冻干b型流感嗜血杆菌结合疫苗稳定性研究.PDFVIP

冻干b型流感嗜血杆菌结合疫苗稳定性研究 袁军 李新国 [摘要] 目的 对以乳糖作为稳定剂的b型流感嗜血杆菌(Haemophilusinfluenzaetypeb，Hib)结 合疫苗冻干剂型进行稳定性研究。方法 选取3批冻干Hib结合疫苗，分别于2～8℃保存42个月， 20～25℃保存7个月，37℃保存5周。并于考察期内对疫苗进行外观检查、检测回收率 （KD＜0.2）、游 离多糖含量、水分和小鼠效力试验，观察其是否发生降解。结果 在考察期内，冻干疫苗小鼠效力试验 阳转率均为100％，外观检查均符合规定，回收率(KD＜0.2)均≥68％，游离多糖均≤18％，水分均 ≤3.0％。各项指标均达到中国药典要求。结论 冻干疫苗于2～8℃保存42个月，20～25℃保存7个 月，37℃保存5周质量稳定。 嗜血菌，流感；疫苗，结合；冷冻干燥法 Studyonstabilityofafreeze-driedHaemophilusinfluenzaetypebconjugatevaccine YUANJun LI Xin-guoBacterialVaccineDepartment,WuhanInstituteofBiologicalProducts,Wuhan430207,China [Abstract] Objective Toresearchthestabilityofafreeze-driedHaemophilusinfluenzaetypeb(Hib) conjugatevaccineusinglactoseasastabilizer.Methods Threebatchesofthefreeze-driedHibconjugate vaccinewereselectedtobestoredat2-8℃ for42months,20-25℃ for7monthsand37℃ for5weeks, respectively.Testsforappearance,recoveryrateofpolysaccharide(KD＜ 0.2),freepolysaccharidecontent, moisturecontentandmousepotencytestwereperformedduringobservationtoseewhetherdegradationofthe vaccineoccurred.Results Theseroconversionrateinmousepotencytestwas100％,theappearanceof vaccinewasfitforthestandard,recoveryrateofpolysaccharide(KD＜0.2)was≥68％,freepolysaccharide content≤ 18％,moisturecontent≤3.0％ forallthreebatchesofthefreeze-driedvaccineduringobservation. Alltheindexesoffreeze-driedvaccinereachtherequirementsofChinesePharmacopeia.Conclusion The freeze-driedHibconjugatevaccinehasstablequalitywhenstoredat2-8℃ for42months,20-25℃ for7 monthsand37℃ for5weeks. Haemophilusinfluenzae;Vaccines,conjugate;Freezedrying 10.3760/cma.j.issn.1673-4211.2011.05.003 430207武汉生物制品研究所菌苗室 万方数据 应发生 万方数据 符合要 万方数据 周全检合格 万方数据