消糖宁胶囊质量标准的研究

Quality Control of Xiaotangning Capsules

目的建立消糖宁胶囊的质量标准。方法采用TLC法对西洋参、黄连、枸杞子、红花进行了定性分析;应用HPLC法对盐酸二甲双胍进行了含量测定,流动相为乙睛-0.05%庚烷磺酸钠溶液(以10%磷酸调pH 4.0)(25∶75);流速1 ml·min-1;检测波长233 nm。结果 TLC法可准确地对西洋参、黄连、枸杞子、红花进行定性鉴别;盐酸二甲双胍在0.2156～0.8624μg范围内线性关系良好(r=0.9999),平均回收率为99.7%。结论该方法简便、快速、准确、重复性好,可作为消糖宁胶囊的质量控制标准。

Objective To establish a quality standard for Xiaotangning capsules. Methods TLC methods were used to identify panacis quinque folium,coptidis rhizome, lycii fructus and carthami flos. Metformin hydrochlo-ride in Xiaotangning capsules was determined by HPLC. Results Good linearity was shown at the concentration of 0. 2156 - 0. 8624 （jig for metformin hydrochloride. The average recovery of metformin hydrochloride was 99. 7% . Conclusion This qualitative and quantitative method is specific and repeatable,which can be applied to quality con-trol of Xiaotangning capsules.