解毒化瘀颗粒小鼠急性毒性反应随机平行对照研究

Acute Toxicity of Jiedu Huayu Granule on Random Parallel Control

[目的]观测解毒化瘀颗粒小鼠急性毒性反应,确定最大给药量。[方法]使用随机平行对照方法,40只昆明小白鼠,SPF实验动物室适应饲养7d,禁食饲料不禁饮水16h,随机数字表法分两组,20只/组(雄雌各10只),灌胃干预。干预组:解毒化瘀颗粒(20m L kg-1体重,浓度5.0g,生药m L-1,剂量100g生药?kg-1),3次/d(相当生药20×5.0×3=300g生药kg-1 d-1)。对照组:蒸馏水。观测干预后14d内各组小鼠中毒表现、体重和死亡等情况。[结果]干预后14d,体重两组无明显变化(P>0.05)。干预组雌性与雄性小鼠各器官系统均未出现中毒反应,整个试验过程无小鼠死亡。[结论]解毒化瘀颗粒小鼠灌胃300g生药kg-1 d-1无急性毒性反应,相当60kg体重成人口服量(1.58g生药kg-1 d-1)190倍。

[Objective] Observation on acute toxicity of mice granule reaction, to determine the maximum dosage.[Method] Using random parallel control method, 40 adult Kunming mice, SPF experimental animal roomadaptation feeding 7d, fasting feed can not help drinking water 16 h, using a random number table divided into intervention group and control group, 20 rats/group（male and female each 10）. The intervention group byintragastric gavage of 20 m L kg-1 amount of the drug concentration was 5.0g crude drug m L-1 granule testliquid, dose of 100 g crude drug kg-1, 3 times/d, rather dosage 20×5×3=300g.kg-1 d-1 crude drug; the same method in the control group were fed with distilled water. Recorded after administration of 14 d in mice poisoningperformance, weight and death etc.[Results] After administration of 14 d, the two group the body weight did not change significantly（P〈0.05）. The intervention group of female and male mice of each organ system did not show toxic reaction, the whole testing process without the mice to death. [Conclusion] Jiedu Huayu granules can be given orally 300 g crude drug kg-1 d-1, 60 kg equivalent weight of adult oral dose（1.58 g crude drug kg-1 d-1） 190 times.