目的 為銀翹解毒系列制劑研究制定統(tǒng)一通用的薄荷與荊芥的質(zhì)量控制方法.方法 以薄荷酮、薄荷腦和胡薄荷酮為指標(biāo),采用HP-5毛細(xì)管柱(30 m×0.32 mm,0.25 μm),50～240 ℃程序升溫進(jìn)行分析,并測定了5種劑型9個(gè)品種共38批樣品中3個(gè)成分的量.結(jié)果 薄荷酮、薄荷腦、胡薄荷酮3種成分在5個(gè)劑型中重復(fù)性RSD(n=5)為0.52%～1.95%;加樣回收率分別為96.29%～102.83%、97.55%～99.96%、95.36%～103.51%.結(jié)論 本實(shí)驗(yàn)建立的方法重復(fù)性好,準(zhǔn)確度高,適用于銀翹解毒全部系列品種中薄荷酮、薄荷腦和胡薄荷酮3種揮發(fā)性成分的質(zhì)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《中國藥典》立項(xiàng)課題