[关键词]
[摘要]
中药质量决定着中药的安全性与有效性,中药质量控制体系的现代化是中医药国际化进程的重要前提。当前,中药质量研究方法是中药行业的关键技术问题。近年来,随着生命科学、化学科学、分析科学的飞速发展,中药质量研究水平有了极大地提升,但仍停留在化学成分和生物效应2种评价模式阶段。对于单成分,由于效应与成分的含量呈正比,可采用化学成分模式进行质量控制,但对于中药多成分体系,建立效应与成分间的量效关系,寻找到能反映其质量属性的标志物,已成为目前中药质量控制行业关注的焦点。对中药质量研究的现状进行分析,在前期提出的超分子"印迹模板"的"气析"理论基础上,剖析中药质量的超分子"印迹模板"特性,阐明中药质量控制的实质,提出以反映中药效应的超分子"印迹模板"作用属性特征,以物芯指数表征的中药质量标志物控制策略,这将为中药质量控制提供一种更精确的表征和测算新模式。
[Key word]
[Abstract]
The safety and effectiveness of Chinese materia medica (CMM) depend on its quality, and the modernization of CMM quality control system is an important prerequisite for the internationalization of traditional Chinese medicine (TCM). Up to now, the quality research approach of CMM is the key technology for TCM industry. In recent years, with the development of modern life science, chemistry science, analytical science and technology, the quality research level of CMM has been greatly improved, but it still stays on the two evaluation models based on chemical composition and biological effect. For single compound, because the effect is proportional to the content of components, the chemical composition can be used for quality control. However, for multi-component system of CMM, how to establish the dose-effect relationship between effects and components and find the markers reflecting their quality has become the focus of the quality control of CMM for TCM industry. Based on the theory of supramolecular "imprinting template" and "Qi-xi" put forward earlier, this paper first analyzed the characteristics of supramolecular "imprinting template" for the quality of CMM, clarified the essence of quality control of CMM, and proposed the attributes of supramolecular "imprinting template" to reflect the main effect of CMM. The control strategy of quality markers of CMM represented by core index will provide a new and more accurate characterization and calculation model for quality control of CMM.
[中图分类号]
[基金项目]
国家自然科学基金资助项目(81874507);国家自然科学基金资助项目(81703824);国家自然科学基金资助项目(81573691);湖南省科技厅重点实验室建设资助项目(2016TP1017);湖南省教育厅创新平台开放基金项目(18K071);湖南省自然科学基金资助项目(2016JJ4065);湖南省研究生科研创新项目(CX20190570);湖南中医药大学研究生科研创新课题(2018CX18)