一种新的静注人免疫球蛋白制剂制备工艺的研究

Preparation of a new human immunoglobulin for intravenous injection

目的初步探讨一种新的静注人免疫球蛋白的制备工艺对制品得率和主要质量指标的影响。方法以组分Ⅱ+Ⅲ经过溶解、辛酸沉淀、Capto-Q层析、Macrocap-Q层析、收集流穿液,经超滤、浓缩,制备静注人免疫球蛋白,检测蛋白液中Ig A、Ig M、白蛋白、PKA、ACA含量、纯度、收率,并与低温乙醇法比较。结果与低温乙醇法比较,辛酸沉淀法可显著降低制品中Ig A、Ig M、白蛋白、PKA含量,提高产品得率。结论采用辛酸沉淀工艺制备静注人免疫球蛋白可提高制品的质量和产量。

Objective To prepare a new human immunoglobulin product for intravenous injection. Methods The human immunoglobulin for intravenous injection was prepared by melting component Ⅱ＋Ⅲ, followed by octanoic acid precipitation, Capto-Q chromatography, Macrocap-Q chromatography, ultrafiltration and concentration. The Ig A, Ig M, albumin, PKA, ACA content, purity, and yeild were tested and compared with those with low temperature ethanol extraction method. Results Compared with the low temperature ethanol extraction method, octanoic acid precipitation significantly reduced the content of Ig A, Ig M, albumin and PKA, and improved the product recovery rate. Conclusion Octanoic acid precipitation can improve the quality and yield of intravenous human immunoglobulin.