不同压缩式雾化器对吸入用盐酸氨溴索溶液的雾化效果研究  

Nebulization effect of different compressed air nebulizers on the inhalation of ambroxol hydrochloride solution

作　　者：李逸飞 董亚男 王勇[1] 朱建强[1,2] 王博 LI Yi-fei;DONG Ya-nan;WANG Yong;ZHU Jian-qiang;WANG Bo(Tianjin Pharmaceutical Research Institute Co.,Ltd.,Tianjin 300301;State Key Laboratory of Drug Delivery Technology and Pharmacokinetics,Tianjin Institute of Pharmaceutical Research,Tianjin 300301)

机构地区：[1]天津药物研究院药业有限责任公司,天津300301 [2]释药技术与药代动力学国家重点实验室,天津300301

出　　处：《中南药学》2023年第8期2041-2046,共6页Central South Pharmacy

基　　金：国家“重大新药创制”科技重大专项资助项目(No.2017ZX09201002-001-004)。

摘　　要：目的比较3种不同品牌雾化器对吸入用盐酸氨溴索溶液的雾化效果。方法采用新一代撞击器及呼吸模拟装置,测定3种雾化器配合吸入用盐酸氨溴索溶液使用的空气动力学粒径分布和递送速率、递送总量,选取微细粒子剂量、微细粒子分数、质量中位数空气动力学粒径和几何标准偏差等参数,表征不同雾化器对吸入用盐酸氨溴索溶液的雾化效果。结果单因素方差分析结果显示,8个主要指标的P值均小于0.05,说明3种雾化器的雾化效果差异有统计学意义。雾化器A对吸入用盐酸氨溴索溶液的雾化效果最佳。结论本研究测定的结果表明了不同雾化器对吸入液体制剂的递送速率、递送总量及体外空气动力学粒径分布特征均有较大影响。为保证临床用药效果,应加强吸入液体制剂与雾化装置的关联研究,且应制订严格的雾化器标准。Objective To compare the nebulization effect of three different nebulizers on the inhalation ambroxol hydrochloride solution.Methods Three different nebulizers were used to determine the aerodynamic particle size distribution,delivery rate and total delivery of ambroxol hydrochloride inhalation solution by next generation impactor and breath simulator.The fine particle dose,fine particle fraction,mass median aerodynamic diameter and geometric standard deviation were selected to characterize the nebulization effect of different nebulizers for ambroxol hydrochloride inhalation solution.Results The ANOVA analysis showed that the P values of eight main indexes were all less than 0.05,suggesting the difference in the nebulization effect of three nebulizers was obviously significant.Nebulizer A has the best nebulization effect on ambroxol hydrochloride inhalation solution.Conclusion Nebulizers have great effect on the delivery rate,total delivery and aerodynamic particle size distribution of inhalation solution.Correlation between inhalation solution and nebulizers should be studied,and the quality standard of nebulizers should be established to ensure clinical efficacy.

关 键 词：吸入用盐酸氨溴索溶液 雾化器 递送速率 递送总量 空气动力学粒径分布 

分 类 号：R96[医药卫生—药理学]