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目的:建立核糖核酸类药物免疫活力测定方法。方法:选用小鼠白细胞黏附抑制试验,对实验重要参数,如小鼠品系、药物作用浓度,黏附时间,缓冲液成分和细胞密度等进行探讨研究,初步建立了该类药物的免疫活力测定方法。并用该方法对核糖核酸Ⅰ、核糖核酸Ⅱ和核糖核酸Ⅲ各2批样品进行了免疫活力测定。结果:确定了适合该类产品免疫活力测定方法的实验参数:小鼠品系对实验结果无影响,药物作用浓度为10 mg·ml-1,黏附时间为2 h,缓冲液中必须含钙镁离子,细胞密度约为4×107个/ml。用该方法对该类产品进行免疫活力测定,3次重复实验,结果均合格,RSD均低于20%。结论:白细胞黏附抑制试验可作为评价核糖核酸类药物免疫活力的方法。
Objective: To establish a method for determination of immunological activity of ribonucleic acid drugs. Methods: The mouse leukocyte adhesion inhibition test was used to study the important parameters of the experiment, such as the mouse strain, drug concentration, adhesion time, buffer composition and cell density. Immunoassays were performed on 2 batches of each of ribonucleic acid Ⅰ, ribonucleic acid Ⅱ and ribonucleic acid Ⅲ using this method. Results: The experimental parameters suitable for the determination of immunoeactivity of these products were determined: the mouse strains had no effect on the experimental results, the drug concentration was 10 mg · ml-1, the adhesion time was 2 h, and the buffer contained calcium and magnesium ions , The cell density is about 4 × 107 cells / ml. The method was used to measure the immunoeactivity of these products. The results of three replicate experiments were satisfactory and the RSDs were less than 20%. Conclusion: Leukocyte adhesion inhibition test can be used as a method to evaluate the immunological activity of ribonucleic acid drugs.