国内外鼻喷流感减毒活疫苗给药装置喷雾特性的对比  

Comparative study of spray characteristics of domestic and foreign nasal spray delivery devices for live attenuated nasal influenza vaccine

作　　者：魏巍 张春 原秀娟 曹铭 陈伟东 张立娜 朱志明 王亚军 WEI Wei;ZHANG Chun;YUAN Xiujuan;CAO Ming;CHEN Weidong;ZHANG Lina;ZHU Zhiming;WANG Yajun(Changchun BCHT Biotechnology Co.,Changchun 130012,Jilin Province,China)

机构地区：[1]长春百克生物科技股份公司,吉林长春130012

出　　处：《中国生物制品学杂志》2023年第11期1291-1296,共6页Chinese Journal of Biologicals

基　　金：吉林省科技发展计划(20180311006YY)。

摘　　要：目的对国内外鼻喷流感减毒活疫苗(live attenuated influenza vaccine,LAIV)给药装置喷雾特性进行对比。方法采用激光衍射法测定国内外两种鼻喷给药装置雾化颗粒粒径分布(DV10、DV50、DV90)、<10μm雾滴占比、Span跨度,Spray view仪器检测喷雾模式[最大直径(D_(max))、最短直径(D_(min))、椭圆率(ovality,D_(max)/D_(min))]和喷雾几何形态(喷雾角度及宽度),并进行比较分析。结果国内外两种鼻喷给药装置雾化颗粒的DV10、DV50、DV90粒径分布、<10μm雾滴占比及Span跨度差异均无统计学意义[莱文方差等同性检验F分别为0.622、0.135、3.067、0.212、0.058,P分别为0.434、0.714、0.085、0.647、0.810,且假定等方差显著性(双尾)值分别为0.439、0.228、0.281、0.539、0.910];喷雾模式的D_(max)、D_(min)、ovality差异均无统计学意义[莱文方差等同性检验F分别为2.102、2.666、0.514,P分别为0.158、0.114、0.479,且假定等方差显著性(双尾)值分别为0.651、0.407、0.160];喷雾角度及宽度的平均值比值分别为0.92和0.91,均在0.90~1.11范围内。结论国内外鼻喷给药装置均满足鼻喷LAIV的鼻喷给药要求,可用于鼻喷疫苗和药物的递送。Objective To compare the spray characteristics of domestic and foreign nasal spray delivery devices for live attenuated influenza vaccine(LAIV).Methods The particle size distribution(DV10,DV50 and DV90),the proportion of droplets smaller than 10μm and Span of atomized particles of two brands of nasal spray delivery devices at home and abroad were measured by laser diffraction method,the spray pattern[maximum diameter(D_(max)),shortest diameter(D_(min))and ovality(D_(max)/D_(min))]and spray geometry(spray angle and width)were detected by Spray view,and the comparative analysis was performed.Results There was no significant difference in DV10,DV50,DV90 particle size distribution,proportion of droplets smaller than 10μm and Span of atomized particles between the two kinds of domestic and foreign nasal spray delivery devices[F-values of Levene's test for equality of variances were 0.622,0.135,3.067,0.212 and 0.058,P-values were0.434,0.714,0.085,0.647 and 0.810,and significance(two-tailed)values of equal variances assumed were 0.439,0.228,0.281,0.539 and 0.910,respectively];D_(max),D_(min)and ovality of the spray patterns showed no significant difference[F-values of Levene's test for equality of variances were 2.102,2.666 and 0.514,P-values were 0.158,0.114 and0.479,and significance(two-tailed)values of equal variances assumed were 0.651,0.407,and 0.160,respectively];The geometric mean ratios of spray angle and width were 0.92 and 0.91,respectively,which ranged from 0.90 to 1.11.Conclusion Both the domestic and foreign nasal spray delivery devices meet the delivery requirement of the nasal spray LAIV,which can be used for the delivery of nasal spray vaccines and drugs.

关 键 词：鼻喷流感减毒活疫苗 鼻喷给药装置 喷雾特性 

分 类 号：R197.39[医药卫生—卫生事业管理]