生物检定法在中药质量评价中的应用研究进展

Application of bioassay in quality evaluation of Chinese medicine:a review

中药质量关乎临床疗效和行业发展根基。然而当下以化学成分为主的中药质量评价方法虽可控制药物一致性和稳定性,但却难以真实反映临床疗效,其局限性日益凸显。生物检定法则以临床疗效为导向,借以生物活体、组织或细胞等为评价模式,具有关联疗效的优点,可切实反映中药质量。中药生物检定法起步虽早,却发展缓慢,而今又被重新重视,但现有研究系统性不强且规范性偏弱。该文依据中药传统功效差异对现有生物检定法在中药中的应用情况予以综述,对研究最为广泛的清热类和活血化瘀类中药现有生物检定技术的关键技术、试验体系、共性问题等进行了探讨,同时从关联临床疗效、与化学分析关联性及生物检定技术自身境况等角度提出了未来发展建议,以期为该方法的进一步完善及推广应用提供参考。

The quality of Chinese medicine is the foundation of the clinical effects and industrial development.Component analysis ensures the consistency and stability of medicinals,but fails to evaluate the clinical efficacy.Bioassay is an analytical method to evaluate the effect of a substance on living organisms,tissues,or cells,which is an optimal option for assessing the quality of Chinese medicine.Bioassay of Chinese medicine starts early but progresses slowly.At the moment,it has attracted the interest of scholars.However,no systematic research is available.This study aims to summarize the research on the application of bioassay in quality evaluation of Chinese medicine,focusing on the application of key techniques and experimental systems in bioassay in heat-clearing and blood-activating and stasis-eliminating Chinese medicine and the common problems.Meanwhile,suggestions were proposed in terms of the association with clinical efficacy and chemical analysis and the status quo of biological assay.This study is expected to promote the study and application of bioassay.