冻干b型流感嗜血杆菌结合疫苗稳定性研究  

Study on stability of a freeze-dried Haemophilus influenzae type b conjugate vaccine

作　　者：袁军[1] 李新国[1] 

机构地区：[1]武汉生物制品研究所菌苗室,430207

出　　处：《国际生物制品学杂志》2011年第5期237-242,共6页International Journal of Biologicals

摘　　要：目的对以乳糖作为稳定剂的b型流感嗜血杆菌（Haemophilus influertzae 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％，游离多糖均≤18％，水分均≤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 a freeze-dried Haemophilus influenzae type b （Hib） conjugate vaccine using lactose as a stabilizer. ：Methods Three batches of the freeze-dried Hib conjugate vaccine 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 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 ≤3.0% for all three batches of the freeze-dried vaccine during observation. All the indexes of freeze-dried vaccine reach the requirements of Chinese Pharmacopeia. Conclusion The freeze-dried Hib conjugate vaccine has stable quality when stored at 2-8 ℃ for 42 months, 20-25 ℃ for 7 months and 37℃ for 5 weeks.

关 键 词：嗜血菌 流感 疫苗 结合 冷冻干燥法 

分 类 号：R3[医药卫生—基础医学]