中国中药杂志

2020, v.45(14) 3340-3350

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牡丹皮道地性物质基础组分结构特征及多维结构质量控制实践与发展
Practice and development of structural characteristics and quality control of multi-dimensional structure of basic components of genuine material of Moutan Cortex

杨立诚;夏昀卿;张萌;朱毛毛;封亮;贾晓斌;
YANG Li-cheng;XIA Yun-qing;ZHANG Meng;ZHU Mao-mao;FENG Liang;JIA Xiao-bin;School of Traditional Chinese Pharmacy, China Pharmaceutical University;College of Pharmacy, Jiangsu University;Nanjing Institute of Product Quality Inspection;

摘要(Abstract):

中药是中华民族几千年临床用药的实践产物,其物质基础是揭示中药作用本质的关键,更是解决中药质量控制难题的根本保证。然而,中药物质基础是通过多靶点、多途径、相互协同发挥整体药效作用,造成了其质量控制指标不明确。近年来中药质量控制标准发生了从外观性状到重视内部物质基础的巨大变化,但是也仅局限于对单个成分或多个成分的把控,脱离了中药整体性的特征,无法保证其内在的有效性与安全性。该文以牡丹皮为例,结合《中国药典》分析了牡丹皮质量标准的演变,全面总结了牡丹皮的物质基础,并基于"组分结构"理论,围绕牡丹皮物质基础与其制剂的质量控制现状两方面对其进行解析,阐述了多维质量控制的发展趋势,为今后建立更为合理的中药质量控制体系奠定基础。
Traditional Chinese medicine is the product of clinical medication practice of the Chinese nation for thousands of years. Its material basis is the key to reveal the essence of the roles of traditional Chinese medicine, and the fundamental guarantee to solve the difficulties in the quality control of traditional Chinese medicine. However, the material basis of traditional Chinese medicine is to exert the overall pharmacodynamic effect through multi-targets, multi-approaches and mutual cooperation, resulting in unclear quality control index. In recent years, the quality control standards of traditional Chinese medicine have experienced great changes by shifting the focus from the appearance characteristics to the internal material basis, which however is limited to the control of a single com-ponent or multiple components. In other words, the intrinsic effectiveness and safety could not be guaranteed without the characteristics of the integrity of traditional Chinese medicine. With Moutan Cortex as an example, this paper analyzed the evolution of Moutan Cortex quality standards based on Chinese Pharmacopoeia, and comprehensively summarized the material basis of Moutan Cortex. Based on the theory of "component structure", this study analyzed current quality control of the material basis of Moutan Cortex and its preparations, and expounded the development trend of multi-dimensional quality control, so as to lay a foundation for establishing a more rational quality control system for traditional Chinese medicine in the future.

关键词(KeyWords): 牡丹皮;物质基础;组分结构理论;多维结构;质量控制
Moutan Cortex;material basis;compositional structural characteristics;multidimensional structure;quality control

Abstract:

Keywords:

基金项目(Foundation): 国家自然科学基金项目(81703775,81973536);; 中国药科大学双一流项目(CPU2018GF07,CPU2018GY11)

作者(Author): 杨立诚;夏昀卿;张萌;朱毛毛;封亮;贾晓斌;
YANG Li-cheng;XIA Yun-qing;ZHANG Meng;ZHU Mao-mao;FENG Liang;JIA Xiao-bin;School of Traditional Chinese Pharmacy, China Pharmaceutical University;College of Pharmacy, Jiangsu University;Nanjing Institute of Product Quality Inspection;

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