益肺通络颗粒质量标准研究

Study on Quality Standard for Yifei Tongluo Granules

目的建立益肺通络颗粒的质量标准。方法采用薄层色谱法对方中黄精、紫花地丁、百部进行定性鉴别;采用高效液相色谱法对矮地茶的主要成分岩白菜素进行含量测定。结果在薄层色谱中可检出黄精、紫花地丁、百部的特征斑点,且斑点清晰,易于观察;岩白菜素进样量在0.054～0.54μg范围内与峰面积线形关系良好(r=0.999 06),平均回收率为98.54%,RSD为1.31%(n=6)。结论所用方法简便、准确、重现性好,可作为该制剂的质量控制方法。

Objective To establish the quality standard for Yifei Tongluo Granules. Methods Polygonati Rhizoma, Violae Herba and Stemonae Radix were qualitatively identified by the thin layer chromatography（TLC）. The content of bergeninum was determined by high performance liquid chromatography（HPLC）. Results The characteristic spots of Polygonati Rhizoma,Violae Herba and Stemonae Radix in TLC were clear and distinguished well. The linear range of bergeninum was 0.054-0.54 μg（r=0.999 06）.The average recovery rate was 98.54% with the RSD = 1.31% （n = 6）. Conclusion The method is simple, accurate and repeatable,which can be used for the quality control of Yifei Tongluo granules.