益贞颗粒急性毒性实验研究

以益贞颗粒对小鼠灌胃,观察小鼠死亡情况及相关指标的变化情况来评价其安全性.通过半数致死量实验分别以不同浓度的益贞颗粒对小鼠灌胃,观察7d未见小鼠死亡,无法测出半数致死量;进行最大耐受量实验,实验小鼠以益贞颗粒最大混悬浓度和可承受的最大体积1d内灌胃2次,连续观察14d,每天记录小鼠的一般状况、体质量、进食量和饮水量.14d后处死动物,观察并记录脑、心、肝、脾、肺、肾、睾丸/卵巢等主要脏器的病变情况,若肉眼可见病理变化则即刻进行组织病理学检查.结果表明,14d内小鼠活动正常,无1只小鼠死亡.益贞颗粒组实验小鼠的体质量、进食量和饮水量与空白对照比较均无显著性差异(P>0.05);肉眼观察脑、心、肝、脾、肺、肾、睾丸/卵巢等主要脏器未发现有明显异常.实验小鼠灌胃益贞颗粒的量相当于成人临床日用量的93倍,说明益贞颗粒无明显毒性,临床常用量是安全可靠的.

Experimental Study of Acute Toxicity of Yizhen Granule in Mice

The acute toxicity tests by gavaging Yizhen granule in mice are carried out to observe theirs safe- ties. In the half lethal dose （LD50） experiment, the experimental mice were gavaged with Yizhen granule. None of tested mice died seven days later. The LD50 can not measure up. To measure the maximum toler- ance, the highest concentration and largest amount was given to the mice by gavaging Yizhen granule twice a day. General conditions, body weight, food intake and drinking amount of the animals were observed. The experiment was carried out after 14 days, pathological changes conditions of brain, heart, liver, spleen, lung, kidney, testis/ovary and so forth were observed and recorded with the naked eye. All mice healthily survived during the period of test; and no obvious symptoms were observed. The body weight, food intake and drink- ing amount of mice in Yizhen granule treated group did not significantly differ compared with the control group, and there was no abnormal changes on brain, heart, liver, spleen, lung, kidney, testis/ovary and so forth with the naked eye. The maximum tolerance doses of Yizhen granule was as 93 times as that used in clinical adult daily dosage. Yizhen granule has low toxicity, which are relatively safe and reliable to be taken at the prescribed dose.