Gaffney P J, Curtis A D
Thromb Haemost. 1985 Feb 18;53(1):134-6.
An international collaborative study involving seven laboratories was undertaken to assess which of three lyophilised preparations might serve as an International Standard (I.S.) for tissue plasminogen activator (t-PA). Two of the preparations were isolates from human melanoma cell cultures while one was of pig heart origin. A clot lysis assay was used by all participants in the study. The data suggested that both preparations of human cell origin were comparable, in that their log dose-response lines were parallel, while that of the porcine preparation was not. Accelerated degradation studies indicated that one melanoma extract (denoted 83/517) was more stable than the other and it was decided to recommend preparation 83/517 as the standard for t-PA. The International Committee for Thrombosis and Haemostasis (Stockholm 1983) has recommended the use of this material as a standard and it has been established by the Expert Committee on Biological Standardization of the World Health Organization as the International Standard for tissue plasminogen activator, with an assigned potency of 1000 International Units per ampoule.
开展了一项涉及七个实验室的国际合作研究，以评估三种冻干制剂中哪一种可作为组织型纤溶酶原激活剂（t-PA）的国际标准品（I.S.）。其中两种制剂是从人黑色素瘤细胞培养物中分离得到的，而另一种源自猪心脏。该研究的所有参与者均使用了凝块溶解试验。数据表明，两种源自人类细胞的制剂具有可比性，因为它们的对数剂量反应线是平行的，而猪源制剂的则不然。加速降解研究表明，一种黑色素瘤提取物（编号83/517）比另一种更稳定，因此决定推荐83/517制剂作为t-PA的标准品。国际血栓与止血委员会（1983年，斯德哥尔摩）已建议使用该物质作为标准品，并且它已被世界卫生组织生物标准化专家委员会确立为组织型纤溶酶原激活剂的国际标准品，每安瓿指定效价为1000国际单位。
