地黄提取物的急性毒性和亚慢性毒性试验研究

Study on Acute Toxicity and Sub-chronic Toxicity of the Extract of Rehmannia glutinosa

试验通过考察地黄提取物的急性毒性和亚慢性毒性,评价其安全性,为临床用药提供理论依据。急性毒性试验采用昆明种小鼠进行半数致死量(LD50)和最大给药量(MTD)的测定。亚慢性毒性选取80只SD大鼠,分为低、中、高地黄提取物组和对照组,连续灌胃30d,试验结束后进行血液常规和血液生化指标检测,处死后测定脏器系数,并做病理组织学观察。急性毒性试验结果显示,在试验期内未发现小鼠死亡,未测得LD50,小鼠最大给药量为61.54g/kg。亚慢性毒性结果显示,各给药组大鼠的体重、血液生化指标、脏器系数及内脏组织病理学观察与对照组均无显著差异(P>0.05),未见与药物作用有关的病理变化。结果表明,在本试验条件下,根据世界卫生组织(WTO)有关外源性化学物急性毒性分级标准,地黄提取物属实际无毒物质,结合急性毒性和亚慢性毒性试验结果,说明按临床剂量使用地黄提取物是安全无毒的。

The purpose of this experiment was to study the acute toxicity and long term sub chronic toxicity of the extract of Rehmannia glutinosa in mice,evaluate the clinical safety of medication and provide theoretical basis for clinical application.Mice were chosen to measure the median lethal dose(LD50)and maximal tolerance dose(MTD).In the sub chronic toxicity test,80SD rats were divided into four groups:Low dose,middle dose,high dose test groups with the extract of Rehmannia glutinosa and control group with normal saline for30d.On the31th day,the rats were killed and the blood routine index,biochemistry index and the organ coefficient were measured.The MTD was61.54g/kg,according to the judgmental standard of the acute toxicity,the extract of Rehmannia glutinosa was safe.The sub chronic toxicity test results showed that there were no significant difference in body weight and blood chemistry indexes and organ coefficient among the four groups(P>0.05)and there were no pathological change because of the medication.The result indicated that the extract of Rehmannia glutinosa was no acute toxicity under the condition of this test according to acute toxicity classification standard of exogenous by WTO,and it was no sub chronic toxicity too,which suggested the extract had a good clinical safety.