CDAP活化制备C群脑膜炎球菌结合疫苗原液的稳定性试验  

Stability test for meningococcal serogroup C conjugate bulk by process of CDAP activation

作　　者：萧在澜 徐永浩[1] 刘佳[1] 孔素娟[1] 刘爱萍[1] 王媛[1] 冯琪瑢 刘方蕾[1] 吴兵[1] 于旭博 袁菲[1] 谢贵林 

机构地区：[1]兰州生物制品研究所有限责任公司甘肃省疫苗工程技术研究中心,甘肃兰州730046 [2]中国生物技术股份有限公司,北京100029

出　　处：《微生物学免疫学进展》2015年第5期27-32,共6页Progress In Microbiology and Immunology

摘　　要：目的：评价以1－氰基－4－二甲氨基－吡啶四氟硼酸（ CDAP ）活化制备的C群脑膜炎球菌结合疫苗原液的稳定性。方法以变通的现有工艺为基础，选取C群脑膜炎球菌结合疫苗原液连续3批样品，分别放置于（37＆#177;2）℃、（25＆#177;2）℃，和2～8℃三种温度下，根据稳定性试验原则定期取样并进行主要指标的检测，评估原液的稳定性。结果 C群脑膜炎球菌结合疫苗原液于2～8℃保存18个月，（25＆#177;2）℃保存20周，37℃保存7天，各项检测指标均符合质量标准的要求。结论在2～8℃之下，施行变通的工艺， C群脑膜炎球菌结合疫苗原液可稳定存放18个月。Objective To evaluate the stability of Meningococcal serogroup C conjugate bulks which were activated by CDAP.Methods Based on the present technical process, three consecutive batches of group C meningococcal conjugate bulks were selected, and kept in three different temperatures, as （37±2） ℃, （25±2） ℃and 2-8 ℃.The main indexes of bulks were performed in sampling periodically and detecting according to the principle of stability test, so as to assess the stability of the conjugate.Results The conjugate bulks were stable when stored at 2-8 ℃for 18 months, （25±2） ℃for 20 weeks, 37 ℃for 7 days, and all test indexes met the requirement of quality standard.Conclusion Under the condi-tion of 2-8 ℃, these meningococcal serogroup C conjugate vaccine bulks can be steadily preserved for 18 months in the modified process.

关 键 词：1-氰基-4-二甲氨基-吡啶四氟硼酸(CDAP) C群脑膜炎球菌 结合疫苗 稳定性试验 温度 

分 类 号：R392-33[医药卫生—免疫学]