平胃胶囊的小鼠急性毒理学研究

The Acute Toxicology Research of Pingwei Capsule on Mice

目的观察平胃胶囊临床用药的安全性。方法以昆明小鼠40只随机分为对照组和给药组,每组20只,雌雄各半。给药组给予平胃胶囊混悬液1 m L灌胃,对照组给予等量生理盐水灌胃,各组每日均连续灌胃5次。灌胃结束后观察一般情况和体质量变化,连续观察14 d后处死,检测血清肝肾功能和脏器指数,采用HE染色鉴别两组小鼠组织病理学差异。结果观察期间给药组小鼠均未出现中毒反应及死亡,两组小鼠体质量、脏器指数均无明显差异性变化(P>0.05);主要脏器大体标本颜色、形态未见明显异常改变,肝、肾、胃等组织HE染色无变性、炎症、坏死等改变;两组血清肝肾功能指标无明显差异(P>0.05)。结论小鼠每日最大给药量为150 kg/d,相当于临床每日用量的125倍(>100倍),表明平胃胶囊临床剂量服用安全。

Objective： To study the clinical safety of the Pingwei Capsule. Methods： 40 Kunming mice were randomly divided into the control group and the administration group, 10 males and 10 females in each group. The administration group were given 1 mL mixed suspension of Pingwei Capsule by garage,while the control group were given equal normal saline by gavage,5 times a day for each group. After it,the general situation and the change of body mass were observed. The mice were executed after 14 day continuous observation. Serum and re- nal function index and the index of viscera were detected. Differences in histopathology were identified with HE staining. Results： During administration,the mice in the administration group were not poisoned and died. The changes of the body mass and viscera index were not significantly different （P〉 0.05）. The color and shape of main organs gross specimen had no obvious abnormal change. HE staining of liver, kidney, stomach and other or- gans had no change, inflammation and necrosis. Serum and renal function index of the two group had no obvious difference （P〉 0.05）. Conclusion： Maximum daily dosage of the mice is 150 kg/d,equal to 125 times of clinical daily dosage（〉 100 times）,which indicates that the Pingwei Capsule has clinical safety.