Discrimination and identification of Q-markers based on 'Spider-web' mode for quality control of traditional Chinese medicine

Discrimination and identification of Q-markers based on 'Spider-web' mode for quality control of traditional Chinese medicine
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DOI:
10.1016/j.phymed.2017.12.034
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发表时间:
2018-05-15
期刊:
影响因子:
7.9
通讯作者:
Wang, Yuefei
Wang, Yuefei
中科院分区:
医学1区
文献类型:
--
作者:
Jiang, Zhenzuo;Yang, Jing;Wang, Yuefei

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背景:中药临床应用的安全性和有效性直接关系到中药的质量。中药质量控制是中药质量的关键问题,也是中药现代化的障碍。目的:建立基于质量标记物识别的中药质量控制策略。方法:以含量、稳定性、药代动力学和药理4个维度的7个变量为主要变量,以回归面积(A)和变异系数(CV)为指标,采用“蜘蛛网”模型评价中药候选化合物的质量标记物性质。结果:优选回归面积(A)较大、变异系数(CV)较小的化合物作为Q标记,使其具有良好的含量、稳定性、药代动力学和药理活性。相反,由于Q标记物的性质不理想,回归面积(A)较小,变异系数(CV)较大,不能代表中药材的质量。结论:蜘蛛网模型可以过滤掉多余的成分,重点放在质量控制的关键指标--Q标记物上。在众多复杂的中药成分中,筛选出的Q标记具有最佳的含量、稳定性、药代动力学和药理综合特性,能够全面表征中药的内在品质。综上所述,本工作建立的新策略为中药质量控制提供了一个有价值的视角。
Background: The safety and effectiveness of traditional Chinese medicine (TCM) in clinical practice is directly related to the quality of TCM. And, the quality control of TCM is a pivotal issue to the quality of TCM, but also an obstacle impeding the modernization of TCM.Purpose: The purpose of this work is to compile and develop a strategy based on discrimination and identification of quality markers (Q-markers) for quality control of TCM.Methods: Mainly established by seven variables derived from four dimensions including content, stability, pharmacokinetics and pharmacology, the 'Spider-web' mode was undertaken to assess the Q-marker property of candidate compounds originated from TCM by taking regression area (A) and coefficient variation (CV) of the tested compounds into account. The importance index (ImI), ImI = A x 1/CV, was suggested to focus Q-markers.Results: The compounds with larger regression area (A) and less coefficient variation (CV) are preferentially adopted as Q-markers, which should possess the satisfactory properties of content, stability, pharmacokinetics and pharmacological activity. To the contrary, the compounds are excluded on the grounds of the unsatisfactory Q-markers' property, less regression area (A) and larger coefficient variation (CV), which cannot represent the quality of TCM.Conclusions: The 'Spider-web' mode can filter out the redundant constituents and focus on the key indexes of quality control - Q-markers. The screened Q-markers possess the optimal integrated properties of content, stability, pharmacokinetics and pharmacology among the numerous and complicated ingredients of TCM, which can comprehensively characterize inherent quality of TCM. In summary, the novel strategy established in this work provides a valuable perspective for the quality control of TCM.