Smith J K, Evans D R, Stone V, Snape T J
Transfusion. 1979 May-Jun;19(3):299-306. doi: 10.1046/j.1537-2995.1979.19379204211.x.
A fractionation method has been modified to produce a factor VIII concentrate of intermediate purity and a potency of about 12 iu/ml, suitable for injection by syringe. The solubility, ease of filtration and purity of the concentrate have been improved by including a stage in which contaminants are precipitated at controlled temperature, pH and ionic strength. A summary of the first 50 production-scale batches is presented. Plasma can be harvested from whole blood and frozen within eight hours of donation, or after overnight storage of whole blood, with no significant difference in overall yield.
一种分馏方法已被改进，以生产出中间纯度且效价约为12国际单位/毫升的凝血因子VIII浓缩物，适合用注射器注射。通过增加一个步骤，即在可控的温度、pH值和离子强度下使污染物沉淀，提高了浓缩物的溶解度、过滤便利性和纯度。本文给出了前50个生产规模批次的总结。血浆可从全血中采集，并在献血后8小时内或全血过夜储存后冷冻，总体产量无显著差异。
