肾炎胶囊大鼠长期毒性试验

Chronic Toxicity of Shenyan Capsules on Rats

目的探讨连续灌胃给予肾炎胶囊对大鼠产生的毒性反应。方法给予大鼠肾炎胶囊1.5,0.5 g/kg(分别为临床拟用剂量的50倍和16.7倍)连续灌服6个月,停药1个月,分别观察大鼠的生长发育及血液学常规、血液生化、脏器系数及病理组织学变化。结果各剂量组大鼠发育正常,各项检测指标未见与用药相关的异常变化,主要脏器病理形态未出现明显毒性病变。结论肾炎胶囊长期用药对大鼠无明显毒性,临床拟用剂量安全。

Objective To observe the chronic toxicity of Shenyan Capsule on rats.Methods Wistar rats were orally given Shenyan Capsule at dose of 1.5,0.5 g/kg（equal to 50 and 16.7 times of clinic dosage respectively）,reated for 6 months and stopped for 1 month.The animal growth condition,indexes of hemotology and biochemistry,and the histopathology of the major organs were examined.Results The outer appearance and behavior,weights,organ coefficient,the indexes of haematology and biochemistry in rats had no significant difference by comparing with control group.The pathological examination did not discover significant pathological changes related to drug toxicity and the delayed toxicity reaction after drug administration.Conclusion Shenyan Capsules have no significant toxicity for long — term administration on rats.It infers that the drawing — up doses in clinic will be safe.