冻干人用狂犬病疫苗(Vero细胞)对大鼠的生殖毒性  

Reproductive toxicity of freeze dried purified Vero cell rabies vaccine in rats

作　　者：闫昆明[1] 李志龙[1] 段叶叶 王桂荣[1] 李娜[1] 段雪峰[1] 高湛翱 高伟星 陈晓丹 郭世杰[4] 陈立新[1] 

机构地区：[1]长春生物制品研究所有限责任公司,长春130062 [2]大连东方雍和生物科技发展有限公司,大连116600 [3]大连汉信生物制药有限公司,大连116600 [4]吉林大学第一医院,长春130021

出　　处：《中国免疫学杂志》2015年第12期1642-1647,共6页Chinese Journal of Immunology

基　　金：国家科技重大专项资金资助(2011ZX09401-305-08)

摘　　要：目的:观察不同剂量冻干人用狂犬病疫苗(Vero细胞)对大鼠的胚胎-胎仔发育毒性,为评价冻干狂犬病疫苗的安全性提供依据。方法:雌性SD大鼠60只,随机分为4组:低剂量疫苗组(1剂/次)、高剂量疫苗组(2剂/次)、阴性对照组和辅料对照组,于交配前第0、3、7、14天免疫,21天合笼交配后,妊娠第7和14天再次免疫,分别观察各项生殖毒性指标。结果:各剂量组孕鼠生殖能力及胎仔生长发育各项指标均未见明显差异。结论:高剂量冻干人用狂犬病疫苗(Vero细胞)对大鼠无生殖毒性作用。Objective： To observe the reproductive toxicity of different dose freeze dried purified Vero cell rabies vaccine in rat. Methods： Total 60 female rats were randomly assigned into 4 groups： low dose vaccine group（ 1 dose / time）,high dose vaccine group（ 2 doses / time）,negative control group and auxiliary control group. All groups were injected rabies vaccine on day 0,3,7,14 before copulation. Rats copulated on day 21. The pregnant rats were injected on day 7,14 during pregnancy. All indexes of reproductive toxicity were observed. Results： There were no obvious difference on reproductive ability of pregnant rats and the growth and development of fetal rats in all experimental groups. Conclusion： High dose of freeze dried purified Vero cell rabies vaccine has no reproductive toxicity in rat.

关 键 词：狂犬病疫苗 VERO细胞 毒性试验 大鼠 

分 类 号：R373.9[医药卫生—病原生物学]