盐酸氮?斯汀鼻喷雾剂仿制药与原研药喷雾特性的比较研究
Spray characteristics between generic and original azelastine hydrochloride nasal spray
李文博 1童颖1
作者信息
- 1. 武汉药品医疗器械检验所,武汉 430075;国家药监局药物制剂质量研究与控制重点实验室,武汉 430075
- 折叠
摘要
目的 研究盐酸氮䓬斯汀鼻喷雾剂原研药与仿制药的粒径分布、喷雾形态、喷雾模式,并评价两者喷雾特性的一致性.方法 采用激光粒度仪测定雾滴粒径分布,SprayVIEW激光成像系统研究喷雾模式和喷雾形态.结果 原研药和仿制药在检测距离为 6 cm处的椭圆度分别为:(1.152±0.052)、(1.306±0.049),喷雾面积分别为(490.3±43.6)mm2、(365.6±55.5)mm2,喷雾角度分别为(25.5±1.9)°、(22.4±1.0)°,雾滴粒径分布D50分别为(45.01±1.81)μm、(57.39±3.39)μm,D90 分别为(81.93±6.83)μm、(146.47±14.05)μm,仿制药的喷雾特性与原研药比较差异具有统计学意义(P＜0.05).结论 盐酸氮䓬斯汀鼻喷雾剂原研药具有良好的喷雾特性,仿制药与原研药存在差异性.
Abstract
Objective To evaluate consistency in the spray characteristics(droplet size distribution,spray pattern,and plume geometry)of the original and generic azelastine hydrochloride nasal sprays.Methods The particle size distribution,spray pattern and plume geometry were determined by laser particle size analyzer and SprayVIEW laser Imaging system,respectively.Results The ovality ratio of the original and generic drugs detected at 6 cm distance were(1.152±0.052)vs(1.306±0.049);the spray area were(490.3±43.6)mm2 vs(365.6±55.5)mm2;the spray angle were(25.5±1.9)° vs(22.4±1.0)°;the D50 and D90 were(45.01±1.81)μm vs(57.39±3.39)μm,and(81.93±6.83)μm vs(146.47±14.05)μm,having significant differences(P＜0.05),respectively.Conclusion The original drug of azelastine hydrochloride nasal spray has a good spraying characteristics.The generic drug needs improvement.
关键词
盐酸氮䓬斯汀鼻喷雾剂/粒径分布/喷雾形态/喷雾模式/一致性Key words
azelastine hydrochloride nasal spray/droplet size distribution/plume geometry/spray pattern/consistency引用本文复制引用
基金项目
国家药监局药物制剂质量研究与控制重点实验室开放基金(YWZJQN-202202)
出版年
2024
NETL
NSTL
万方数据