摘要
目的采用挤出滚圆法制备阿托伐他汀钙速释微丸,研究处方及制备工艺。方法在单因素实验的基础上,以微丸的粉体学性质、收率和体外溶出度为评价指标,对影响微丸成型的关键工艺参数进行正交设计优化。结果用挤出滚圆法制备的阿托伐他汀钙速释微丸圆整度好、粒度分布窄、收率高,且在30 min体外溶出均在95%以上。结论成功地制备了阿托伐他汀钙微丸,该制备工艺重现性好、质量高,具有理想的速释效果。
Objective To prepare Atorvastatin Calcium Fast-release Pellets by extrusion-spheronization and study the influence of formulation and process parameters on the properties of the pellets. Methods Using single factor test,for-mulation and preparation technology of the pellets were optimized. Effects of the key parameters on the properties of the pel-lets,yield and dissolution were investigated using orthogonal design. Results Atorvastatin Calcium Fast-release Pellets presented perfect sphericity and high yield with sharp size distribution. More than 95% of the drugs were released from the pellets in 30 min. Conclusion Atorvastatin Calcium Fast-release Pellets were successfully prepared by extrusion-spher-onization with good reproducibility and high-quality,and had a remarkable fast-release property in vitro.
出处
《药学研究》
CAS
2014年第12期705-706,723,共3页
Journal of Pharmaceutical Research
关键词
挤出滚圆法
阿托伐他汀钙
速释微丸
正交设计
Extrusion-spheronization
Atorvastatin calcium
Fast-release pellets
Orthogonal design
