冻干ACYW 135群脑膜炎球菌多糖疫苗的稳定性

Stability of freeze-dried groups A,C,Y and W135 meningococcal polysaccharide vaccine

目的评价冻干ACYW135群脑膜炎球菌多糖疫苗的稳定性。方法取3批冻干ACYW135群脑膜炎球菌多糖疫苗,分别置2~8℃及37℃存放,于不同时间点（37℃第1、2、3、4、12、24、48周;2~8℃第3、6、12、18、24、30、36个月）取样,上XK16/100 Sepharose CL-4B层析柱后,采用火箭电泳法检测4种多糖分子大小（KD值）及多糖回收率。另取3批疫苗,置2~8℃存放,分别于第12、18、24、30个月取样,进行疫苗全面检定;取同批疫苗进行酸（调p H值至5.0和4.0）、碱（调p H值至10.0和12.0）处理后置2~8℃,于不同时间点取样,上XK16/100 Sepharose CL-4B层析柱后,采用火箭电泳法检测多糖KD值及回收率。结果于2~8℃存放36个月、37℃存放24周的疫苗的多糖KD值及回收率,以及2~8℃存放30个月的疫苗的鉴别试验、外观、水分、多糖含量、分子大小及回收率、无菌检查、异常毒性检查、热源试验、细菌内毒素检查结果均符合企业内部《ACYW135群脑膜炎球菌多糖疫苗制造和检定规程》（草案）要求。疫苗调p H值至5.0及10.0后置2~8℃存放48 h,多糖KD值及回收率均符合本企业内部《ACYW135群脑膜炎球菌多糖疫苗制造检定规程》（草案）要求。结论冻干ACYW135群脑膜炎球菌多糖疫苗于2~8℃存放30个月,性能稳定。

Objective To evaluate the stability of freeze-dried groups A,C,Y,W135 meningococcal polysaccharide vaccine.Methods Three batches of freeze-dried groups A,C,Y and W135 meningococcal polysaccharide vaccine were stored at2 ~ 8 and 37 ℃,from which samples were taken at various time points（weeks 1,2,3,4,12,24 and 48 after storage at 37 ℃ and months 3,6,12,18,24,30 and 36 after storage at 2 ~ 8 ℃）,and determined for KDvalues and recovery rates of four polysaccharides by rocket immunoelectrophoresis. Another three batches of vaccine were stored at 2 ~ 8 ℃,from which samples were taken in months 12,18,24 and 30 for overall control tests. The vaccines of the same batches were treated with acid（the p H value was adjusted to 5. 0 and 4. 0） and base（the p H value was adjusted to 10. 0 and12. 0） and stored at 2 ~ 8 ℃,from which samples were taken at various time points,and determined for KDvalue and recovery rate of polysaccharides by rocket immunoelectrophoresis. Results The KDvalue and recovery rate of polysaccharides in vaccines after storage at 2 ~ 8 ℃ for 36 months and at 37 ℃ for 24 weeks,as well as the identity,appearance,moisture content,polysaccharide content,molecular size and recovery rate,sterility,abnormal toxicity,pyrogen and bacterial endotoxin content met the internal requirements for groups A,C,Y,W135 meningococcal polysaccharide vaccine（draft）. Otherwise,the KDvalue and recovery rate of polysaccharides of vaccine of which the p H value was adjusted to 5. 0 and 10. 0,after storage at 2 ~ 8 ℃ for 48 h,met the above-mentioned requirements.Conclusion The property of freezed-dried groups A,C,Y and W135 meningococcal polysaccharide vaccine was stable after storage at 2 ~ 8 ℃ for 30 months.