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目的考察甲型H1N1流感病毒裂解疫苗的稳定性,以保证临床用药质量。方法将3批甲型H1N1流感病毒裂解疫苗分别于37℃和2~8℃放置不同时间,进行鉴别试验、外观、装量、pH、血凝素含量、硫柳汞含量、无菌检查、异常毒性检查、细菌内毒素含量、卵清蛋白含量等全项目检测,观察疫苗的热稳定性和长期稳定性。结果 3批甲型H1N1流感病毒裂解疫苗于37℃放置7 d,各项指标均符合甲型H1N1流感病毒裂解疫苗制造和检定规程要求,且与0 d结果比较无明显差异;3批甲型H1N1流感病毒裂解疫苗于2~8℃放置18个月,各项指标均达到合格要求。结论甲型H1N1流感病毒裂解疫苗的热稳定性及长期稳定性均良好,表明甲型H1N1流感病毒裂解疫苗质量稳定。
Objective To investigate the stability of influenza A H1N1 influenza virus vaccine in order to ensure the quality of clinical medication. Methods Three batches of Influenza A H1N1 influenza virus vaccine were placed in different time at 37 ℃ and 2 ~ 8 ℃ for different time, respectively. The appearance, loading, pH, hemagglutinin, thimerosal, sterility and abnormal toxicity , Bacterial endotoxin content, ovalbumin content of the entire project testing, observation of vaccine thermal stability and long-term stability. Results Three batches of influenza A H1N1 influenza virus lysed vaccine were stored at 37 ℃ for 7 days. All the indexes were in accordance with the manufacturing and testing requirements of influenza A (H1N1) influenza virus vaccine. There was no significant difference between the two groups on 0 d. Three batches of H1N1 Influenza virus lysis vaccine placed in 2 ~ 8 ℃ for 18 months, the indicators have reached the eligibility requirements. Conclusion The thermal stability and long-term stability of influenza A (H1N1) virus lytic vaccine are good, indicating that the quality of the influenza A H1N1 influenza virus vaccine is stable.