SPF金黄仓鼠种群的建立及质量控制
|
摘要
目的为配合乙型脑炎减毒活疫苗世界卫生组织(WHO)预认证,建立高质量的SPF金黄仓鼠种群。方法通过剖宫产手术按照既定的配种方式建立SPF金黄仓鼠新种群,全面质量控制,定期抽样检测。结果建立了SPF金黄仓鼠核心群和生产群,19种病毒、6种寄生虫和17种细菌检测阴性。结论新建SPF金黄仓鼠种群质量符合WHO TRS 980的要求。
Objective To establish high-quality SPF golden hamster colonies in accordance with WHO pre-certification of live attenuated Japanese Encephalitis Vaccine. Methods A new SPF golden hamster colony was established by caesarean based on the established mating method. The colonies were under general quality control with regular sampling tests. Results The foundation stocks and production stocks of SPF golden hamsters were established, which were negative in 19 virological items、6 parasitological items and 17 bacteriological items. Conclusion A new SPF golden hamster colony is successfully established, the quality meets the requirements of WHO TRS 980.
Objective To establish high-quality SPF golden hamster colonies in accordance with WHO pre-certification of live attenuated Japanese Encephalitis Vaccine. Methods A new SPF golden hamster colony was established by caesarean based on the established mating method. The colonies were under general quality control with regular sampling tests. Results The foundation stocks and production stocks of SPF golden hamsters were established, which were negative in 19 virological items、6 parasitological items and 17 bacteriological items. Conclusion A new SPF golden hamster colony is successfully established, the quality meets the requirements of WHO TRS 980.
引文
[1]国家药典委员会.中华人民共和国药典(三部)[M].2015年版.北京:中国医药科技出版社,2015:122-126.
[2]WHO Expert Committee on biological Standardization.WHOTechnical Report Series(No.980)[M].2012:417-418.
[3]GB14922.2-2011,实验动物微生物学等级及监测[S].
[4]GB14922.1-2001,实验动物寄生虫学等级及监测[S].
[5]杨陵江.世界卫生组织疫苗预认证介绍[J].国际生物制品学杂志,2012,35(6):324-328.
[6]陈俏梅,张建光,束培中,等.综合方法建立清洁级仓鼠种群的初步研究[A].杭州:中国实验动物学会第六届学术年会论文集,2004.
[7]夏放,姚亚夫,周卫,等.SPF金黄仓鼠原代肾细胞安全性研究[J].实验动物科学与管理,2006,23(增刊):73-76.
[2]WHO Expert Committee on biological Standardization.WHOTechnical Report Series(No.980)[M].2012:417-418.
[3]GB14922.2-2011,实验动物微生物学等级及监测[S].
[4]GB14922.1-2001,实验动物寄生虫学等级及监测[S].
[5]杨陵江.世界卫生组织疫苗预认证介绍[J].国际生物制品学杂志,2012,35(6):324-328.
[6]陈俏梅,张建光,束培中,等.综合方法建立清洁级仓鼠种群的初步研究[A].杭州:中国实验动物学会第六届学术年会论文集,2004.
[7]夏放,姚亚夫,周卫,等.SPF金黄仓鼠原代肾细胞安全性研究[J].实验动物科学与管理,2006,23(增刊):73-76.