清窦灵合剂及浸膏的急性毒理学研究

A Study on Acute Toxicity of Traditional Chinese Medicine Mixture and Extractum Qing Douling

目的观察清窦灵合剂及浸膏的急性毒理作用。方法昆明种小鼠80只(雌雄各半)随机分为4组,每组20只,清窦灵合剂组按每次0.8 mL/20 g体积灌胃给药,24 h内灌胃3次,每次间隔4 h。对照组1小鼠给予生理盐水灌胃,方法、剂量同清窦灵合剂组。清窦灵浸膏组按每次0.8 mL/20 g体积灌胃给药,1次/d,对照组2小鼠给予生理盐水灌胃。方法、剂量同清窦灵浸膏组。观察14 d,记录小鼠的外观、饮食、活动、排泄、体质量及死亡等情况,14 d后解剖小鼠观察其重要脏器的变化。结果小鼠灌服清窦灵合剂120倍临床剂量,清窦灵浸膏162倍临床剂量,未见明显的急性毒性反应。清窦灵合剂组、清窦灵浸膏组、对照组1、2一般表现、主要脏器均未见明显异常改变,14 d内实验组与对照组体质量差异无统计学意义(P>0.05)。结论清窦灵合剂及浸膏临床使用剂量和给药途径是安全的。

Objective To observe the acute toxicity of the Traditional Chinese Medicine mixture and extractum of Qing Douling. Methods 80 Kunming mice to （male and female half） were ran- domly divided into four groups, each group of 20.The Group of Traditional Chinese Medicine mixture of Qing Douling was treated with Traditional Chinese Medicine mixture of Qing Douling with a dosage of 0.8 mL/20 g to fill the stomach, 3 times within 24 hours with an interval 4 h. The same dosage of Saline solution was used to fill the stomach in Control group I as in the group of Traditional Chinese Medicine mixture of Qing Douling. Extractum of Qing Douling group was treated with Extractum of Qing Douling with a dosage of 0.8 mL/20 g to fill the stomach, once a day. The same dosage of Saline solution was used to fill the stomach in Con- trol group II as in the group of extractum of Qing Douling. The appearance, diet, activity, ex- cretion, body weight and death in mice within 14 days were observed. The changes in vital or- gans （heart, liver, spleen, lung,kidney, stomach, intestines, etc.） were observed after anat- omy.Results No obvious acute toxicity reaction was observed in the mice treated with the Tradi- tional Chinese Medicine mixture of Qing Douling to fill the stomach, 120 times of clinical dos- age. The same is true of the mice treated with extractum of Qing DouLing to fill the stomach,162 times of clinical dosage.The general feature and main organs in the experimental group and control group showed no obvious change, and no statistically significant difference in body weight was observed in experimental groups and control groups within 14 days （P〉0.05）.Con- clusion It is clinically safe to administer Traditional Chinese Medicine mixture of Qing Douling Prescription with such dosage in this way.