清热散结片/胶囊的研究现状及探讨

Current study status and discussion on Qingre Sanjie Tablets/Capsules

清热散结片和清热散结胶囊均为中药千里光的单方制剂,因含有酚酸类和黄酮类化合物而具有消炎解毒、散结止痛等作用,临床应用较广泛。清热散结片/胶囊中还含有生物碱类物质,主要是吡咯里西啶类生物碱(PAs)。PAs既有一定药理活性,可用于皮肤癌、宫颈癌、食管癌、白血病等肿瘤疾病的辅助治疗,又具有肝毒性、致癌性、致突变性,近年来受国内外学者关注较多。本文围绕清热散结片/胶囊的化学成分及质量控制、药理作用和临床应用以及安全性评价研究等方面进行综述,着重分析其中PAs的研究进展,分析不足并提出建议,以期为两种制剂全面的用药风险评估及风险控制提供借鉴。

Both Qingre Sanjie(heat dissipation)Tablets and Qingre Sanjie Capsules are monomer preparations of Chinese materia medica Qianliguang,which are widely used clinically for their effects of anti-inflammation,detoxifying,and eliminating stagnation to stop pain due to the presence of phenolic acids and flavonoids.The Qingre Sanjie Tablets/Capsules also contain alkaloids,mainly pyrrolizidine alkaloids(PAs),which have certain pharmacological activities and can be used for the adjuvant treatment of skin cancer,cervical cancer,esophageal cancer,leukemia and other tumor diseases,but also have hepatotoxicity,carcinogenicity and mutagenicity,and have received much attention from scholars at home and abroad in recent years.Based on the review of the chemical composition and quality control,pharmacological effects,clinical applications,and safety assessment studies of Qingre Sanjie Tablets/Capsules,this paper focuses on analyzing the advances and shortcomings in the study of PAs and making further suggestions,in order to provide reference for the comprehensive medication risk assessment and risk control of the two formulations.