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目的:观察大鼠口服蛭龙活血通瘀胶囊的长期毒性作用。方法:采用临床拟用剂量法(ACD法)以7.875、15.75、31.5g·kg-1·d-1生药(相当于临床用药剂量的15、30、60倍)连续灌胃给药12周,观察大鼠的生长发育、血液学、血液生化学、脏器系数、组织病理学变化及停药2周后上述指标的变化。结果:连续灌胃12周后,大鼠体重、行为活动、重要脏器系数、大鼠血液学和血液生化学指标与对照组比较均未见明显影响,主要脏器的病理组织学检查与对照组比较亦未见明显病理改变;停药2周恢复期大鼠各项观察指标与对照组比较,差异无显著性。结论:在本实验条件下,蛭龙活血通瘀胶囊对受试动物未见明显的长期毒性作用,表明该药具有良好的安全性。
Objective: To observe the long-term toxic effects of oral administration of Zhi Long Huoxue Tongyu Capsule in rats. Methods: The ACD method was used for continuous oral administration of 7.875, 15.75, 31.5g · kg-1 · d-1 crude drugs (equivalent to 15, 30, and 60 times of clinical dosage) The growth and development, hematology, blood biochemistry, organ coefficient, histopathological changes and the changes of these indexes after 2 weeks of withdrawal were observed. Results: After 12 weeks of continuous gavage, the body weight, behavioral activity, vital organ coefficient, hematology and blood biochemistry indexes of rats had no significant difference compared with the control group. The histopathological examination and control There was no obvious pathological change in the group. The observation indexes of the rats in the recovery phase of 2 weeks of withdrawal were not significantly different from those in the control group. Conclusion: Under the experimental conditions, no obvious long-term toxicity was observed in the test animals, indicating that the drug has good safety.