| abstract |
The present invention relates to a preparation method for intravenous injection of COVID-19 human immunoglobulin, the method comprising the following steps: (1) convalescent plasma of COVID-19 convalescent patients, or a novel coronavirus vaccine (SARS-CoV-2 vaccine) ) immunized healthy human plasma, or recovered convalescent plasma or immune plasma after virus inactivation; (2) Component II precipitation (FII precipitation) obtained by gradient treatment of inactivated plasma with low temperature ethanol method; (3) Component II Precipitate dissolving, refining and filtering, and then ultrafiltration; (4) After preparation and sterilization filtration of the ultrafiltrate, a COVID-19 human immunoglobulin (IgG) stock solution is obtained. The stock solution is incubated at low pH, nanofiltration, and sterilization filtration. Then, the intravenous injection of COVID-19 human immunoglobulin is obtained. |