Nebulization Characteristics Study of Human Interferon α1b for Injection Based on ELISA
10.3870/j.issn.1004-0781.2025.11.017
- VernacularTitle:基于双抗体夹心ELISA技术的注射用人干扰素α1b雾化特性研究
- Author:
Miao LI
1
;
Jinqiu HUANG
;
Peng SHEN
;
Zhenyu ZHONG
;
Xiaogang JIANG
;
Jialu HOU
;
Ning HE
;
Guang FENG
;
Jiangtao BAI
Author Information
1. 武汉药品医疗器械检验所,国家药品监督管理局药物制剂质量研究与控制重点实验室,武汉 430075
- Publication Type:Journal Article
- Keywords:
Human interferon α1b;
Nebulization characteristics;
Delivery rate;
Total drug substance delivered;
Fine particle fraction
- From:
Herald of Medicine
2025;44(11):1821-1829
- CountryChina
- Language:Chinese
-
Abstract:
Objective To investigate the nebulization characteristics of human interferon α1b for injection.To characterize and compare the delivery rate,total drug substance and the aerodynamic characteristics between the two types of nebulizer.Methods Connect two types of nebulizers with a breathing simulator,respectively,and simulate the breathing patterns of an infant and child.Measure the delivery rate,total delivered dose,and delivery uniformity.The aerodynamic properties of human interferon α1b for injection were evaluated by the next generation impactor(NGI).The content of human interferon α1b was quantified by double antibody sandwich ELISA.Results In the three batches of samples in infant mode,the delivery rate and total delivered dose determind by A nebulizer were 0.45,0.49,0.44 μg·min-1,3.06,3.21,3.81 μg,respectcively;and 0.12,0.14,0.16 μg·min-1,0.73,0.73,0.75 μg,respectcively by B nebulizer.In child mode,the delivery rate and total delivered doses determined by A nebulizer were 1.36,1.49,1.20 μg·min-1,7.44,7.17,and 6.54 μg,respectcively;and 0.37,0.36,0.43 μg·min-1,1.66,1.59,and 1.41 μg,respectcively by B nebulizer.In child and infant mode,the ten results of the total drug substance delivered determined by nebulizer A were both between 65%to 135%of the average.The FPD,FPF,MMAD,and GSD determined by A neublizer of three batch samples were 2.48,2.92,2.35 μg,59.0%,57.4%,59.1%,4.18,4.34,4.15 μm,1.94,1.98,2.01,respectively.The FPD,FPF,MMAD and GSD determined by B neublizer of three batches samples were 2.70,3.38,3.06 μg,67.6%,66.4%,66.3%,3.55,3.65,3.68 μm,2.03,2.04,2.06,respectively.Conclusions The data obtained in this research characterized the in vitro nebulization characteristics of human interferon α1b for injection and provided a theoretical basis and reference for in vitro study and clinical practice.The influence of different types of nebulizers on nebulization characteristics was evaluated as well.It is suggested that the quality standard of nebulizers be strictly formulated and the use of nebulizers be standardized.
