酶联免疫吸附分析法测定重组人生长激素中的大肠杆菌肽

Enzyme-linked Immunosorbent Assay of E. coli Peptides in Recombinant Human Growth Hormone Preparations

本文应用双抗夹心式ＥＬＩＳＡ法，测定重组人生长激素及其制剂中宿主蛋白杂质的含量。采用大肠杆菌肽为标准抗原，辣根过氧化物酶标记抗体，以四甲基联苯胺为底物。测定结果表明，该法的线性范围为０．３９～２５ｎｇ／ｍｌ；平均回收率为１０２．６％；最低检出限量为０．３９ｎｇ／ｍｌ。本法具有特异性强、灵敏度高、定量准确等优点。

An enzyme-linked immunosorbent assay(ELISA)has been used for the quantitation of the most probable E. coli peptides(ECP)contaminants of E.coli produced r-DNA derived human growth hormone(r-hGH).Horseradish Peroxidase(HRP)and Tetramethyl benzidine(TMBZ) were applied to this experiment.The lowest limits of detection was 0.39ng/ml;recovery was 102.6%:linear relation is obtained in the range of 0.39～25ng/ml.The results for samples detected were satisfactory.This method is sensitive,accurate and reproducible,The assay was demonstrated to be specific for ECPs contaminated in r-hGH purification processes.