摘要
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 prove the structural homogeneity of three batches of recombinant human urinary type plasminogen activator (rhu PA) in pilot scale production, and to set up an index for quality control in rhu PA production. Methods: The three batches of rhu PA products were hydrolyzed by trypsin in non reduced condition, and the hydrolysates were analyzed with RP HPLC to get peptide maps. Results: The peptide maps of rhu PA products were highly identical, and the numbers of detected peaks in maps correspond to the theoretical deduction. Conclusions: The identical maps of three batches reflect the structural homogeneity of rhu PA in pilot production. These peptide maps set up an index for quality control in rhu PA production. [
出处
《军事医学科学院院刊》
CSCD
北大核心
2000年第4期265-267,共3页
Bulletin of the Academy of Military Medical Sciences
基金
国家“八六三”计划资助项目(Z18-03-05)
关键词
尿型纤溶酶原激活剂
肽图谱
中试生产
urinary type plasminogen activator
peptide mapping
pilot scale production
