玉液合剂质量标准研究

Study on Quality Standard of Yuye Mixture

目的建立玉液合剂的质量标准。方法采用薄层色谱法鉴别处方中的粉葛、黄芪;采用高效液相色谱法测定粉葛中葛根素的含量,色谱柱为Hypersil C18柱(150 mm×4.6 mm,5μm),流动相为甲醇-水(22∶78),流速1.0 mL/min,检测波长250 nm,柱温30℃。结果薄层色谱鉴别特征斑点明显。葛根素进样量在0.009 6~0.480 0μg范围内与峰面积有良好的线性关系,r=1.000 0;平均加样回收率为100.21%,RSD=1.03%(n=6)。结论所建立的薄层色谱鉴别和含量测定方法专属性强、重复性好,可用于玉液合剂的质量控制。

Objective To establish the quality standard of Yuye Mixture. Methods The thin layer chromatography( TLC) was used to identify Pachyrhizua angulatus and Astragalus of the prescription. The content of puerarin was determined by the high performance liquid chromatography( HPLC). The HPLC method was established with the Hypersil C18(150 mm ×4. 6 mm,5 μm). The mobile phase was methanol- water( 22 ∶ 78). The flow rate was 1. 0 mL / min. The detection wavelength was 250 nm; the column temperature was 30 ℃.Results The characteristic spots of TLC was obvious. The sample size of puerarin was linear in the concentration range of 0. 009 6-0. 480 0 μg with correlation coefficient( r = 1. 000 0). The average recovery rate was 100. 21%,RSD = 1. 03%( n = 6). Conclusion The established TLC identification method and HPLC content determination method are strongly specific,better reproducible and can be used for the quality control of Yuye Mixture.