基于临床疗效和全程质控的中药制剂研究进展

Research progress of Chinese herbal preparation based on clinical efficacy and whole quality control

中药制剂是建立在中医理论体系上的传统处方制剂。目前,中药制剂的临床疗效和质量通常采用化学单体来标化和控制,缺乏与药效的关联性,无法反应中药的整体药效。本文总结了目前基于化学特性的中药制剂优化和质量控制的现状,归纳基于临床疗效和全程质控的中药制剂优化方法和理论。认为中药制剂优化研究应当以临床疗效为导向,以早期临床研究结果为药物制剂优化和质量控制的指标;引入从药材种植至制剂成型的全程质控思想,借鉴谱效学、代谢组学、血清药理学和网络药理学等新技术和方法,建立基于临床疗效和全程质控的中药制剂研究流程和质量体系,期望为中医药制剂的现代化和国际化提供思路和理论依据。

Chinese herbal preparation is a kind of traditional prescription preparation based on theory of traditional Chinese medicine（TCM） system. At present, the clinical efficacy and quality of TCM are commonly standardized and controlled by chemical substances, which lack the relation with clinical effects, and can＇t reflect the overall efficacy of TCM. This paper summarizes current situation of standardization and quality control of Chinese herbal preparation based on chemical characteristics, and concludes optimization method and theories based on clinical efficacy and quality control of the entire process. The optimization of Chinese herbal preparation should be oriented by clinical efficacy, and early clinical studies results should be used as the indicators of drug preparation optimization and quality control. The concept of full quality control from the cultivation of medicinal herbs to preparations is introduced. Spectrum pharmacodynamics, metabolomics, serum pharmacology, network pharmacology and other new technologies and method should be applied to establish Chinese medicine research and full quality control system based on clinical efficacy and whole quality control. The paper desires to provide ideas and theoretical foundation for TCM modernization and internationalization.