雷公藤制剂中雷公藤红素的含量研究

Determination of contents of tripterine in tripterygii preparations

目的:建立雷公藤制剂中雷公藤红素含量的HPLC测定方法,并对市售雷公藤制剂样品中雷公藤红素含量进行比较研究。方法:HPLC外标法。Hanbon Kromasil C18色谱柱,流动相甲醇-1%酸水(83∶17),流速1.0 mL.min-1,检测波长425 nm。结果:雷公藤片中雷公藤红素含量最高,在每片89.04～344.0μg;雷公藤多苷片中雷公藤红素含量在每片14.98～217.80μg;昆明山海棠片中雷公藤红素的含量是每片22.32μg,含量相对较低些。结论:不同的雷公藤制剂中雷公藤红素有很大差异。雷公藤片中雷公藤红素的含量明显高于雷公藤多苷片和昆明山海棠片。不同厂家生产的、不同批次的雷公藤制剂中雷公藤红素存在着显著差异。因此,对其进行质量监控和制定合理的质量控制标准势在必行。

Objective： To establish the HPLC method of determining the contents of tripterine in Tripterygii preparations purchased from drugstores. Method： An external standard method by HPLC with Hanbon Kromasil C18 column as fixed phase and methanol-1% HAc （83： 17） as mobile phase was adopted. The detection wavelength was 425 nm and the flow rate was 1.0 mL · min^-1. Resuit： The contents of tripterine in TWH F. tablets were between 89. 04 and 344. 0 μg/tablet, and is higher than those in TWH F. polyglycosidium （14. 98-217.80 μg/tablet） and Kunmingshanhaitang tablets （22. 32 μg/tablet）. Conclusion： The contents of tripterine, in different Tripterygium preparations vary significantly, and in Tripterygium preparations from different manufacturers and different production lots are being remarkable discrepancy. So it is necessary to enhance quality monitoring and to establish the rational quality control standard for Tripterygii preparations.