【摘要】 中药的安全性和有效性依赖于质量的稳定可控，而可控的质量评价标准是中医药现代化与国际化的重要战略。活血化瘀类中药成分复杂，单一成分评价模式难以全面反映其整体药效与质量，而生物活性测定法可从整体生物效应角度，评价该类中药的有效性与安全性，已逐渐成为中药质量评价的重要手段。文章梳理了当前活血化瘀类中药质量评价的现状及存在的不足，重点总结了用于该类中药质量评价的生物活性测定方法及其方法学验证。同时，探讨了生物活性测定法在活血化瘀类中药质量标准完善、药效物质研究中的应用价值与发展前景，为该类中药质量评价体系的优化、临床合理用药及中医药现代化发展提供参考与借鉴。更多还原

【Abstract】 The safety and efficacy of traditional Chinese medicine(TCM) depend on the stability and controllability of its quality, and a controllable quality evaluation standard is an important strategy for the modernization and internationalization of TCM. TCMs for activating blood circulation and resolving stasis possess complex chemical compositions. Evaluation based on a single component is insufficient to comprehensively reflect their overall efficacy and quality. In contrast, bioactivitybased assay can assess the efficacy and safety of such medicines from the perspective of holistic biological effects, and have gradually become an important approach for TCM quality evaluation. This paper reviews the current status and limitations of quality evaluation of blood-activating and stasis-resolving TCMs, focusing on the bioactivity determination methods and their methodological validation employed in quality assessment. Furthermore, it discusses the application value and prospects of bioactivity assays in improving quality standards and investigating pharmacodynamic substances of these TCMs. This review provides a reference for optimizing the quality evaluation system, promoting rational clinical application, and facilitating the TCM modernization.更多还原