方国良,马波,杨丽,吴秀丽,李子财,徐东梅,钱雯,黄镇
FANG Guo-liang,MA Bo,YANG Li,WU Xiu-li,LI Zi-cai,XU Dong-mei,QIAN Wen,HUANG Zhen

• 1:玉溪沃森生物技术有限公司
• 2:云南沃森生物技术股份有限公司

摘要(Abstract)：

目的评价b型流感嗜血杆菌(Haemophilus influenzae type b,Hib)结合疫苗于2~8℃存放的稳定性。方法选取由玉溪沃森生物技术有限公司生产的上市销售的11批Hib结合疫苗,置2~8℃存放,分别于第0、3、6、9、12、18、24和30个月取样,进行鉴别试验、外观检查、多糖含量、p H值、氯化钠含量、高分子结合物含量、多糖分子大小、效力试验、无菌检查、热原检查、异常毒性检查和细菌内毒素检查,评价疫苗的稳定性。结果 Hib结合疫苗于2~8℃放置30个月,各项指标均符合质量标准的要求。结论 Hib结合疫苗于2~8℃存放30个月,稳定性良好。
Objective To evaluate the stability of Haemophilus influenza type b(Hib)conjugate vaccine stored at 2 ~ 8 ℃.Methods A total of 11 batches of Hib conjugate vaccine put on the market after lot release, manufactured by Yuxi Walvax Biotechnology Co., Ltd., were stored at 2 ~ 8 ℃, from which samples were taken at months 0, 3, 6, 9, 12, 18, 24 and 30 after storage for identity test, inspection on final containers, determinations of polysaccharide content, p H value,sodium chloride content, high molecular conjugate content and polysaccharide molecular size, potency test, sterility test,pyrogen test, abnormal toxicity test and bacterial endotoxin test to evaluate the stability. Results All the indexes of Hib conjugate vaccine met the quality standard 30 months after storage at 2 ~ 8 ℃. Conclusion Hib conjugate vaccine showed high stability after storage at 2 ~ 8 ℃ for 30 months.

关键词(KeyWords)： b型流感嗜血杆菌结合疫苗;稳定性
Haemophilus influenzae type b(Hib)conjugate vaccine;Stability

Abstract:

Keywords:

基金项目(Foundation):

作者(Author): 方国良,马波,杨丽,吴秀丽,李子财,徐东梅,钱雯,黄镇
FANG Guo-liang,MA Bo,YANG Li,WU Xiu-li,LI Zi-cai,XU Dong-mei,QIAN Wen,HUANG Zhen

DOI: 10.13200/j.cnki.cjb.001079

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