目的  对以乳糖作为稳定剂的b型流感嗜血杆菌(Haemophilus influenzae type b, Hib)结合疫苗冻干剂型进行稳定性研究。方法  选取3批冻干 Hib 结合疫苗,分别于2～8 ℃保存42个月，20～25 ℃保存7个月，37 ℃保存5周。并于考察期内对疫苗进行外观检查、检测回收率（KD＜0.2）、游离多糖含量、水分含量和小鼠效力试验，观察其是否发生降解。结果  在考察期内冻干疫苗小鼠效力试验阳转率均为100%，外观检查均符合规定，回收率（KD＜0.2）均≥68%，游离多糖含量均≤18%，水分含量均≤3.0%。各项指标均达到中国药典要求。结论  冻干疫苗于2～8 ℃保存42个月，20～25 ℃保存7个月，37 ℃保存5周质量稳定。

 Objective   To research the stability of freeze-dried Haemophilus influenzae type b (Hib) conjugate vaccine using lactose as a stabilizer. Methods   Three batches of freezedried Hib conjugate vaccines were selected to be  stored at 2-8 ℃ for 42 months, 20-25 ℃ for 7 months and 37 ℃ for 5 weeks, respectively. Tests for appearance, recovery rate of polysaccharide (KD＜0.2),  free polysaccharide content, moisture content  and mouse potency test were performed during the observation to see whether degradation of the vaccine occurred.  Results  The seroconversion rate in mouse potency test was 100% ,the appearance of vaccine was fit for the standard;,recovery  rate of polysaccharide (KD＜0.2) was ≥68%, free polysaccharide content≤18% , moisture content  ≤3% for all three batches of freeze-dried vaccines during observation. All the indexes of freeze-dried vaccine reach the requirements of Chinese Pharmacopeia. Conclusions   The qualities of freeze-dried Hib conjugate vaccine are stable when stored at 2-8 ℃ for 42 months,  20-25 ℃ for 7 months and  37 ℃ for 5 weeks.