布洛芬缓释胶囊释放度一致性研究

Study on the consistency of release rate of Ibuprofen Sustained-release Capsules

目的测定五种不同pH溶出介质中的溶出曲线,对布洛芬缓释胶囊的释放度进行深入研究,以评价仿制药品的质量。方法筛选各种溶出介质的测定条件,使布洛芬在多种pH介质中释放度大于85%。采用FDA规定的相似因子f2值进行对比研究。结果自制品与对照品的释放度都很小时,f2值高即相似度高,掩盖了二者的差异,改变释放度测定条件后,释放度提高,f2值下降,揭露了二者的差异。结论提高难溶性药物在各种介质中的释放度,更能真实地反映出仿制品与对照品之间的差异,科学指导仿制品的处方研究。

Objective To determine the dissolution curve in five dissolution mediums with different pH and make a thorough study of Ibuprofen Sustained -release Capsules＇ release rate, in order to evaluate the quality of generic drug. Methods The determination conditions of various dissolution medium were filtered, and the release rates of ibuprofen in a variety of pH medium were greater than 85%. Comparative study of similarity factor f2 value of FDA regulations was carried out. Results When the release rates of self - made products and reference substance were very small, semblance was high while f2 value was high. It covered up the differences between the two. The release rate was increased and the f2 value was decreased after changing the determination conditions of release, the differences between the two were exposed. Conclusion Increasing the release rate of insoluble drugs in various mediums can more truely reflect the differences between self - made products and reference substance, and scientifically guide prescription research of self - made products.