马来酸曲美布汀缓释片释放度考察

Dissolution of Trimebutine Maleate Sustained-release Tablets

目的:建立一种马来酸曲美布汀缓释片释放度的测定方法,以考察其质量。方法:以0.1 mol.L-1盐酸溶液为释放介质,介质量为900 ml,转速为50 r.min-1,采用紫外-可见分光光度法于268 nm波长处测定吸光度。结果:马来酸曲美布汀在4.78～42.98μg.ml-1浓度范围内与其吸光度呈良好的线性关系(r=0.999 8);平均回收率为99.93%,RSD为0.62%;3批样品在2,4,8 h的平均累计释放量分别为34.8%,55.5%,82.6%。结论:该方法操作简单,准确可靠,可作为马来酸曲美布汀缓释片释放度的测定。

Objective ： To determine the release rate of trimebutine maleate sustained-release tablets to inspect its quality. Method： The release medium was 0.1 mol · L-1 hydrochloride solution 900 ml, the rotation speed was 50 r ·min-1, and the absorbance was determined at 268nm by ultraviolet-visible sepctrophotometry （UV）. Result： A good linear relationship between the absorbance and the concentration was shown within the range of 4.78 - 42,98μg ml - 1 （ r = 0. 999 8）. The average recovery was 99.93 % （ RSD = 0.62% ）. The average cumulative release rate of three batches of the samples was 34.8% （2 h）, 55.5% （4 h） and 82.6% （8 h）, respectively. Conclusion： The method is simple and accurate, and suitable for the release rate determination of trimebutine maleate sustained-release tablets.