野大黄散提取物的毒性分析

Toxicity Analysis of the Extract of Yedahuang Powder

为探讨野大黄散提取物临床应用的安全性,以昆明小鼠为研究对象,进行急性毒性和亚慢性毒性试验。急性毒性试验测定野大黄散提取物的半数致死量(LD 50)和最大耐受量(MTD);亚慢性毒性试验分别以2、10、20 g/kg 3种剂量的野大黄散提取物,连续对小鼠灌胃35 d,观察小鼠临床表现,计算脏器指数,检测血常规、血清生化、免疫学指标,观察脏器组织病理变化,综合判定野大黄散提取物的毒性。结果显示,急性毒性试验无法测定半数致死量,MTD≥120 g/kg。亚慢性毒性试验,与生理盐水对照组比较,野大黄散提取物10 g/kg和2 g/kg剂量组小鼠的淋巴细胞数、呼吸道与肠道sIgA分泌水平和血清IgG水平显著提高(P<0.05),各给药组心脏、肝脏、脾脏、肾脏等脏器组织无明显病理变化。试验结果表明,野大黄散提取物属无毒物质,是安全性较高的中药制剂。

In order to explore the safety of Yedahuang powder extract in clinical application,Kunming mice were selected as the research object to carry out acute toxicity and subchronic toxicity tests.The median lethal dose(LD 50)and maximal tolerable dose(MTD)of Yedahuang powder extract were measured in acute toxicity test.2,10 and 20 g/kg of Yedahuang powder extract were used in subchronic toxicity test,respectively.The mice were given extract by gavage for 35 days to observe the clinical manifestations,calculate the organindex,detect the blood routine,serum biochemical and immunological indexes,and observe the pathological changes of organ tissues to determine the toxicity.The results showed that the LD 50 could not be determined in acute toxicity test,and the MTD was≥120 g/kg.In the subchronic toxicity test,compared with the normal saline control group,the lymphocyte number,the secretion level of sIgA in respiratory tract and intestinal tract and the level of IgG in serum of mice in the 10 g/kg and 2 g/kg dose groups of Yedahuang powder extract were significantly increased(P<0.05),and there were no significant pathological changes in the heart,liver,spleen,kidney and other tissues of each group.The results show that the extract of Yedahuang powder is a kind of non-toxic substance,and it is a safe Chinese medicine preparation.