重组人干扰素-β1b对恒河猴免疫原性的影响  

The effect of recombinant human interferon-β 1b on the immunogenicity in rhesus monkeys

作　　者：原野[1] 吴纯启[1] 廖明阳[1] 张振龙[2] 邓宛明[2] 

机构地区：[1]军事医学科学院毒物药物研究所,北京100850 [2]北京生物制品研究所,北京100024

出　　处：《中国新药杂志》2004年第1期28-30,共3页Chinese Journal of New Drugs

摘　　要：目的:研究重组人干扰素-β 1b(rhIFN-β1b)对恒河猴的免疫原性及其对疗效的潜在影响。方法:实验分溶剂对照组及rhIFN-β1b低、中、高剂量组,分别皮下注射1.25％人血清白蛋白0.36mL·kg-1及rbIFN-β1b 4.0×106,1.2×107及3.6×107IU·kg-1,连续90d。血清结合抗体测定采用ELISA法,中和抗体测定采用细胞病变抑制法。结果:给药3周后,3个给药组动物均出现rhIFN-β1b结合抗体,4周后抗体滴度达最大值,不同剂量组间在结合抗体滴度方面未见明显的剂量-反应关系。同时,给药3周后血清中出现中和抗体,以后抗体滴度逐步升高。停药30d后,中和抗体滴度逐渐降低。结论:恒河猴重复给予rhlFN-β1b后,体内产生结合抗体和中和抗体,但给药组动物未观察到明显的病理学和生化指标异常,提示该生物制品重复使用是安全的。Objective:To study the effect of recombinant human interferon-β 1b (rhIFN-β 1b) on the immunogenicity in rhesus monkeys. Methods:Rhesus monkeys were divided to receive once daily 1.25% human serum albumin in a dose of 0. 36mL·kg-1(control group) ,once daily rhIFN-β1b in a dose of 4.0×106,1. 2×07,or 3. 6×107IU·kg-1 for 90 continuous days. The rhIFN-β1b binding and neutralizing antibodies were determined once a week by ELISA for the former and by cytopathic effect assay for the later. Results: After 3 weeks,rhIFN-β 1b binding and neutralizing antibodies were identified in all rhIFN-β1b treated animals and the maximum antibodies titer were obtained after 4 weeks treatment. No obvious dose-effect relationship existed between groups receiving different doses of rhIFN-β1b. Conclusion: That both the binding and neutralizing antibodies of rhIFN-β1b were found in rhesus monkeys after repeated treatment with rhIFN-β1b,but there were no obvious pathological and clinical biochemistry abnormalities, indicated that the biological product is safe in repeated uses.

关 键 词：免疫原性 重组人干扰素-β1b 恒河猴 中和抗体 

分 类 号：R965[医药卫生—药理学]