羧甲基壳聚糖病毒灭活/去除工艺验证Verification of inactivation / removal procedure for carboxymethyl chitosan
杨倩;宋战昀;张旭光;李敏思;王向辉;隋佳辰;张健;郑言;魏春艳;王振国;
摘要(Abstract):
目的对羧甲基壳聚糖病毒灭活/去除工艺进行验证。方法模拟生产条件,选择猪细小病毒(porcine parvovirus,PPV)、伪狂犬病病毒(pseudo rabies virus,PRV)、鸭肝炎病毒Ⅰ型(duck hepatitis virus-Ⅰ,DHV-Ⅰ)、牛滤过性腹泻病毒(bovine viral diarrhea virus,BVDV)作为指示病毒,采用高温碱化和醇洗灭活/去除病毒,Karber法计算病毒滴度,荧光PCR检测病毒灭活/去除效果。结果 3批甲壳素经碱化反应处理,PRV、PPV、BVDV、DHV-Ⅰ的平均灭活对数值分别为≥6.736、≥6.597、≥6.138和≥5.806 log TCID50/0.1 ml;3批羧甲基壳聚糖经醇洗处理,PRV、PPV、BVDV、DHV-Ⅰ的平均灭活对数值分别为≥6.763、≥6.569、≥6.167和≥5.587 log TCID50/0.1 ml。碱化反应与醇洗处理前感染PRV、PPV、BVDV、DHV-Ⅰ样品荧光PCR检测平均Ct值分别为23.465、23.387,24.873、24.706,26.887、25.376,27.386、24.629,处理后样品的荧光PCR检测平均Ct值均>40。结论羧甲基壳聚糖经高温碱化和醇洗反应处理均能有效灭活病毒,保证了产品的安全性。
关键词(KeyWords): 甲壳素;羧甲基壳聚糖;病原体灭活/去除;验证
基金项目(Foundation): 国家自然科学基金项目(31001065);; 国家质检总局科技计划项目(2013IK033)
作者(Author): 杨倩;宋战昀;张旭光;李敏思;王向辉;隋佳辰;张健;郑言;魏春艳;王振国;
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DOI: 10.13200/j.cnki.cjb.001333
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