| 盛海,卢晨,冯霞,等.人干扰素 α2b注射液雾化吸入过程中的药雾粒度分布及沉降量的评价[J].安徽医药,2024,28(2):246-250. |
| 人干扰素 α2b注射液雾化吸入过程中的药雾粒度分布及沉降量的评价 |
| Evaluation of particle size distribution and sedimentation of human interferon α2b injection during aerosol inhalation |
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| DOI：10.3969/j.issn.1009-6469.2024.02.008 |
| 中文关键词: 干扰素 α-2b 投药，吸入 粒径分布 药物沉降 |
| 英文关键词: Interferon alfa-2b Administration,inhalation Particle size distribution Drug sedimentation |
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| 中文摘要: |
| 目的评价人干扰素( IFN)α2b注射液雾化吸入质量的重要参数药雾粒度分布，比较不同配制方法下药雾粒度分布的差异，为临床用药提供依据和参考。方法研究时间 2022年 3―7月。采用激光衍射的方法测定 IFNα2b注射液雾化过程中的药雾粒度分布，并比较不同配制方法下药雾粒度分布的差异。利用文献发表的不同大小颗粒在呼吸道沉降的分布系数和测定的不同大小药雾颗粒的体积累积分布数据，估算出不同呼吸道区域 IFNα2b药雾颗粒的沉降量。结果随着雾化时间的延长，药雾颗粒体积平均直径有稍许增大趋势，在全部雾化过程中， IFNα2b注射液( 1 mL药液∶ 1 mL生理盐水)药雾颗粒的平均特征粒径 X90，为( 7.88±0.09)μm，X50，3为( 2.80±0.05)μm，X10，为( 0.82±0.01)μm。雾化吸入 IFNα2b注射液适宜用生理盐水稀释，最 |
| 英文摘要: |
| Objective To Determinate aerosol particle size distribution that is the important parameters for evaluating the inhalationqualityof human interferon α2b injection.Methods Laser diffraction method was used to measure the size distribution and dynamicchange of IFNα2b aerosol particles during atomization from March to July 2022.This study was also conducted to determine the opti.mum dilution and dilution ratio of human interferon α2b by the determination of size distribution, to determine the particle size distribu.tion of human interferon α2b aerosol under optimum conditions,and to estimate the distribution of aerosol in the whole respiratory tract.Results With the extension of atomization time, VMD of IFNα2b aerosol particles gradually increased slightly.The characteristic par.ticle diameter of aerosol particles of human interferon α2b injection (1 mL liquid∶1 mL normal saline) was (7.88±0.09)μm for X90,3,(2.80±0.05)μm for X50,3, (0.82±0.01)μm for X10,3.The optimal dilution ratio is 1.0-1.5 mL of normal saline added to 1 mL of drug solu.tion.According to the above operation method,the VMD of human interferon α2b aerosol particles is 3.61-3.67 μm, and dQ3(0.5-5.0 μm) of aerosol particles is 72.72%-73.82%. If 3 million IU of human interferon α2b were atomized and inhaled, we estimated that about1 599,900 IU of the drug would be distributed in the oropharyngeal and nasal regions, 374 900 IU would be distributed in the lungs,and 133,500 IU would be distributed in the tracheobronchial region.Conclusions Our results support diluting 1 mL human interferon α2b injection with 1.0-1.5 mL normal saline when inhaled.In this way,the total volume of aerosol particles suitable for respiratory drugdelivery is the largest.There may be more aerosol particles containing IFNα2b to sedimentate in trachea bronchus and alveoli. |
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