滋肾降糖颗粒的质量控制研究

Study on the Preparation Technology and Quality Control for Zishenjiangtang Granule

目的：建立滋肾降糖颗粒质量控制方法。方法采用薄层色谱法鉴别样品中枳壳、淫羊藿，采用高效液相色谱法测定样品中黄芪甲苷的含量，建立质量控制方法。结果枳壳、淫羊藿薄层鉴别斑点清晰，专属性好，黄芪甲苷在16.304~407.6μg/mL之间呈良好的线性关系（r=0.9995，n=5），平均回收率为99.4%，RSD%为1.95%（n=9）。结论所建立的方法操作简单、专属性强、重现性好、结果准确可靠，可作为控制滋肾降糖颗粒质量的方法。

Objective To establish the method for determining zishenjiangtang granules. Method Using thin layer chromatography sample identification Aster, Herba epimedii, using HPLC Astragaloside, establish quality control methods. Result Aster ,Herba epimedii TLC spots were clear, specific, one method for the determination Astragaloside was good. Good linear relationship was achieved between astragaloside peak area when the concentration range of which was 16.304~407.6μg/mL（r=0.9995,n=5）,the average recovery rate was 99.4%（RSD=1.95%, n=9）. Conclusion The method is feasible, reliable, accurate and specific. It can be used for quality control of Zishenjiangtang Granule effectively.