壮尔颗粒的毒理学实验研究

目的:考查动物灌胃给予壮尔颗粒的急性毒性和长期毒性。方法:以最大浓度、最大容积的壮尔颗粒给予小鼠,求出最大给药量;大鼠分壮尔颗粒高、中、低剂量组,对照组,连续灌胃13周,停药恢复期2周。观察实验期间大鼠的行为活动、外观体征、体重、摄食量的变化,给药末和恢复期末两次解剖,检测血液常规、血液生化、脏器系数,观察组织器官病理学变化。结果:24h最大给药剂量为72g/kg壮尔颗粒(相当于生药264g/kg,为临床有效剂量31倍);长期毒性实验,壮尔颗粒对大鼠经口给药的高剂量为24.0g/(kg·d)壮尔颗粒(相当于生药88g/(kg·d),为临床有效剂量的15.3倍),无明显毒性反应。结论:壮尔颗粒安全可靠。

Study on the Toxic Effective of Zhuang''''er Grandules

Objective:To study both the acute and chronic toxic effect of Zhuang’er Grandules.Methods:After the maximal density and capacity administering rats by gavage,we gained the maximal dose;There were 4 groups of high,middle,lower dosage of Zhuang’er Grandules and the control group.During continuously feeding rats orally for 13 weeks and recovering 3 weeks,we observed rats’ behavior,appearance,body weight,appetite.After feeding and recovering,the haematological and biochemical markers,coefficient of the main organs and pathological examinination of the rats were investigated .Results:The maximal dose was 72g/(kg·d) Zhuang’er Grandules according with 264g/kg crude materials,respectively 31 times as much as the clinical dosage.The experiment of chronic toxicity showed that the high dosage of 24.0 g/(kg·d) Zhuang’er Grandules led to no remarkable toxic effect.Conclusion:Zhuang’er Grandules is absolutely safe.