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在静脉注射免疫球蛋白(IVIG)的制备中,采用有机溶剂结合表面活性剂(S/D)处理或60℃10小时液态加热(巴氏灭活法)的方法对组分Ⅱ(IgG)进行病毒灭活处理,灭活效果用指示病毒进行了评价,结果表明:S/D法可有效灭活脂包膜病毒VSV和Sindbis,巴氏灭活法则对上述病毒以及Vaccinia和Echo病毒均有较好的灭活作用。经病毒灭活处理的免疫球蛋白,在理化及生物学特性上基本未受到不利影响,用两种方法分别处理组分Ⅱ后制备的IVIG,其主要特性指标均符合该制品的有关质量规定。
In the preparation of intravenous immunoglobulin (IVIG), component II (IgG) was treated with organic solvent combined with surfactant (S / D) treatment or liquid state heating at 60 ° C for 10 hours (pasteurization method) Virus inactivation treatment and inactivation effect were evaluated with the indicator virus. The results showed that the S / D method could effectively inactivate the lipid enveloped virus VSV and Sindbis. The pasteurization rule was more effective on the above viruses and Vaccinia and Echo viruses Good inactivation. The immunoglobulin inactivated by virus basically had no adverse effect on the physico-chemical and biological properties. The IVIG prepared by the two methods were treated respectively by two methods. The main characteristics of the immunoglobulin were in accordance with the quality requirements of the product.