动物造模 z-bio 2022-11-30 478

　　Objective: To collect the determination results of peripheral blood lymphocyte subsets completed by the National Center for Drug Safety Evaluation and Monitoring from 2007 to 2019 under the conditions of quality management of drug non-clinical research, and to establish the corresponding relationship between BALB/c mice, SD rats and cynomolgus monkeys. Normal value reference range.

　　Methods: Heparin sodium anticoagulation tube was used to collect the peripheral blood of animals. The blood samples of 303 BALB/c mice, 359 SD rats and 460 cynomolgus monkeys were stained with different fluorescent antibody combinations, and the samples were analyzed by flow cytometry. Lymphocytes expressing CD3+, CD4+, CD8+ and CD20+ (only cynomolgus monkeys) were classified and counted. All data were classified by gender and age (rat and mouse), and the normal reference value range and 95% confidence interval were calculated respectively.

　　Results: The CD4+/CD8+ lymphocyte ratio of BALB/c mice ranged from 1.07 to 8.59; the CD4+/CD8+ lymphocyte ratio of SD rats ranged from 0.54 to 11.67; the CD4+/CD8+ of cynomolgus monkeys aged 3 to 4 years old The lymphocyte ratio and CD3-CD20+ lymphocyte percentage ranged from 0.35 to 4.22 and 1.40 to 51.99%, respectively.

　　Conclusion: The classification and counting of lymphocyte subsets is an important reference index for the evaluation of immunotoxicity of biological products, and the collection and establishment of relevant background data can help to make a reasonable toxicity evaluation of drugs.