摘要
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.
出处
《中国实验方剂学杂志》
CAS
北大核心
2010年第7期22-24,共3页
Chinese Journal of Experimental Traditional Medical Formulae
关键词
胆宁分散片
溶出度
盐酸小檗碱
高效液相
Danning Dispersible Tablets
dissolution rate
berberine hydrochloride
HPLC
作者简介
赵晓霞，副研究员，中药新药研究开发。
[通讯作者]吴涛，助理工程师，中药制剂，Tel：（010）81766827，E-mail：wt126@hotmail．com
