Coan M H
Cutter Biological of Miles, Inc., Berkeley, California 94701.
Am J Med. 1988 Jun 24;84(6A):32-6. doi: 10.1016/0002-9343(88)90155-6.
Alpha-1-proteinase inhibitor (human) (A1PI) has now been prepared as a lyophilized concentrate and has been tested clinically in humans with A1PI deficiency (also called alpha-1-antitrypsin deficiency). The protein was purified from plasma (Cohn fraction IV-1) by precipitation and ion-exchange chromatography. The resulting product behaves almost indentically to the A1PI in plasma, showing that the process is gentle and nondenaturing. In order to lower the risk of transmission of disease, the product has been heat-treated. Although this resulted in some aggregation of protein, no new antigenic sites were created. Biologic, immunologic, and physiologic studies have shown that the protein behaves normally.
α-1-蛋白酶抑制剂（人源）（A1PI）现已制成冻干浓缩物，并已在患有A1PI缺乏症（也称为α-1-抗胰蛋白酶缺乏症）的人类患者身上进行了临床测试。该蛋白质通过沉淀和离子交换色谱法从血浆（科恩IV-1组分）中纯化得到。所得产物的行为与血浆中的A1PI几乎完全相同，表明该过程温和且不会使蛋白质变性。为了降低疾病传播风险，该产品已进行了热处理。尽管这导致了一些蛋白质聚集，但并未产生新的抗原位点。生物学、免疫学和生理学研究表明，该蛋白质表现正常。
