目的 研究吸入用乙酰半胱氨酸溶液的雾化特性，建立体外评价方法。方法 使用呼吸模拟装置对吸入用乙酰半胱氨酸溶液的递送速率和递送总量进行研究，使用新一代药用多级撞击器（NGI）测定空气动力学粒径分布。结果 不同雾化装置检测递送速率和递送总量数据存在明显差异，但使用同品牌雾化装置时吸入用乙酰半胱氨酸溶液自制样品和参比制剂的递送速率和递送总量无明显差异。不同雾化装置检测空气动力学粒径分布数据存在明显差异，但是使用同一品牌雾化装置，吸入用乙酰半胱氨酸溶液自制样品与参比制剂无明显差异。结论 所测定的体外数据描述了吸入用乙酰半胱氨酸溶液的体外特征，可为该制剂的体外评价提供参考。

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