Heimburger N, Schwinn H, Gratz P, Lüben G, Kumpe G, Herchenhan B
Arzneimittelforschung. 1981;31(4):619-22.
A process is described to produce a highly purified factor VIII concentrate heated in solution. Pooled cryoprecipitate from citrated plasma is adsorbed on aluminum hydroxide gel. The fibrinogen is removed by heat denaturation in the presence of glycine; factor VIII is precipitated with sodium chloride from the supernatant. The precipitate is dissolved in a saccharose/glycine solution and heated at 60 degrees C for 10 h. The factor VIII is then separated by further precipitation with sodium chloride, the precipitate dissolved, dialysed and sterilized by filtration. The factor VIII concentrate contains approximately 6 units F VIII:C per mg protein. the ratio of F VIII R:Ag/F VIII:C is 3. The product is free from coagulable protein and gamma-globulins. The efficacy of the heating step in the reduction of the hepatitis B-infectious titre was proved in chimpanzees. For this purpose, hepatitis B virus was added to the pooled cryoprecipitate.
描述了一种生产在溶液中加热的高纯度凝血因子VIII浓缩物的方法。来自枸橼酸盐血浆的混合冷沉淀吸附在氢氧化铝凝胶上。在甘氨酸存在下通过热变性去除纤维蛋白原;从上清液中用氯化钠沉淀凝血因子VIII。沉淀物溶解在蔗糖/甘氨酸溶液中并在60℃加热10小时。然后通过用氯化钠进一步沉淀分离凝血因子VIII,将沉淀物溶解、透析并通过过滤灭菌。凝血因子VIII浓缩物每毫克蛋白质含有约6单位F VIII:C。F VIII R:Ag/F VIII:C的比值为3。该产品不含可凝固蛋白和γ球蛋白。在黑猩猩中证明了加热步骤在降低乙型肝炎感染滴度方面的功效。为此,将乙型肝炎病毒添加到混合冷沉淀中。