DNA重组hGH的生物测定方法的探讨　Ⅱ．胫骨法  

Investigation of Bioassay of hGH Ⅱ.Tibia method for Hypophysectomized Rats

作　　者：李湛君[1] 阎安庄[1] 

机构地区：[1]中国药品生物制品检定所

出　　处：《药物分析杂志》1995年第2期8-11,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：本文对ＤＮＡ重组ｈＧＨ的另一生物测定方法即未成年去垂体大鼠胫骨骨骺软骨增宽法进行了探讨，摸索了胫骨染色切片后软骨宽度测量方法。实验结果表明在一定剂量范围内ｌｏｇ剂量与胫骨反应呈直线关系，胫骨法（λ＝０．２８）比体重法（λ＝０．４５）更精密。通过对多批进口和国产ｒｈＧＨ产品用胫骨法进行生物测定，得出本法具有灵敏、精密、成功率高等优点。For the bioassay determination of recombinant DNA derived human growth hormone(rhGH),the in vivo body weigth gain(BWG) bioassay in immature hypophysectomized rats is investigated.A series of assays showed that the dose range of linear effect of logarithm of dose to response are 0.004 to 0.500IU/rat /day for bGH and also 0.015 to 0.135 IU/rat/day for hGH. The best assay conditions with improved precision(λ)are obtained.This paper selected 60～80g hypophysectomized rats the GH divided in 2 daily injections,for 4 and 6 days.This method has been applied in bioassay for several rhGH products from home and abroad and is proved suitable for rhGH.

关 键 词：生长激素 DNA重组 生物测定 胫骨法 

分 类 号：R392－33[医药卫生—免疫学]