猪瘟活疫苗耐热保护剂的筛选及安全性评价  

Screening and safety evaluation of heat-resistant protective agents for live classic swine fever vaccine

作　　者：周富昌 廖常如 陈韦韦 周琪 周家富 施江 符晓阳 ZHOU Fuchang;LIAO Changru;CHEN Weiwei;ZHOU Qi;ZHOU Jiafu;SHI Jiang;FU Xiaoyang(Research and Development Center,Royal(Wuxi)Bio-pharmaceutical Co.,Ltd.,Wuxi 214028,Jiangsu Province,China)

机构地区：[1]罗益(无锡)生物制药有限公司研发中心,江苏无锡214028

出　　处：《中国生物制品学杂志》2023年第6期647-650,共4页Chinese Journal of Biologicals

基　　金：江苏省细菌疫苗工程技术研究中心项目(BM2014148)。

摘　　要：目的筛选猪瘟(classic swine fever,CSF)活疫苗耐热保护剂配方,以延长疫苗在恶劣条件下的保存时间。方法用含有不同含量明胶、D-山梨醇、海藻糖和水解酪蛋白的配方配制的耐热保护剂,与CSF活病毒抗原混合后冻干,筛选外观合格的成品进行常规检测和耐老化试验,耐老化试验合格的成品经耳下颈部超剂量(10和30头份)免疫仔猪各5头,评价疫苗的安全性。结果制备的6批冻干CSF活疫苗成品中有3批(20200301、20200302、20200303)各项指标均符合现行《中国兽药典》要求,冻干损失在0.04~0.33个滴度,水分含量均小于2%;20200301、20200302批成品耐老化试验合格。疫苗免疫后30 min,所有仔猪均未观察到不良临床症状;疫苗免疫后连续测温14 d,10和30头份疫苗接种的仔猪体温均正常。结论筛选的2个耐热保护剂配方均可用于CSF活疫苗的冻干,且耐老化效果及对仔猪的安全性均良好。Objective To screen the formulation of heat-resistant protective agent for live classic swine fever(CSF)vaccine in order to prolong the preservation time of vaccine under harsh conditions.Methods The heat-resistant protective agent prepared based on the formula containing gelatin,D-sorbitol,trehalose,D casein hydrolysate of different contents was mixed with the live virus antigen of CSF and then lyophilized.The finished products with qualified appearance were screened for routine detection and aging resistance test,and the over-dose(10 and 30 portions)of the products qualified in the aging resistance test were used to immunize piglets via subauricular neck,5 for each to evaluate the safety of the vaccines.Results Among the 6 batches of lyophilized live CSF vaccine,3 batches(20200301,20200302 and 20200303)met the requirements of the current Chinese Veterinary Pharmacopoeia.The lyophilized loss was within 0.04~0.33 titers,and the moisture contents were all less than 2%;20200301 and 20200302 batches of finished products passed the aging resistance test.No adverse clinical symptoms were observed in all piglets 30 min after vaccination;The body temperatures of piglets vaccinated with 10 and 30 doses of vaccine were normal for 14 d after vaccination.Conclusion The two formulations of heatresistant protective agent selected might be used for freeze-dried preparations of live CSF vaccine with good effect of aging resistance and safety to piglets.

关 键 词：猪瘟活疫苗 耐热保护剂 冻干 安全性 

分 类 号：Q-311[生物学]