论文部分内容阅读
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。
Purification of the Japanese Encephalitis virus monoclonal antibody ascites was made with a clean-grade F1 generation mouse, which was crudely precipitated with octanoic acid and ammonium sulfate, and then purified by gel filtration column chromatography. Per milliliter ascites can be obtained monoclonal antibody 4 ~ 4.5mg, purity greater than 95%, the recovery rate of 60% to 70%, plaque neutralization assay activity greater than 5 × 105, no mouse virus contamination by the detection Are in line with human mouse monoclonal antibody requirements. According to the relevant regulations developed into treatment of encephalitis monoclonal antibody injection, a comprehensive test in line with clinical trials standards.