胆宁分散片溶出度研究

Dissolution Test of Danning Dispersible Tablets

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 the method of dissolution test for Danning Dispersible Tablets.Method：Paddle method was used at the rotary speed of 100 r·min^-1,the dissolving time was 30 minutes and the dissolving medium was 0.5%sodium laurylsulfate.The dissolution rate of berberine hydrochloride was determined by HPLC with a ZORBAX RX-C 18（4.6 mm×150 mm,5μm） column.The mobile phase was consisted with acetonitrile-0.1 mol·L^-1 monopotassium phosphate-0.025 mol·L^-1 sodium laurylsulfate（50∶25∶25） and the flow rate was 1.0 mL·min^-1 .The detection wavelength was at 288 nm.Result：The cumulate dissolution rate of Danning Dispersible Tablets had little difference in and between batches.The cumulate dissolution percentage tended to be stable after 30 minutes,and the average cumulate dissolution rate was 89.39%.Conclusion：The method established is simple,accurate and repeatable for the quality control of Danning Dispersible Tablets.