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[中药生物药剂学分类系统的研发思路]

[Research and development thought on biopharmaceutics classification system of Chinese materia medica].

作者信息

Liu Yang, Wang Zi-Yu, Xu Wen-Juan, Zhang Cai-Juan, Dong Ling

机构信息

Beijing University of Chinese Medicine Beijing 102488,China.

出版信息

Zhongguo Zhong Yao Za Zhi. 2019 Sep;44(17):3637-3644. doi: 10.19540/j.cnki.cjcmm.20190629.310.

Abstract

The biopharmaceutics classification system( BCS) is a scientific framework or method for classifying drugs based on drug solubility and permeability,which can be used to provide drug bioavailability-absorption correlation analysis. Based on the characteristics of multi-component and multi-target of traditional Chinese medicine( TCM) as well as the concept,method and technology of BCS,the research group proposed biopharmaceutics classification system of Chinese materia medica( CMMBCS) and carried out research and data accumulation of classical prescriptions. Based on the previous research results,further development ideas under the CMMBCS concept and framework were further proposed in this study. In the course of research,the influence of the intermediate links of the complex interactions of the multi-component environment was omitted,and the component absorption studies on the main clinical effects of prescription ingredients were directly concerned,or the components and data were reversely extracted from the aspects of metabolism,pharmacodynamic pathways and absorption principles. Studies were conducted from two aspects( single component and compound prescription) to comprehensively evaluate the absorption properties of TCM compound. In the research path,the different ways in which Chinese medicine could exert its efficacy were fully considered,and CMMBCS classification and establishment rules were clarified mainly by focusing on the absorption pathway into the blood. Specifically,the network pharmacology and molecular docking technology were used to screen the compound index components of TCM; the absorption rules were studied by the physiologically based pharmacokinetic models and the absorption parameters of CMMBCS were calculated by reverse reasoning. Then the CMMBCS classification of TCM prescription was corrected by studying the efficacy or absorption pathway. In this paper,the theoretical framework and research methodology of CMMBCS were systematically improved based on the establishment of CMMBCS basic theory,the supplementary of drug-oriented research ideas and the application of modern mature Chinese medicine methodology.

摘要

生物药剂学分类系统(BCS)是一种基于药物溶解度和渗透性对药物进行分类的科学框架或方法,可用于提供药物生物利用度 - 吸收相关性分析。基于中药多成分、多靶点的特点以及BCS的概念、方法和技术,研究团队提出了中药生物药剂学分类系统(CMMBCS),并开展了经典方剂的研究和数据积累。基于前期研究成果,本研究进一步提出了CMMBCS概念和框架下的进一步发展思路。在研究过程中,忽略了多成分环境复杂相互作用中间环节的影响,直接关注处方成分主要临床效应的成分吸收研究,或从代谢、药效学途径和吸收原理等方面反向提取成分和数据。从单成分和复方两个方面进行研究,以全面评价中药复方的吸收特性。在研究路径上,充分考虑了中药发挥疗效的不同方式,主要围绕入血吸收途径明确了CMMBCS分类及建立规则。具体而言,运用网络药理学和分子对接技术筛选中药的复方指标成分;采用生理药代动力学模型研究吸收规律,并通过反向推理计算CMMBCS的吸收参数。然后通过研究疗效或吸收途径对中药方剂的CMMBCS分类进行校正。本文基于CMMBCS基础理论的建立、以药物为导向研究思路的补充以及现代成熟中药方法学的应用,系统完善了CMMBCS的理论框架和研究方法。

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