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Objective: To investigate the aerodynamic characteristics of the nebulized recombinant human inter- feron α1b(rhIFN α1b)injection and its delivery in different respiratory modes both in vitro. Methods: The particle size distribution and aerodynamic properties of the nebulized rhIFN α1b injection for inhalation were evaluated with Spraytec STP5313 and the next generation pharmaceutical impactor(NGI). The total delivered dose and delivery rate were deter- mined using a breathing simulator. Results:After atomization, the D50 of rhIFN α1b droplets was 2.74 μm, the fine par- ticle fraction(FPF)was 77.49%, the mass median aerodynamic diameter(MMAD)was 3.26 μm, and the geometric standard deviation(GSD)was 1.93. In neonatal, infant, and child breathing modes, the delivered total amount of rhIFN α1b by spraying for 220 seconds was 2.10, 2.44, and 3.51 μg, respectively. Conclusion: After atomization, the particle size of rhIFN α1b injection was small enough to be transmitted to the lung, and the total delivered dose and delivery rate showed a tendency of increase in turn in the neonatal, infant, and child breathing modes, indicating that the effective dose of the drug and the age of patients should be considered when formulating the clinical treatment plan.
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Objective To systematically assess the safety of recombinant human interferon α1b(rhIFNα1b) as therapy for viral diseases in children,so as to provide on evidence-based medicine for the clinical treatment.Methods Randomized controlled trails (RCTs) of rhIFNα1b for viral diseases in children were investigated through PubMed literature retrieval service system,Science Citation Index,China National Knowledge Infrastructure,WanFang Database;RCTs were selected according to the inclusion and exclusion criteria.Related data were extracted and the Meta-analysis was performed.Results Nineteen RCTs were involved,including 2 731 patients.In the overall,59/1 437 cases (4.1％) in the rhIFNα1b treatment group and 79/1 294 cases (6.1％) in the control group had adverse reactions.The Meta-analysis revealed that in the overall and in atomization inhalation subgroup,the incidence of adverse reactions was significantly lower in the rhIFNα1b treatment group than that in the control group [Z =2.18 (P =0.03),RR =0.71(95％ CI:0.52-0.97);Z =2.44(P =0.01),RR =0.53 (95％ CI:0.32-0.88)].But,there was no significant difference in the incidence of adverse reactions between the rhIFNα1b treatment group and the control group in intramuscular injection subgroup,and the test for overall effect was Z =0.78 (P =0.43),RR =0.86 (95 ％ CI:0.58-1.26).The incidence of adverse reactions of the control group was significantly higher than that of the rhIFNα1b treatment group in gastrointestinal adverse reaction [Z =2.20 (P =0.03),RR =0.60 (95 ％ CI:0.39-0.95)],and the incidence of adverse reactions of the rhIFNα1b treatment group was significantly higher than that of the control group in nervous system symptoms [Z=2.09(P=0.04),RR =4.28(95％ CI:1.10-16.72)].Conclusion Compared with other antiviral drugs,the treatment of pediatric common viral diseases with rhIFNα1 b has good safety,low incidence of adverse reactions,and the incidence of adverse reactions through atomization inhalation can be lower than that of intramuscular injection.
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Objective To study the inhibitory effect of recombinant human interferon α1b (IFN-α1b) on enterovirus 71 (EV71) in vitro and to investigate the antiviral mechanism of IFN-α1b.Methods The cytotoxity of IFN-α1b and the inhibition of IFN-α1b on cytopathic effect before and after EV71 infection were measured in rhabdomyosarcoma (RD) cell line.The in vitro inhibition of IFN-α1b on EV71 RNA and VP1 protein,and the protection of IFN-α1b on EV71 infected cells were also investigated.Then the EV71 invasion prevention of IFN-α1b induced transmembrane protein IFITM3 was evaluated.Results When treated 12h before or 1h after EV71 infection,IFN-α1b presented a IC50 258.53IU/ml and 2113.58IU/ml with SI>16497 and >3271,respectively,suggesting that IFN-α1b had obvious anti EV71 activity,and IFN-α1b treatment before EV71 infection was more effective.This study also showed that IFN-α1b significantly inhibited EV71 RNA replication and protein synthesis,and delayed the progeny virus release,which might prevent EV71 invasion by inducing IFITM3 expression.Conclusion IFN-α1b has anti EV71 activity and can act as an antiviral agent by influencing the viral life cycle including invasion,replication,assembly and release.
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Objective To evaluate the quality status of recombinant human interferon α1b injection and find out some quality problems.Methods Totally 31 batches of recombinant human interferon α1b for injection and 11 batches of recombinant human interferon α1b injection from two enterprises were examined according to Chinese Pharmacopoeia Volume Ⅲ (2010),and the quality status of recombinant human interferon α1b injection was evaluated by statistical analysis of the results.Results All 42 batches of samples were qualified.The production process of each enterprise was steady.Conclusion At present the quality of recombinant human interferon αlb injection is generally good.The current standards are feasible,but the specified standard of osmolality needs to be improved.
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Obgective To investigate the impact of different ways and doses of recombinant human interferon o1b(rhIFN-α1b) on antiviral effect on respiratory syncytial virus(RSV)-effected mice and signal pathway of JAK/ STAT.Methods Forty-eight mice were divided randomly into 6 groups,negative control group,RSV-infection model group,12.5,25.0,50.0 μg rhIFN-α1 b atomization inhalation of intervention group,and 12.5 μg rhIFN-α 1 b injection of intervention group.After continuous drug therapy for 5 days,the left lung tissues of mice were aseptically dissected in the sixth day.Then it were observed lung tissue pathology changes by optical microscope,and expression of STAT1 and STAT2 protein with laser scanning confocal microscopy.Results It was observed that RSV-infection model mice's lungs had significant inflammatory injury under light microscope.After treatments of rhIFN-α 1b,it showed that the mice lung tissue had recovery of inflammation on different degrees.The group of inhaled rhIFN-o1b 50.0 μg was damaged on lightest degree.There were statistically significant differences between each group (all P ＜ 0.05).The expression of STAT1 and STAT2 protein in RSV-infection model mice's lungs decreased remarkably under fluorescene microscopy.Treatments of rhIFN-α 1b increased the expression of STAT1 and STAT2 inhibited by RSV-infection.The expression of STAT1 and STAT2 protein of the inhaled rhIFN-α1b 50.0 μg group increased significantly.The differences between groups were statistically significant(all P ＜ 0.05).Conclusions rhIFN-α 1 b played an important role in anti-RSV effects,simultaneously,it could improve the activity of JAK/STAT signal pathway inhibited by RSV-infection.The treatment effect of rhIFN-α 1b deliveried by atomization inhalation was better than that of intraperitoneal injection.And curative effect is proportional to the atomization inhalation dose within a certain range.