乐脉分散片中丹参素溶出度研究

Study on Dissolution Test of Le Mai Dispersible Tablets

目的:建立测定乐脉分散片中丹参素的体外溶出测定方法。方法:以250mL0.1mol.L-1 HCl为溶出介质,采用桨法,50r.min-1,采用HPLC法测定乐脉分散片中丹参素的溶出度,计算累积释放度。结果:丹参素检测浓度在1.55～15.48μg.mL-1(r=0.999 8)范围内线性关系良好,平均回收率为98.48%(n=9),RSD=1.49%,3批样品20min时的溶出度均>90%。结论:该方法简便、准确、可靠,可用于乐脉分散片中丹参素的溶出度测定。

Objective：To establish determination method for the dissolution of danshensu in Le Mai dispersible tablet in vitro. Methods ： 250mL 0.1 mol·L^-1 HCl was used as dissolution medium for paddle method, with the rotate speed of 50 r ·min^-1. The contents of danshensu were determined by HPLC. The accumulative dissolution percentages were calculated. Results ： Linear range of danshensu was good in 1.55-15.48·mL^-1（r=0 . 9998）, The average recoveries（n=9） of danshendu was 98.48%, RSD= 1.49%. The dissolution of three batch of Le Mai dispersible tablet in vitro at 20 min were more than 90 %. Conclusion： The method is simple, accurate and reproducible for the dissolution determination of danshensu in Le Mai dispersible tablets.