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目的:研究心脑宁胶囊对SD大鼠的长期毒性作用,为临床应用提供参考。方法:将120只SD大鼠分成高、中、低剂量组和对照组,连续给药24周,恢复4周,观察记录动物一般行为、体重、摄食量、脏器系数,检测血常规、血液生化指标,并做病理组织学检查。结果:长期毒性试验中,心脑宁各剂量组与对照组比较,摄食量、体重和脏器系数未出现显著性差异,血常规和血液生化指标结果显示,与对照组相比,部分给药组的Neu,Eos,WBC,RBC,TBIL和Cr有差异,其余均正常。病理检查未见与药物有关的异常。结论:心脑宁胶囊以相当于临床60倍的剂量对SD大鼠灌胃给药24周,未表现出明显的毒性作用,安全性良好。
Objective: To study the long-term toxicity of Xinnaoning capsule on SD rats and provide reference for clinical application. Methods: 120 Sprague-Dawley rats were divided into high, medium and low dose groups and control group. The rats were continuously administered for 24 weeks and recovered for 4 weeks. The general behavior, body weight, food intake, organ coefficient, blood routine, Biochemical indicators, and histopathological examination. Results: In the long-term toxicity test, there was no significant difference in the food intake, body weight and organ coefficient between each dose group of Xinnaoning and the control group. The blood routine and blood biochemical indexes showed that compared with the control group, Group Neu, Eos, WBC, RBC, TBIL and Cr were different, the rest were normal. Pathological examination showed no drug-related abnormalities. Conclusion: Xinnaoning Capsule has been administered orally to SD rats for 24 weeks at a dose equivalent to 60 times the clinical dose, showing no obvious toxic effect and good safety.