蒙药桔梗八味颗粒的急性毒性实验研究

Experimental Study on Acute Toxicity of MongolianMedicine Platycodon Grandiflorum Bawei Granule

目的:进行大鼠经口给予桔梗八味颗粒的急性毒性评价,观察其安全性。方法:采用最大给药量试验。选用SPF级SD种离乳大鼠,按体重随机分为对照组和桔梗八味颗粒组,给药组灌胃给药2次,累计给药剂量28.88g(生药)/kg,对照组同法给同体积纯净水。给药后连续14天观察动物的一般状态、中毒反应和死亡情况等;观察期结束后对各组大鼠进行剖检,肉眼观察各组织脏器的变化。结果:同对照组比较,给药组2次给药后大鼠均未见到明显异常变化;在给药后14天观察期内大鼠全部存活;外观、活动行为、体位姿态、进食、饮水、二便、皮毛、呼吸状态及排泄均未见明显异常;观察期结束时,剖检各组大鼠,肉眼观察各组织脏器均未见明显异常改变。结论:桔梗八味颗粒一日内以最大给药浓度,最大给药体积对大鼠灌胃给药2次,大鼠累计给药剂量为28.88(生药)/kg,相当于临床剂量的147倍,除动物体重降低外,未见其他毒性反应。

Objective:To evaluate the acute toxicity of Platycodon grandiflorum Bawei granules administered orally to rats and observe its safety.Methods:Use the maximum dose test.SPF SD weaned rats were selected and randomly divided into the control group and the Platycodon grandiflorum Bawei granule group according to their body weight.The administration group was given intragastric administration twice,and the cumulative administration dose was 28.88g(crude medicine)/kg.Give the same volume of purified water.After the administration,the general state,poisoning reaction and death of the animals were observed for 14 consecutive days;after the observation period,the rats in each group were subjected to necropsy to observe the changes of various tissues and organs with naked eyes.Results Compared with the control group,the rats in the administration group did not see obvious abnormal changes after two doses;all rats survived during the 14-day observation period after the administration;appearance,activity behavior,posture,eating,drinking,There were no obvious abnormalities in stool,fur,respiratory status and excretion;at the end of the observation period,the rats in each group were autopsied,and there were no obvious abnormal changes in all tissues and organs observed by naked eyes.Conclusion:Platycodon grandiflorum Bawei Granules are given to rats by gavage twice a day at the maximum concentration and maximum dose volume.The cumulative dose for rats is 28.88(crude medicine)/kg,which is equivalent to 147 times the clinical dose,except Except for the weight loss of animals,no other toxic reactions were seen.