前列舒乐泡腾片质量标准研究

目的:研究与修订前列舒乐泡腾片的质量标准。方法:化学鉴别法鉴别复方中药中的川牛膝和车前草;薄层色谱法鉴别中药复方中的蒲黄和黄芪。高效液相色谱法测定淫羊藿苷的含量,色谱柱为Polairs C18(150×4.6mm,5μm),流动相为乙腈-水(25∶75),检测波长270nm,流速1.0mL/min。结果:在薄层色谱中可鉴别出黄芪、蒲黄,无阴性干扰。淫羊藿苷在0.0493~0.4437μg范围内有良好的线性关系(r=0.9999),平均加样回收率(n=6)为99.33%(RSD=1.28%)。结论:该定性定量方法简便易行,重现性好,可作为前列舒乐泡腾片的质量标准基础。

Study on quality Standard of Qianlieshule effervescent tablets

Objective To develop the quality control standard of Qianlieshule effervescent tablets.Methods Radix Astragali and Pollen Typhae in Qianlieshule effervescent tablet were identified by TLC.Radix Cyathulae and Herba Plantaginis in Qianlieshule effervescent tablet were identified by chemical identification.The content of icariin was determined by HPLC,with acetonitrile-H2O(25:75) as mobile phase at a flow rate was of 1.0 mL/min,detected at 270nm.Results The TLC spots of Radix Astragali and Pollen Typhae were distinctive and coincident with the standards.By using our chromatographic condition,icariin could be baseline separated with other constituents in the sample,determined with satisfactory accuracy and precision,with average recovery of 99.33%,the RSD was 1.28%(n=5).The linear range of icarrin was 0.0493～0.4437μg(r=0.9999).Conclusion The research on Qianlieshule effervescent tablet is simple,feasible,reproducible and providing a basis for quality control of the medicine.