摘要目的:研究西林瓶和预灌封注射剂吸附破伤风疫苗在非临床阶段的安全性差异，为预灌封注射剂型临床使用的安全性提供参考。方法:对西林瓶和预灌封注射剂吸附破伤风疫苗分别进行体外溶血试验、主动全身过敏试验和肌肉刺激试验以评价其制剂安全性。取兔1只进行体外溶血试验，观察样品的溶血情况；取豚鼠36只进行主动全身过敏试验，观察豚鼠出现的全身反应及死亡情况；取兔16只进行肌肉刺激试验，观察注射局部的刺激反应，并进行组织病理学检查。结果:2种吸附破伤风疫苗在体外溶血试验中，对兔红细胞皆有凝聚作用，未见溶血；主动全身过敏试验中，在0.1 ml和0.5 ml致敏剂量下均未见过敏反应；肌肉刺激试验中，单次注射0.5 ml后注射部位肌肉可见轻度刺激性，停药后可恢复，与疫苗中含有铝佐剂相关。结论:西林瓶和预灌封注射剂吸附破伤风疫苗安全性均良好。

abstractsObjective:To investigate the difference in safety of vial and prefilled syringe of adsorbed tetanus vaccine in the non-clinical phase and to provide reference for the safety of clinical use of prefilled syringe.Methods:The safety of adsorbed tetanus vaccine in vial or prefilled syringe was evaluated by in vitro hemolysis test, active systemic allergy test and muscle stimulation test. One rabbit was taken for in vitro hemolysis test to observe the hemolysis of the sample. Thirty-six guinea pigs were taken for active systemic allergy test to observe the systemic reaction and death. Sixteen rabbits were taken for muscle stimulation test, and the stimulation reaction of injection area was observed visually, and pathological examination was carried out on tissues. Results:Both adsorbed tetanus vaccines had a coagulation effect on rabbit red blood cells with no hemolysis after in vitro hemolysis test. After active systemic allergy test, there was no allergic reaction at the sensitization dosages of 0.1 ml and 0.5 ml. Through the muscle stimulation test, a single injection of 0.5 ml showed mild irritation on the muscles at the injection site which recovered after the treatment stopped, which was related to the aluminum adjuvant contained in the vaccine. Conclusion:The adsorbed tetanus vaccines in vial and prefilled syringe both show good safety.