摘要
目的制备冻干b型流感嗜血杆菌（Haemophius in fluenzae typeb，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于。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28d，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28d，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。
Objective To prepare a freeze-dried Haemophilus influenzae type b （Hib） polysaccharide conjugate vaccine and evaluate its safety and stability. Methods The vaccine was freeze- dried 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 ~C 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 d0.6 ~C 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 12-15μg/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.
出处
《国际生物制品学杂志》
CAS
2014年第3期110-113,共4页
International Journal of Biologicals
关键词
嗜血菌
流感
b型
疫苗
结合
冻干
乳糖
免疫原性
Haemophilus influenzae, type b
Vaccines, conjugate
Freeze-dried
Lactose
Immunogenicity
