瑞康益肝胶囊长期毒性实验研究

目的观察瑞康益肝胶囊对大鼠长时间给药可能产生的毒性反应,为临床应用提供毒理学依据。方法分别以相当于人日用量的150,50,25倍,经180 d大鼠灌胃给药,观察给药中、末期及停药恢复期动物的一般状况、主要血液学指标、生化学指标和脏器病理组织变化。结果各实验期动物一般状况良好,体重、脏器系数值、主要血液学指标、生化学指标与空白对照组基本一致;给药末期和恢复期高剂量动物尿液分析指标和空白对照无统计学差别;解剖主要脏器未见明显肉眼可见的病理性改变,组织学检查未发现明显病理改变。结论该品长期服用无明显毒性,停药后未见药物延迟性毒性反应。

Long-term Toxicity of Ruikang Yigan Capsule on Rats in vivo

ObjectiveTo observe the long-term toxicity of Ruikang Yigan Capsule on rats.MethodsWistar rats were given Rui Kang Yigan Capsule by gavage for 180 days,once a day,with three doses of 1.50 g/kg,0.50 g/kg and 0.25g/kg(equal to 150,50 and 25 times of clinic dosage respectively).The animal general condition,indexes of hemotology and biochemistry,and the histopathology of the major organs were examined during both medium and end term of the treatment.Meanwhile,the condition of convalescence was observed in 2 weeks after feeding.ResultsThe general condition of the treated rats were found normal both during and after feeding the medicine;their weight,organ coefficients,main indexes of hemotology and biochemistry were basically the same as the control.The index of urine analysis,main indexes of hemotology and biochemistry were basically the same as the control.The index of urine analysis showed no significant difference with that of the control.The histopathological examinations of the major organs also showed no significant changes.ConclusionRuikang Yigan Capsule has no significant toxicity or delayed toxicity after long-term administration on rats,which indicates that this capsule would be safe for the clinical use.