DNA重组hGH的生物测定方法的探讨　Ⅰ．去垂体大鼠体重增加法

Investigation of Bioassay of hGHⅠ.Weight Gain of the Hypophysectomized Rats

为用于ＤＮＡ重组ｈＧＨ的生物测定，本文探讨了未成年去垂体大鼠体重增加法。实验表明：牛生长激素ｂＧＨ在０．００４～０．５００ＩＵ／鼠、ｄ，人生长激素ｈＧＮ在０．０１５～０．１３５ＩＵ／鼠、ｄ剂量范围内ｌｏｇ剂量（Ｘ）与反应（Ｙ）呈直线关系。６０～８０ｇ去垂体大鼠，每天给药２次，连续给药４ｄ或６ｄ为最佳实验条件。通过多批进口和国产ＤＮＡ重组ｈＧＨ产品的生物测定，说明用该法检测ｒｈＧＨ是颇为实用的方法之一。

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.