目的 研究坤泰胶囊浸膏连续ig给药6个月对大鼠的毒性。方法 将120只大鼠随机分为4组:药物组大鼠分别ig坤泰胶囊浸膏25.0、12.5、5.0 g/kg, 对照组大鼠ig相同体积的蒸馏水。给药180 d后, 每组处死动物数的2/3(n=20), 并对其进行生化检测和病理解剖;剩余的动物(n=10)在停药30 d后进行可逆性实验检测。结果 坤泰胶囊浸膏对大鼠的生长发育、造血功能和血液生化学指标均无明显的毒性, 对大鼠的心、肝、脾、肺、肾、子宫、卵巢、睾丸、垂体、脑等组织的形态学检查亦未发现有明显损伤性毒性变化。结论 坤泰胶囊长期服用毒性低, 临床用药量安全。

Objective To observe the property and degree of long-term toxicity of Kuntai and evaluate whether the toxic injure can be prevented or recovered, so as to provide the reference for clinical safe use. Methods One handred and twenty rats were randomly divided into four groups, Kuntai (25.0, 12.5, and 5.0 g/kg) groups and control (ig same volume of distilled water) group for all being treated for 180 d, respectively. Then the rats were sacrificed 2/3 (n = 20) in each group and the anatomy and pathological biochemical detection were carried on. And the remainings (n = 10) were sacrificed after 30 d of withdrawal drug to use for the reversible experiment. Results There is no significance of the extract from Kuntai Capsule on the growth/hematopoietic function/biochemical criterion of serum or the pathological feature, i.e. toxicity changes with obvious injury in heart, liver, spleen, lung, kidney, uterus, ovaries, testes, the pituitary gland, and brain. Conclusion There is very low toxicity of the extract from Kuntai Capsule for the long-term safe use which is benefit in clinic.