熔融法制备酮洛芬缓释微丸研究

 目的采用熔融法制备酮洛芬缓释微丸。方法选用聚乙二醇、硬脂酸为固体黏合剂,羟丙基甲基纤维素、乳糖、淀粉为填充剂,制备酮洛芬缓释微丸。通过相似因子法对体外溶出实验数据进行分析,比较不同释放曲线的相似性。结果选择适宜的搅拌速度、温度和处方中硬脂酸、聚乙二醇、乳糖、羟丙基甲基纤维素的用量等,可得到体外具有较为理想的释药行为的酮洛芬缓释微丸。结论用两种黏合剂制备的缓释微丸,体外释放均可达到10 h以上。

Formulation and Evaluation of Sustained Release Pellets of Ketoprofen by Melt Pelletization

OBJECTIVE To prepare and evaluate the sustained release ketoprofen pellets by melt pelletization.METHODS The sustained release pellets were based on the combination of stearic acid /PEG4000 as meltable binder and lactose / HPMC / starch as filler.After the determination of size distribution,the similarity factor f_2 was used to assess the similarity between two in vitro dissolution profiles.RESULTS By means of choosing the optimum stirrer speed,temperature and the optimum amount of stearic acid,PEG4000,lactose and HPMC,ketoprofen sustained release pellets showed the idea release behavior in vitro.CONCLUSION The in vitro dissolution tests of ketoprofen sustained release pellets can sustained release over 10 h with the two meltable binder.