首页|网络药理学应用于中药新药研发专家共识总论

网络药理学应用于中药新药研发专家共识总论

扫码查看
中药新药研发已逐步形成了基于中医药理论、人用经验、临床试验相结合(简称"三结合")的新体系,但鉴于中医"辨证论治"、中药"成分多样、机制复杂"的特点,当前中药新药研发仍存在物质基础及整体作用机制研究不充分、证据链体系不完整等问题。同时,在人用经验收集、临床疗效评价、功效成分质控等方面还存在诸多难题,制约了中药新药研究与开发的创新进程。网络药理学以"网络靶标"为核心理论,突破了传统"单靶标"还原分析研究模式的局限,强调以疾病或证候生物网络为靶标的综合效应来表征中药方剂的整体调节机制,这与中医药整体观的思想相契合,为研究中药复杂作用机制及中药新药研发提供了与中医药整体观相符的新方法,在国际上被认为是"新一代药物研究模式"。为推动中药评价的新工具、新方法和新标准的研究,并突破中药监管领域的基础性、关键性、前沿性技术难题,该共识针对中药新药研发的"三结合"审评证据体系,探讨网络药理学作为新理论、新方法和新工具应用于中药新药研发的特点、进展与挑战、可应用路径和具体应用情形,旨在提升中药新药的研发质量,加快中药新产品研发效率。
General expert consensus on application of network pharmacology in research and development of new traditional Chinese medicine drugs
The research and development of new traditional Chinese medicine drugs has gradually formed a new system based on the combination of traditional Chinese medicine theory,human experience,and clinical trials(referred to as the"three combinations").However,given the characteristics of traditional Chinese medicine's"syndrome differentiation and treatment"and"diverse components and complex mechanisms",there are still problems in the current research and development of new traditional Chinese medicine drugs,such as insufficient research on the material basis and overall mechanism of action,and incomplete evidence chain system.At the same time,there are still many challenges in collecting human experience,evaluating clinical efficacy,and controlling the quality of active ingredients,which restrict the innovation process of research and development of new traditional Chinese medicine drugs.Network pharmacology,based on the core theory of"network targets",breaks through the limitations of the traditional"single target"reduction analysis research model,emphasizing the comprehensive effects of disease or syndrome biological networks as targets to characterize the overall regulatory mechanism of traditional Chinese medicine prescriptions.This is in line with the idea of the holistic view of traditional Chinese medicine,providing a new method consistent with the holistic view of traditional Chinese medicine for studying the complex mechanism of action of traditional Chinese medicine and the development of new traditional Chinese medicine drugs.It is internationally recognized as a"next generation of drug research model".In order to promote the research of new tools,methods,and standards for the evaluation of traditional Chinese medicine,and to break through the fundamental,critical,and cutting-edge technical challenges in the field of traditional Chinese medicine regulation,this consensus aims to explore the characteristics,progress,challenges,applicable paths,and specific application situations of network pharmacology as a new theory,method,and tool applied to the research and development of new traditional Chinese medicine drugs,in order to improve the quality of research and development of new traditional Chinese medicine drugs and accelerate the efficiency of research and development of new traditional Chinese medicine products.

network pharmacologyresearch and development of new traditional Chinese medicines drugsexpert consensus

李梢、肖伟

展开 >

清华大学北京市中医药交叉研究所/自动化系,北京 100084

中药制药过程控制与智能制造技术全国重点实验室,江苏连云港 222047

网络药理学 中药新药研发 专家共识

国家药品监督管理局委托研究课题国家中医药管理局科技项目药品监管科学全国重点实验室课题江苏省基础研究计划自然科学基金-前沿引领技术基础研究专项国家中医药管理局"岐黄学者"中医药领军人才项目天津市市场监督管理委员会科技计划重点项目

20211440216GZY-KJS-2024-032023SKLDRS0104BK202320142022-W35

2024

中国中药杂志
中国药学会

中国中药杂志

CSTPCD北大核心
影响因子:1.718
ISSN:1001-5302
年,卷(期):2024.49(18)