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Abstract] Objective For the purpose of scientific evaluation and improvement on unreasonable parameter of viral inactivation,the dynamics curve of time corresponding to effect by given viral inactivation factor treated to blood plasma product were analyzed.Methods Aimed at vesicular stomatitis virus, sindbis virus, human immunodeficiency virus, polioviruses, pseudorabies virus,encephalon-yocarditis virus; validate data of viral inactivated on pasteurization of albumin, human rabies immunoglobulin with pH 4, human immunoglobulin and human hepatitis B immunoglobulin for intravenous injection with pH 4/pasteurization,treatment on human fibrinogen and human coagulation factor Ⅷ with solvent/detergent and vapor heating at 100 ℃30 min were systemic regularized respectively.The mean and standard deviation also coefficient of variation for virus survival titer in different time were stated, dynamics curve of virus inactivation were made and analyzed.

目的 分析血液制品特定灭活因子的时效动力学曲线,科学性地评价与改进不合理的病毒灭活参方法系统性整理针对水疱性口炎病毒、黄热病毒、脊髓灰质炎病毒、伪狂犬病毒、脑心肌炎病毒、人类免疫缺陷病毒,人血白蛋白采用巴氏消毒法,狂犬病人免疫球蛋白采用低pH常温孵放法,静注人免疫球蛋白、静注人乙肝免疫球蛋白采用低pH/巴氏消毒法;人纤维蛋白原、人凝血因子Ⅷ采用有机溶剂/去污剂与干热法灭活病毒的验证资料,统计3批样品取样点的残余病毒滴度均值、标准差与变异系数,制作灭活病毒动力曲线图并进行分析。

Methods Aimed at vesicular stomatitis virus, sindbis virus, human immunodeficiency virus, polioviruses, pseudorabies virus,encephalon-yocarditis virus; validate data of viral inactivated on pasteurization of albumin, human rabies immunoglobulin with pH 4, human immunoglobulin and human hepatitis B immunoglobulin for intravenous injection with pH 4/pasteurization,treatment on human fibrinogen and human coagulation factor Ⅷ with solvent/detergent and vapor heating at 100 ℃30 min were systemic regularized respectively.

系统性整理针对水疱性口炎病毒、黄热病毒、脊髓灰质炎病毒、伪狂犬病毒、脑心肌炎病毒、人类免疫缺陷病毒,人血白作者:魏宪义,魏红,蹇远勇,陈海,刘文芳目的分析血液制品特定灭活因子的时效动力学曲线,科学性地评价与改进不合理的病毒灭活参数。

Abstract] objective for the purpose of scientific evaluation and improvement on unreasonable parameter of viral inactivation,the dynamics curve of time corresponding to effect by given viral inactivation factor treated to blood plasma product were analyzed.methods aimed at vesicular stomatitis virus, sindbis virus, human immunodeficiency virus, polioviruses, pseudorabies virus,encephalon-yocarditis virus; validate data of viral inactivated on pasteurization of albumin, human rabies immunoglobulin with ph 4, human immunoglobulin and human hepatitis b immunoglobulin for intravenous injection with ph 4/pasteurization,treatment on human fibrinogen and human coagulation factor ⅷ with solvent/detergent and vapor heating at 100 ℃30 min were systemic regularized respectively.the mean and standard deviation also coefficient of variation for virus survival titer in different time were stated, dynamics curve of virus inactivation were made and analyzed.results human albumin pasteurization inactivated vsv and sindbis virus,hrig low ph inactivated vsv and sindbis virus,hrig low ph inactivated hiv virus,ivig low ph/pasteurization inactivated hiv virus,ivig low ph inactivated hiv virus,hbig low ph/pasteurization inactivated vsv,sindbis and polio virus.conclusion suggestion about improvement on unreasonable parameter and standard of virus inactivation is made,cultivate target virus directly from final product by appropriate cell or method to monitoring viral safety of blood plasma product is advanced.

目的 分析血液制品特定灭活因子的时效动力学曲线,科学性地评价与改进不合理的病毒灭活参数。方法系统性整理针对水疱性口炎病毒、黄热病毒、脊髓灰质炎病毒、伪狂犬病毒、脑心肌炎病毒、人类免疫缺陷病毒,人血白蛋白采用巴氏消毒法,狂犬病人免疫球蛋白采用低ph常温孵放法,静注人免疫球蛋白、静注人乙肝免疫球蛋白采用低ph/巴氏消毒法;人纤维蛋白原、人凝血因子ⅷ采用有机溶剂/去污剂与干热法灭活病毒的验证资料,统计3批样品多个取样点的残余病毒滴度均值、标准差与变异系数,制作灭活病毒动力曲线图并进行分析。结果人血白蛋白巴氏灭活vsv与sindbis病毒,hrig低ph灭活vsv和sindbis病毒,hrig低ph灭活hiv病毒,ivig低ph/巴氏灭活hiv病毒,ivig低ph灭活hiv病毒,hbig低ph/巴氏灭活vsv、sindbis与polio病毒。结论建议改进病毒灭活验证标准与不合理的灭活参数;采用终产品样品通过合适细胞或方法直接培养目标病毒来有效监测血液制品的病毒安全性。

Methods Aimed at vesicular stomatitis virus, sindbis virus, human immunodeficiency virus, polioviruses, pseudorabies virus,encephalon-yocarditis virus; validate data of viral inactivated on pasteurization of albumin, human rabies immunoglobulin with pH 4, human immunoglobulin and human hepatitis B immunoglobulin for intravenous injection with pH 4/pasteurization,treatment on human fibrinogen and human coagulation factor Ⅷ with solvent/detergent and vapor heating at 100 ℃30 min were systemic regularized respectively.The mean and standard deviation also coefficient of variation for virus survival titer in different time were stated, dynamics curve of virus inactivation were made and analyzed.

系统性整理针对水疱性口炎病毒、黄热病毒、脊髓灰质炎病毒、伪狂犬病毒、脑心肌炎病毒、人类免疫缺陷病毒,人血白蛋白采用巴氏消毒法,狂犬病人免疫球蛋白采用低pH常温孵放法,静注人免疫球蛋白、静注人乙肝免疫球蛋白采用低pH/巴氏消毒法;人纤维蛋白原、人凝血因子Ⅷ采用有机溶剂/去污剂与干热法灭活病毒的验证资料,统计3批样品多个取样点的残余病毒滴度均值、标准差与变异系数,制作灭活病毒动力曲线图并进行分析。

Methods Aimed at vesicular stomatitis virus, sindbis virus, human immunodeficiency virus, polioviruses, pseudorabies virus,encephalon-yocarditis virus; validate data of viral inactivated on pasteurization of albumin, human rabies immunoglobulin with pH 4, human immunoglobulin and human hepatitis B immunoglobulin for intravenous injection with pH 4/pasteurization,treatment on human fibrinogen and human coagulation factor Ⅷ with solvent/detergent and vapor heating at 100 ℃30 min were systemic regularized respectively.

系统性整理针对水疱性口炎病毒、黄热病毒、脊髓灰质炎病毒、伪狂犬病毒、脑心肌炎病毒、人类免疫缺陷病(本论文仅供参考,如需转载本文,请务必注明原作者以及转载来源:论文图书馆 www.lwlib.com)作者:魏宪义,魏红,蹇远勇,陈海,刘文芳目的分析血液制品特定灭活因子的时效动力学曲线,科学性地评价与改进不合理的病毒灭活参数。

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