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t-pA是一种内源性的血纤维蛋白溶酶原激活剂。1987年,Alteplase,即一种重组t-pA已由Genentech制成并经美国许可用于急性心肌梗塞病,t-pA的标准地已由英国国家生物标准品和质控研究所实施。第一个t-pA国际标准品建立于1984年,从黑素瘤细胞培养物的上清液中获得,这一标准品被指定用来测定血浆和生物制品中的t-pA活性以及成批生产的t-pA制剂的活性。对于第二个国际标准品,已有两种候选的制剂被检测。一种是从黑素瘤细胞培养物上清液中提纯的,另一种是由Genenfech等提供的重组t-pA制剂。这两种制剂都顺利地与第一个t-pA国际标准品进行了比较,并且
t-pA is an endogenous plasminogen activator. In 1987, Alteplase, a recombinant t-pA, has been made by Genentech and licensed by the United States for use in acute myocardial infarction. The t-pA standard has been implemented by the National Institute of Bioscience and Human-Chemistry. The first t-pA international standard, established in 1984, was obtained from the supernatant of melanoma cell culture and was designated for the determination of t-pA activity in plasma and biological products as well as in batches Activity of t-pA preparations produced. For the second international standard, two candidate formulations have been tested. One is purified from the melanoma cell culture supernatant and the other is the recombinant t-pA preparation provided by Genenfech et al. Both formulations were successfully compared to the first t-pA international standard, and