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目的制备布洛芬缓释微丸并优化其处方与工艺。方法以圆整度和释放度为评价指标,分别对工艺因素(挤出速度、滚圆速度及滚圆时间)和处方因素(微晶纤维素与低取代羟丙基纤维素的比例、润湿剂的用量)进行单因素考察,在单因素考察的基础上进行正交优化试验,确定布洛芬骨架缓释微丸的处方工艺。结果优化条件所得微丸外观圆整,粒子大小分布均匀,具有明显的缓释特性。结论该方法可行、通过以上处方和工艺可以制备无需包衣的骨架型缓释微丸。
Objective To prepare ibuprofen sustained-release pellets and optimize its formulation and process. Methods The indexes of roundness and release were taken as the evaluation indexes. The effects of process factors (extrusion speed, spheronization speed and spheronization time) and prescription factors (the ratio of microcrystalline cellulose to low substituted hydroxypropyl cellulose, Dosage) for single factor study, based on the single factor study orthogonal optimization test to determine the formulation of ibuprofen matrix sustained-release pellets. Results Optimized conditions, the obtained pellets were round in appearance with uniform particle size distribution and had obvious sustained-release characteristics. Conclusion This method is feasible. With the above prescriptions and processes, the sustained-release pellets without coating can be prepared.