动物造模 z-bio 2021-11-10 943

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

　　Method: Use heparin sodium anticoagulation tube to collect animal peripheral blood. 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. Differential counts of lymphocytes expressing CD3+, CD4+, CD8+ and CD20+ (only cynomolgus monkeys). After all data are classified by sex and age (rats and mice), the normal reference value range and 95% confidence interval are 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+ ratio of cynomolgus monkeys aged 3 to 4 years old The range of lymphocyte ratio and CD3-CD20+ lymphocyte percentage are 0.35~4.22 and 1.40%~51.99%, respectively.

　　Conclusion: The classification and counting of lymphocyte subgroups is an important reference indicator for the immune toxicity evaluation of biological products. The collection and establishment of relevant background data will help to make a reasonable toxicity evaluation of the drug.