市售雷公藤多苷片中雷公藤内酯甲含量比较

Content Comparison of Wilforlide A in Tripterygium Tablets Sold in Market

目的比较不同厂家雷公藤多苷片中雷公藤内酯甲的含量,考察其质量稳定性。方法色谱柱采用Thermo BDS Hypersil C18柱(250 mm×4. 6 mm,5μm),流动相为甲醇-乙腈-水(64∶16∶20),流速为1. 0 m L/min,柱温为25℃,检测波长为210 nm。结果 9家生产厂家的雷公藤多苷片中雷公藤内酯甲含量差异较大,最高为30. 2μg,最低为6. 7μg。结论不同厂家的雷公藤多苷片质量不一,而其有效治疗量与最小中毒量比较接近,应同时规定制剂标准含量的上下限,以规范企业生产,保证用药安全、有效。

Objective To compare the contents of wilforlide A in Tripterygium Tablets from different manufactures and investigate the quality and stability of Tripterygium Tablets. Methods The chromatographic column was Thermo BDS Hypersil C18 column（250 mm x 4.6 mm, 5 μm）, the mobile phase was methanol-acetonitrile-water（64： 16：20）, the flow rate was 1.0 mL/min, the column tempera- ture was 25 ℃, and the detection wavelength was 210 nm. Results The contents of wilforlide A in Tripterygium Tablets from 9 manu- factures were found to be great diverse. The highest content was 30.2 μg while the lowest was 6.7 μg. Conclusion The quality of TriptmTgium Tablets from different manufactures were unstable, and the minimum amount of poisoning is close to effective amount of treatment. In order to standardize the production of manufactures, ensure the safety and effectiveness of drug use, the standard of prepa- ration should also specify the upper and lower limits of the content.