Preparation process of human hepatitis B immunoglobulin

Abstract

The invention discloses a preparation process of human hepatitis B immunoglobulin. The preparation process comprises the following steps: adopting plasma higher than the standard, and separating by a low-temperature ethanol method and a filter press technique to obtain sediment of components II and III; dissolving and carrying out dissolution and filter pressing to obtain refined sediment of components II and III; dissolving, adjusting reaction parameters, carrying out filter pressing, depth filtration, ultrafiltration and dialysis, and adjusting protein fluid parameters; carrying out column chromatography purification by using DEAE Sepharose Fast Flow weak anion exchange gel; carrying out ultrafiltration, and adjusting the pH to 4.05-4.15; adding maltose as a protecting agent; carrying out inactivation of low-pH inoculated viruses and virus removal by a DV20 filter element, carrying out secondary ultrafiltration, and controlling the maltose residue to be not higher than 2g/L; and then adding glycine as a protecting agent and the like, so as to prepare the specific human hepatitis B immunoglobulin of which the purity is over 99.0% and the valence is not lower than 100 IU/ml, wherein the total content of IgG monomer and dimer in the specific human hepatitis B immunoglobulin is over 98.0%. Compared with a traditional low-temperature ethanol method, the preparation process can improve the yield of human hepatitis B immunoglobulin by 7.5%-10%.

Description

technical field [0001] The invention relates to a preparation process of hepatitis B human immunoglobulin, which belongs to the field of biopharmaceuticals. Background technique [0002] Hepatitis B immunoglobulin (HBIG) is a specific immunoglobulin prepared by separation, purification and virus inactivation from plasma with high hepatitis B surface antibody titer collected by hepatitis B vaccine immune health donors , has specific passive immunity, can neutralize the surface antigen in the body and clear the virus. [0003] Clinically, human hepatitis B immunoglobulin can play important functions in the following aspects: 1. Block vertical mother-to-child transmission of hepatitis B. Hepatitis B virus can be transmitted vertically from mother to baby to infect newborns. Most babies are infected by inhaling maternal blood, amniotic fluid or vaginal secretions during delivery. Once a baby is infected with hepatitis B virus, 80-90% will become a chronic carrier. Therefore, ...

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