基因工程药物质控方法(ELISA和HPLC)研究及应用

目的:1.建立适用于重组人生长激素(rh-GH)生产质量控制的大肠杆菌蛋白残留(ECP)测定方法。2.完成对重组人激素H1(rh-H1)的重要质量控制项目:含量、纯度、肽图的检定。方法:采用双抗体夹心酶联免疫吸附法(ELISA)对rh-GH产品中的ECP残留进行检测,并按照中国药典、生物制品规程及ICH有关要求进行方法学验证。采用反相高效液相色谱法对rh-H1进行了含量测定、纯度检查和肽图分析。结果:1.根据研究所得真实可靠的方法学评价结果,建立并规范了可用于rh-GH常规生产工艺控制的宿主蛋白残留检测方法。2.对三批rh-H1原液检定结果分别为,含量:100.5%、101.1%、99.8%;纯度:98.0%、98.4%、97.8%;肽图:三批原液肽图均与对照品一致。表明该产品的此三项指标均符合规定。

Research and Application of Genetics Engineering Medicine Quality Control (ELISA & HPLC)

Destination: 1.Established a ECP rudiment test method that suit for the mensurate quality of rg-GH.2. Finished the item of quality control of rh-H1: content . purity and peptide map .Method: We used the ELISA to test the rudiment of ECP of product and based on the requirement of CP. Biotechnical products regulation .ICH to prove the methodology. We mensurate the content . purity and peptide map of rh-H1 by rp-HPLC . Consequence : 1.Based on the real methodology results and created a method apply on the ECP rudiment test on the ordinary manufacture .2.content results:100.5% 101.1% .99.8%; purity : 98.0%.98.4%.97.8%; peptide map : The three results of sample accord with the reference . thus three item of this production accord with the regulation .