盐析法与低温乙醇法制备抗人T细胞猪免疫球蛋白工艺的对比

Comparative study on procedures of anti-human T lymphocyte porcine immunoglobulin by salting out method and Cohn fractionation

目的两种常用抗人T细胞猪免疫球蛋白(anti-human T lymphocyte porcine immunoglobulin)制备工艺的对比。方法以人T淋巴细胞免疫的健康猪血浆为原料,采用硫酸铵-Sephadex A-50和Cohn低温乙醇法,经醛化人健康红细胞、醛化人胎盘渣及混合人血浆吸收后,制备抗人T细胞猪免疫球蛋白,参考《中国药典》三部(2010版)相关附录,进行中间品及成品检定。结果用硫酸铵盐析法与低温乙醇法连续分别制备了3批产品,每批投浆量约5 000 ml;3批中间品鉴别试验及3批成品检定结果均符合《中国药典》三部(2010版)相关要求,两种工艺方法均适用于制备抗人T细胞猪免疫球蛋白,但在质量和收获率上,低温乙醇法更具优势。结论低温乙醇法制备抗人T细胞猪免疫球蛋白更适用于生产。

Objective To compare two procedures for preparation of anti-human T lymphocyte porcine immunoglobulin. Methods Anti-human T lymphocyte porcine immunoglobulin was prepared by ammonium sulphate-Sephadex A-50 and Cohn fractionation methods respectively,in which the foreign antibodies were absorbed with aldehydated healthy human erythrocytes,aldehydated human placenta residue and pooled human plasma. The intermediates and final product were subjected to control tests according to the requirements in Chinese Pharmacopoeia（Volume Ⅲ,2010 edition）. Results Three consecutive batches of anti-human T lymphocyte porcine immunoglobulin were prepared by two procedures respectively,for each of which about 5 000 ml of plasma was used. The results of identity tests on intermediates and control tests on final products met the relevant requirements in Chinese Pharmacopoeia（Volume Ⅲ,2010 edition）. Both the procedures were suitable for preparation of anti-human T lymphocyte porcine immunoglobulin. However,the product prepared by low-temperature ethanol fractionation was superior to that by ammonium sulphate-Sephadex A-50 in quality and recovery rate. Conclusion Low-temperature ethanol processes was more suitable for production of anti-human T lymphocyte porcine immunoglobulin as compared with salting out method.