喉宁雾化吸入溶液的雾化特性分析  

Nebulization Characteristics Study of Houning Inhalation Solution

作　　者：田珩[1] 杨仪雪 吴纯敏 严全鸿[1] TIAN Heng;YANG Yixue;WU Chunmin;YAN Quanhong(NMPA Key Laboratory for Quality Control and Evaluation of Pharmaceutical Excipients,Guangdong Institute for Drug Control,Guangzhou 510180,China)

机构地区：[1]广东省药品检验所,国家药品监督管理局药用辅料质量控制与评价重点实验室,广州510180

出　　处：《中国药学杂志》2024年第15期1416-1423,共8页Chinese Pharmaceutical Journal

基　　金：2022年度广东省中医药局项目资助(20221057)。

摘　　要：目的 对喉宁雾化吸入溶液的雾化特性进行研究,为该类制剂的临床用药提供参考。方法 采用呼吸模拟器和新一代撞击器,以紫丁香苷为指标性组分,建立喉宁雾化吸入溶液递送速率、递送总量和体外空气动力学分布的测定方法,考察不同的压缩机、雾化器、雾化方式和呼吸模式对雾化效果的影响。结果 在相同的雾化条件下,采用成人呼吸模式,压缩型雾化器的递送速率为23.3~52.2μg·min^(-1)、递送总量为178.8~353.2μg、模拟喉部沉积比为2.1%,超声雾化器的递送速率为3.2~21.2μg·min^(-1)、递送总量为12.9~82.7μg、模拟喉部沉积比为0.7%,振动筛网式雾化器的递送速率为7.2~16.5μg·min^(-1)、递送总量为93.5~217.2μg、模拟喉部沉积比为0.1%,各类装置的质量中值动力学粒径在2.2~3.6μm之间;儿童呼吸模式下各类型装置的递送速率为1.5~24.3μg·min^(-1)、递送总量为26.3~215.4μg。结论 雾化器的类型和品牌对喉宁雾化吸入溶液的递送速率和递送总量有较大影响,建议临床使用时应尽量根据实际需要选择适宜的雾化装置;儿童呼吸模式下喉宁雾化吸入溶液递送速率及递送总量均有所降低,提示临床应根据患者年龄和肺部功能情况调整雾化剂用量和雾化时间。OBJECTIVE To investigate the nebulization characteristics of Houning inhalation solution(HNIS)in vitro and to provide the reference for the clinical administration.METHODS The delivery rate(DR),delivered amount(DA) and aerodynamic particle size distribution(APSD) in vitro of HNIS were determined by means of respiratory simulator and the next generation impactor(NGI)with the syringin as the indication component and compared among the different types of nebulizers,compressors,atomization modes and breathing patterns.RESULTS In the same atomization condition and under the adult breathing pattern,the DR were between 23.3-52.2 μg·min~(-1),the DA were between 178.8-353.2 μg and the deposition fraction in simulated throat(DFST) was about 2.1% for the jet nebulizers,the DR were between 3.2-21.2 μg·min~(-1),the DA were between 12.9-82.7 μg and the DFST were about 0.7% for the ultrasonic nebulizers,the DR were between 7.2-16.5 μg·min~(-1),the DA were between 93.5-217.2 μg and the DFST were about 0.1% for the mesh nebulizers,the mass median aerodynamic diameter(MMAD) were between 2.2-3.6 μm.In the same atomization condition and under the child breathing simulation,the DR were between 1.5-24.3 μg·min~(-1),the DA were between 26.3-215.4 μg.CONCLUSION The nebulization characteristics of HNIS are significant affected by the patterns and brands of the atomiztion equipment,suggesting that the atomization system should be selected according to the requirement in the clinical.Under the child breathing pattern,with the DA and DR reduced,the dosage and atomization time should be adjusted according to the age and pulmonary function of the patients to ensure the safety and efficiency of clinical medication.

关 键 词：喉宁雾化吸入溶液 雾化器 递送速率 递送总量 体外空气动力学分布 呼吸模式 紫丁香苷 

分 类 号：R944[医药卫生—药剂学]