幼龄SD大鼠重复给药毒性试验背景数据的建立  

Development of background data on repeated toxicity studies in juvenile SD rats

作　　者：崇立明[1,3] 杨阳 陈丽芬[1,2,3] 许丽 陈丁实 王忠辉[1,2,3] 周莉 孙祖越 CHONG Li-ming;YANG Yang;CHEN Li-fen;XU Li;CHEN Ding-shi;WANG Zhong-hui;ZHOU Li;SUN Zu-yue(Shanghai Institute of Planned Parenthood Research,National Evaluation Center for Toxicology of Fertility Regulating Drugs,Shanghai 200032,China;NHC Key Lab.of Reproduction Regulation,Shanghai 200032,China;Reproductive and Developmental Research Institute,Fudan University y Shanghai 200032,China)

机构地区：[1]上海市计划生育科学研究所药理毒理学研究室,中国生育调节药物毒理检测中心,上海200032 [2]国家人口和计划生育委员会计划生育药具重点实验室,上海200032 [3]复旦大学生殖与发育研究院,上海200032

出　　处：《中国新药杂志》2021年第1期17-24,共8页Chinese Journal of New Drugs

基　　金：国家“重大新药创制”科技重大专项资助项目(2018ZX09201017-002);上海市科委研发平台专项(17DZ2293600)。

摘　　要：目的:对本研究室幼龄SD大鼠4周重复给药毒性试验中正常对照组的各项指标进行统计整理,建立本研究室的数据背景资料,为儿科药物非临床安全性评价提供参考。方法:从本研究室2015—2019年进行的儿科药物重复给药毒性试验中,选取全部正常对照组幼龄SD大鼠的数据,包括体重、摄食量、生殖发育(龟头包皮腺裂开和阴道张开时间)、骨骼发育(顶臀长、胫骨长度和密度)、血液学、血生化、免疫和脏器指标进行统计分析。结果:经过数据统计分析,得出不同性别幼龄SD大鼠各项指标的均值、标准差、最大值、最小值、95%置信区间和变异系数。结论:初步建立了不同性别和年龄的幼龄SD大鼠各项指标的正常值参考范围。Objective:To summarize the indexes of juvenile SD rats in control group of the 4-week repeated administration toxicity test in our laboratory,and to establish the background data of our laboratory so as to provide reference for the evaluation of non-clinical safety of pediatric drugs.Methods:From repeated administration toxicity test of pediatrics between 2015 and 2019,the indexes of juvenile SD rats were selected and analyzed,including body weight,feed consumptions,reproductive development(preputial separation and vaginal patency),skeletal development(crown-rump length,tibia length and bone density),hematology,blood biochemistry,immunization and viscera index.Results:The mean value,standard deviation,maximum and minimum values,95%confidence interval as well as coefficient of variation of all indicators from juvenile SD rats in different genders were obtained through statistical analysis.Conclusion:The reference ranges of normal values of juvenile SD rats for different genders and ages were established.

关 键 词：幼龄 SD大鼠 重复给药毒性 背景数据 

分 类 号：R99[医药卫生—毒理学]