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治疗用乙型脑炎单克隆抗体注射液的研制
引用本文:过琴媛,张碧如,邹林,寿伟华,李鸿斌,全昱东,万邦礼,李玲玲,黄文萱,王兵,宋爱京,马文煜,黄庆生.治疗用乙型脑炎单克隆抗体注射液的研制[J].粉末涂料与涂装,1997,10(1):16-20.
作者姓名:过琴媛  张碧如  邹林  寿伟华  李鸿斌  全昱东  万邦礼  李玲玲  黄文萱  王兵  宋爱京  马文煜  黄庆生
作者单位:卫生部北京生物制品研究所!北京,100024,卫生部北京生物制品研究所!北京,100024,卫生部北京生物制品研究所!北京,100024,卫生部北京生物制品研究所!北京,100024,卫生部北京生物制品研究所!北京,100024,卫生部北京生物制品研究所!北京,100024,卫生部北京生物制品研究所!北京,100
基金项目:国家“八五”重点攻关项目!85-722-18-01
摘    要:用清洁级F1代小鼠制备日本脑炎病毒单克隆抗体腹水,经辛酸沉淀、硫酸铵盐析粗提后,再通过凝胶过滤柱层析纯化。每毫升腹水可得到单克隆抗体4~4.5mg,纯度大于95%,回收率为60%~70%,蚀斑中和法测定活性大于5×105,无鼠源病毒污染,经各项检测均符合人用鼠源性单克隆抗体的要求。按有关规程研制成治疗用乙型脑炎单克隆抗体注射液,经全面检定符合临床试验的标准。

关 键 词:抗乙型脑炎病毒单抗  凝胶过滤  人用鼠源性单抗

Preparation of Therapeutic Japanese Encephalitis McAb
Guo Qinyuan, Zhang Biru, Zou Lin et al.Preparation of Therapeutic Japanese Encephalitis McAb[J].Chinese Journal of Biologicals,1997,10(1):16-20.
Authors:Guo Qinyuan  Zhang Biru  Zou Lin
Abstract:The McAb to Japanese encephalitis were extracted from the ascitic fluid from clean F1 mice by octanic acid and (NH4)2SO4 precipitations, then purified by gel filtration column chromatography. 4-4. 5mg McAb was extracted from 1ml asctic fluid. The McAb was not contaminated by mouse-derived viruses, and the activities detected by plaque neutralizeation test were above 5 ×105. The purity and recovery rate were over 95 % and 60% ~70%respectively. All the detection results of the other items met the requirements of mouse-derived McAbs for human use. Therapeutic injections were prepared with the McAbs according to the related requirements. Overall detection results proved that the injections could be used for clinical trials.
Keywords:JE McAb  Gel filtration  Mouse-derived  McAbs for human use
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