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按照Cohn,Kistler-Nitschmann改良冷乙醇法分离血浆以制备免疫球蛋白糊膏,其中含有的乙醇在制备免疫球蛋白液体制剂时必须将其去除。 在正常免疫球蛋白制剂生产中乙醇用冻干去除。 作者欲证实是否应用超滤替代冻干可改善免疫球蛋白制剂的乙醇去除,并降低多聚体含量。 用前述两种方法生产5%免疫球蛋白制剂,以比较其乙醇浓度和分子大小分布。
Plasma was isolated according to Cohn, Kistler-Nitschmann’s modified cold ethanol method to prepare immunoglobulin pastes that contained ethanol that had to be removed in the preparation of immunoglobulin liquid preparations. Ethanol is removed by lyophilization in the production of normal immunoglobulin preparations. The authors wish to demonstrate whether ultrafiltration instead of lyophilization can improve ethanol removal of immunoglobulin preparations and reduce multimer content. The 5% immunoglobulin preparation was produced by the two aforementioned methods to compare its ethanol concentration and molecular size distribution.