蒙成药德都红花-7味散长期毒性试验研究

Study on the Long-term Toxic Effect of Deduhonghua-7 Powder

目的:观察大鼠长期口服德都红花-7味散产生的毒性反应,为临床提供安全用药依据。方法:取wister大鼠,按体重随机分为空白对照组和德都红花-7味散低剂量组(1.34g.kg-1.d-1)、高剂量组(5.36g.kg-1.d-1),连续灌胃给药6个月,观察实验动物外观体征、体重、给药后的反应;检测血常规、凝血四项、血液生化指标;计算脏器指数,常规对主要脏器做he染色,观察组织形态学改变。结果:连续灌胃给药6个月和停药1个月后,给药组与空白对照组比较外观体征、行为活动、体重、脏器系数、血常规分析、凝血四项均无明显改变。生化检测中给药六个月后德都红花-7味散高剂量组ALT、AST、CRE与空白对照组比较明显下降,P<0.05;停药后1个月生化检测CRE仍低于空白对照组,P<0.05,其它检测项目均无明显改变。组织病理学检查各脏器均未发现明显的病理改变。结论:德都红花-7味散在临床剂量的120倍,即5.36g/kg内给予大鼠长期灌胃给药较安全,为临床用药提供了安全性依据。

Objective ： To evaluate the long - term toxicity of Deduhonghua - 7 powder on rats and to provide the scientific basis for its clinical usage. Methods： Wistar rats were randomly divided into control group and Deduhonghua -7 powder low dose group （1.34g ·kg^-1·d^-1） ,high dose group （5.36g ·kg^-1·d^-1）, the rats were consecutively drenched Deduhong hua- 7 powder for 6 months. The appearance of signs,body weight and reaction were observed after administration;blood,coagulation,blood biochemical indicators were tested organ index of the animals were calculated; conventional staining of HE dyed on major organs and histological changes were observed. Result： Consecutively medica- tion for 6 months and 1 month after drug discontinuance, treated group compared with control group, there were no signif- icant changes on appearance of the signs, behavior, body weight, organ coefficient, blood analysis, coagulation. Treated group compared with control group, ALT,AST,CRE in Deduhonghua -7powder high dose group was decreased obviously after administration for 6 months （ P 〈 0.05）. 1 month after drug withdrawal, CRE still lower than that in the control group （ P 〈 0.05 ）. There was no significant change in the other test items. Histopathological examination of the organs had no significant pathological changes. Conclusion： It is safer to take Deduhonghua -7powder under the 120 times of the clinical dose that is 5.36g/kg on rats providing the scientific basis for its clinical usage.