奥美拉唑肠溶微丸胶囊的制备

目的制备奥美拉唑肠溶微丸胶囊。方法采用流化床包衣技术,在空白丸芯上依次包以主药层、隔离层和肠溶层,制备成奥美拉唑肠溶微丸,并对其处方和工艺进行优化,将肠溶微丸装入普通胶囊制成奥美拉唑肠溶微丸胶囊。结果将奥美拉唑、羟丙基甲基纤维素(5 mPa.s)、无水碳酸钠、聚山梨酯-80、二甲基硅油和水混合制成主药层包衣溶液,以无水碳酸钠作为隔离层的碱性调节剂,EUDRAGITL30D-55作为肠溶包衣材料,自制的3批奥美拉唑肠溶微丸胶囊在人工肠液中45 min的释放度分别为(98.0±1.2)%、(95.3±4.0)%和(94.3±1.8)%。结论以肠溶微丸技术制备奥美拉唑肠溶胶囊,工艺可行,重复性良好,质量稳定可靠。

Preparation of Omeprazole Enteric Capsules by Encapsulating Enteric-coated Pellets

Objective To develop omeprazole enteric-coated pellet capsules.Methods Omeprazole enteric-coated pellets were prepared with air-flow coating apparatus by coating blank pellets with the medicine layer,insulation layer and enteric layer.The formulation composition and process factors were optimized.Omeprazole enteric capsules were conformed by encapsulating enteric-coated pellets into hard gelatin capsules.Results The medicine layer coating solution was made by mixing omeprazole,HPMC（5 mPa·s）,anhydrous sodium carbonate,Tween-80 and methylsilicone oil with water.Anhydrous sodium carbonate was used as the alkaline adjustment agent of the insulation layer.EUDRAGIT L30D-55 was used as the enteric coating material.The cumulative release of three batches of omeprazole enteric-coated pellet capsules in artificial intestinal solution within 45 min was（98.0±1.2）%,（95.3±4.0）% and（94.3±1.8）%,respectively.Conclusion This method is feasible for preparation of omeprazole enteric capsules by encapsulating enteric-coated pellets,able to obtain good repeatability and stable quality.