新药长毒试验动物血液生化测定规范化研究系列之五--SPF级SD大鼠血液生化参考值的建立

目的建立新药慢性毒性试验SD大鼠血液生化正常参考值。方法采用全自动生化测定仪对不同年龄、不同性别SPF级SD大鼠的血液生化值进行了测定。结果取得不同年龄、性别SD大鼠血液生化值平均值及正常参考值范围。多数生化指标受年龄及性别因素影响。其中，不同性别总胆红素（TBil）、碱性磷酸酶（ALP）、甘油三酯（TG），不同年龄碱性磷酸酶（ALP）、肌酸激酶（CK）、甘油三酯（TG）、总胆固醇（CHO）变化最具规律性。结论在新药慢性毒性试验中，雌、雄sD大鼠血液生化指标不宜合并统计，在比对正常参考值时应考虑到性别与年龄的因素。

Establishment of the Range of Normal Values of Blood Biochemical Measurements in SPF SD Rats

Objective To establish normal range and mean values of blood biochemical measurements in SPF SD rats used in long-term toxicity test. Methods Blood samples were taken from SPF SD rats in different age and sex. A number of blood biochemical parameters were measured using an automatic biochemical analyzer. Results Normal range and mean values of all data were obtained. Most biochemical values were influenced by age and sex of the rats. The variations of TBil, ALP, TG in rats of different sex and ALP, CK, TG, CHO in rats in different age showed a clear regularity. Conclusion It is inappropriate to combine the biochemical data obtained from female and male rats together for statistical analysis in long-term toxicity test. Attention should be paid to the influence of age and sex of rats when biochemical data collected in an experiment are compared with normal values and ranges.