一种临床使用的巴氏消毒抗凝血酶III浓缩物。

A pasteurized antithrombin III concentrate for clinical use.

作者信息

Smith J K, Winkelman L, Evans D R, Haddon M E, Sims G

出版信息

Vox Sang. 1985;48(6):325-32. doi: 10.1111/j.1423-0410.1985.tb00192.x.

DOI:10.1111/j.1423-0410.1985.tb00192.x

Abstract

A method for large-scale production of a pasteurized antithrombin III (AT III) concentrate for therapeutic use has been adapted from published methods. It includes the following steps: (1) batchwise adsorption onto heparin-Sepharose from plasma depleted of cryoprecipitate and prothrombin complex; (2) chromatographic elution at high salt concentration; (3) pasteurization for 10 h at 60 degrees C in the presence of added citrate ion; (4) desalting on Sephadex G-25, and (5) sterile filtration and freeze-drying. Seven batches prepared in this manner gave a mean yield of 269 U AT III/kg plasma. The product passed all the usual animal safety and pyrogenicity tests and has been used successfully in several courses of treatment of congenital deficiencies.

摘要

一种用于大规模生产治疗用巴氏消毒抗凝血酶III（AT III）浓缩物的方法是根据已发表的方法改编而来的。它包括以下步骤：（1）从去除冷沉淀和凝血酶原复合物的血浆中分批吸附到肝素琼脂糖上；（2）在高盐浓度下进行色谱洗脱；（3）在添加柠檬酸盐离子的情况下于60℃巴氏消毒10小时；（4）在葡聚糖凝胶G-25上进行脱盐，以及（5）无菌过滤和冻干。以这种方式制备的七批产品的平均产量为每千克血浆269 U AT III。该产品通过了所有常规的动物安全性和热原性测试，并已成功用于先天性缺陷的多个治疗疗程。