伤寒Vi多糖蛋白结合疫苗原液稳定性研究  

Stability for bulks of typhoid Vi polysaccharide protein conjugate vaccine

作　　者：刘月萍[1] 周海飞[1] 罗树权[1] 许博[1] 冯宜扬[1] 谢贵林 谭小梅[1] 

机构地区：[1]兰州生物制品研究所有限责任公司第一研究室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》2017年第2期42-48,共7页Progress In Microbiology and Immunology

基　　金：重大新药创制科技重大专项疫苗综合性大平台(2013ZX09402302-212)

摘　　要：目的评价伤寒Vi多糖蛋白结合疫苗原液的稳定性,为该疫苗原液的制备、储存提供有力的数据支持。方法选取3批伤寒Vi多糖蛋白结合疫苗原液分别放置于(37±2)℃、(25±2)℃和2~8℃温度下,根据稳定性研究方案定期取样,对其主要评价指标(多糖含量、结合物含量、相对分子质量、鉴别试验)进行检测,评估疫苗原液的稳定性。结果伤寒Vi多糖蛋白结合疫苗原液于2~8℃放置22个月,(25±2)℃放置52 w,(37±2)℃放置24 w时,各项主要评价指标均符合其质量标准的要求。结论伤寒Vi多糖蛋白结合疫苗原液稳定性良好,在2~8℃可稳定存放22个月。Objective To evaluate the stability for bulks of typhoid Vi polysaccharide protein conjugate vaccine, and pro- vide supportive data in preparation and storage of the bulks. Methods Three batches of bulks for typhoid Vi polysaccharide protein conjugate vaccine were selected, stored at three different conditions, （37±2） ℃ , （25±2） ℃ and 2-8 ℃ , and sampling and detecting were performed periodically, including the main indexes of bulks such as polysaccharide con- tent, conjugated polysaccharide, molecular weight and identification test according to the principle of stability test, in evaluation of the stability for the bulks. Results The bulks were stable when stored at 2-8 ℃ for 22 months, （25±2） ℃ for 52 weeks and 37 ℃ for 24 weeks, moreover the tested all indexes met the related quality standard. Conclusion The bulks of typhoid Vi polysaecharide protein conjugate vaccine matained a good stability, and could be stored at 2- 8 ℃ for 22 months.

关 键 词：伤寒Vi 结合疫苗 原液 稳定性 温度 

分 类 号：R392[医药卫生—免疫学]