盐酸氨溴索干粉吸入剂的制备工艺  

Preparation of ambroxol hydrochloride dry powder inhalation

作　　者：任亚超[1] 王蕾[1] 孟康康[1] 唐星[1] 

机构地区：[1]沈阳药科大学药学院,辽宁沈阳110016

出　　处：《沈阳药科大学学报》2008年第7期519-523,共5页Journal of Shenyang Pharmaceutical University

摘　　要：目的优化盐酸氨溴索干粉吸入剂的制备工艺。方法采用喷雾干燥法制备盐酸氨溴索干粉吸入剂,采用双层液体碰撞器测定盐酸氨溴索干粉吸入剂体外沉积率,扫描电镜观察粉粒的形态,激光粒度测定仪测定粒径大小,以产品收率、粉末的空气动力学径、休止角及体外沉积率为考察指标,通过正交设计结合多指标综合评价法优化最佳制备工艺。结果通过正交试验-多指标综合评价,最佳制备工艺为:进口温度110℃、喷液速度1.8 mL.min-1、泵压170 kPa、气流量0.7 m3.min-1。结论按最佳制备工艺制得的干粉收率的质量分数为62.10%,空气动力学径Da 3.05μm,休止角36.16°,沉积率32.05%。正交实验结合多指标综合评价法用于盐酸氨溴索干粉吸入剂制备工艺的优化实用有效。Objective To optimize the process conditions of ambroxol hydrochloride （AH） dry powder inhalation by orthogonal design. Methods AH dry powder inhalation was prepared by spray-drying method. Following spray-drying, resultant powders were characterized using scanning electron microscopy and laser diffraction, and the aerosolisation performance was determined using twin-stage liquid impinger. The process conditions were optimized with orthogonal design combined with multi-index test. The powder yield, aerodynamic diameter, angle of repose and respirable fraction were used as indices for orthogonal design. Results The results of optimized process parameters were confirmed with inlet temperature of 110~C, liquid feed rate of 1.8mL·min^-1, atomizing air pressure of 170 kPa, and drying air flow rate of 0.7 m^3·min^-1. Conclusions 62.10 % field; 3.05 μm aerodynamic diameter, 36.16° angle of repose and 32.05 % respirable fraction are obtained by the optimal process conditions. Orthogonal design combined with multi-index test can be used to optimize the preparation technique for AH dry powder inhalation.

关 键 词：盐酸氨溴索 干粉吸入剂 正交设计 多指标综合评价法 

分 类 号：R94[医药卫生—药剂学]