论文部分内容阅读
目的应用挤出滚圆法制备复方醋氯芬酸速释微丸,研究制备的处方和工艺。方法采用单因素实验优化制剂处方及工艺条件,评价微丸的粉体学性质、收率和体外溶出度。对影响成球的4个关键参数黏合剂用量、挤出速度、滚圆速度和滚圆时间进行正交设计筛选优化。结果用挤出滚圆法制备的复方醋氯芬酸速释微丸圆整度好、粒度分布窄、收率高,且在45min内体外溶出均达80%以上。结论成功地制备了复方醋氯芬酸速释微丸,该制备工艺重现性好、质量高、具有理想的速释效果。
Objective To prepare the compound aceclofenac sustained-release pellets by extrusion spheronization and study the preparation prescription and technology. Methods The formulation and process conditions were optimized by single factor experiment to evaluate the powder properties, yield and in vitro dissolution of pellets. The four key parameters influencing ball formation were optimized by orthogonal design, such as binder dosage, extrusion speed, rolling speed and spheronization time. Results The compound aceclofenac sustained-release pellets prepared by extrusion spheronization had good roundness, narrow particle size distribution and high yield, and the dissolution rate reached more than 80% in 45 minutes. Conclusion The compound aceclofenac sustained-release pellets were successfully prepared. The preparation process has good reproducibility, high quality and an ideal immediate release effect.