INACTIVATION OF 12 VIRUSES BY HEATING STEPS APPLIED DURING MANUFACTURE OF A HEPATITIS-B VACCINE

INACTIVATION OF 12 VIRUSES BY HEATING STEPS APPLIED DURING MANUFACTURE OF A HEPATITIS-B VACCINE
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DOI:
10.1002/jmv.1890230313
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发表时间:
1987-11-01
影响因子:
12.7
通讯作者:
LUCAS, CJ
LUCAS, CJ
中科院分区:
医学3区
文献类型:
--
作者:
LELIE, PN;REESINK, HW;LUCAS, CJ

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两次加热循环(在103度下90秒)的效果。摄氏65度,10小时。C)在生产血浆源性乙型肝炎疫苗期间使用,经验证可灭活12个病毒科。15分钟升温至65度。C已经完全灭活了9个病毒科代表,即痘病毒(牛痘)、小核糖核酸病毒(脑心肌炎病毒)、托加病毒(Sindbis病毒)、冠状病毒(小鼠肝炎病毒)、正流病毒(流感病毒)、横纹肌病毒(水疱性口炎病毒)、疱疹病毒(巨细胞病毒)、慢病毒(人类免疫缺陷病毒)和逆转录病毒(小鼠白血病病毒)。在65度长时间加热后。C或在103度下加热90秒。C、细小病毒(犬细小病毒)和噬菌体phiX174也完全失活。以猿猴病毒40 (SV40)为代表的木瓜病毒是最耐热的病毒。在103℃下培养90秒后,SV40的传染性降低104个TCID50 / ml。C,但观察到边际残留活性(< 1.5 TCID50 / ml)。随后在65度下进行10小时的巴氏消毒。C没有进一步降低SV40的传染性。这项研究表明,在疫苗生产过程中使用的两个热灭活步骤可以杀死可能存在于人类血液中的多种病毒。
The efficacy of two heating cycles (90 sec at 103.degree. C and 10 hr at 65.degree. C) used during manufacture of a plasma-derived hepatitis-B vaccine was validated for the inactivation of 12 virus families. A period of 15 min warming up to 65.degree. C had already completely inactivated representatives of nine virus families, ie, poxvirus (vaccinia), picornavirus (encephalomyocarditis virus), togavirus (Sindbis virus), coronavirus (mouse hepatitis virus), orthomyxovirus (influenza virus), rhabdovirus (vesicular stomatitis virus), herpes virus (cytomegalovirus), lentivirus (human immunodeficiency virus), and retrovirus (murine leukemia virus). After prolonged heating at 65.degree. C or heating for 90 sec at 103.degree. C, parvovirus (canine parvovirus) and the phage phiX174 were also completely inactivated. Papovavirus represented by simian virus 40 (SV40) was the most heat-resistant virus evaluated. The infectivity of SV40 was reduced by 104 Tissue Culture Infectious Doses (TCID50) per ml after 90 sec at 103.degree. C, but a marginal residual activity (< 1.5 TCID50 per ml) was observed. Subsequent pasteurization for 10 h at 65.degree. C did not further reduce the infectivity of SV40. This study shows that the two heat-inactivation steps used during the production of this vaccine kill a wide variety of viruses that might be present in human blood.