The invention relates to a method for separating and purifying
fibrinogen with low impure
protein, and belongs to the technical field of
blood product production. The method comprises the following steps: preparing a
raw material component I, dissolving and filtering an FI precipitate, dissolving with a dissolving solution A, and filtering to obtain a filtrate A; purifying and separating
polyethylene glycol, adjusting the pH value of the filtrate A, adding
polyethylene glycol to precipitate, dissolving the precipitate by using the dissolving solution B, and filtering; s / D inactivation: adding an S / D solution into the filtrate B for
virus inactivation;
ethanol purification and separation: adding
ethanol to the inactivated solution to precipitate
protein, dissolving the precipitate with a dissolving solution B, and filtering; purifying and separating
glycine, adding
glycine precipitation protein into the filtrate C, dissolving the precipitate by using the dissolving solution C, and filtering; carrying out
ultrafiltration dialysis, and dialyzing and concentrating the filtrate D; preparation: diluting the
stock solution to a proper concentration; the semi-finished product is subpackaged, freeze-dried and subjected to
dry heat inactivation treatment. The method can effectively remove impure proteins, improve the purity of
fibrinogen and ensure the product safety.