组分中药理论创新与实践范例:冠心宁片创制研究  

Theoretical innovation of component-based Chinese medicine and its exemplary practice:the study on creating Guanxinning Tablets

作　　者：程翼宇[1,2] 王毅[1,2] 刘雳 赵筱萍[2,4] 仲怿[1] 黄明[2] 张伯礼[2] CHENG Yi-yu;WANG Yi;LIU Li;ZHAO Xiao-ping;ZHONG Yi;HUANG Ming;ZHANG Bo-li(College of Pharmaceutical Sciences,Zhejiang University,Hangzhou 310058,China;State Key Laboratory of Component-based Chinese Medicine,Tianjin University of Traditional Chinese Medicine,Tianjin 301617,China;Chiatai Qingchunbao Pharmaceutical Co.,Ld.,Hangzhou 310023,China;Cllege of Basic Medical Sciences,Zhejiang Chinese Medical University,Hangzhou 310053,China)

机构地区：[1]浙江大学药学院,浙江杭州310058 [2]组分中药国家重点实验室天津中医药大学,天津301617 [3]正大青春宝药业有限公司,浙江杭州310023 [4]浙江中医药大学基础医学院,浙江杭州310053

出　　处：《中国中药杂志》2022年第17期4545-4550,共6页China Journal of Chinese Materia Medica

基　　金：国家重点基础研究发展计划“973”项目(2012CB518400)。

摘　　要：针对中药新药研发领域亟需破解的科技难题,秉持理法方药一致的中医药理念,汇聚人工智能、药物信息学、系统药理学与中药化学等学科智慧,首次提出组分中药智能创制技术方法学。以冠心宁片创研过程为范例,阐释组分中药智能创制原理,简要论述中药功效实体的组分配伍优化设计方法;通过多模态多尺度的系统性药效药理研究,探求“说清楚、讲明白”其临床治病的作用机制;着重示范基于生产全流程智能仿真的中试车间及工程化验证平台,并概述中药新药智造生产线设计原则。工业研究结果表明,自主创建的制药过程质量可控性评价方法以及智造生产线能够用于高质量生产冠心宁片。通过上述多学科跨界融合创新研究,开拓了现代中药创制新路。Upholding the wisdom of traditional Chinese medicine that the therapeutic principle,method,formula and medicine are coherent with each other,we propose the technical methodology for intelligent creation of component-based Chinese medicine by integrating multidisciplinary knowledge such as artificial intelligence,pharmaceutical informatics,system pharmacology and phytochemistry.Taking the creation of Guanxinning Tablets as an example,we expound the technical principle for creating component-based Chinese medicine and briefly describe the design method for optimizing the entity of Chinese medicine efficacy by rational combination of active components.Our research sought to"clarify and explain"the mechanism of its clinical treatment action through multi-modal and multi-scale systematic pharmacology studies.This work emphatically demonstrates the pilot workshop and engineering validation platform based on the intelligent simulation of whole production process,and outlines the design principles of the intelligent production line for innovative Chinese medicine.The results of industrial research show that the ourself established method for evaluating the process quality controllability and intelligent production line can be applied to manufacturing Guanxining Tablets with high quality.Through the innovative research of multidisciplinary cross-border integration,the present work explored a new way for the creation of modern Chinese medicine.

关 键 词：组分中药 功效组分 功效实体 现代中药创制 过程质量可控性 冠心宁片 

分 类 号：R283.6[医药卫生—中药学]