目的 通过文献计量学方法系统梳理中药致肝毒性研究的整体态势，揭示其研究热点与发展趋势，并从物质基础、作用机制、研究方法、减毒策略及临床评价等维度展开探讨，为中药安全性评价与合理应用提供参考。方法 检索中国知网（China National Knowledge Infrastructure，CNKI）和Web of Science（WOS）数据库中关于中药致肝毒性的中英文文献，检索时间为1982年1月—2025年7月，利用CiteSpace文献计量学工具对研究文献发表的时间分布、核心作者、核心研究机构、高频关键词及突现词进行分析，揭示该领域的研究前沿和热点。结果 分别从CNKI和WOS数据库筛选获得552篇中文文献和181篇英文文献。中英文文献发文量最多的作者均是肖小河和王伽伯，中英文文献发文量最多的研究机构均是北京中医药大学和上海中医药大学。文献计量学结果显示，中药致肝毒性研究的发文量逐年增加，研究热点主要集中于高风险药材（何首乌、大黄及雷公藤等）、毒性成分（蒽醌类、吡咯里西啶类生物碱等）及其分子作用机制。进一步分析可知，中药致肝毒性研究已逐步构建起从基础机制解析到临床安全性评价的系统研究链条。物质基础与作用机制方面，聚焦于高风险药材及其活性成分，揭示了代谢活化、氧化应激、免疫炎症与细胞凋亡等多通路协同介导的肝损伤机制；研究方法层面，经历了从传统动物实验与病理学观察到细胞与分子生物学、系统毒理学、网络药理学及新兴类器官和肝芯片等多学科交叉手段的演进；减毒策略方面，围绕药材炮制、合理配伍、剂型优化以及药物基因组学指导下的个体化干预等途径，形成了较为系统的减毒体系；临床评价方面，病例报告、因果判定体系与真实世界研究的不断完善，推动了中药安全性研究逐渐趋向循证化与国际化。结论 当前中药致肝毒性研究呈现出由定性描述向定量分析、经验判断向证据支撑的科学化发展路径，未来研究需在深入揭示其物质基础与作用机制的同时，强化新兴技术与大数据挖掘应用，完善安全性评价体系，为中药的合理用药与现代化发展提供支撑。

Objective To systematically review the overall landscape of research on hepatotoxicity associated with traditional Chinese medicine (TCM) using bibliometric methods, identify key research areas and emerging trends, and conduct a multidimensional analysis encompassing material basis, mechanisms of action, research methodologies, toxicity reduction strategies, and clinical evaluation, thereby providing reference for TCM safety research and rational application. Methods Chinese and English literature on hepatotoxicity of TCM was retrieved from the China National Knowledge Infrastructure (CNKI) and Web of Science (WOS) databases. The search period spans from January 1982 to July 2025. The CiteSpace bibliometric tool was employed to analyze the temporal distribution of published studies, core authors, key research institutions, high-frequency keywords, and emerging terms, thereby revealing research frontiers and hotspots in this field. Results A total of 552 Chinese-language articles were identified from the CNKI database, while 181 English-language articles were retrieved from the WOS database. The authors with the highest number of publications in both Chinese and English literature are Xiao Xiaohe and Wang Jiabo. The research institutions with the highest number of publications in both Chinese and English literature are Beijing University of Chinese Medicine and Shanghai University of Traditional Chinese Medicine. Bibliometric analysis indicates a steady annual increase in publications on TCM-induced hepatotoxicity. Research hotspots primarily focus on high-risk herbs (e.g., Polygonum multiflorum, Rheum officinale, Tripterygium wilfordii), toxic constituents (e.g., anthraquinones and pyrrolizidine alkaloids), and their molecular mechanisms. Further analysis revealed that research on hepatotoxicity caused by TCM has progressively established a systematic research chain spanning from fundamental mechanism analysis to clinical safety evaluation. Regarding material basis and mechanisms of action, research have focused on high-risk herbs and their active components, revealing multi-pathway synergistic mechanisms of liver injury mediated by metabolic activation, oxidative stress, immune inflammation, and apoptosis. Regarding research methodologies, research have evolved from traditional animal experiments and pathological observations to multidisciplinary approaches including cellular and molecular biology, systems toxicology, network pharmacology, and emerging organoids and liver-on-a-chip technologies. Regarding toxicity reduction strategies, a systematic toxicity reduction system has been established through the approaches of herbal processing, rational combination, formulation optimization, and personalized interventions guided by pharmacogenomics. Regarding clinical evaluation, the continuous refinement of case reporting, causality determination systems, and real-world studies has propelled TCM safety research toward evidence-based and international standards. Conclusion Current research on hepatotoxicity of TCM demonstrates a scientific progression from qualitative descriptions to quantitative analysis, and from empirical judgments to evidence-based conclusions. Future studies should deepen the elucidation of material bases and action mechanisms while strengthening the application of emerging technologies and big data mining. This will enhance the TCM safety evaluation system, providing support for rational TCM use and its modernization.

G350;R285

国家自然科学基金项目（82505211）;中国科学院成都文献情报中心创新基金青年项目（E4Z0000605）