脑蛋白水解物溶液的灭活/去除病毒工艺研究

Process study of brain protein hydrolysate of inactivate and virus removal

目的 研究脑蛋白水解物灭活/去除病毒工艺.方法 选择细小病毒科细小病毒属的猪细小病毒（PPV）、弹状病毒科水疱性口炎病毒属的水泡性口炎病毒（VSV）做为指示病毒,其中PPV代表无囊膜脱氧核糖核酸（DNA）病毒,VSV代表有囊膜核糖核酸（RNA）病毒.模拟生产工艺中的病毒灭活步骤100℃×30 min,超滤作为灭活/去除病毒条件.将病毒分别按照1∶9加入到脑蛋白水解物溶液中,进行高温和超滤灭活/去除病毒.以猪肾细胞（PK-15）细胞培养PPV,以非洲绿猴肾细胞（Veto细胞）培养VSV,测定病毒滴度.结果 PPV、VSV通过灭菌,病毒半数组织培养感染剂量（TCID50）分别为6.15 log/0.1 mL （logs）、5.37 log/0.1 mL（logs）;去除工艺平均病毒降低系数分别为6.15 log/0.1 mL （logs）、5.37 log/0.1 mL（logs）.结论 生产脑蛋白水解物溶液工艺中的高温和超滤均是有效的病毒灭活/去除工艺.

Objective To study the process of brain protein hydrolysate of inactivate and virus removal.Methods The Parvoviridae parvovirus genera of porcine parvovirus （PPV）,vesicular stomatitis virus rhabdovirus genera of vesicular stomatitis virus （VSV） were chosen as a model virus,wherein PPV represents no envelope deoxyribonucleic acid（DNA） virus,VSV represents the envelope ribonucleic acid（RNA） virus.Simulation of the production process of virus inactivation steps 100 ℃× 30 min,ultrafiltration as inactivation/removal condition.The virus respectively according to 1 ∶ 9 into the brain protein hydrolysate,high temperature and ultra filtration virus inactivation/removal.In pig kidney cells （PK-15） in PPV cell culture,Africa green monkey kidney cells（Vero cells） cultured VSV,determination of virus titer.Results PPV and VSV through the sterilization,virus median tissue culture infective dose（TCID50） were 6.15log/0.1mL（logs）,5.37 log/0.1mL（logs） ;removal processaverage virus reduction coefficient were 6.15log/0.1mL（logs）,5.37 log/0.1mL（logs）.Conclusion The high temperature and ultra filtration produces brain protein hydrolysate solution process are effective virus inactivation/removal process.