目的 为银翘解毒系列制剂研究制定统一通用的薄荷与荆芥的质量控制方法.方法 以薄荷酮、薄荷脑和胡薄荷酮为指标,采用HP-5毛细管柱(30 m×0.32 mm,0.25 μm),50～240 ℃程序升温进行分析,并测定了5种剂型9个品种共38批样品中3个成分的量.结果 薄荷酮、薄荷脑、胡薄荷酮3种成分在5个剂型中重复性RSD(n=5)为0.52%～1.95%;加样回收率分别为96.29%～102.83%、97.55%～99.96%、95.36%～103.51%.结论 本实验建立的方法重复性好,准确度高,适用于银翘解毒全部系列品种中薄荷酮、薄荷脑和胡薄荷酮3种挥发性成分的质量控制.

Objective To develop a universal and common used method on quality control of Menthae Haplocalycis Herba and Schizonepetae Herba in all preparations of Yinqiao Jiedu serial products. Methods The samples were analyzed on HP-5 column (30 m × 0.32 mm, 0.25 μm) with temperature programmed from 50 ℃ to 240 ℃ using menthone, menthol, and pulegone as markers. The methodology validation was made and determination was carried out with 38 batches of samples of five different preparations of Yinqiao Jiedu products. Results The RSD (n = 5) of repeatabilities of three components were 0.52% to 1.95%; The average recoveraries of menthone, menthol, and pulegone were 96.29%—102.83%, 97.55%—99.96%, and 95.36%—103.51%, respectively. Conclusion The method developed was in good repeatability and accuracy, and it can be applied in quality control on volatile constituents in all preparations of Yinqiao Jiedu serial products.

2015版《中国药典》立项课题