The invention discloses a process for preparing
human serum albumin. According to the process, a low-temperature
ethanol separation method is adopted, and the
human serum albumin is prepared from
human plasma. The process comprises the steps of dissolving
plasma; preparing an ingredient I; preparing an ingredient II and an ingredient III; preparing an ingredient IV; preparing an ingredient V; refining the ingredient V; carrying out
ultrafiltration; diluting; carrying out
pasteurization; sterilizing and packaging albumen; incubating products; and packaging finished products. The process has the advantages that
solid-liquid separation is carried out by adopting a pressure
filtration technology, so that the
albumin yield which is higher than 29 g / L
plasma is increased remarkably, the purity is higher than 98%, and the stability of the products is improved remarkably; Zetaplus deep filter-core
filtration is combined with the
prolongation of
pasteurization time, so that the PKA (
Protein Kinase A) level of the products is effectively controlled to be lower than 20IU / ml, and the risks of excessive heat source and
virus infection in the products are reduced; and during the process,
sodium chloride solutions of two gradient concentrations are used for carrying out
ultrafiltration, so that not only can the
ethanol residual quantity of the products be controlled to be lower than 0.025%, but also the aluminum residual quantity can be effectively minimized to be lower than 50 micrograms / L.