正交设计法优化布洛芬缓释骨架片的处方工艺

目的:制备布洛芬缓释骨架片并筛选其最佳工艺条件。方法:以累积释放百分率为考察指标,以羟丙甲纤维素(HPMC)、微晶纤维素(MCC)处方中用量及片剂的硬度等为考察因素,采用正交试验设计L9(34)进行处方和工艺优化。结果:优化布洛芬缓释骨架片处方工艺中HPMC、MCC处方中用量分别为12.5%、3.0%,片剂硬度为80 N;制备的3批布洛芬缓释骨架片可持续释放24 h,具有明显的缓释效果,其释放符合Higuchi方程(r>0.980 0)。结论:优化的工艺可行,可延长布洛芬的释药时间。

Optimization of Formulation and Preparation Process of Ibuprofen Sustained-release Matrix Tablets by Or- thogonal Design

OBJECTIVE： To prepare Ibuprofen sustained-release matrix tablets and optimize the formulation of it. METHODS： Taking accumulative release percent as index, the formulation and preparation process were optimized by L9（3^4） orthogonal experi- ment design using the amount of HPMC and MCC, hardness of the tablets as factors. RESULTS： The optimum formulation and preparation process of Ibuprofen sustained-release tablets were as follows： the amounts of HPMC and MCC were 12.5% and 3.0% ; the hardness of tablets was 80 N. 3 batches of Ibuprofen sustained-release tablets were released for consecutive 24 h and showed obvious sustained-release behavior; it was in line with Higuchi equation （r〉0.980 0）. CONCLUSIONS： Optimized tech- nology is feasible and can prolong drug-release time of ibuprofen.