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异丙托溴铵吸入气雾剂的喷雾模式和喷雾形态测定
异丙托溴铵吸入气雾剂的喷雾模式和喷雾形态测定
魏宁漪,高 蕾,周 颖,林 兰,宁保明

中国食品药品检定研究院,北京 100050
Determination of the spray pattern and plume geometry of ipratropium bromide inhalation aerosol
(National Institutes for Food and Drug Control, Beijing 100050,China)

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起始页:38

摘要:[摘要] 目的:比较不同来源异丙托溴铵吸入气雾剂的喷雾模式和喷雾形态,评价异丙托溴铵吸入气雾剂的雾化性能。方法:采用激光成像系统测定异丙托溴铵气雾剂的喷雾模式和喷雾形态,喷雾模式根据长径、短径和椭圆比等参数进行评价,喷雾形态根据形态角度和形态宽度等参数进行评价,结合递送剂量均一性结果,比较不同来源气雾剂的雾化差异。结果:厂家A的递送剂量不高,但是喷雾面积最大,雾化效果最好。厂家C和D递送剂量过高,雾化面积较小,雾化效果较差。结论: 4种不同来源的气雾剂喷雾模式和喷雾形态差别较远,应是由于不同来源的气雾剂包材、处方和工艺不同造成,为体外评价气雾剂等效性提供参考。

关键词:[关键词] 异丙托溴铵吸入气雾剂;激光成像系统;喷雾模式;喷雾形态

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Abstract:[Abstract] Objective: To compare spray pattern and plume geometry of different ipraropium bromide inhalation aerosols, and assess characteristics of different samples in vitro equivalence. Methods: Spray pattern and plume geometry of ipraropium bromide inhalation aerosols were determined by SprayVIEW. Spray pattern was evaluated by analyzing parameters of spray area, major axis, minor axis and elliptical ratio. Moreover, plume geometry was evaluated based on parameters of plume angle and plume width, and the difference in samples was compared according to the uniformity of delivery dose. Results: Sample from producer A had less delivery dose and better spray area, so its atomization was the best. Samples from producer C and producer D had higher delivery dose and less spray area, so their atomization was poor. Conclusion: Spray pattern and plume geometry from four producers are different obviously, which may be caused by package, formulation and process. These results provide evidence for assessing in vitro equivalence of inhalation aerosols.

Key words:[Key words] ipratropium bromide inhalation aerosol; SprayVIEW; spray pattern; plume geometry

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