藿芪灌注液毒性研究

为了测定小鼠口服藿芪灌注液的急性毒性和长期毒性，评价其安全性，为临床安全用药提供依据，采用最大给药量法进行了急性毒性研究，选择健康小鼠20只，24 h内按40 g/kg体重灌胃给药3次，给药后连续观察10天，测定其1日最大给药量，确定藿芪灌注液的急性毒性。将80只健康大鼠随机分为高、中、低剂量组和对照组，每组雌雄各10只，高、中、低剂量组分别按20、10、3 g/kg体重灌服藿芪灌注液，对照组按20 mL/kg灌服生理盐水，每天一次，连续给药35天，通过临床观察、病理组织学检查、血液生理生化指标测定，研究其长期毒性。结果表明，小鼠口服藿芪灌注液的1日最大给药量为120 g/kg，相当于临床奶牛日用量的600倍。藿芪灌注液不影响大鼠的采食、活动、饮水、增重、脏器指数、血液生理生化指标，不会引起大鼠发病和死亡。说明藿芪灌注液实际无毒，至少在20 g/kg体重给药剂量下大鼠连续给药35天是安全的。

Toxicity of Huoqi Perfusate

To evaluate safety of huoqi perfusate and provide evidence for clinical dosage, acute toxicity and long-term toxicity of huoqi perfusate were determined by intragastric administration. Acute toxicity trial was taken on 20 mice which were subjected to gastric perfusion with huoqi perfusate of 40 g per kilogram body weight 3 times in 24 hours according to the maximum daily dose. To determine the maximum daily dose, the mice were observed for 10 days after the medicine was administered. Long-term toxicity trial was carried out on 80 rats which were randomly divided into three treatment groups and one control group with 10 females and 10 males in each group. The rats in three treatment groups, which were high-dose group, middle-dose group and low-dose group, were respectively administered huoqi perfusate by intragastric administration 20, 10 and 3 g per kilogram body weight everyday for 35 consecutive days. Huoqi perfusate was replaced by 20 mL/kg normal saline in the control group. To determine long-term toxicity, clinical observation, histopathological examination and the measurement of blood physiology and biochemical indicators were conducted. The results showed that the maximum daily dose of intragastric administration of huoqi perfusate in mice was 120 g/kg, which was 600 times of the daily dose of dairy cows. Huoqi perfusate did not affect foraging, activity, drinking, weight gain, organ index and blood physiology and biochemical indicators of rats, and would not cause morbidity and mortality in rats, indicating that intragastric administering huoqi perfusate by 20 g per kilogram body weight for 35 consecutive days was safe for rats.