【作者】 胡波； 袁进； 谭昌耀； 蒋丽明； 金瓯； 张雪艳；

【Author】 HU Bo,YUAN Jin,TAN Chang-yao,JIANG Li-ming,JIN Ou,ZHANG Xue-yan (Chengdu Institute of Biological Products,Chengdu 610023,China)

【机构】 成都生物制品研究所生物技术研究室；

【摘要】 目的:考察毕赤酵母表达的含前S抗原重组乙型肝炎疫苗原液和成品的稳定性。方法:取3批原液,置4℃存放,分别于0、1、2、3、6月时取样,测定各时间点的乙肝表面抗原S、前S1(PreS1)、前S2(PreS2)抗原酶标活性及HPLC纯度。另取3批成品,进行加速(25℃)和长期(4℃)稳定性考察。分别于0、1、2、3、6月时和0、3、6、9、12、18月时取样,进行小鼠效力、pH、细菌内毒素、无菌试验等测定。结果:3批原液于4℃保存6个月,乙肝表面抗原S、PreS1、PreS2抗原酶标活性及HPLC纯度均无明显变化。3批成品在加速和长期稳定性试验各个时间点的小鼠效力、pH、细菌内毒素和无菌试验等均检定合格。结论:毕赤酵母表达的含前S抗原重组乙型肝炎疫苗具有较好的稳定性。更多还原

【Abstract】 Objective:To study the stability of bulk and final products of recombinant hepatitis B vaccine containing PreS Antigens derived from Pichia pastoris.Methods:Three batches of bulk were stored at 4℃and samples were taken at time points of month 0,1,2,3,and month 6 separately.The titers of hepatitis B virus S,PreS1,PreS2 antigens,and purity by HPLC of each bulk at each time point were measured.On the other hand,three consecutive batches of final products were investigated in accelerated(25℃)and long-term(4℃) stability tests.Samples were taken at time points of month 0, 1,2,3,and month 6 for accelerated test and time points of month 0,3,6,9,12,and month 18 for long-term test.Potency in mice,pH,endotoxin,and sterility of each final product at each time point were detected separately.Results:The titers of S, PreS1,PreS2 antigens,and purity by HPLC of the three batches of bulks had no significant changes during the 6 month storage.The potency in mice,pH,endotoxin,and sterility of three consecutive batches of final products were qualified at each time point both in accelerated and long-term tests.Conclusion:The recombinant hepatitis B vaccine containing PreS Antigens derived from Pichia pastoris has good stable characteristics both in bulk and final product.更多还原