目的 总结康龙化成（北京）生物技术有限公司安评机构临床病理实验室2014—2016年测定的SD大鼠和比格犬的血液学、生化、血凝指标的参考值范围。方法 收集并分析了2014—2016年的SD大鼠和比格犬的血液学、血清生化、血凝指标数据，其中548只SD大鼠（266只雄性和282只雌性）和2010只比格犬（998只雌性和1 012只雄性）。SD大鼠平均10～12周龄，雄性SD大鼠体质量350～400 g，雌性SD大鼠体质量220～270 g。比格犬平均7～9月龄，体质量8～11 kg。收集终末期剖检时对照组SD大鼠的血液样本、最近1次给药前比格犬健康体检的血液样本。采血前实验动物禁食过夜，SD大鼠使用70% CO₂和30% O₂混合麻醉，比格犬不麻醉。测试使用Siemens Advia 2120i血常规分析仪、Hitachi 7080生化分析仪、Instrumentation Laboratory ACL 9000血凝分析仪。采用均数加减1.96个标准差计算出正常参考值范围。结果 计算得出的SD大鼠的血液学、血清生化、血凝指标背景参考值与已有国外报道的文献基本一致；比格犬的血液学、血清生化、血凝指标背景参考值未见报道，填补了本部分研究的空白。结论 得出的SD大鼠和比格犬的血液学、血清生化、血凝指标背景参考值有助于毒理学家、病理学家分析比较，判定解释实验结果。

Objective To summarily introduce how to establish the range of reference values for SD rat and Beagle dog in Pharmaron's pathology laboratory. Methods Clinical pathology data within three years (2014—2016) from 548 SD rats (266 males and 282 females) and 2 010 Beagle dogs (1 012 males and 998 females) were corrected and analyzed. The average age of SD rats and Beagle dogs were 10 to 12 weeks (body weight at 350—400 g for male rats, at 220—270 g for female rats) and 7 to 9 months (body weight at 8—11 kg for dogs), respectively. Blood samples of SD rats were collected from control groups at the phase of terminal sacrifice, while Beagle dogs' were collected from all groups at the phase of recent pre-dose prior to randomization. All rats and dogs were food fasted over night for clinical pathology blood sampling. Analysis were performed using Bayer Advia 2120i hematology analyzer, Hitachi 7080 automatic chemistry analyzer and Instrumentation Laboratory ACL 9000 coagulation analyzer. Statistical analysis determined the mean (x), standard deviation (s) and 95% confidence intervals using the formula of x±1.96 s to calculate the range of reference value. Results By comparison, our clinical pathology data of SD rats were similar to the results from existing reports. The background reference values of hematology, serum biochemistry and blood coagulation indexes of Beagles dogs have not been reported, which fills the blank of this part of the study. Conclusion The results indicated that our clinical pathology parameters from SD rats and Beagle dogs were reliable and useful for toxicological pathologists and study directors in their data interpretation.

R965.3