摘要
目的验证和评价猪纤维蛋白原生产工艺中有机溶剂/去污剂(solvent/detergent,S/D)法联合干热法灭活病毒的有效性.方法以辛德比斯病毒、乙型脑炎病毒和伪狂犬病毒为指示病毒,验证猪血浆S/D法灭活病毒的有效性;以脑心肌炎病毒和猪细小病毒为指示病毒,验证猪纤维蛋白原冻干制剂干热法灭活病毒的有效性.结果S/D法中,辛德比斯病毒、乙型脑炎病毒和伪狂犬病毒清除滴度下降均大于4 lg;干热法中,脑心肌炎病毒和猪细小病毒清除滴度下降均大于4 lg.结论S/D法和干热法联合能有效灭活上述指示病毒,可提高猪纤维蛋白原产品的安全性.
Objective To verify and evaluate the efficacy of the solvent/detergent(S/D)method combined with dry-heating method to inactivate viruses in the preparation of porcine fibrinogen.Methods Sindbis virus,Japanese encephalitis virus,and pseudorabies virus were used as indicator viruses for S/D virus inactivation.Encephalomyocarditis virus and porcine parvovirus were used as indicator viruses for dry-heating virus inactivation.Results Reductions in titers of three indicator viruses by S/D method were>4 lg.Reductions in titers of two indicator viruses by dry-heating method were>4 lg.Conclusion S/D method and dry-heating method combined effectively inactivate the indicator viruses,thus can improve the safety of porcine fibrinogen.
作者
张理火
薛磊
Zhang Lihuo;Xue Lei(R&D Department,Shanghai Li Kang Rui Biological Engineering Co.,Ltd.,Shanghai 201707,China;Department of Thoracic Surgery,Second Affiliated Hospital of Naval Medical University,Shanghai 200003,China)
出处
《国际生物制品学杂志》
CAS
2024年第1期25-28,共4页
International Journal of Biologicals
