沙美特罗替卡松吸入粉雾剂溶出度的测定研究  

Dissolution test study of salmeterol xinafoate and fluticasonepropionate powder for inhalation

作　　者：王婷 周颖 孙春萌 魏宁漪 WANG Ting;ZHOU Ying;SUN Chun-meng;WEI Ning-yi(NMPA Key Laboratory for Research and Evaluation of Pharmaceutical Preparations and Excipients,Department of Pharmaceutics,School of Pharmacy,China Pharmaceutical University,Nanjing 211198,China;NMPA Key Laboratory of Research and Evaluation of Chemical Drug Quality,Institute for Chemical Drug Control,National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国药科大学药学院药剂系,国家药品监督管理局药物制剂及辅料研究与评价重点实验室,南京211198 [2]中国食品药品检定研究院化学药品检定所,国家药品监督管理局化学药品质量研究与评价重点实验室,北京102629

出　　处：《中国新药杂志》2025年第8期857-862,共6页Chinese Journal of New Drugs

基　　金：中国食品药品检定研究院关键技术研究基金资助项目(GJJS-2022-4-3)。

摘　　要：目的:本研究以沙美特罗替卡松吸入粉雾剂为研究对象开发溶出度检查方法,采用新一代撞击器(next generation impactors,NGI)将药物粉末进行粒径分级,取可沉积在人体肺部的微细粒径药物即沉积在NGI第二层级中的药物颗粒以桨法开展溶出度研究。方法:采用LC-MS/MS法测定沙美特罗和丙酸氟替卡松浓度并绘制溶出曲线。结果:沙美特罗在1.80~10.79 ng·mL-1、丙酸氟替卡松在6.51~39.06 ng·mL-1浓度范围内线性关系良好,相关系数均大于0.995,精密度、稳定性和重复性良好,沙美特罗加标回收率90%~94%,丙酸氟替卡松加标回收率92%~100%,该方法稳健可靠,适用于沙美特罗替卡松吸入粉雾剂溶出度测定。Objective:In this study,salmeterol ticasone inhalation powder aerosol was used as the research object to develop a dissolution detection method,and the particle size of the drug powder was graded by next generation impactors(NGI),and the dissolution of the drug particles deposited in the second level of NGI was studied by taking the fine particle size drug that can be deposited in the human lungs,and the paddle method.Methods:High performance liquid chromatography-tandem mass spectrometry(LC-MS/MS)was used to determine the concentrations of salmeterol and fluticasone propionate and plot the dissolution curves.Results:Salmeterol had a good linear relationship between 1.8~10.79 ng·mL-1 and fluticasone propionate in the concentration range of 6.51~39.06 ng·mL-1,the correlation coefficient was greater than 0.995,the precision,stability and repeatability were good,the recovery rate of salmeterol spike was 90%~94%,and the recovery rate of fluticasone propionate spiked was 92%~100%.Conclusion:This method is robust and reliable,and is suitable for the determination of dissolution of salmeterol ticasone inhalation powder aerosol.

关 键 词：沙美特罗替卡松吸入粉雾剂 溶出度 新一代撞击器 

分 类 号：R943[医药卫生—药剂学]