摘要
为了筛选耐热、安全的猪瘟活疫苗冻干工艺,探索工艺放大规律,为耐热冻干工艺从实验室到生产提供理论依据和技术支撑。根据新型猪瘟耐热配方的热参数科学设计冻干程序,通过冻形、加速耐老化实验、残余水分等指标筛选冻干程序并进行工艺放大。结果表明,新型猪瘟耐热活疫苗溶液的共晶点为-26.4七、塌陷温度-22.4--20.4 X.,筛选得到冻干程序3,当预冻温度为-42 t,主干燥温度为-10 t时为最优曲线。将程序3在0.15 m2-0.5 m2-2 m?进行逐级工艺放大摸索,规模放大3倍(0.5 n/)时程序可不变,放大到13倍(2 m2)时需在主干燥阶段下调隔板温度、延长干燥时间。采用新型猪瘟耐热配方及程序3制备的冻干活疫苗产品可在37 t保存20 d、45 t保存14 d;动物实验安全。上述结果表明成功筛选出新型猪瘟耐热配方的配套冻干工艺,并实现了工艺的逐级放大。
To screen the thermostable and safe freeze-drying procedure of swine fever vaccine, the magnification oflyophilization was explored to provide theoretical basis and technical support for heat-resistant freeze-drying processfrom laboratory to production. The freeze-drying procedures were designed based on the thermal parameters, andscreened through the freezing shape, accelerated aging experiment, residual water and other indicators. The resultsshowed that the eutectic point of the new swine fever-resistant live vaccine solution was 一 26.4 , the collapsetemperature -22.4 to - 20.4 ℃,and the freeze・drying procedure 3 was screened as the optimal curve when theprefreeze temperature was -42 ℃ and the main drying temperature was 一 10 C This study successfully screened theoptimal freeze-drying process 3 was adequate for 0.5 m2 freeze-dryer, and the temperatures of pre-freezing and primarydrying were -42 ℃ and -10℃,respectively. The procedure 3 in 0.15 m2—0.5 m2—2 m2 enlarged the process of the process groping, scaled up 3 times (0.5 m2) when the program could remain unchanged, zoomed in to 13 times(2m2) under the main drying phase which needed reducing the partition temperature and extending the drying time.Frozen live vaccine products prepared with a new swine fever-resistant formula and program 3 could be saved at 37 ℃for 20 d, 45 for 14 d, and animal experiments were safe. These results showed that the freeze-drying process of thenew heat-resistant formulation was successfully screened out, and the process was enlarged step by step.
作者
左晓昕
赵艳红
邓碧华
胡来根
宋伟
吕芳
卢宇
侯继波
ZUO Xiaoxin;ZHAO Yanhong;DENG Bihua;HU Laigen;SONG Wei;LYU Fang;LU Yu;HOU Jibo(Institute of Veterinary Immunology&Engineering,Jiangsu Academy of Agricultural Sciences,Nanjing 210014,China;National Research Center of Engineering and Technology for Veterinary Biologicals,Jiangsu Academy of Agricultural Sciences,Nanjing 210014,China;Chengdu Tec bond Biological Products Co.,Ltd.,Chengdu 610100,China;Jiangsu Co-Innovation Center for the Prevention and Control of Important Animal Infectious Disease and Zoonose,Yangzhou University,Jiangsu Yangzhou 225009,China;Jiangsu Key Laboratory for Food Quality and Safety-State Key Laboratory Cultivation Base,Ministry of Science and Technology,Jiangsu Yangzhou 225009,China;School of Pharmacy,Jiangsu University,Jiangsu Zhenjiang 212013,China)
出处
《中国农业科技导报》
CAS
CSCD
北大核心
2019年第12期110-118,共9页
Journal of Agricultural Science and Technology
基金
国家重点研发计划项目(2017YFD0500706-2)
江苏省农业科学院探索性颠覆性创新计划项目(ZX[17]2016)
关键词
猪瘟
冷冻干燥
工艺放大
耐热性能
安全性
classical swine fever virus
freeze drying
process magnification
heat resistance
security
