不同喷射雾化器对吸入混悬液体外沉积性质的影响

摘要

目的：分析并比较使用3种喷射雾化器测定布地奈德吸入混悬体外沉积的结果。方法以自制布地奈德吸入混悬液为模型药物，使用百瑞Turob BOY N、BOY SX和欧姆龙NE-C28雾化器，通过呼吸模拟器和新一代药用撞击器（NGI）测定其体外沉积性质。结果百瑞两型雾化器递送速率相近，欧姆龙的递送速率较低，递送总量均约在0.11μg；3种雾化器测得的质量平均空气动力学粒径（MMAD）为4.95~6.54μm，几何标准偏差（GSD）为1.66~2.10，微细粒子剂量（FPD）87.64~101.47μg，微细粒子有效沉积率（FPF）37.75%~53.88%。由统计学分析可知不同雾化器对递送总量不产生显著性差异，而对递送速率（P＜0.01）和空气动力学测定结果（P＜0.05）产生显著差异。结论不同喷射式雾化器对布地奈德吸入混悬液体外沉积有一定影响，所选的3种雾化器中欧姆龙NE-C28适用性较好。%Objective To analyze and compare in vitro deposition results of budesonide inhalation suspension made by 3 jet nebulizers. Methods Self-made budesonide inhalation suspension was selected as a model drug,and the in vitro deposition proper⁃ties was determined by breathing simulator and the next generation pharmaceutical impactor(NGI)with Pari Turob BOY N、BOY SX and Omron NE-C28 nebulizers. Results The mass median aerodynamic diameter(MMAD)of aerosol measured with the three kinds of nebulizers ranged between 4.95 and 6.54μm,geometric standard deviation(GSD)ranged between 1.66 and 2.10,fine particle dose (FPD)ranged between 87.64 and 101.47μg and fine particle fraction(FPF)ranged between 37.75%and 53.88%. Delivery rates of Pari Turob BOY N and BOY SX were similar,while the delivery rate of Omron NE-C28 was low. The total delivery of each nebulizer was about 0.11μg. Statistical analysis showed that different nebulizer had no significant difference on delivered dose ,but had signifi⁃cant difference on delivered rate(P<0.01)and aerodynamic measurement results(P<0.05). Conclusion Different jet nebulizers for budesonide inhalation suspension have certain influence on its in vitro deposition. The suitability of the Omron NE-C28 is the best among the three kinds of nebulizers.