益气降糖胶囊的质量标准研究

Study on the quality standard of Yiqijiangtang capsule

目的建立益气降糖胶囊的质量标准。方法采用TLC法对处方中的黄芪、人参、黄连进行定性鉴别;采用HPLC法测定制剂中人参皂苷Rg1和Re的含量。结果 TLC法可检出黄芪、人参、黄连的特征斑点;人参皂苷Rg1的线性范围为0.4020～4.0200μg(r=0.9999),平均回收率为99.51%(RSD=1.21%,n=6);人参皂苷Re的线性范围为0.2040～2.0400μg(r=0.9999),平均回收率为99.26%(RSD=1.33%,n=6)。结论本质量标准可有效地控制益气降糖胶囊的质量。

Objective To establish the quality standard of Yiqijiangtang capsule. Methods Astragali radix, Ginseng radix and Rhizoma and Coptidis Rhixoma were identified by TLC, and the content of ginsengoside Rgl and Re in the preparation were determined by HPLC. Results Astragali radix, Ginseng radix and Rhizoma and Coptidis Rhixoma could be identified by TLC. The linear range of ginsengoside Rgl was 0.402 0-4.020 0 μg （r = 0.999 9）, and the average recovery was 99.51% （RSD = 1.21%, n = 6）. The linear range of ginsengoside Re was 0.204 0-2.040 0 μg （r = 0.999 9）, and the average recov- ery was 99.26% （ RSD = 1.33%, n = 6） . Conclusion The quality of Yiqijiangtang capsule can be controlled effectively ac- cording to the quality standard.