生物检定法与HPLC法测定重组人生长激素(rhGH)效价的相关性验证

The Relative Correlation of Bioassay and HPLC for Recombinant DNA-derived Human Growth Hormone(rhGH)

对生长激素的检定和质量控制的重要指标之一是效价测定，其传统经典的方法为在体生物测定法—体重法和胫骨法．随着基因工程技术的发展和质量标准的不断完善，对ｒｈＧＨ的效价测定已用理化分析方法代替生物测定方法．本实验通过对进口和国产的多批ｒｈＧＨ制剂和原料的效价的对比实验，证明生物测定和理化测定的结果基本吻合，具有良好的相关性，为理化测定最终代替生物测定提供了实验依据．

The potency for growth hormone(GH) is one of the important parameter in quality control.Historically,it depended on the use of in vivo bioassay.Today,it has been suggested that the in vivo bioassay of GH could be replaced with physico-chemical assay in routine control.Size-exclusion HPLC method was compared with GH bioassay in our laboratory.The potency of various rhGH preparations and materials from many manufacturers at home and abroad was determined by in vivo bioassay including weight gain and tibial width in hypophysectomized rat and size-exclusion HPLC to examine the relative correlation of the two methods.Experimantal results showed that the contents obtained by HPLC method is generally in agreement with the potency by bioassay.Based on the study,the bioassay of rhGH could be replaced with HPLC in routine control.