非洛地平固体分散体缓释片的研制与优化

为探讨非洛地平固体分散体缓释片的研制与优化,在单因素试验的基础上,采用正交试验设计的方法,对处方因素进行详细的考察,进一步优化处方工艺,并对按最优处方制备的样品进行验证.结果显示:优选的非洛地平固体分散体缓释片处方工艺合理,由其制备的缓释片体外释药2h释放度为20%~25%,4h释放度为44%~46%,8h释放度为78%~84%,12h释放度为96%~100%.

On Optimization and Preparation of Felodipine Solid Dispersions and its Sustained-Release Tablets

To improve the release of Felodipine, solid dispersion techniques were used, and a 12h sustained-release drug was prepared with the solid dispersions.Solid dispersions (SD) were prepared by melting method with PEG6000 as a carrier.On the basis of the single factor test, the orthogonal test was conduct to get optimized formulation, which took two kinds of HPMC as sustained-release material, and sustained-release tablet was prepared by powder direct-compression method.Results show that the release of Felodipine was improved markedly with the solid dispersion techniques.Also, the drug release of self-made sustained-release tablet and the reference drug were consistent highly in vitro.the whole key quality of sustained-release tablet meet the requirements.It is concluded that the way that sustained-release drug were prepared with solid dispersions, which were made first to improve the dissolution of drug is a simple and feasible thought.