CAJ | 학술논문

目的制备冻干b型流感嗜血杆菌(Haemophius in fluenzae type b,Hib)结合疫苗,并对其安全性和稳定性进行研究.方法用2.5％乳糖为稳定剂对疫苗进行冻干.对冻干疫苗从热原、异常毒性、破伤风类毒素毒性逆转和过敏原性4个方面进行安全性评价.将疫苗于37℃放置28 d,观察其稳定性,并检测其免疫原性.结果制备的冻干Hib结合疫苗各项安全性指标均符合要求.3只家兔免疫后体温升高均低于0.6℃.豚鼠和小鼠免疫后在7d观察期内全部健存,且在试验结束后体重均增加.疫苗在37℃放置28 d,各项检测指标均合格,多糖含量为12～15μg/剂,高分子结合物含量为82％～86％.免疫小鼠的抗体阳转率≥95％.结论冻干Hib结合疫苗是安全的且稳定性良好,为评价疫苗的保护效果及确定效期奠定了基础.
목적 제비동간b형류감기혈간균(Haemophius in fluenzae type b,Hib)결합역묘,병대기안전성화은정성진행연구.방법 용2.5％유당위은정제대역묘진행동간.대동간역묘종열원、이상독성、파상풍류독소독성역전화과민원성4개방면진행안전성평개.장역묘우37℃방치28 d,관찰기은정성,병검측기면역원성.결과 제비적동간Hib결합역묘각항안전성지표균부합요구.3지가토면역후체온승고균저우0.6℃.돈서화소서면역후재7d관찰기내전부건존,차재시험결속후체중균증가.역묘재37℃방치28 d,각항검측지표균합격,다당함량위12～15μg/제,고분자결합물함량위82％～86％.면역소서적항체양전솔≥95％.결론 동간Hib결합역묘시안전적차은정성량호,위평개역묘적보호효과급학정효기전정료기출.
Objective To prepare a freeze-dried Haemophilus influenzae type b (Hib) polysaccharide conjugate vaccine and evaluate its safety and stability.Methods The vaccine was freezedried by using 2.5％ lactose as stabilizer.The safety was evaluated in terms of pyrogen,abnormal toxicity,toxicity reverse of tetanus toxoid,and allergenicity.The stability of vaccine was determined by an accelerated stability test at 37 ℃ for 28 days.Immunogenicity was detected by a routine ELISA.Results The safety analysis showed that the vaccine met requirements.The increase of body temperature was ＜0.6 ℃ in 3 rabbits after immunization.All guinea pigs and mice survived the 7-day observation period and gained weight after test.All indicators were qualified after storing the vaccine at 37 ℃ for 28 days.The contents of polysaccharide and high molecular weight conjugate were 12-15 μg/dose and 82％-86％,respectively.Seroconversion rate was above 95％ in the immunized mice.Conclusions The freeze-dried Hib conjugate vaccine is safe and stable.The study lays the base for evaluating protective effect and determining validity period of the vaccine.