乙型脑炎减毒活疫苗批签发管理与质量评价  

Lot Release and Quality Evaluation for Japanese Encephalitis Live Vaccine

作　　者：贾丽丽[1,2] 杨悦[1] 王志伟[2] 岳广智[2] 徐宏山[2] 刘欣玉[2] 董关木[2] 

机构地区：[1]沈阳药科大学,沈阳110016 [2]中国药品生物制品检定所

出　　处：《中国药事》2009年第10期989-992,共4页Chinese Pharmaceutical Affairs

摘　　要：目的比较乙型脑炎减毒活疫苗实施批签发前后的质量变化,评价疫苗的质量控制。方法通过对市场抽检疫苗样品和批签发送检的疫苗样品质控关键项目测定结果及制造和检定记录摘要审核,对疫苗的质量和改进趋势进行分析、归纳和总结。结果3个企业生产的乙脑活疫苗在1990～2004年期间,尤其是生产初期,疫苗病毒滴度≥5.7lgpfu.mL-1的批次合格率为58.6%～100%;疫苗热稳定性试验合格批次占15%～100%;其中A企业2001～2004年,疫苗热稳试验100%合格。从2005年实施批签发后,3个企业生产的乙脑活疫苗病毒滴度均为100%合格。2006和2008年国家市场监督抽验的疫苗病毒滴度结果合格率达97.4%。结论乙脑活疫苗实施批签发后的病毒滴度合格率达100%,较实施前有明显提高。国家市场监督抽验的疫苗测定结果显示,乙脑活疫苗的质量稳定,病毒滴度合格率为97.4%。通过疫苗批签发可以准确、具体的了解企业生产和质量管理情况,督促企业规范生产、完善工艺、加强质量管理。Objective To compare quality variations of Japanese encephalitis attenuated live vaccine after and before lot release for evaluating the quality of the vaccine.Methods With protocol review and crucial item tests to evaluate quality of the vaccine.Results From 1990 to 2004,especially initial period in production,the conform rate about virus titer were 58.6-100%（≥5.7lgpfu·mL-1）by three manufacturers.The thermostability test were 15%-80%.After lot release,all of the three companies productions have been conformed （100%） in virus content of vaccine since 2005. In 2006 and 2008, the qualified rate of vaccine virus titer reached 97.4% in the national market audit sampling. Conclusions After lot release, the qualification rate of Japanese encephalitis attenuated live vaccine reached 100%, improved obviously before administration. The results of audit sampling from market showed the quality of the vaccine were stable, 97.4% of them can reach national standards. The lot release of vaccine can help us to see the production and the quality control status accurately and supervise companies to standardize the process of manufacture, improve the technics and enhance the quality control.

关 键 词：乙型脑炎减毒活疫苗 批签发 质量评价 

分 类 号：R186.8[医药卫生—流行病学] R95[医药卫生—公共卫生与预防医学]