基于生物活性的质量标志物：中药质量控制的新策略。
Quality markers based on biological activity: A new strategy for the quality control of traditional Chinese medicine.
机构信息
Chinese Materia Medica College, Tianjin University of Traditional Chinese Medicine, Tianjin, China; Tianjin State Key Laboratory of Modern Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin, China.
State Key Laboratory of Drug Delivery Technology and Pharmacokinetics, Tianjin Institute of Pharmaceutical Research, Tianjin, China.
出版信息
Phytomedicine. 2018 May 15;44:103-108. doi: 10.1016/j.phymed.2018.01.016. Epub 2018 Feb 7.
BACKGROUND
The quality and quality evaluation system of traditional Chinese medicine (TCM) are crucial in the safety and effectiveness assessment of TCM. However, they are also the major bottlenecks that restrict the quality control of TCM. Given the nature of Chinese medicine and the limitations of science and technology, the quality evaluation of TCM involves a few difficulties. Therefore, scholars have conducted considerable amount of research on this topic and obtained promising results. Biological potency and biomarkers have been used to evaluate the quality of TCM. Previous studies provided new strategies and methods to establish a system on quality evaluation.
PURPOSE
This review aims to provide a new strategy for the quality control of Chinese herbal medicine by combining biological potency and biomarkers based on biological effects.
METHODS
We reviewed the quality evaluation system of Chinese herbal medicine, focusing on quality markers (Q-markers) based on biological effects and the application of these markers in the quality evaluation of Chinese herbal medicine. We also reviewed the factors affecting quality, the difficulties related to the quality evaluation system and the attempt of researchers to improve the quality control of TCM.
RESULTS
We propose Q-biomarkers by integration of biological potency and biomarkers to evaluate the quality of TCM. The quality markers provided us significant insights in the process of definition. We further optimised the concept of Q-markers and summarised their definition and properties (including quantification, specificity and related to biological response) in accordance with the requirement of the quality evaluation of TCM.
CONCLUSION
We propose the use of Q-biomarkers in vivo related to specific diseases as a new strategy for the quality evaluation of Chinese herbal medicine. The quality evaluation system of Q-biomarkers would provide a new perspective to standardise and globalise TCM.
背景
中药的质量和质量评价体系是中药安全性和有效性评价的关键，但也是制约中药质量控制的主要瓶颈。鉴于中药的性质和科学技术的局限性，中药质量评价存在一些难点。因此，学者们对此进行了大量的研究，并取得了可喜的成果。生物效力和生物标志物已被用于评价中药的质量。以往的研究为建立质量评价体系提供了新的策略和方法。
目的
本文旨在通过结合基于生物效应的生物效力和生物标志物，为中药的质量控制提供新的策略。
方法
我们综述了中药质量评价体系，重点介绍了基于生物效应的质量标志物（Q-标志物）及其在中药质量评价中的应用。我们还综述了影响质量的因素、质量评价体系面临的困难以及研究人员为提高中药质量控制所做的尝试。
结果
我们提出了 Q-生物标志物的概念，通过整合生物效力和生物标志物来评价中药的质量。质量标志物在定义过程中为我们提供了重要的见解。我们进一步优化了 Q-标志物的概念，并根据中药质量评价的要求，对其定义和特性（包括定量、特异性和与生物反应相关）进行了总结。
结论
我们提出将与特定疾病相关的体内 Q-生物标志物用作中药质量评价的新策略。Q-生物标志物的质量评价体系将为中药的标准化和全球化提供新的视角。
Zotero 插件