冻干静脉注射人血丙种球蛋白的研制

Preparation of a Freeze-dried Intravenous lmmunoglobulin

作者参照瑞典ＫａｂｉＶｉｔｒｕｂ药厂的“Ｇａｍｍｏｎａｔｉｖ”的制备方法，以低温乙醇法的ＦⅡ沉淀为原料，经ＤＥＡＥ－ＳｅｐｈａｄｅｘＡ－５０吸附，加入人血白蛋白作为稳定剂制备静脉注射人血丙种球蛋白（ＩＶＩＧ）。该制剂的γ－球蛋白纯度＞９４％，ＩｇＧ单体二聚体含量＞９７％，ＩｇＧ各亚类均存在且构成比与正常人血浆相似。抗补体活性（ＡＣＡ）和前激肽释放酶激活剂活性（ＰＫＡ）符合规程要求，安全性和稳定性好。该制剂为冻干剂型，便于运输和保存。

A method of preparing IVIG with albumin as a stabilizer was introduced. The IVIG was prepared from fraction Ⅱ of cold ethanol fractionation. The γ-globulin purity,IgG monomer and dimer contents were>94% and>97% respectively. All IgG subclasses were present in proportion to the ratio of them in normal human plasma. Both ACA and PKA tests met the requirements for IVIG. The IVIG is a freeze-dried preparationwhich is safe and stable.