基于喷雾冷冻干燥技术制备甘露醇吸入粉雾剂的研究  

Fabrication of Mannitol Dry Powder for Inhalation Via Spray Freeze Drying Technology

作　　者：仇实 严珅 张盛宇 吴铎 Qiu Shi;Yan Shen;Zhang Shengyu;Wu Duo(School of Chemical and Environmental Engineering,College of Chemistry,Chemical Engineering and Materials Science,Soochow University,Jiangsu,215123)

机构地区：[1]苏州大学材料与化学化工学部化工与环境工程学院,江苏215123

出　　处：《当代化工研究》2024年第7期163-165,共3页Modern Chemical Research

基　　金：2022年国家自然科学基金项目“喷雾冷冻干燥微粒结构调控及其体外肺部递送性能研究”(项目编号:22278284)。

摘　　要：甘露醇吸入粉雾剂可治疗成人肺部囊性纤维化和作为哮喘引发剂以供哮喘患者的临床诊断,而目前其主流的制备工艺通常为喷雾干燥技术,所得样品的性质性能较单一且不可控,因此围绕配方设计及工艺优化制备体外气溶胶性能优越的甘露醇吸入粉雾剂仍具有挑战。基于此,本研究采用一种新型微流控喷雾冷冻干燥技术制备了一系列甘露醇吸入粉雾剂,重点考察了前驱液溶剂组成与喷雾冷冻温度对甘露醇微粒结构属性的影响规律和调控机制。结果表明,乙醇的加入有助于形成堆积的针状晶体有效提高了其体外气溶胶性能,最优样品的微细颗粒分数可达64%。Mannitol inhalation powder can treat adult cystic fibrosis and serve as an asthma initiator for clinical diagnosis in asthma patients,Spray drying is the commonly used granulation technology for fabricating mannitol dry powder inhaler.However,the properties of the resulting spray drying samples are relatively uncontrollable.Hence,the development of mannitol dry powder inhaler with excellent aerosol performance through formulation design and process parameter optimization is still challenging.Herein,a series of mannitol powder for inhalation were fabricated via a novel micro-fluidic spray freeze drying technology.The influences of solvent composition of feed solution and spray freezing temperature on the structural properties.The addition of ethanol promoted the formation of stacking needle-like crystals,resulting in the better in vitro aerosol performance.The optimal sample showed a fine particle fraction of 64%.

关 键 词：甘露醇吸入粉雾剂 喷雾冷冻干燥 结构属性 体外气溶胶性能 

分 类 号：R94[医药卫生—药剂学]