重组人生长激素的质量鉴定

Study on the Quality of the Internal Recombinant Human Growth Hormone

用ＳＤＳ－ＰＡＧＥ、ＩＦＥ、ＲＰ－ＨＰＬＣ、ＨＩＣ、ＨＰＳＥＣ、ＨＰＬＣ－胰肽图谱分析、生物测定、斑点免疫印迹、ＥＬＩＳＡ和地高辛标记ＤＮＡ探针等多种手段，对国产ｒ－ｈＯＨ进行全面质量鉴定并与国外同类产品进行比较。其结果表明，国产ｒ－ｈＧＨ的质量基本达到国外同类产品的水平。为ＤＮＡ重组药物的质控积累了重要数据。

he internal r-hGH was appraised by various analytical techniques involving SDS-PAGE、LEF、HIC、HPSEC、RP-HPLC、ELISA、Bioassay、 Dot-immunobinding assay and DIG DNA labeling. Resultsshowed that the internal r-hGH had the same good quality as overseas pred ucts.