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。
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.
出处
《中国生物制品学杂志》
CAS
CSCD
1997年第1期16-20,共5页
Chinese Journal of Biologicals
基金
国家"八五"重点攻关项目!85-722-18-01
关键词
乙型脑炎病毒
单克隆抗体
注射液
研制
JE McAb
Gel filtration
Mouse-derived
McAbs for human use
