 5;147:473-478. doi: 10.1016/j.jpba.2017.06.048. Epub 2017 Jun 19.
Quality control is always the critical issue for Chinese medicines (CMs) with their worldwide increasing use. Different from western medicine, CMs are usually considered that multiple constituents are responsible for the therapeutic effects. Therefore, quality control of CMs is a challenge. In 2011, the strategies for quantification, related to the markers, reference compounds and approaches, in quality control of CMs were reviewed (Li, et al., J. Pharm. Biomed. Anal., 2011, 55, 802-809). Since then, some new strategies have been proposed in these fields. Therefore, the review on the strategies for quality control of CMs should be updated to improve the safety and efficacy of CMs. Herein, novel strategies related to quality marker discovery, reference compound development and advanced approaches (focused on glyco-analysis) for quality control, during 2011-2016, were summarized and discussed.
质量控制一直是中药（CMs）的关键问题，随着其在全球范围内的使用日益增加。与西药不同，CMs 通常被认为是多种成分共同作用于治疗效果。因此，CMs 的质量控制是一个挑战。2011 年，对 CMs 质量控制中与标志物、对照化合物和方法相关的定量策略进行了综述（Li 等人，J. Pharm. Biomed. Anal.，2011，55，802-809）。自那时以来，这些领域已经提出了一些新的策略。因此，为了提高 CMs 的安全性和疗效，应该更新 CMs 质量控制策略的综述。在此，总结和讨论了 2011-2016 年期间与质量标志物发现、对照化合物开发和先进方法（重点是糖分析）相关的 CMs 质量控制的新策略。
