清肺消炎丸对幼龄小鼠急性毒性实验研究

目的]研究清肺消炎丸对幼龄小鼠的急性毒性,评价其用药安全性,为该中成药制剂在儿科临床的安全应用奠定基础。方法]参照经典的急性毒性实验研究方法进行清肺消炎丸半数致死量(LD50)预试和最大给药量实验,观察幼龄小鼠的毒性反应、体质量变化、饮食饮水、脏器系数、肝肾功能和内脏的组织形态学改变。结果] LD50预试结果表明受试小鼠均未出现死亡,也未表现出明显的中毒症状,清肺消炎丸的毒性较小,无法测出LD50,故直接进行最大给药量实验。最大给药量实验结果表明,幼龄小鼠给药后的状态、体质量、脏器系数、肝肾功能各项指标以及脏器的组织形态等均正常。本实验中幼龄小鼠1 d的给药剂量为72 g/kg,相当于6~12岁儿童临床用药量的252倍。结论]清肺消炎丸的毒性极低,对儿童患者具有较高的临床安全性。

Experimental study on acute toxicity of Qingfei Xiaoyan Wan in young mice

Objective] To evaluate the safety of Qingfei Xiaoyan Wan and lay the foundation for safe clinical applications in pediatrics,study the acute toxicity of Qingfei Xiaoyan Wan in young mouse.Methods] The LD₅₀ preliminary test and maximum dose test of Qingfei Xiaoyan Wan were carried out according to the classical acute toxicity test methods. The toxicity,weight change,food and drinking water,organ coefficient,liver and kidney function and histomorphological changes of organs were observed in young mouse.Results] The LD₅₀ preliminary test results showed that there was no death of mouse and no obvious poisoning symptoms,indicating that Qingfei Xiaoyan Wan was less toxic and could not detect the LD₅₀,so the maximum dose test was directly performed. The maximum dose test results showed that body weight,organ coefficient,liver and kidney function indicators,and histomorphological changes of organs in young mouse were normal. In this experiment,a young mouse was administered at a dose of 72 g/kg a day,which is equivalent to 252 times the clinical dose of children aged 6 to 12 years.Conclusion] Qingfei Xiaoyan Wan has extremely low toxicity and has high clinical safety in pediatric clinical practice.