重组人生长激素降解产物的检测分析

Detection of Degradation Products of r-hGH

本文报告用ＳＤＳ－ＰＡＧＥ、ＩＥＦ、ＲＰ－ＨＰＬＣ、ＨＰＳＥＣ和ＨＩＣ手段分析检测ｒ－ｈＧＨ的降解产物，各种形式的降解产物至少能被一种手段检测出。通过对国内外产品实际测定，结果证实这些手段能严格监控生产过程中的降解反应，对终产品的质控是必不可少的。

Methods in this publication were examined for the detection of degradation products of recombinant human growth hormone (r-hGH). The analytical procedures involved RP-HPLC.isoelectric focusing (IEF), polyacrylamide gel electrophoresis in the presence of sodium dodecyl sulfate (SDS-PAGE), hydrophobicinteraction chromatography (HIC) and high performance size-exclusion chromatography (HPSEC). The degration reactions product identified using these techniques were those of deamination, proteolysis, aggregation and so on. It showed that each of the various forms of growth hormone produced with respect to different degradation processes could be separated by at least one of the above mentioned analytical techniques.