盐酸氨溴索吸入溶液的空气动力学粒径分布测定  

Determination of aerodynamic particle size distribution of ambroxol hydrochloride inhalation solution

作　　者：魏宁漪[1] 周颖[1] 陈翠翠[1] 林兰[1] 宁保明[1] WEI Ning-yi;ZHOU Ying;CHEN Cui-cui;LIN Lan;NING Bao-ming(National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国新药杂志》2018年第17期1994-1998,共5页Chinese Journal of New Drugs

基　　金：国家"重大新药创制"科技重大专项资助项目(2015ZX093001002009)

摘　　要：目的:研究盐酸氨溴索吸入溶液的雾化特性,建立空气动力学粒径分布测定方法。方法:选用了2种不同的雾化器,采用新一代撞击器(NGI)方法测定空气动力学粒径分布,选取微细粒子剂量(FPD)、质量中值空气动力学粒径(MMAD)和几何标准偏差(GSD)等参数,表征盐酸氨溴索吸入溶液的体外雾化数据。结果:采用A型雾化器测定FPD为1.577 mg,MMAD为4.010μm,GSD为2.229;采用B型雾化器测定FPD为1.762 mg,MMAD为3.341μm,GSD为2.284。结论:本研究测定的体外数据描述了盐酸氨溴索吸入溶液的体外空气动力学粒径分布特征,为此类制剂的体外研究提供参考,并为NGI方法的建立和验证提供参考和依据。评价雾化器对吸入溶液剂的影响,建议严格雾化器标准并规范雾化器的使用。Objective： To establish the method of determining aerodynamic particle size distribution（ APSD） and study the nebulization characteristics of ambroxol hydrochloride inhalation solution. Methods： Two different nebulizers were used to determine the APSD of ambroxol hydrochloride inhalation solution by next generation impactor（ NGI） method. Fine particle dose（ FPD）,mass median aerodynamic diameter（ MMAD） and geometric standard deviation（ GSD） were selected to characterized the in-vitro nebulization of ambroxol hydrochloride inhalation solution. Results： The FPD,MMAD and GSD determined by type A nebulizer were 1. 577 mg,4. 010 μm and2. 229,respectively. The FPD,MMAD and GSD determined by type B nebulizer were 1. 762 mg,3. 341 μm and2. 284,respectively. Conclusion： The APSD obtained in this research characterized the in-vitro nebulization of ambroxol hydrochloride inhalation solution. The research provided reference for the in-vitro research of inhalation solution preparations,and provided reference and basis for the establishment and validation of NGI method. The influence of nebulization of inhalation solution by two types of nebulizers was evaluated in the research. It is suggested that the quality standard of nebulizers be strictly formulated and the use of nebulizers be standardized.

关 键 词：盐酸氨溴索吸入溶液 空气动力学粒径分布 微细粒子剂量 雾化器 

分 类 号：R944.7[医药卫生—药剂学]