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目的制备奥沙西罗包衣控释片,考察处方组成和工艺因素对制剂质量及体外释药行为的影响,并分析其释药机制。方法以乙基纤维素(EC-45cP)为骨架材料、乙基纤维素(EC-10cP)为成膜材料、聚乙二醇6000(PEG6000)为增塑剂,采用滚转包衣锅包衣,药物作为致孔剂控制药物释放,考察处方因素,片芯制备和包衣工艺等对制剂质量及体外释放行为的影响。结果片芯骨架材料用量、致孔剂用量、增塑剂用量、包衣厚度等因素对药物释放有明显影响。制剂体外释药行为符合零级动力学方程。结论薄膜包衣法制得奥沙西罗控释片,调整处方组成可获得12 h平稳释药的制剂。
OBJECTIVE To prepare oseltamivir coated controlled release tablets and investigate the effects of formulation and process factors on preparation quality and drug release in vitro, and to study its drug release mechanism. Methods Ethyl cellulose (EC-45cP) as matrix material, EC-10cP as film-forming material and PEG6000 as plasticizer were coated with a roll coating pan , Drugs as a porogen to control drug release, investigate the prescription factors, core preparation and coating process on the quality of the preparation and in vitro release behavior. Results The amount of core material, the amount of porogen, the amount of plasticizer, the thickness of coating and other factors had a significant effect on drug release. The in vitro release behavior of the preparation complies with the zero-order kinetic equation. Conclusion Oxyhexil controlled release tablets were prepared by film coating method.