消旋卡多曲口服散剂溶出度方法的建立

目的:建立消旋卡多曲散剂的溶出度方法.方法:对11种溶出介质进行筛选,在多个时间点取样以绘制溶出曲线,采用HPLC法进行结果检测,最终选用2.0%SDS作为消旋卡多曲散刑的溶出介质.同时,进行了线性,回收率,溶液的稳定性等相应的方法学验证.结果:对两个规格(10和30 mg)每个规格各3批的消旋卡多曲散剂进行溶出曲线的测定,在60 min的时间点累计溶出量均大于70%.结论:由于消旋卡多曲组分的水溶性不好,溶出介质都包含有机溶剂,而本研究筛选出的2%SDS溶出介质,既能满足消旋卡多曲散剂溶出度检测的要求,同时不包含有机溶剂,也符合目前实验设计尽量避免使用有机溶剂的趋势.为水溶性较差组分制剂的溶出度方法的建立提供了一种思路.

Establishment of Method for Dissolution Test of Racecadotril Powder

Objective: Establishment of method for dissolution test of Racecadotril Powder.Method: The research screened 11 dissolution mediums,and sampling at several time points for drawing dissolution curve.An HPLC method was used to detect the results,and finally chosed 2%SDS as the optimal dissolution medium.Results: The total 6 batches of racecadotril powder samples(10mg and 30 mg strength)were detected the dissolution curve,and the accumulated dissolution all exceed 70% at 60 minute time point.Conclusion: Because of racecadotril substance indissolvable in water,the dissolution mediun often contained organic solvent;and the research chosed 2%SDS as the optimal dissolution medium,not only establish the method of determination of dissolution,but also avoid using organic solvent.It is important to provide an idea for establishment of method for dissolution test of indissovable substance preparation.