中国中药杂志2025，Vol.50Issue(20)：5605-5612,8.DOI:10.19540/j.cnki.cjcmm.20250708.601
人工智能赋能下基于人用经验的中药新药研发展望
Prospects for development of new traditional Chinese medicine drugs based on human use experience empowered by artificial intelligence
摘要
Abstract
The development of traditional Chinese medicine(TCM)new drugs is undergoing profound transformation under the increasingly rigorous global standards of evidence-based medicine and drug regulatory science.A full-cycle R&D model based on human use experience(HUE)has emerged as a strategic bridge linking TCM theory,historical usage,clinical evaluation,and innovative drug development.On this foundation,artificial intelligence(AI)is empowering all stages of TCM new drug development with unprecedented depth.These include:semantic understanding,reconstruction,and dialogue of literature based on natural language processing(NLP)and large language models(LLMs);safety modeling and druggability assessment driven by statistical learning,including deep learning;syndrome objectification via multimodal learning that integrating heterogeneous data such as tongue images,pulse patterns,and electronic medical records;and intelligent optimization of clinical research through adaptive trial design,platform trials,and reinforcement learning.This paper systematically reviews the critical roles of AI throughout the TCM new drug lifecycle-from candidate selection,HUE-based evidence structuring,and safety prediction,to clinical trial design,regulatory submission,post-marketing risk identification,and secondary development-highlighting the paradigm shift enabled by the deep integration of AI and HUE.It further proposes the construction of an integrated intelligent TCM new drug development platform that forms a closed-loop system of"data-driven,model-supported,and intelligent decision-making",promoting the transformation of TCM R&D from empirical reasoning to one driven by high-dimensional knowledge graphs,expert-AI collaborative learning,and multi-source evidence integration.Looking forward,AI is expected to further facilitate individualized therapeutic modeling,intelligent optimization of herbal compatibility strategies,repositioning of indications for compound formulas,and intelligent alignment with international regulatory pathways.This will accelerate the establishment of an internationally adaptive and standardized intelligent TCM new drug development system.This study provides both a theoretical foundation and practical direction for building a future-oriented innovation ecosystem and enhancing the global competitiveness of China's TCM new drug industry.关键词
人用经验/人工智能/中药新药Key words
human use experience/artificial intelligence/new TCM drug引用本文复制引用
鲁路,倪世豪,陈星伶,陈嘉慧,林声荣,吴之国,杨忠奇..人工智能赋能下基于人用经验的中药新药研发展望[J].中国中药杂志,2025,50(20):5605-5612,8.基金项目
国家自然科学基金项目(82374406) （82374406）
杨忠奇省名中医传承工作室项目[粤中医办函(2023)108号] （2023）
广州市重点研发计划项目(2024B03J1298) （2024B03J1298）
广东省教育厅高校科研项目(2024KTSCX11) （2024KTSCX11）
广州中医药大学青年菁英人才培养"揭榜挂帅"团队项目 （）
广州市科技计划项目(2025A04J5311) （2025A04J5311）
