[关键词]
[摘要]
中药大品种二次开发研究是中药创新研究的重要内容,是继承和发展中医药理论,突破制约中医药理论和中药产业发展瓶颈的重要路径。以六经头痛片为研究对象,进行系统的二次开发研究,通过药材、成品以及口服入血成分的辨识和表征,阐释了六经头痛片的化学物质组,进一步通过G-蛋白偶联受体结合实验以及网络药理学分析,筛选和明确了主要药效物质基础;通过与头痛相关的整体及动物模型、离体器官、细胞、相关功能受体以及网络药理学研究,揭示六经头痛片的作用机制;通过拆方研究并与同类中药以及化学药比较,阐释该药的组方特点和配伍规律,提炼和发现其作用特点、比较优势和临床核心价值;通过从化学物质组的辨识与指认、成品质量信息的各原料药材的来源与归属、多指标成分的定量测定、指纹图谱共有模式的建立以及多批样品测定等方面进行系统研究,建立六经头痛片的药材与成品的质量控制体系,对原有的质量标准进行了全面的提升,保证产品的质量均一、稳定、可控。为该品种的临床推广应用和指导临床实践提供了重要的理论和实验依据,并为其他中药大品种的二次开发研究提供了可参考的思路与模式。
[Key word]
[Abstract]
To study the secondary development of major Chinese materia medica (CMM) varieties is the important content of CMM innovation research, and it is also the important approach of inheriting and developing traditional Chinese medicine (TCM) theory and breaking the bottleneck restricting the development of TCM theory and CMM industry development. In this paper, the secondary development of Liujing Toutong Tablets (LTT) was systematically studied. The chemical components of LTT were elucidated by identification and characterization of herbs, LTT and components ingested into the blood. The main effective components were further screened and cleared by binding experiments of G protein coupled receptors and network pharmacology analysis. The mechanism of LTT was explained by the studies of animal models, isolated organs, cells, functional receptors, and network pharmacology related with headache. The formula features, compatibility regularity were clarified and the action properties, comparative advantages and core clinical value were found and refined by the research of decomposed recipes and the comparison with the similar CMM recipes and chemical drugs. The quality control systems of LTT and related herbs were established by systematic research of identification and characterization of chemical components, the LTT chemical information herbal source, content determination of multi-target ingredients, establishment of the characteristic mode of HPLC fingerprint, sample determination of multiple batches. The original quality standards were promoted comprehensively ensuring the uniformity, stability and controllability of product quality. This study not only provided important theoretical and experimental basis for clinical application and guiding clinical practice, but also provided research ideas and modes for the secondary development of other major CMM.
[中图分类号]
[基金项目]