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影响喷射式雾化器药物输出量的因素的放射性测定研究。

A radiometric study of factors affecting drug output of jet nebulizers.

作者信息

Mittal G, Kumar N, Rawat H, Chopra M K, Bhatnagar A

机构信息

Institute of Nuclear Medicine and Allied Sciences, Defence R & D organization, Brig. S. K. Mazumdar Road, Delhi-110 054, India.

出版信息

Indian J Pharm Sci. 2010 Jan;72(1):31-8. doi: 10.4103/0250-474X.62234.

Abstract

Jet nebulizers show an unreasonable variation in drug output and nebulization rates that leads to clinical and regulatory problems. Current evaluation methods appear inadequate for the purpose. Our objective was to evaluate Technetium-99m radiometry to study nebulizer parameters and the factors influencing it quantitatively. Drug output, output rate and residual mass and the effect of excipient, temperature, surface tension, air-jet speed, and equipment brand and aging were studied. Though nebulization of radiolabeled drugs followed first-order kinetics, the rates were significantly different; the heaviest drug (Tc-99m colloid) and Tc-99m salbutamol had the least nebulization. Nebulization rate for the first minute was invariably higher than the mean rate signifying the concentration effect of the solute. Drug residue was 35-75%. Drug output of different nebulizer chamber and air compressor brands was different to the extent of 270% and 180% respectively. 'Aging' of fluid chamber, cold drug fluid and obstruction in air-jet resulted in significant reduction in output, while addition of 2% saline as excipient did not change the output rate. Addition of ethyl alcohol resulted in a maximum of 260% enhancement (with Tc-99m salbutamol), while further reduction in surface tension was counterproductive irrespective of the drug used. We conclude that radiometry can provide valuable parametric information on the performance of different jet nebulizers.

摘要

喷射式雾化器在药物输出量和雾化速率方面存在不合理的差异,这导致了临床和监管问题。目前的评估方法似乎不足以达到这一目的。我们的目标是评估锝-99m放射性测定法,以定量研究雾化器参数及其影响因素。研究了药物输出量、输出速率、残留量以及赋形剂、温度、表面张力、喷气速度、设备品牌和老化的影响。尽管放射性标记药物的雾化遵循一级动力学,但速率有显著差异;最重的药物(锝-99m胶体)和锝-99m沙丁胺醇的雾化最少。第一分钟的雾化速率始终高于平均速率,这表明溶质的浓度效应。药物残留率为35%-75%。不同雾化器腔室和空气压缩机品牌的药物输出量差异分别高达270%和180%。液体腔室“老化”、冷药液体和喷气口堵塞导致输出量显著降低,而添加2%的盐水作为赋形剂并未改变输出速率。添加乙醇最多可使雾化增强260%(使用锝-99m沙丁胺醇时),而进一步降低表面张力则会产生相反的效果,且与所使用的药物无关。我们得出结论,放射性测定法可以提供有关不同喷射式雾化器性能的有价值的参数信息。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/93d7/2883224/3e64f260b578/IJPhS-72-31-g001.jpg

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