牛多杀性巴氏杆菌病疫苗效力检验用攻毒菌的研究
Study on Lyophilized Challenge Bacteria for the Potency Testing of Bovine Pasteurellosis multocida Vaccine Evaluation
王琦 1李建 1刘元杰 1刘燕 1姚文生 1王秀丽1
作者信息
- 1. 中国兽医药品监察所(农业农村部兽药评审中心),北京 100081
- 折叠
摘要
为提高我国牛多杀性巴氏杆菌病疫苗效力评价方法的稳定性、可靠性及检验效率,研究制备了活菌数定量的攻毒用牛多杀性巴氏杆菌C45-2 株的冻干菌.对其性状、纯粹、真空度、剩余水分、均一性、活菌数稳定性及毒力稳定性进行了检验和评价.冻干攻毒菌在疫苗效力检验中进行应用,并与-70℃冻存的攻毒菌液进行了比较研究.结果表明,定量冻干菌的性状、纯粹、真空度和剩余水分均符合冻干制品的要求;均一性检查变异系数与低温冻存菌液变异系数均小于 6%,均一性良好;保存15 个月活菌数稳定性良好,较冻存菌液有明显的优势;保存12 个月内毒力略有下降,但不影响疫苗的效力检验,可有效评价疫苗质量.试验表明冻干菌株能满足牛多杀性巴氏杆菌效力检验使用,且简化了细菌培养步骤,提高了检验结果的稳定性和工作效率.
Abstract
In order to improve the stability,reliability and test efficiency of the evaluation method for the efficacy of bovine Pasteurella multocida vaccine in China,a quantitative lyophilized strain of Pasteurella multocida C45-2 virulent strain was developed and its characters,purity,vacuum,residual moisture,uniformity,live bacteria stability and virulence stability were tested and evaluated.It was also used in the test of vaccine efficacy,and compared with the bacterial solution frozen at-70℃.The results showed that the characters,purity,vacuum degree and residual moisture of the lyophilized strains met the standards of lyophilized products.The coefficient variation of uniformity test were both less than 6%among frozen bacterial solution and lyophilized strains,showing good uniformity.The number of viable bacteria was stable in 15 months while the virulence was slightly decreased after 12 months,however it has little effect on the potency test of the vaccine,and the quality of the vaccine could be effectively evaluated.The test results showed that the lyophilized strain could meet the requirements of evaluating the potency of Pasteurella multocida in bovine,the procedure of bacteria culture was simplified,and the stability and efficiency of test results were improved.
关键词
牛多杀性巴氏杆菌病疫苗/效力检验/冻干攻毒菌Key words
bovine pasteurellosis multocida vaccine/potency test/lyophilized challenge bacteria引用本文复制引用
基金项目
国家重点研发计划(2022YFD1800600)
国家重点研发计划(2022YFD1800604)
出版年
2024
国家科技期刊平台
NSTL
万方数据