通迪胶囊的长期毒性研究  

Long-term Toxicity Study of Tongdi Capsule

作　　者：郑东森 季晖[1] 胡庆华[1] 

机构地区：[1]中国药科大学,江苏南京210009

出　　处：《中国民族民间医药》2017年第9期40-45,共6页Chinese Journal of Ethnomedicine and Ethnopharmacy

摘　　要：目的:观察通迪胶囊对SD大鼠的长期毒性作用,为临床应用提供参考依据。方法:将120只SD大鼠分成4组,通迪胶囊高剂量组、中剂量组、低剂量组和阴性对照组,连续给药26周,恢复4周,每周记录摄食量和体重,分别于第13周、26周和恢复4周后处死三分之一大鼠,检测血液学、血液生化学指标,系统尸解并计算脏器系数,对重要脏器做病理组织学检查。结果:通迪胶囊各剂量组与对照组比较,摄食量、体重和脏器系数未出现统计学差异(P>0.05),血液学、血液生化指标和病理组织学检查未见与通迪胶囊相关异常,恢复期未见迟发性毒性。结论:实验设置的最低剂量为临床剂量的15.5倍,故该药在临床剂量下长期使用毒性低,安全性良好。Objective To study the long - term toxicity of tongdi capsule in SD rats and provide a reference for clinical application. Methods 120 SD rats were randomly divided into four groups ： high dose group, middle dose group, low - dose group and negative control group. All rats were administrated for 26 weeks and then recovered for 4 weeks, recorded food intake and body weight weekly. 1/3 rats were killed after 13 weeks, 26 weeks and the remaining recovered for 4 weeks. The hematological and biochemical parameters, organ coefficient and histopathology of major organs were measured. Results There was no significant influence of tongdi capsule on food intake, body weight, histopathology, organ coefficient, hematological and biochemical parameters （ P 〉 0. 05 ） . Conclusion The lowest dose set by the experiments is 15.5 times of clinical dose, therefore the tongdi capsule is safe in clinical use.

关 键 词：通迪胶囊 长期毒性 SD大鼠 

分 类 号：R285.5[医药卫生—中药学]