尿型纤溶酶原激活剂 (u PA)是新一代的基因工程溶栓药物。建立了重组人糖基化尿型纤溶酶原激活剂的中试生产工艺。中试产品的结构正确性和一致性分析是证明产品质量的重要依据 ,所以 ,对三批产品进行了抗原特异性分析。结果 ,u PA三批中试产品SDS PAGE显示的蛋白区带与免疫印迹显示的免疫活性区带没有批次差别 ,说明u PA三批中试产品表现了一致的u PA的免疫原性 Urinary type plasminogen activator (uPA) is a new generation of genetically engineered thrombolytic drugs. A pilot production process of recombinant human glycosylation urinary plasminogen activator was established. The structural correctness and consistency analysis of the pilot products is an important basis to prove the product quality. Therefore, the antigen-specific analysis of the three batches of products was conducted. As a result, there was no batch difference between the protein bands displayed by the SDS PAGE of the u PA three batches of the test products and the immunoreactive bands displayed by the immunoblot, indicating that the u PA three batches of the pilot products exhibited consistent u PA immunogenicity