森林脑炎灭活疫苗对新西兰白兔肌肉刺激及豚鼠全身过敏试验

摘要: 目的比较生产场地变更前后森林脑炎灭活疫苗对新西兰白兔肌肉的刺激性和豚鼠的全身过敏反应，评估生产场地变更后森林脑炎灭活疫苗的动物安全性。方法采用两个生产场地各3 批森林脑炎灭活疫苗，其对新西兰白兔肌肉刺激试验进行对比分析，将12 只新西兰白兔随机分为两组，每组6 只，雌雄各半。两个生产场地均设佐剂对照组和森脑疫苗试验组，采用同体左、右侧自身对比法。分别于左、右侧股四头肌肌内注射佐剂和森脑疫苗。临床观察至第3 天解剖。大体剖检、常规病理制片、病理组织学检查及显微摄影记录。全身过敏试验取豚鼠6只，每只腹腔注射0. 5 mL，间日一次，连续3 次，每日观察每只豚鼠的行为和特征。首次致敏和激发前称量每只豚鼠的体质量，然后分成两组，每组3 只，分别在第一次注射后第14 日及第21 日静脉注射供试品1 mL，观察30 min。结果注射森脑疫苗后，有与佐剂对照组相似的肌肉刺激性损伤。生产场地变更前后，注射森脑疫苗局部肌肉组织的病理改变未见明显差异。结论生产场地变更后森脑疫苗与生产场地变更前森脑疫苗效力相同，具有可靠的动物安全性。

Forest Encephalitis Inactivated Vaccine Rabbits and Guinea Pigs systemic Allergic Muscle Stimulation Test

Abstract: Objective The aim of the study is to compare the muscle stimulationand systemic allergic reactions of encephalitis inactivated vaccine before and after changing production sites in rabbits and guinea pigs and evaluate the safety of production． Method The experiments used 3 batches encephalitis inactivated vaccine produced in both production sites． Their muscle stimulation was tested in 12 rabbits which were randomly divided into two groups with equal number of male and female． Using adjuvant as control group and the Mori brain vaccine as experimental group，in the same body adjuvant and Mori brainvaccine were injected into left and right quadriceps intramuscularly． Three days after the animals were killed and necropsied， gross and routine pathological examinations were performed． Systemic allergy test was performed in six guinea pigs ( 3 animals in each group) ， and each was given 3 times intraperitoneal injection of 0. 5 mL sample，every the other day，and the behavior and characteristics of each guinea pig were recorded． At the 14th and 21st days，1 mL sample was injected intravenously． Result The injections of Mori brain vaccine and adjuvant hadthe similar muscle irritation and production sites change did not significantly alter the pathological appearance in local muscle tissue． Conclusion Mori brain vaccine after changing production site is safe in the animal experiments．