Wang Ya-Dan, Wang Qi, Zhang Jian-Bao, Dai Zhong, Lin Na, Wu Xian-Fu, Ma Shuang-Cheng
National Institutes for Food and Drug Control Beijing 100050,China.
China Association of Traditional Chinese Medicine Beijing 100061,China.
Zhongguo Zhong Yao Za Zhi. 2019 Aug;44(16):3368-3373. doi: 10.19540/j.cnki.cjcmm.20190606.501.
Tripterygium wilfordii preparations,with various biological activities such as immunosuppressive,anti-inflammatory and anti-cancer effects,are widely used in the treatment of autoimmune diseases such as rheumatoid arthritis,lupus erythematosus,and nephrotic syndrome. They have definite therapeutic effect,but often cause serious adverse reactions and result in damages to liver,kidney,blood,reproduction,and other systems due to their complex compositions,great toxicity,and narrow margin between the toxic and therapeutic dosages. At present,T. wilfordii preparations produced by different manufacturers exhibit large variations in clinical efficacy and side effects in account of their different chemical compositions and quality fluctuation due to differences in raw materials and production process. However,the existing quality standards are controversial in terms of index components and content limit,which cannot be effectively used for the overall quality control of the preparations. In this paper,the research progress on chemical constituents,quality standard and quality control methods of four T. wilfordii preparations including Tripterygium Tablets,Tripterygium Zongtie Tablets,Tripterygium Shuangceng Tablets and Tripterygium Glycosides Tablets was reviewed,in order to provide ideas and reference for the quality improvement of this type of preparations.
雷公藤制剂具有免疫抑制、抗炎和抗癌等多种生物活性,广泛应用于类风湿关节炎、红斑狼疮和肾病综合征等自身免疫性疾病的治疗。它们有确切的治疗效果,但由于其成分复杂、毒性大、毒效剂量范围窄,常引起严重不良反应,导致肝、肾、血液、生殖等系统损害。目前,不同厂家生产的雷公藤制剂因化学成分不同以及原材料和生产工艺差异导致质量波动,临床疗效和副作用差异较大。然而,现有质量标准在指标成分和含量限度方面存在争议,无法有效用于制剂的全面质量控制。本文综述了雷公藤片、雷公藤总萜片、雷公藤双层片和雷公藤多苷片四种雷公藤制剂的化学成分、质量标准及质量控制方法的研究进展,以期为该类制剂的质量提升提供思路和参考。