通过系统梳理苦参Sophorae Flavescentis Radix的传统应用基础与现代研究进展，重点从化学成分、共性药理机制及安全性特征等方面进行综合分析，为其科学研究与规范化应用提供参考。基于苦参、生物碱、总黄酮、免疫抗炎、安全性评价等关键词，检索万方、中国知网、PubMed、Web of Science等数据平台，并系统分析了近10年来国内外有关研究文献，对其传统医学认知、现代药理研究进行系统归纳总结，重点评述了苦参的药效物质基础和临床应用机制。苦参含有多类化学成分，其中以生物碱类为主，黄酮类、多糖类等成分亦参与其整体药效发挥。现代药理研究发现，苦参以免疫-炎症调控为核心，通过靶向桥粒芯糖蛋白2修复屏障及双向调节免疫极化（M1/M2）发挥整体药效。其物质基础表现出明确的结构-协同规律，非生物碱组分可通过抑制活性氧/NOD样受体热蛋白结构域3通路调控生物碱的毒性阈值，体现出显著的“药效-毒性”平衡特征。同时，苦参相关不良反应主要与生物碱类成分、剂量及给药方式密切相关，其安全性风险具有一定的可控性。苦参的现代研究在一定程度上验证了其传统功效基础，但仍存在成分-作用关系不清、机制整合不足及系统安全性评价有限等问题。未来研究应加强多成分协同机制及安全性风险控制研究，以促进苦参的合理开发与临床规范应用。

This paper reviews the traditional application basis and modern research progress of Kushen (Sophorae Flavescentis Radix), and performs a comprehensive analysis focusing on its chemical constituents, shared common pharmacological mechanisms, and safety profiles, thereby providing a scientific reference for its research and standardized application. Using keywords such as Sophorae Flavescentis Radix, alkaloids, total flavonoids, immune-inflammatory regulation, and safety evaluation, this review collected relevant domestic and foreign relevant literature published in the past decade was retrieved from databases including Wanfang, China National Knowledge Infrastructure, PubMed, and Web of Science. The retrieved studies were systematically analyzed to summarize the traditional medical understanding and modern pharmacological research, with special emphasis on the pharmacodynamic material basis and clinical application mechanisms of Sophorae Flavescentis Radix. Sophorae Flavescentis Radix contains multiple classes of chemical components, predominantly alkaloids, while flavonoids, polysaccharides, and other constituents also contribute to its holistic efficacy. Modern pharmacological studies have revealed that Sophorae Flavescentis Radix exerts its overall effects through immune-inflammatory regulation as the core mechanism, specifically by targeting desmoglein-2 for barrier repair and bidirectionally modulating immune polarization (M1/M2). Its material basis exhibits clear structure-synergy patterns, non-alkaloid components can regulate the toxicity threshold of alkaloids by inhibiting the reactive oxygen species/NOD-like receptor family pyrin domain containing 3 pathway, demonstrating a significant “efficacy-toxicity” balance feature. Meanwhile, adverse reactions related to Sophorae Flavescentis Radix are closely associated with its alkaloid components, dosage, and administration routes, suggesting that the safety risks are manageable to a certain extent. Modern research on Sophorae Flavescentis Radix has, to some extent, validated its traditional efficacy basis. However, critical issues remain, such as unclear relationships among components, insufficient integration of mechanisms, and limited systematic safety evaluations. Future research should strengthen studies on multi-component synergistic mechanisms and safety risk control to promote the rational development and standardized clinical application of Sophorae Flavescentis Radix.

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浙江省科技厅重点研究项目“尖兵领雁＋X”科技计划（2026C04025）；青海省科技厅项目（2025-NK-P36）