目的 考察格隆溴銨吸入噴霧劑的霧化特性。方法 采用激光成像系統(tǒng)和新一代撞擊器等測定格隆溴銨吸入噴霧劑的噴霧模式、噴霧形態(tài)、遞送劑量均一性和空氣動力學粒徑分布。結(jié)果 樣品的橢圓度均符合美國食品藥品管理局指導原則建議，不同樣品噴霧模式和噴霧形態(tài)同一參數(shù)之間RSD值均小于7%，樣品的罐間和罐內(nèi)遞送劑量均一性良好。格隆溴銨吸入噴霧劑與霧化吸入溶液的質(zhì)量中值、幾何標準偏差值基本一致，在肺內(nèi)沉積方面上高于霧化吸入溶液。結(jié)論 格隆溴銨吸入噴霧劑具備良好的霧化特性。

Objective To investigate the nebulization characteristics of glycopyrronium bromide inhalation spray. Methods A laser imaging system and next generation impactor (NGI) were used to determine the spray pattern, plume geometry, delivery dose uniformity, and aerodynamic particle size distribution (APSD) of glycopyrronium bromide inhalation spray. Results The elliptical ratio of glycopyrronium bromide inhalation spray conformed to the FDA guidance principle. RSD values of each sample parameter of the spray pattern and plume geometry were less than 7%. The delivery dose uniformity between and within the cans of the samples was good. MMAD and GSD values of glycopyrronium bromide inhalation spray were basically same as those of atomized inhalation solution, and higher than that of atomized inhalation solution in terms of intrapulmonary deposition. Conclusion Glycopyrronium bromide inhalation spray has good atomization characteristics.

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