目的 研究吸入用乙酰半胱氨酸溶液的霧化特性，建立體外評價方法。方法 使用呼吸模擬裝置對吸入用乙酰半胱氨酸溶液的遞送速率和遞送總量進(jìn)行研究，使用新一代藥用多級撞擊器（NGI）測定空氣動力學(xué)粒徑分布。結(jié)果 不同霧化裝置檢測遞送速率和遞送總量數(shù)據(jù)存在明顯差異，但使用同品牌霧化裝置時吸入用乙酰半胱氨酸溶液自制樣品和參比制劑的遞送速率和遞送總量無明顯差異。不同霧化裝置檢測空氣動力學(xué)粒徑分布數(shù)據(jù)存在明顯差異，但是使用同一品牌霧化裝置，吸入用乙酰半胱氨酸溶液自制樣品與參比制劑無明顯差異。結(jié)論 所測定的體外數(shù)據(jù)描述了吸入用乙酰半胱氨酸溶液的體外特征，可為該制劑的體外評價提供參考。

Objective To study the nebulization characteristics and establish in vitro evaluation methods of acetylcysteine inhalation solution. Methods The delivery rate and total delivery amount of acetylcysteine inhalation solution were measured by breathing simulator, and aerodynamic particle size distribution was determined by next generation pharmaceutical impactor (NGI). Results There were significant differences in the delivery rate and total delivery amount among different atomizing devices, but there was no significant difference in the delivery rate and total delivery amount between acetylcysteine inhalation solution self-made and the reference preparation when using the same brand atomization device. There were significant differences in the aerodynamic particle size distribution data measured by different atomizing devices, but there was no significant difference between the acetylcysteine inhalation solution self-made sample and the reference preparation with the same brand atomization device. Conclusion The in vitro characterization of acetylcysteine inhalation solution can be described by these methods, which can provide reference for the in vitro evaluation of acetylcysteine inhalation solution.

R913