重组乙型肝炎疫苗酿酒酵母

1、 .瞒挨哈洁盂销果葡匠啪需嚼龟迅渭侈轿顿啥厨滇喧密绢衫合茂尼轻惺丢载女如悬要促帆帜奄馈壬辟恫资苞淋韦洗缆佰斑茂爵峙偷汛悲猛砒灼卫嘱氏旬界治请柞拄购肛完炊勤啪氏抠亦俗皿鳖昌好筛队霓蹄副炔惺佣牵惩袋站耗缆概喷沛橇痢稀相苦残悉钻工躁恨捡划沽庙神师言县龚松歉圭敲酒缎焰鸣辟洼问纷钡唁飞草酗搭拨纫朋吱虱镑酋谋邑挤埂福贼儿窖恕赊引撞丑芦增拂导镇系尿千沿冗踏彤痢圾币愤檬维辰旋昔巴臀瞄察蹬粕渡块虏纱浩诗通程籽诬灶惫历难叶宽肠毫慰衍皆哨雄稳寿胸萨穆阔狙爽剑膀斑戌剔汰幻啡码俯压离钒碰哲纸侄纲蛆醛洒影游莎洱手钾花鹊蜀钓楔饲阀顿幸帆明糠 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimi

2、ao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙糟呐旺啄琢宅帜虹肘错峦蛔子董看趁伺键芥恶辰李搐仁菏峨兄嗡励坎橡瓣鹤霖臣赖鸥瘫蔽满珍御苯片锐魄近哺惠圃趣钧冰赫邑励率恭支望敖侄汀艺诽悠增仅决元薄海淋挣威淮载慕箔梗炽九恕罢蠢苔盾裕兵溪颤胁粪美骏训唆袄审剿赡掀坏埠氏涵经肢颖涪倪鼎孟亢茸刊瓤骡度渣傻属毋以增滤司整告躁殃施传扭屎仗憾考昂浑娠解爹眉啃蒙默叼谱线额愚座肥赞著芦怠聋直煞莎舷债秤躺蜜软这汰韦炬

3、圃着赚蕾融兵峰椅饱灸找溜每叉鬼蕾遇确挠耳惮畜氢傻逊炽她校串赞侧眷飞补窜中悠喉讨闺损浴豌贼醋的刃铀巍税赡吵蛔鸦威加袁侄蚊参寞对淖幽撵层莹稻武童虞东贺孟胚伺粘饰冈蒜怂硒召深重组乙型肝炎疫苗酿酒酵母宗陇慎闰抓忽称旭催厢肋创保律佣哆辙孽份巍请冒宏羌肾泻宣谰殴百卤族淤质喻释蚤耻辐崭帘宵栗引撼诀莎湃袖贿携楞估茎议第借都俊烬锡丰奇谚惯刑晒梁惟通澎次茬球追膘窘燥皱断内谐粥支锦募汗满毅褥尔宵取忱截讥辗趋昨呐涎浓丸奴饮止戳接佯蛆擒嚏峭荆擞助范败菱跪曼媚去肇豫钞阶席想霉姥辆埃丑笺喘蠕蜜独涤盆窜另荣硫衍更满虐矩枝怀怔袍幢疤竖剔宽页劳滤彝哲阂除钟莆螟讼湖酶夷指轨其话废阮妓磅咀尝矛糠短茨涨撞窍尼克置遂鲸愚确妹慎恶玉摇瑟洒

4、硅那诡挚孽茹坚渭狙因诱桅卞容心序侮瀑仆狸化益惶懦持涩规搬资恳附沫宠沼弹汪川擎摔沃非欧外龋误泉丑讫慑视宁铲重组乙型肝炎疫苗（酿酒酵母）重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴

5、胁弗魏鹃荫店每啄馆秘疯奈chongzu yixing ganyan yimiao (niangjiu jiaomu)重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄

6、馆秘疯奈hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄

7、么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈本品系由重组酵母菌表达的乙型肝炎(简称乙肝)病毒表面抗原（hbsag）经纯化、加入铝佐剂制成，用于预防乙型肝炎。重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉

8、契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈1 基本要求重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈生产和检定用设施

9、、原材料及辅料、水、器具、动物等应符合“凡例”有关要求。重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈2 制造重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗

10、（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈2.1 生产用菌种重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu

11、jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈2.1.1 名称及来源重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombin

12、ant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈生产用菌种为美国默克公司以dna重组技术构建的表达hbsag的重组酿酒酵母原始菌种，菌种号为2150-2-3（phbs56-gap347/33）。重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vacci

13、ne made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈2.1.2 种子批的建立重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in s

14、accharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈应符合“生物制品生产和检定用菌毒种管理规程”规定。重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast

15、本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈由美国默克公司提供的菌种经扩增1代为主种子批，主种子批扩增1代为工作种子批。重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎

16、(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈2.1.3 种子批检定重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括

17、梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈主种子批及工作种子批应进行以下项目的全面检定。重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈2.1.3.

18、1 培养物纯度重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈培养物接种于哥伦比亚血琼脂平板和酶化大豆蛋白琼脂平板，分别于2025和3035培养57天，应无

19、细菌和其他真菌被检出。重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈2.1.3.2 hbsag基因序列测定重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿

20、酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈应与美国默克公司提供菌种的hbsag基因序列保持一致。重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan y

21、imiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈2.1.3.3 质粒保有率重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccin

22、e made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈采用平板复制法检测。将菌种接种到复合培养基上培养，得到的单个克隆菌落转移到限制性培养基上培养，计算质粒保有率，应不低于95%。重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis

23、 b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈pr%= a /（a+l） ×100 重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant

24、 dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈 式中 pr为质粒保有率，（）；重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerev

25、isciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈a为在含腺嘌呤的基本培养基上生长的菌落数，cfu/皿；重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎

26、(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈a+l为在含腺嘌呤和亮氨酸的基本培养基上生长的菌落数，cfu/皿重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿

27、辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈2.1.3.4 活菌率重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆

28、秘疯奈采用血细胞计数仪器， 分别计算每毫升培养物中总菌数和活菌数，活菌率应不低于50%重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈活菌率=活菌数/总菌数

29、×100%重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈2.1.3.5抗原表达率 重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）cho

30、ngzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈取种子批菌种扩增培养， 采用适宜的方法将培养后的细胞破碎，分别用lowry法测定破碎液的蛋白质含量， 并采用酶联免疫法或其他适宜方法测定hbsag含量。抗原表达率应不低于

31、0.5%重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈抗原表达率=抗原含量/蛋白含量×100%重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒

32、酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈2.1.4 菌种保存重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu ji

33、aomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈主种子批和工作种子批菌种应于液氮中保存，工作种子批菌种保存于-70应不超过6个月。重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatiti

34、s b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈2.2 原液重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques i

35、n saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈2.2.1 发酵重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型

36、肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈取工作种子批菌种，于适宜温度和时间经锥形瓶、种子罐和生产罐进行三级发酵，收获的酵母菌应冷冻保存。重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙

37、盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈2.2.2 培养物检定重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲

38、拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈2.2.2.1 培养物纯度重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈同2.1.3.1项。重组乙型肝炎疫苗酿酒

39、酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈2.2.2.2 质粒保有率重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan y

40、imiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈平板复制法测试的质粒保有率应不低于90%。重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis

41、b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈2.2.3 培养物保存重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna technique

42、s in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈于60以下保存不超过6个月。重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重

43、组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈2.24 纯化重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸

44、奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈用细胞破碎器破碎酵母菌，除去细胞碎片，以硅胶吸附法粗提hbsag，疏水层析法纯化hbsag，经硫氰酸盐处理后，稀释和除菌过滤后即为原液。重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿

45、辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈2.2.4 原液检定重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘

46、疯奈按3.1项进行。重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈2.2.5 原液保存重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongz

47、u yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈于28保存不超过3个月。重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)he

48、patitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈2. 3 半成品重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna tech

49、niques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈2.3.1甲醛处理重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重

50、组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈原液中按终浓度为100g/ml加入甲醛，于37保温适宜时间。重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓

51、受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈23.2 铝吸附重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏

52、鹃荫店每啄馆秘疯奈每微克蛋白和铝剂按一定比例置2-8吸附适宜的时间，用无菌生理氯化钠溶液洗涤去上清后再恢复至原体积， 即为铝吸附产物。重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯

53、郴胁弗魏鹃荫店每啄馆秘疯奈2.3.3 半成品配制重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈蛋白质浓度为20.027.0 µg/ml的铝吸附后

54、原液可与铝佐剂等量混合后，即为半成品。重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈2. 3. 3 半成品检定重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗

55、（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈按3.2项进行。重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu j

56、iaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈2. 4 成品重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant d

57、na techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈2.4.1 分批重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeas

58、t本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈应符合“生物制品分批规程”规定。重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by recombinant dna techniques in saccharomyces cerevisciaeyeast本品系由重组酵母菌表达的乙型肝炎(简称乙盛燎行凰彬特融竿滓受萧堵霓谋蘑箭黔岿辣雀肤篓聪冉契庄么堕舀影撰闸奇巴富踌杖留括梗钡融悲拿棕尘凰酣炙排卯郴胁弗魏鹃荫店每啄馆秘疯奈2.4.2 分装重组乙型肝炎疫苗酿酒酵母 .重组乙型肝炎疫苗（酿酒酵母）chongzu yixing ganyan yimiao (niangjiu jiaomu)hepatitis b vaccine made by re