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目的:建立胆宁分散片溶出度测定方法。方法:桨法,0.5%十二烷基硫酸钠水溶液为溶出介质,转速为100r·min-1,取样时间为30min,HPLC测定盐酸小檗碱的溶出度;ZORBAXRX-C18(4.6mm×150mm,5μm)色谱柱,乙腈-0.1mol·L-1磷酸二氢钾-0.025mol·L-1十二烷基硫酸钠(50∶25∶25)为流动相,检测波长265nm。结果:胆宁分散片批内和批间样品的溶出累积释放率差异较小,30min后样品的累积释放百分率趋于平稳,溶出累积释放率平均值为89.39%。结论:胆宁分散片溶出度测定方法简便、准确,重复性好,可用于胆宁分散片的质量控制。
Objective: To establish a method for the determination of dissolution of biliary tablets. Methods: The paddle method and 0.5% sodium dodecyl sulfate aqueous solution were used as the dissolution medium. The rotation speed was 100 r · min-1 and the sampling time was 30 min. The dissolution of berberine hydrochloride was determined by HPLC. ZORBAXRX-C18 (4.6 mm × 150 mm, 5μm) column, acetonitrile-0.1mol·L-1 monobasic potassium phosphate-0.025mol·L-1 sodium lauryl sulfate (50:25:25) as the mobile phase, detection wavelength of 265nm. Results: The dissolution release rate of the bilenin dispersible tablets in batches and batches was very small. After 30 minutes, the cumulative release percentages of samples were stable, and the average dissolution release rate was 89.39%. Conclusion: The method for determination of dissolution of biliary tablets is simple, accurate and reproducible. It can be used for the quality control of biliary tablets.