A群C群脑膜炎球菌-b型流感嗜血杆菌(结合)联合疫苗的稳定性  

The stability of group A&C meningococcal and Haemophilus influenzae type b( conjugate) combined vaccine

作　　者：穆姗姗 王振业 姜志毅 陈中伟 刘晓磊 孙述学 MU Shan-shan;WANG Zhen-ye;JIANG Zhi-yi;CHEN Zhong-wei;LIU Xiao-lei;SUN Shu-xue(Beijing ChengdaTianhe Biotechnology Co.,Ltd..Beijing 101111,China)

机构地区：[1]北京成大天和生物科技有限公司,北京101111

出　　处：《中国新药杂志》2022年第10期950-954,共5页Chinese Journal of New Drugs

摘　　要：目的:评价以白喉毒素无毒变异体CRM197为载体蛋白的A群C群脑膜炎球菌-b型流感嗜血杆菌(结合)联合疫苗(以下简称Nm AC-Hib联合疫苗)于不同温度条件下存放的稳定性。方法:将3批Nm AC-Hib联合疫苗分别放置于2℃~8℃,20℃~25℃,37℃条件下,定期取样,进行A群、C群、Hib多糖含量及游离多糖含量的测定,以及进行外观检查、pH值和水分含量的测定,在部分时间点同时进行鉴别试验、细菌内毒素检查、渗透压摩尔浓度、无菌检查、异常毒性及效力试验。结果:Nm AC-Hib联合疫苗于2℃~8℃保存27个月、20℃~25℃放置12个月及37℃放置6个月后,3种抗原的含量均较稳定,其他各项检测指标均符合企业内控标准。结论:以白喉毒素无毒变异体CRM197为蛋白载体的Nm AC-Hib联合疫苗具备良好的长期稳定性和热稳定性。Objective: To evaluate the stability of group A&C meningococcal and Haemophilus influenzae type b( conjugate) combined vaccine( Nm AC-Hib) which is conjugated to non-toxic variant of diphtheria toxin CRM197 under various storage temperatures. Methods: Three batches of Nm AC-Hib combined vaccines were stored at 2 ℃ ~ 8 ℃,20 ℃ ~ 25 ℃ and 37 ℃ . Samples were taken at different time points under different conditions for tests and assays including saccharide content,free-saccharide proportion,appearance,p H,and moisture content.Identification,bacterial endotoxins,osmolarity,sterility,mouse toxicity test and mouse efficiency test were also conducted at scheduled point-in-time. Results: All of the tested items met the enterprise standard after the vaccines were stored at 2 ℃ ~ 8 ℃ for 27 months,20 ℃ ~ 25 ℃ for 12 months and 37 ℃ for 6 months. And the polysaccharide contents of the vaccine had no significant changes over time. Conclusion: The Nm AC-Hib combined vaccine with CRM197 as carrier protein has good long-term stability and thermal stability.

关 键 词：脑膜炎球菌 B型流感嗜血杆菌 联合疫苗 CRM197 稳定性 

分 类 号：R978.7[医药卫生—药品]