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.

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 using 2.5% lactose as a stabilizer. The safety was evaluated in terms of pyrogen, abnormal toxicity, toxicity reverse of tetanus toxoid, allergenicity. The stability of 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 the corresponding requirements. All indicators were qualified after the vaccine was stored at 37 ℃ for 28 days.Seroconversion rate was above 95% in the immunized mice.  Conclusions  The freeze-dried Hib conjugate vaccine was safe and stable. The study lays the base for evaluating protective effect and determining validity period of the vaccine.