SPF 金黄地鼠种群标准化管理与质量控制

摘要: 金黄地鼠( Golden hamster; Mesocricetus auratus) 又称叙利亚地鼠，金黄色，成年个体体质量120-150 g，染色体 22 对。目前世界各国饲养的不同品系的金黄地鼠，都是1930 年在叙利亚发现的同胞后代，由于同一祖先，遗传学上血缘相近。金黄地鼠被广泛用于微生物学，肿瘤学，内分泌学，组织移植等的研究，此外还被大量用于制造乙型脑炎疫苗和狂犬疫苗。成都公司长期使用金黄地鼠制造乙型脑炎减毒活疫苗，本公司2003 年底建立SPF 金黄地鼠核心种群， 2004 年3 月建立规模化生产种群， 13 年来累计生产SPF 金黄地鼠180 万只，供应乙脑减毒活疫苗生产150 万只，累计生产乙型脑炎减毒活疫苗2. 3 亿人份，创造产值21 亿元人民币，其中乙脑疫苗出口创汇9 000 万美元。为了长期保持SPF 金黄地鼠种群遗传稳定性和质量稳定性，我们建立了一整套标准化的饲养管理制度和质量控制体系， 10 多年来，无论是公司自检，还是送中检院国家专业实验室检测或是送国外专业实验室检测，均未检测出需要排除的病原微生物和寄生虫， 2013 年我公司的乙脑减毒活疫苗制品成功通过WHO 预认证，作为关键原材料的SPF 金黄地鼠质量也得到了WHO 检查官的认可。

The Standardized Management and Quality Control of SPF Golden Hamster Colony

Abstract: The golden hamster ( golden hamster; Mesocricetus auratus) and also called Syrian hamster，golden yellow，adult weight is 120-150 g，chromosome 22． At present the different strains of golden hamster in the world are the progeny of hamsters found in Syria in 1930 year and they have a common ancestor and genetic kinship． The golden hamsters were widely used in microbiology，oncology，endocrinology，tissue transplantation research，in addition they has also been used extensively for manufacturing JE vaccine and rabies vaccine． The Chengdu company used the golden hamsters for manufacturing the JE attenuated live vaccine for long time． The SPF golden hamster key colony was established by the end of 2003 and achieve to the scale production of the golden hamsters in March，2004． For 13 years，total output of SPF golden hamsters is 1． 8 million and are supplied 1． 5 million for manufacturing JE attenuated live vaccine． Total output of JE attenuated live vaccine is 230 million doses and create the industrial value of 2． 1 billion ＲMB ( including export MYM90 million) ． In order to maintain a long － term genetic stability and quality stability of SPF golden hamster colony，we established a set of standardized management system and quality control system． Over the past 10 years，whether it is the company＇s self inspection or sent to the national laboratory testing or sent to foreign laboratory testing． All testing results are negative． In 2013，JE attenuated live vaccine passed though pre － certification by the WHO successfully，as key raw materials， SPF golden hamsters，their quality has also been recognized by WHO inspector．