两种测定硫酸沙丁胺醇吸入气雾剂中微细粒子剂量方法比较

Comparison Two Methods of Detecting Fine Particle Dose in Salbutamol Sulfate Inhalation Aerosol

目的采用二级撞击器(Twin-stage impactor,TSI)与多级(八级)撞击器(Andersen cascade impactor,ACI)分别检测硫酸沙丁胺醇吸入气雾剂微细粒子剂量,并对结果进行对比分析。方法以硫酸沙丁胺醇吸入气雾剂为模型,使用TSI及ACI的微细粒子剂量检测方法,对样品的微细粒子剂量进行测定。结果 TSI可快速获得空气动力学直径小于6.4μm的微细粒子剂量,但是不能获得药物颗粒的空气动力学粒度分布,ACI可以获得不同范围空气动力学粒径的微细粒子剂量;TSI与ACI都要控制气流量以确保测定空气动力学粒径分布的准确性。结论与TSI相比,ACI装置评价硫酸沙丁胺醇吸入气雾剂质量时更为全面。

OBJECTIVE Fine particle dose of salbutamol sulfate inhalation aerosol was determined by twinstage impactor（ TSI） and multistage（ 8） impactor（ Andersen cascade impactor,ACI） separately and comparative analysis of the results. METHODS Analyzed fine particle dose by TSI and ACI which used Salbutamol inhalation aerosol as a model. RESULTS TSI analyzed fine particle dose which was less than 6. 4μm rapidly couldn＇t get the aerodynamic particle size distribution. But ACI could analyze both; Both TSI and ACI should to control the airflow in order to ensure aerodynamic particle size distribution accurately detected. CONCLUSION Compared with TSI,ACI is more comprehensive for evaluating salbutamol sulfate inhalation aerosol.