小儿闰土颗粒质量标准研究

Study on Quality Standard of Xiaoer Runtu Granule

目的制定小儿闰土颗粒质量标准。方法采用薄层色谱法对制剂中的香附、白术、砂仁、陈皮进行鉴别;采用高效液相色谱法测定白芍中芍药苷的含量。结果用薄层色谱法能较好地鉴别出制剂中的香附、白术、砂仁、陈皮;芍药苷在1.176～11.760μg范围内线性关系良好,r=0.99999,平均回收率为99.42%,RSD=2.26%。结论本法简便、准确、重复性好,可用于本制剂的质量控制。

Objective To establish the quality standard of Xiaoer Runtu granule. Methods Xiangfu, Baizhu, Sharen and Chenpi were identified by TLC. The content of paeoniflorin was determined by HPLC. Results TLC could identify Xiangfu, Baizhu, Sharen and Chenpi. The peoniflorin showed good linear correlation at the range of 1.176- 11.760 μg, r =0.99999, the average recovery of paeoniflorin was 99.42%, RSD=2.26%. Conclusion The method is simple and can be used to control the quality of Xiaoer Runtu granule with high accuracy and good reproducibility.