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目的 :证明重组人尿型纤溶酶原激活剂 (recombinanthumanurinarytypeplasminogenactivator,rhu PA)中试规模 3批产品在结构上的同一性 ,建立生物工程产品质量控制的一项指标。方法 :rhu PA 3批中试产品在非还原条件下经胰蛋白酶水解以后 ,进行RP HPLC肽图分析。结果 :rhu PA 3批中试产品的肽图完全一致 ,且检出峰数目与理论推测值相符。结论 :3批产品肽图一致性为rhu PA产品的结构同一性提供了有利证据 ,并建立了rhu PA产品质量控制的一项指标。
Objective: To demonstrate the structural identity of three batches of recombinant human urine type plasminogen activator (rhu PA) pilot scale and to establish an index for the quality control of bioengineered products. Methods: Three batches of rhu PA products were hydrolyzed by trypsin under non-reducing conditions and analyzed by RP HPLC. Results: The peptide maps of the three batches of rhu PA products were completely identical, and the number of detected peaks was in line with the theoretical one. Conclusion: The consistency of peptide maps of three batches of products provides favorable evidence for the structural identity of rhu PA products and establishes an indicator of product quality control of rhu PA.