虎杖解毒颗粒(无糖型)的药效毒理学研究

Effects and toxicologic study of Huzhang Antidote Granules(Sugar-free)

目的对虎杖解毒颗粒(无糖型)改制前后的药效、毒性展开研究,科学、客观地评价颗粒的安全性、有效性。方法通过最大给药量实验评价其急性毒性,并采用二甲苯致小鼠耳廓肿胀模型和干酵母致大鼠发热模型,分别观察颗粒改制前后的抗炎、解热作用。结果虎杖解毒颗粒(无糖型)、虎杖解毒颗粒对小鼠的最大给药量分别相当于成人日剂量的218倍和200倍,小鼠均未死亡,生存状况无异常;颗粒对二甲苯所致小鼠耳廓肿胀以及干酵母引起的大鼠发热均有一定抑制作用,强度与剂量相关。结论虎杖解毒颗粒(无糖型)改制前后毒性及药效无明显改变,制剂毒性低,具有一定抗炎、解热作用。

Objective To study the effects and toxicity of Huzhang Antidote Granules(Sugar-free)before and after modification,and to evaluate the safety and effectiveness of the granules scientifically and objectively.Methods The maximum dosage of rat was measured to evaluate the acute toxicity of the granules.The anti-inflammatory and antipyretic effects of the granules were observed using the xylene-induced ear swelling model in mice and the rat fever model induced by dry yeast.Results The maximum dosage of Huzhang Antidote Granules(sugar-free)and Huzhang Antidote Granules in rats was equivalent to 218 times and 200 times that of the clinical adult dosage.None of the mice died,and the survival condition was normal.The granules had a certain inhibitory effect on mouse ear swelling caused by xylene and fever in rats caused by dry yeast.The intensity was related to the dosage.Conclusion The toxicity and effects of Huzhang Antidote Granules(sugar-free)have not changed much before and after modification,the toxicity is low,and have certain anti-inflammatory and antipyretic effects to some extent.