利凡诺—低温乙醇结合法分离的人血免疫球蛋白质量研究

Study of Quality of Human Immunoglobulin Separated by the Rivanol-Cold Ethanol Combination Method(R-E)

本文对分别采用利凡诺—低温乙醇结合法(R—E 法)、低温乙醇法(E 法)和利凡诺—硫酸铵结合法(R—AS 法)分离的人血免疫球蛋白质量进行了对比观察。结果用 R—E 法分离的免疫球蛋白纯度为96.67±0.93%,其中 IgG、IgA 和 IgM 组分占89.26±0.81%、6.29±0.38%和1.16±0.28%(n=10),IgG 单体和双体为95.96±1.38%,多聚体为3.04±0.73%,裂解物为1.02±1.04(n=7)。用 E 法和 R—AS 法分离的同类制品纯度分别为89.20±5.45%和96.22±0.67%,IgG、IgA 和 IgM 组分分别占88.59±4.87%、0.34±0.21%、0.15±0.09%(n=8)和88.90±1.46%、7.08±1.28%、0.24±0.29%(n=6)。E 法制品中 IgG 单体和双体为98.43±0.57%,多聚体为0.96±0.25%,裂解物为0.62±0.33%(n=3)。3种方法分离的免疫球蛋白制品经57℃加热4小时外观无明显变化。

A comparative observation of the quality of human immunoglobulin separated by the Rivanol-coldethanol combination method(R-E),the cold ethanol method(E)and the Rivanol-Ammoniumsulphate method(R-As)was performed.The experimental data and control data are as follows:Purityof immunoglobulin:96.67±0.93%(R-E,n=10);89.20±5.45%(E,n=8)and 96.22±0.67%(R-As,n=6).Proportion of IgG,IgA and IgM:89.26±0. 81%,6.29±0.38% and 1.16±0.28%(R-E,n=10);88.59±4. 87%,0.34±0.21% and 0.15%±0.09%(E,n=8)and 88.90±1.46%,7.08±1.28% and 0.24±0.29%(R-As,n=6)respectively.Proportion of IgG monomers and dimers,polymers,and fragments:95.96±1.38%,3.04±0.73% and 1.02±1.04%(R—E,n=7)and 98.43±0.57%,0.96±0.25% and 0.62±0.33%(E,n=3)respectively.All the preparations separated bythe three methods have been heated for 4 hours at 57℃,with their appearance being unchanged.