丙酸倍氯米松吸入气雾剂体外沉积性质的研究

Study on in vitro Deposition of Beclometasone Dipropionate Inhalation Aerosol

目的:通过测定不同处方和规格的丙酸倍氯米松吸入气雾剂的粒径分布,评估其体外沉积性质,比较不同测定方法的优缺点和处方之间的差异。方法:分别采用双级撞击器(TI)、安德森撞击器(ACI)和新一代撞击器(NGI)测定3种处方丙酸倍氯米松吸入气雾剂的体外空气动力学粒径分布。结果:3种撞击器中,NGI的测定结果偏差最小,对小粒子的截留效果最好;3种处方样品通过不同装置测得的微细粒子剂量分数均值分别为47.3%,56.4%和29.3%,喉部沉降百分比均值分别为34.7%,28.9%和55.3%。结论:3种撞击器均可测定丙酸倍氯米松吸入气雾剂的微细粒子剂量。ACI与NGI可全面分析体外沉积性质,NGI装置重现性和区分力较好,更适用于评价丙酸倍氯米松吸入气雾剂体外沉积性质;不同处方样品的空气动力学参数存在差异,规格和微细粒子剂量不成正比。

Objective: To detect the size distribution of beclometasone dipropionate inhalation aerosol with different formulations and specifications to evaluate the characters of in vitro deposition, and to compare the advantages and disadvantages of different determination methods and the differences among the various formulations. Methods: The aerodynamic particle size distribution(APSD) of beclometasone dipropionate inhalation aerosol with three different formulations was determined respectively by twin-stage inpinger(TI), Andersen cascade impactor(ACI) and next generation impactor(NGI). Results: The fine particles could be captured by NGI with the best efficiency and the least deviation. The fine particle fraction(FPF) of the three formulations was 47.3%,56.4% and 29.3%, respectively, and the deposition fraction in throat was 34.7%,28.9% and 55.3%, respectively. Conclusion: The methods of TI,ACI and NGI can be used to determine the FPF of beclometasone dipropionate inhalation aerosol, while the data of APSD can be obtained only from ACI and NGI with better repeatability and discrimination in NGI. APSD differences are shown among the samples with different formulations, while the FPF decreases with the increase of dose.