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1、布氏菌纯蛋白衍生物doc（PurifiedproteinderivativeDOCofBrucella）bushijunchundanbaiyanshengwu纯化布氏菌素蛋白衍生物（br-ppd）本品系用布氏菌经培养、杀菌、除去菌体后的上清液制成的纯蛋白衍生物，用于布氏病的临床诊断、布氏菌苗接种对象的选择及布氏菌苗接种后机体免疫反应的监测。1基本要求生产和检定用设施、原料及辅料、水、器具、动物等应符合”凡例”的有关要求。布氏菌纯蛋白衍生物（bp-ppd）生产车间必须与其他生物制品生产车间及实验室分开，原液生产全部过程，包括布氏杆菌的灭活，应在
2、完全隔离的区域内进行，所需设备及器具均须单独设置并专用直接用于生产的金属或玻璃等器具，应经过严格清洗及灭菌处理。2制造2.1菌种生产用菌种应符合”生物制品生产检定用菌毒种管理规程”的有关规定。2.2.1名称及来源采用猪布氏菌Ⅰ型CMCC55007（S2）菌株。2。1.2种子批的建立应符合”生物制品生产检定用菌毒种管理规程”的有关规定。2。1.3种子批的传代5代工作种子批启开至菌体收集传代应不超过。2.1.4种子批菌种的检定2.1.4.1染色镜检菌体染色后镜检应为革兰阴性小杆菌。2。1.4.2生化特性1∶1000三胜黄素做变异检查应为阴性；Itc
3、angrowintheculturemedium,doesnotgrowinthebasicfuchsinmedium;producestheobvioushydrogensulfideinthegrowthoftheculture,doesnotneedthecarbondioxide.Serologicalcharacteristicsof2.1.4.3ThestrainsofBrucellareferenceserumagglutinationtitershouldreach1to800(++)above.Cleavagecharacte
4、risticsof2.1.4.4phageItcanbecleavedbyBrucellabacteriophageWb.Preservationof2.and1.5seedbatchesFreezedriedstrainsarepreservedbelow8degrees,andliquidstrainsarepreservedbelow-70centigrade.2.2dopeSeedfor2.2.1productionTheopeningstrainswereinoculatedintheliveragarmedium,37DEGCand
5、culturedfor2to3days,accordingtothegrowthsituation,intheliveronagarslantthenpassaged1times,thegrowthofgoodlawn,availableforalargenumberoftheuseofvaccination.Culturemediumfor2.2.2productionLiverextractagarmediumorotherapprovedmediumwasused.Inoculationandcultureof2.2.3strains2.
6、2.1agoodgrowthinlargelawn,inoculationamountofliverbevelorKbottleasseed,37DEGCandculturedfor2days.Alargehepaticslopeoraliveragarbottlewasinoculatedat37daysfor2days.2.2.4harvestandsterilizationCultureswereterminated,washedwithSodiumChloridePhysiologicalSolution,sterilizedat121
7、Cfor30minutes,centrifugedandremovedthesupernatant,andsupernatantwascollected.Theabovesolutionshouldbeaddedtokeep3.0g/Lphenolorothersuitablepreservatives,preservedin4~8degrees,preservationperiodofnotmorethan30days.Freezingshouldbeprevented.2.2.5purificationThesupernatantwasco
8、llectedforpurification.Theproteinwasprecipitatedwiththreechloroaceticacidan
