更年乐颗粒剂质量标准的研究

Study on Standards for the Quality of “Gengnianle Granule”

为建立更年乐颗粒剂的质量标准 ,以芍药苷、黄连小檗碱作为指标成分 ,进行薄层定性试验、高效液相法定量试验。结果 :芍药苷薄层鉴别试验呈阳性反应 ,高效液相法测定芍药苷在 0 5 4～ 2 16μg间有良好的线性关系 ,回收率为 10 2 0 6% ,RSD为 4 0 3% ;黄连小檗碱高效液相法测定在 0 0 0 65～ 0 13μg间有良好的线性关系 ,回收率为 10 1 2 5 % ,RSD为 3 2 4 %。

Thin-layer qualitative test and high-performance liquid chromatography are employed to measure the contents of Paeoniflorin and Berberine in “Gengnianle Granule”.Results:Thin-layer differential test of Paeoniflorin is positive;the content of Paeoniflorin is between 0.54～2.16μg,with good linear relationship,recovery rate being 102.06% and RSD 4.03%;the content of Berberine is between 0.0065～0.13μg,with good linear relationship,recovery rate being 101.25% and RSD 3.24%.It is revealed that these methods can be used for the quality control of “Gengnianle Granule”.