二妙丸的质量标准研究

Study on Quality Standard of Ermiao Pills

目的:建立二妙丸中有效成分盐酸小檗碱含量测定方法及定性鉴别方法。方法:采用离子对色谱法测定二妙丸中盐酸小檗碱含量。色谱柱:Damonsi(TM)C18(250mm×4.6mm,5μm),流动相∶乙腈-0.1%磷酸(50∶50)(每100mL加入十二烷基磺酸钠0.1g),检测波长265nm。结果:建立了HPLC测定二妙丸中盐酸小檗碱含量方法。结论:方法简便快速,准确,为该制剂的质量分析建立了可靠的控制方法。分析方法稳定可靠,能作为本丸剂的质控标准。

Objective ： To establish the qualitative and quantitative identification methods of the effective component, berberine in the Er Miao Pill. Methods：Ions on the determination of the Miao pills berberine content. Column：Damonsi （TM） C18（250mm×4.6mm,5μm）, mobile phase ： acetonitrile-0. 1% phosphoric acid （ 50：50 ） （ per 100 ml by adding sodium dodecyl sulfate 0. 1 g） ,detected at 265nm. Results：The establishment of the Er Miao Pill by HPLC in berberine in methodology. Concision：The method is the simple, rapid and accurate analysis of the quality of preparations for the establishment of a reliable method of con- trol. Analysis of stable and reliable and serve as the granules of quality control standards.