肝必康胶囊对大鼠的长期毒性试验研究

目的研究肝必康胶囊对大鼠的长期毒性。方法肝必康胶囊以19.2、9.6、4.8 g/kg剂量连续灌服24周,停药2周,分别称量大鼠体重,计算脏器系数,测定血液学和血液生化学指标,并做病理组织学检查。结果肝必康胶囊大、中、小剂量组动物的外观行为、体重、脏器系数、血液学和生化学指标与空白对照组比较均无明显差异;病理检查未见与药物毒性相关的明显病变,停药后也未见药物延迟性毒性反应。结论肝必康胶囊长期用药对大鼠无明显毒性,推论临床拟用剂量应是安全的。

Long-term toxicity experiment of Ganbikang capsule in rats

Objective To observe long-term toxicity of Ganbikang capsule in rats.Methods The rats were orally given Ganbikang capsule 19.2,9.6,and 4.8 grams per kilogram for 24 weeks and thenstopped adiministration for 2 weeks,body weight,organ index,the parameters of hemotology and biochemistry were determined,and the pathological examination were performed.Results The outer appearance and behavior,weight,organ indexes,the parameters of hemotology and biochemistry in rats had no significant difference comparing with control group;the pathological examination showed no significant changes related to drug toxicity and on delayed toxicity reaction in 2 weeks' recovery.Conclusion The Ganbikang capsule has no significant long-term toxicity in rats,and its clinical dose would be safe.