不同方法制备可吸入乳糖颗粒的评价

目的筛选确定可吸入乳糖颗粒的制备方法和工艺。方法采用筛分法、研磨法、重结晶法、冷冻干燥法、喷雾干燥法制备乳糖颗粒,以所制得颗粒的粒径大小和形态以及含水量为主要评价指标,考察处方和工艺因素对颗粒特性的影响,筛选出可吸入颗粒的制备方法和工艺。结果采用优化的喷雾干燥法可获得平均粒径5.0μm以下的球形颗粒,适合于吸入给药;其他方法所获得颗粒平均粒径大、形状不规则,用于吸入给药需要进一步处理。结论喷雾干燥法的优化工艺可用于制备理想的可吸入颗粒。

Evaluation of Inhalable Lactose Particles Prepared by Different Methods

Objective To select and establish a method and process of preparing inhalable particles.Methods The lactose particles were prepared by such methods as sieving,grinding,re-crystallization,freeze drying,spray drying.The particle size and morphology and water content were chosen as the main evaluation indexes to investigate the effect of formulation and process.Results The particles prepared by optimized spray drying process were spherical with an average particle size less than 5.0 μm,which were suitable for inhalation.All the other methods prepared irregular particles of a larger average size,which had to be further processed for inhalation.Conclusion The optimized spray drying method can be used for preparation of ideal inhalable particles.