吸入用伊曲康唑混悬液的体外雾化特性研究  

In vitro study on nebulization characteristics of Itraconazole Suspension for Inhalation

作　　者：金玉婷 堵伟锋 卫星红 石刘玉 丁竞男 JIN Yuting;DU Weifeng;WEI Xinghong;SHI Liuyu;DING Jingnan(Hefei Heyuan Pharmaceutical Co.,Ltd.,Hefei 230031,China;Anhui Institutes for Food and Drug Control,Hefei 230051,China)

机构地区：[1]合肥合源药业有限公司,安徽合肥230031 [2]安徽省食品药品检验研究院,安徽合肥230051

出　　处：《药学研究》2025年第4期349-353,376,共6页Journal of Pharmaceutical Research

基　　金：安徽省药品监督管理局科技创新项目(No.AHYJ-KJ-202211)。

摘　　要：目的 建立体外评价方法,研究自研制剂吸入用伊曲康唑混悬液雾化特性。方法 采用呼吸模拟器法对吸入用伊曲康唑混悬液递送速率和递送总量进行测定,使用NGI新一代药用圆盘撞击器进行空气动力学粒径分布(APSD)研究。结果 不同品牌雾化装置所测递送速率和递送总量、空气动力学粒径分布均有所差异,3批样品测定结果无明显差异。结论 本文建立的测定方法能有效表征吸入用伊曲康唑混悬液的体外雾化特性,可用于该制剂的处方工艺开发与质量控制。Objective To establish an in vitro evaluation method to study the atomization characteristics of Itraconazole Suspension for Inhalation.Methods The delivery rate and total delivery amount of Itraconazole Suspension for Inhalation were measured by respiratory simulator method,and the aerodynamic particle size distribution(APSD)was studied by NGI′s new-generation pharmaceutical disk impactor.Results The delivery rate,total delivery amount,and aerodynamic particle size distribution measured by different brands of atomizer were different,while the results of three batches of samples were similar.Conclusion The method established in this paper can effectively characterize the in vitro atomization characteristics of Itraconazole Suspension for Inhalation,and can be used for the formulation process development and quality control of this preparation.

关 键 词：伊曲康唑 吸入制剂 递送速率 递送总量 空气动力学粒径分布 

分 类 号：R943[医药卫生—药剂学]