Li Shao, Xiao Wei
Institute for TCM-X/Department of Automation, Tsinghua University Beijing 100084, China.
State Key Laboratory on Technologies for Chinese Medicine Pharmaceutical Process Control and Intelligent Manufacture Lianyungang 222047, China.
Zhongguo Zhong Yao Za Zhi. 2024 Sep;49(18):5055-5068. doi: 10.19540/j.cnki.cjcmm.20240818.701.
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.
中药新药研发已逐步形成基于中医理论、人类经验和临床试验相结合（简称“三结合”）的新体系。然而，鉴于中医“辨证论治”及“成分多样、机制复杂”的特点，当前中药新药研发仍存在问题，如对物质基础和整体作用机制研究不足、证据链体系不完善等。同时，在收集人类经验、评估临床疗效及控制活性成分质量方面仍面临诸多挑战，制约着中药新药研发的创新进程。网络药理学基于“网络靶点”核心理论，突破了传统“单一靶点”还原分析研究模式的局限，强调以疾病或证候生物网络的综合效应为靶点来表征中药方剂的整体调控机制。这与中医整体观理念相符，为研究中药复杂作用机制及中药新药研发提供了一种符合中医整体观的新方法，在国际上被公认为“下一代药物研究模式”。为推动中药评价新工具、新方法和新标准的研究，突破中药监管领域的基础性、关键性和前沿性技术挑战，本共识旨在探讨网络药理学作为一种新理论、新方法和新工具应用于中药新药研发的特点、进展、挑战、适用路径及具体应用情况，以提高中药新药研发质量，加快中药新产品研发效率。
