挤出滚圆法制备阿托伐他汀钙速释微丸

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。

Preparation of Atorvastatin Calcium Fast-release Pellets by extrusion-spheronization

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.