Winkelman L, Sims G E, Haddon M E, Evans D R, Smith J K
Thromb Haemost. 1986 Jun 30;55(3):402-5.
A therapeutic concentrate of factor XIII containing both A and B sub-units has been prepared from 300 kg pools of human plasma. The process starts from a cold-ethanol fraction from cryoprecipitate supernatant and therefore does not interfere with the recovery of other clinically valuable plasma proteins. Factor XIII is purified approximately 600-fold from plasma by precipitation with sodium citrate and by the removal of fibrinogen by brief heating. The product has been pasteurised in sorbitol solution to inactivate blood-borne viruses, ultrafiltered to remove sorbitol, adsorbed with bentonite and freeze-dried in a formulation meeting requirements for intravenous injection.
一种含有A和B亚基的凝血因子XIII治疗浓缩剂已从300千克人血浆池制备而成。该工艺始于冷乙醇沉淀上清液的冷乙醇分级分离，因此不会干扰其他具有临床价值的血浆蛋白的回收。通过柠檬酸钠沉淀和短暂加热去除纤维蛋白原，凝血因子XIII从血浆中纯化约600倍。该产品已在山梨醇溶液中进行巴氏消毒以灭活血源病毒，超滤去除山梨醇，用膨润土吸附，并在符合静脉注射要求的制剂中冻干。
