Mariner J C, House J A, Sollod A E, Stem C, van den Ende M, Mebus C A
Tufts University School of Veterinary Medicine, Section of International Veterinary Medicine, North Grafton, MA 01536.
Vet Microbiol. 1990 Jan;21(3):195-209. doi: 10.1016/0378-1135(90)90032-q.
The thermostability of a rinderpest vaccine produced on Vero cells was evaluated using a variety of chemical stabilizers and lyophilization protocols. Three stabilizer preparations and three lyophilization schedules were examined using accelerated stability testing at 37 degrees C. The vaccine preparation exhibiting the greatest stability at 37 degrees C was tested at three additional temperatures, 42, 45 and 56 degrees C, and an Arrhenius plot was constructed from the data. The stability of the reconstituted vaccine produced with the two most efficacious stabilizers was examined using three different diluent preparations. The stabilization method and high Vero cell virus batch titers resulted in a lyophilized vaccine which maintained the minimum required dose of log10 2.5 TCID50 tissue culture infectious dose for more than 20 weeks at 37 degrees C.
使用多种化学稳定剂和冻干方案,对在Vero细胞上生产的牛瘟疫苗的热稳定性进行了评估。使用在37℃下的加速稳定性测试,检查了三种稳定剂制剂和三种冻干方案。在37℃下表现出最大稳定性的疫苗制剂在另外三个温度42℃、45℃和56℃下进行了测试,并根据这些数据构建了阿伦尼乌斯图。使用三种不同的稀释剂制剂,检查了用两种最有效的稳定剂生产的重构疫苗的稳定性。稳定化方法和高Vero细胞病毒批次滴度产生了一种冻干疫苗,该疫苗在37℃下20周以上保持了log10 2.5 TCID50组织培养感染剂量的最低要求剂量。