消糜阴道泡腾片质量标准研究

Study on quality standard for Xiaomi Vagina Effervescent Tablets

目的建立消糜阴道泡腾片的质量控制方法。方法采用TLC法对本品中的黄柏、苦参、冰片、儿茶进行薄层鉴别;采用HPLC法对本品中的人参茎叶总皂苷进行含量测定。结果在TLC色谱图中可检出黄柏、苦参、冰片、儿茶;人参皂苷Re在0.0964～0.482μg范围内呈良好的线性关系(r=0.9999),平均回收率为97.76%,RSD=1.23%。结论所用方法简便、准确,可以用于糜阴道泡腾片的质量控制。

OBJECTIVE To establish the quality standard for Xiaomi Vagina Effervescent Tablets. METHODS Cortex phellodendi,Radixr Sophorae Flavescentis,Borneolum Syntheticum and Catechu were identified by TLC. The content of total ginsenoside in stem and leaf was determined by HPLC. The column of Betasil C18 （4.6mm× 200mm,5μm） was used,the detection wavelength was 203nm and the flow rate was 1.0mL^-1. RESULTS Ginsenoside Re showed a good linear relationship at the range of 0. 0964～0. 482μg （ r=0. 9999）. The average recovery was 97.76%, RSD = 1.23%. CONCLUSION The method was simple with good reproducibility and can be used for the quality control of Xiaomi Vagina Effervescent Tablets.