熔融法制备非诺贝特缓释胶囊的处方工艺研究

摘要

Objective Adopt solid dispersion technique with melting method to replace micropellets-capsule method in preparation of fenofibrate sustain-released capsule.Methods Prepare sustain-released granules with active pharmaceutical ingredient(API)and excipients by melting method,and seal above granules in capsules.Using imported drugs as reference,conduct study vitro-release of self-made sustain-released capsule under the drug-release test conditions in quality standards enacted by SFDA.Results The dis-solution rate of self-made fenofibrate sustain-released capsule is basically the same as that of imported one.Conclusion The prepa-ration of fenofibrate sustain -released capsule by solid dispersion techniques with melting method is technologically accessible,and could be widely adopted in industrial manufacture.%目的：采用熔融法固体分散体技术代替微丸技术制备非诺贝特缓释胶囊。方法将主药与辅料熔融制备缓释颗粒，装入胶囊，以进口品为对照，按国家颁布的质量标准中释放度检查条件考查其释放。结果两者体外释放基本一致。结论熔融法固体分散体技术制备非诺贝特缓释胶囊较微丸技术简单方便，适合工业生产。