非诺贝特缓释胶囊栓的制备及其生物利用度研究

 目的 采用乳化固体分散技术制备非诺贝特缓释胶囊栓。并以非诺贝特为模型药物来说明制剂方法及原理。方法 混合存在极性差异的低熔点原辅料，加热使混合物液化，在乳化剂的作用下，使原本分离的两相混合，形成分散相和连续相，所形成的乳液灌装胶囊，冷却后形成乳化固体分散体胶囊栓。考察该胶囊栓的溶出及所形成的微粒粒径。并与市售缓释品种进行生物利用度比较。并探讨该制剂方法的制剂原理。结果 该胶囊栓具有缓释特征；电镜检查结果显示，该胶囊栓中所形成的微粒粒径可达到1 μm左右；与市售产品相比，生物利用度有了大幅度提高。结论 该制剂方法可以以低成本制备高生物利用度的非诺贝特缓释胶囊栓。

Preparation of Sustained-Release Capsule-Suppositories of Fenofibrate with Emulsified-Solid Dispersing Technology

OBJECTIVE To establish a simple method for preparing sustained-release capsule suppositories of fenofibrate with the emulsified-solid dispersing technology(ESD).METHODS Low melting point materials with the different polarity were used.The mixture was melted into liquid form.With the help of emulsifying agent(s),the seperated phases were mixed.The Continuous phase and dispersed phase were obtained.Capsules were filled with the emulsion,While cooling down,the emulsion of mixture was solidified.The fenofibrate...