助悬剂用量对糠酸氟替卡松鼻喷剂喷雾特性的影响

Effect of Suspending Agent Concentration on Spray Characteristics of Fluticasone Furoate Nasal Spray

目的研究混悬型鼻喷剂中助悬剂Avicel®浓度对鼻喷剂喷雾模式、喷雾形态以及雾滴粒径的影响。方法制备不同Avicel®浓度的糠酸氟替卡松鼻用混悬液。通过SprayVIEW®喷雾测试系统测试鼻喷剂的喷雾特性参数,使用Box-Behnken响应面法分析Avicel®浓度对鼻喷剂体外喷雾特性的影响,同时考察Avicel®浓度对喷雾雾滴粒径的分布影响以及在不同检测距离下雾滴的粒径变化。结果增大Avicel®浓度会显著减小喷雾面积以及喷雾角度和宽度(P<0.001),同时增大D50和整体粒径。增大驱动速度会显著增大喷雾面积、喷雾角度和宽度(P<0.05),驱动加速度对喷雾特性的影响远小于Avicel®浓度和驱动速度。随着检测距离的增加,雾滴粒径分布变得更加集中,雾滴粒径分布跨度变小。结论本研究通过Box-Behnken响应面法发现Avicel®的浓度与驱动速度对喷雾特性的影响存在拮抗作用,为鼻喷剂Avicel®浓度的选择以及装置推荐驱动参数提供了参考。

OBJECTIVE To investigate the effect of the concentration of the suspending aid Avicel®in a suspension nasal spray on the spray pattern,plume geometry and droplet size of nasal spray.METHODS Preparation of Fluticasone furoate nasal suspension with different concentration of Avicel®.Through SprayVIEW®spray test system to test the spray characteristic parameters of nasal spray,and Box-Behnken response surface method was used to analyze the influence of Avicel®concentration on the spray characteristics of nasal spray in vitro.At the same time,the influence of Avicel®concentration on the distribution of spray droplet size and the change of droplet size at different detection distances were investigated.RESULTS Increasing the concentration of the Avicel®would significantly reduce the spray area,spray angle and width(P<0.001),while increasing D50 and overall particle size.It was also found that increasing the actuation velocity would significantly increase the spray area,spray angle and width(P<0.05),and the influence of actuation acceleration on spray characteristics was far less than that of Avicel®concentration and actuation velocity.As the detection distance increased,the droplet size distribution become more concentrated and the span of droplet size distribution become smaller.CONCLUSION In this study,Box-Behnken response surface method is used to observe the antagonistic effects of Avicel®concentration and actuation velocity on spray characteristics,which provides a reference for the selection of Avicel®concentration for nasal sprays as well as the recommended actuation parameters for the device.