紫元益消丸急性毒性实验研究

The experimental study on acute toxicity of ziyuanyixiao pill

目的观察紫元益消丸对昆明小鼠和SD大鼠的急性毒性反应,为新药研发以及临床用药提供剂量依据。方法采用灌胃给药途径,测定小鼠和大鼠分别给予紫元益消丸后的半数致死量和最大耐受量,按公斤体质量计算。结果紫元益消丸急性毒性实验显示受试药物毒性较低,实验动物全部存活故无法测出半数致死量;小鼠的最大耐受量为24.0 g/kg,大鼠的最大耐受量为16.0 g/kg;各组实验动物的体质量未见异常(P>0.05)。结论紫元益消丸按拟定临床剂量用药具有安全性。

Objective To study the acute toxicity in mice and rats to evaluate the clinical safety of medication and provide dose basis for development of new drug.Methods Mice and rats were given intragastric administration by the differente dose of the tested drug,the experimental data were calculated LD50 and MTD with the Bliss method,with the continuous administration and observation for 14 days.Results The mice and rats were all survived and LD50 was not measured.The largest amount of drug for mice was 480 times of clinical dose administration,for rats it was 320 times of clinical dose administration.In addition,no histopathological lesions were observed in the animals.Conclusion Acute toxicity in this experiment condition suggested the tested drug have a good clinical safety.