目的 系统分析小檗碱及其主要衍生物（盐酸小檗碱、二氢小檗碱和四氢小檗碱）的全球专利布局特征，揭示其技术发展趋势与研发热点，为创新药物开发、产业专利布局和中药现代化提供参考。方法 基于全球专利数据库，对小檗碱及其衍生物相关专利进行检索与同族扩展，并通过主题词抽取与聚类分析方法，对不同类型小檗碱专利家族的多元化技术主题、应用领域和区域分布进行系统分析。结果 共识别出1 155个原小檗碱、494个盐酸小檗碱以及65个二氢或四氢小檗碱专利家族。中国是该领域最主要的研发与应用市场。各类小檗碱专利均以药物制备为核心，涉及代谢综合征、肝病、神经退行性疾病等多种适应症。结论 小檗碱及其衍生物领域技术创新活跃，研发热点主要集中在制剂优化、适应证拓展及安全性提升等方面。部分企业在共晶物、脂质体、纳米制剂及复方药物等方向积极布局，体现了该领域正由传统中药活性成分向现代药物工艺和国际化应用方向持续拓展的趋势。

Objective To systematically analyze the global patent landscape of berberine and its major derivatives, including berberine hydrochloride, dihydroberberine, and tetrahydroberberine, to identify technological development trends and research hotspots and provide references for innovative drug development, strategic patent layout, and the modernization of traditional Chinese medicine. Methods Based on global patent databases, patents related to berberine and its derivatives were retrieved and expanded by patent families. Keyword extraction and clustering analysis were applied to analyze diversified technological themes, application areas, and geographical distributions of different categories of berberine-related patent families. Results A total of 1 155 berberine, 494 berberine hydrochloride, and 65 dihydroberberine or tetrahydroberberine patent families were identified. China was the primary market for research and application. Patents mainly focused on pharmaceutical preparations and covered multiple indications, including metabolic syndrome, liver diseases, and neurodegenerative disorders. Conclusion Technological innovation in berberine and its derivatives remains active, with research hotspots concentrated on formulation optimization, expansion of therapeutic indications, and improvement of safety. Some enterprises have actively deployed patents in cocrystals, liposomes, nanoformulations, and compound preparations, indicating a continuous expansion from traditional active components of Chinese medicine toward modern pharmaceutical technologies and international applications.

R284.1;G353.1

中央高校基本科研业务费专项资金资助“利用知识图谱提升科研效率和质量的方法与应用实践”（30925011204）