The invention discloses a method for preparing
human thrombin from cold-removing glue
plasma. Firstly, anion resins are used to absorb prothrombin in the cold-removing glue
plasma, then
elution and filtering are conducted, and a prothrombin solution is obtained; secondly, the prothrombin solution is activated through a CaCL2 solution, and a
thrombin solution is obtained; thirdly, S / D
viral inactivation is conducted on the
thrombin solution; fourthly,
chromatography is conducted through cation columns, and a purified
thrombin solution is obtained; fifthly,
ultrafiltration,
dialysis and concentrate are conducted on the thrombin solution, and the thrombin solution with the
titer meeting the product specification requirement is obtained; sixthly, a
filter element of 20 nm in size is used to conduct
virus removal filtering; seventhly, sterilization filtering is conducted through a
filter element of 0.22 microns in size, and then subpackage is conducted according to the required specifications; eighthly, freeze-
drying is conducted, and
dry heat viral inactivation is conducted on freeze-
drying powder, and a
human thrombin product is obtained. According to the method, the thrombin is purified through the one-step cation columns, operation is simple, thrombin
specific activity is high, and safety of clinic use of the product is guaranteed through a three-step
virus elimination mode.