目的 基于文献计量学总结国内外仿制药领域的研究现状及趋势，为进一步研究提供参考。方法 通过检索收集中国学术期刊全文数据库（CNKI）、Web of Science数据库中收录的相关文献，借助CiteSpace6.3R2、VOSview1.6.20、文献计量学在线分析平台等探讨本领域的作者机构合作、国家合作概况，并分析关键词共现、聚类、突现等，并对分析结果可视化展示。结果 共纳入2 564篇文献，其中中文文献641篇，英文文献1 923篇。刊文趋势表明，国内外仿制药领域研究的发展趋势基本相同。目前本领域研究已有国际化趋势，但我国的国际合作中心性为0。关键词分析显示，国内外仿制药领域研究内容在保持一致的前提下各有侧重，其研究内容与热点可相互补充借鉴。结论 系统分析了2000—2024年间仿制药领域的相关文献，总结了目前全球仿制药领域的研究现状及趋势，并进一步指出国内外研究的异同，可为本领域的进一步研究提供指导。

Objective To explore and summarize the research status and trends in the field of generic drug both at home and abroad based on bibliometrics, and provide certain references for the further research in this field. Methods The relevant articles were searched and collected from China National Knowledge Infrastructure and Web of Science, and CiteSpace6.3R2, VOSview1.6.20, and bibliometric online analysis platforms were utilized to explore the author (institution) cooperation and national cooperation in this field, and visualize the analysis results of keyword co-occurrence, clustering and emergence. Results A total of 2 564 articles were included, including 641 Chinese and 1 923 English articles. The trend of publication indicated that the development trend of this field was basically the same. At present, there was a trend of international cooperation in this field, but the centrality of international cooperation in China was zero. The results of keyword analysis implied that the research content in this field had their own focus while maintaining consistency, which could complement and draw on each other. Conclusion This study systematically analyzes the relevant articles in the field of generic drug from 2000 to 2024, summarizes the current research status and trends as well, and further pointes out the similarities and differences between domestic and foreign research, which can provide guidance for the further research in this field.

R914

湖北省卫生健康委联合基金（WJ2019H181）；湖北省自然科学基金（2022CFD060）；中国药学会全国医药经济信息网科普研究重点项目（CMEI2020KPYJ00318）