富马酸依美斯汀缓释片的制备及释放度的测定

Preparation and release rate determination of Emedastine Difumarate Sustained-release Tablets

目的制备富马酸依美斯汀缓释片,并建立其释放度测定方法。方法以羟丙甲纤维素、乳糖为赋形剂,采用紫外分光光度法,对释放溶剂进行筛选,并进行了释放度回收率、精密度和稳定性测定等方法学研究。结果释放度回收率平均为98.12%,RSD为1.12%(n=9)。以水为释放溶剂,用紫外分光光度法测定三批富马酸依美斯汀的释放度,重复性和均一性良好。结论紫外分光光度法可用于富马酸依美斯汀释放度的测定。

Objective To prepare Emedastine Difumarate Sustained-release Tablets(EDST),and develop a method for the determination of drug release rate.Methods Ultraviolet spectrophotography was used and hypromellose,lactose were used as escipients.Several releasing solvents were screened and recovery test,repeatability test,stability test of drug release rate were carried out to evaluate the applicablility of the method.Results The average recovery of drug release rate was 98.12% and RSD was 1.12% (n=9).Using water as a release solvent,assaying the release rate of three batches of EDST by Ultraviolet spectrophotography,the reproducible and uniform of the results were good.Conclusion Ultraviolet spectrophotography was applicable for the assay of the release rate of EDST.