目的 考察驱动器喷孔的孔径和孔长对定量吸入气雾剂(pressurized metered dose inhalers, pMDIs)羽流特征及体外沉积的影响。方法 以市售沙丁胺醇pMDIs为模型药,采用方差和效应面分析等方法,研究不同孔径、孔长条件下,模型药的喷雾形态、喷射速度及空气动力学粒径分布。结果 延长驱动器孔长会导致角度及沉积相关的关键质量属性减小,而递送率、羽流喷射速度及喉管沉积率与孔长成正相关,其结果具有统计学意义(P<0.05)。增大孔径会降低羽流持续时间,加快羽流速度,增加喉管沉积率,并引起颗粒分布参数的减小。结论 改变驱动器喷孔参数会影响pMDIs的羽流角度、羽流速度及及羽流持续时间等质量属性,并间接引起药物沉积相关的关键质量属性的变化。实际应用中应优先考虑驱动器参数,提高筛选效率。
Abstract
OBJECTIVE To investigate the effect of actuator orifice diameter and orifice length on spray plume characteristics and the in vitro deposition of pressurized metered dose inhalers. METHODS Salbutamol sulphate inhalationaerosol was selected as the model drug. The two-factors and three-levels analysis of variance, and response surface analysis are adopted to analyze the plume geometry, speed and aerodynamic particle size distribution. RESULTS When the orifice length increased,the spray angle and key quality attributes associated with deposition decreased, however delivery rate, spray speed and the ratio of drug deposited at the throat device increased significantly(P<0.05). When the orifice diameter increased, the spray speed and the ratio of drug deposited at the throat device increased, but particle distribution parameters reduced. CONCLUSION The change of spray angle, spray speed and plume time caused by the alteration of orifice diameter and orifice length will lead to the change of aerodynamic particle size distribution. It is recommended that actuator parameters should been given priority in order to improve product screening efficiency.
关键词
驱动器 /
孔径 /
孔长 /
气雾剂 /
空气动力学粒径分布 /
喷雾形态
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Key words
actuator /
orifice diameter /
orifice length /
aerosol /
APSD /
plume geometry
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中图分类号：
R944
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参考文献
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