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目的 进一步提高低pH静脉注射两种球蛋白制剂质量。方法采用一步DEAE-Sepharose FF柱 层析吸附。结果IgA残留量由吸附前的5.60±3.mg/g蛋白下降到1.16±0.38mg/g蛋白,清除率达(75.32± 19.19)%,总蛋白回收达(88.55±2.76)%,IgG纯度进一步提高。制剂中的ACA、PKA、白喉抗体、单体加二聚体比例等指标均符合规程要求。结论 DEAE-Sepharose柱层析吸附可提高IVIg质量。
Objective To further improve the quality of two globulin preparations by low pH intravenous injection. Methods One-step DEAE-Sepharose FF column chromatography was used. The results showed that the amount of IgA residue was 5.60 ± 3 before adsorption. mg / g protein decreased to 1.16 ± 0.38mg / g, the clearance rate reached 75.32 ± 19.19%, the total protein recovery reached 88.55 ± 2.76%, and the purity of IgG was further increased . Preparation of ACA, PKA, diphtheria antibody, monomer plus dimer ratio and other indicators are in line with the rules and requirements. Conclusion DEAE-Sepharose column chromatography can improve the quality of IVIg.