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利用混合谐振声学(HYDRA)技术的新一代雾化器体内沉积研究。

In vivo deposition study of a new generation nebuliser utilising hybrid resonant acoustic (HYDRA) technology.

机构信息

Advanced Drug Delivery Group, School of Pharmacy, Faculty of Medicine and Health, The University of Sydney, Camperdown, New South Wales 2006, Australia.

School of Engineering, RMIT University, Melbourne, Victoria 3001, Australia.

出版信息

Int J Pharm. 2020 Apr 30;580:119196. doi: 10.1016/j.ijpharm.2020.119196. Epub 2020 Mar 4.

Abstract

Conventional nebulisation has the disadvantages of low aerosol output rate and potential damage to macromolecules due to high shear (jet nebulisation) or cavitation (ultrasonic nebulisation). HYDRA (HYbriD Resonant Acoustics) technology has been shown to overcome these problems by using a hybrid combination of surface and bulk sound waves to generate the aerosol droplets. We report the first in vivo human lung deposition study on such droplets. Twelve healthy adult subjects inhaled saline aerosols radiolabelled with technetium-99 m complexed with diethylene triamine penta-acetic acid (Tc-DTPA). The distribution of the aerosolised droplets in the lungs was imaged by single photon emission computed tomography combined with low dose computed tomography (SPECT/CT). The volume median diameter and geometric standard deviation of the droplets were 1.32 ± 0.027 µm and 2.06 ± 0.040, respectively. The mean delivery efficiency from the nebuliser into the body was 51.2%. About 89.1 ± 4.3% and 2.3 ± 1.4% of the inhaled radiolabelled dose deposited in the lungs and oropharynx, respectively. The deposition was symmetrical and diffusive between the two lungs, with a mean penetration index of 0.82. Thus, the prototype HYDRA nebuliser showed excellent in vivo aerosol deposition performance, demonstrating its potential to be further developed for clinical applications.

摘要

常规雾化具有气溶胶输出率低和由于高剪切(射流雾化)或空化(超声雾化)而对大分子潜在损伤的缺点。HYDRA(HYbriD 共振声学)技术通过使用表面和体声波的混合组合来产生气溶胶液滴,已被证明可以克服这些问题。我们报告了此类液滴在体内的首次人体肺部沉积研究。12 名健康成年受试者吸入放射性标记的生理盐水气溶胶,放射性标记物与二亚乙基三胺五乙酸(Tc-DTPA)络合。通过单光子发射计算机断层扫描与低剂量计算机断层扫描(SPECT/CT)相结合,对肺部气溶胶化液滴的分布进行成像。液滴的体积中值直径和几何标准偏差分别为 1.32±0.027μm 和 2.06±0.040。从雾化器输送到体内的平均输送效率为 51.2%。分别约有 89.1±4.3%和 2.3±1.4%的吸入放射性标记剂量沉积在肺部和口咽中。沉积在两肺之间是对称且扩散的,平均穿透指数为 0.82。因此,原型 HYDRA 雾化器表现出出色的体内气溶胶沉积性能,证明其具有进一步开发用于临床应用的潜力。

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