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《国产及进口重组乙型肝炎疫苗(酵母)小鼠体内效力比较-论文.pdf》由会员上传分享,免费在线阅读,更多相关内容在行业资料-天天文库。
1、中国疫苗和免疫2014年4月第2O卷第2期·105·国产及进口重组乙型肝炎疫苗(酵母)小鼠体内效力比较邱少辉,方鑫,何鹏,钟熙,梁争论,沈琦,胡忠玉(中国食品药品检定研究院,卫生部生物技术产品检定方法及其标准化重点实验室,北京100050)摘要:目的比较国产及进口重组乙型肝炎(乙肝)疫苗(酵母)[HepatitisBVaccine(HepB)MadebyRecombinantDeoxyribonucleicAcidTechniquesinYeast]的小鼠体内效力差异。方法选取一定批数的国产及进口HepB一酿酒酵母(SaccharomycesCerevisia
2、eYeast,SCY)和HepB.汉逊酵母(HansenulaPolymorphYeast,HPY),采用1.25微克/毫升(g/m1)、0.31ml、0.08~g/ml三个稀释度,进行小鼠体内效力测定,使用微粒子化学发光免疫分析法(ChemiluminescenceMieroparticleImmunoassay,CMIA)测定抗乙肝病毒表面抗原抗体(AntibodytoHepatitisBVirusSurfaceAntigen,Anti—HBs),对不同疫苗的50%有效剂量(50%EffectiveDose,ED50)及Anti—HBs几何平均浓度(Geo
3、metricMeanConcentration,GMC)进行比较。结果在SCY表达的HepB比较中,国产疫苗B在ED50及Anti-HBsGMC方面均优于其他两家疫苗;在HPY表达的HepB比较中,国产疫苗C的ED。低于其他两家疫苗,进口疫苗的Anti—HBsGMC显著高于国产疫苗。结论部分国产HepB的效力已经达到甚至超过进口疫苗的水平。关键词:乙型肝炎疫苗;酵母;效力中图分类号:R186;R512.62文献标识码:A文章编号:1006-916X(2014)02-0105-04ComparisonofPotencybetweenDomesticandImpo
4、rtedHepatitisBVaccineMadebyRecombinantDeoxyribonucleicAcidTechniquesinYeastinMiceQIUShao-hui,FANGXin,HEPeng,eta1.(NationalInstituteforFoodandDrugControl,KeyLaboratoryoftheMinistryofHealthrResearchonQualityandStandardizationofBiotechProducts,Beo'ing100050,China)Abstract:0bjectiveToco
5、mparethepotencyofdomesticandimportedHepatitisBvaccine(HepB)madebyrecombinantdeoxyribonucleicacidtechniquesinyeastinmice.MethodsAtotalof19batchesofdomesticandimportedHepBexpressedbySaccharomycesCerevisiaYeast(SCY)orHansenulaPolymorphaYeast(HPY)wereselectedtocarryoutpotencyexamination
6、.Thepotencyofeachvaccinesamplewasdeterminedinmicewiththreedilutions.AntibodytohepatitisBvirussurfaceantigen(Anti—HBs)wasdetectedwithchemiluminescencemicroparticleimmunoassayandthe50%effectivedose(ED5o)valuewascalculatedbyReed—Mzznchmethod.Anti—HBsgeometricmeanconcentration(GMC)andth
7、eED5ovaluewerecomparedamongdifferentvaccinegroups.ResultsComparisonamongHepB—SCYmanufacturedbythreedifferentmanufacturers,domesticvaccineBdemonstratedsuperiorityinED50andAnti—HBsGMC.AmongthesethreekindsofHepB—HPY,domesticvaccineChadadvantagesinED5o,whileimportedvaccineshowedsignific
8、anthigherAnti-HBsGM
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