退白汤毒理学实验研究

An experimental study on toxicological assessment for Tuibai decoction

目的:观察退白汤的急性毒性和长期毒性,评价其安全性。方法:急性毒性试验采用最大耐受量(MTD)试验,长期毒性试验给予低、中、高3个剂量(相当于推荐剂量的60,90,120倍量)的退白汤,连续给药26周,进行血液学、血液生化、脏器重量系数、组织病理学检查、常规检查以及可逆性观察。结果:急性毒性试验未见明显中毒症状,不同性别小鼠的急性毒性MTD>120.0g生药/kg;长期毒性试验结果表明,退白汤3个剂量组大鼠的外观体征、行为活动、体质量、食物利用率、血液学、血液生化学、脏体比及病理组织学检查均未见异常,可逆性观察表明退白汤对大鼠未引起延迟毒性,与对照组比较差异均无显著性(P>0.05)。结论:退白汤无毒性反应,长期服用是安全的,为临床应用提供了实验依据。

OBJECTIVE To observe the acute and long-term toxicity, then to evaluate the safety of the Tuihai decoction. METHODS Test of the maximum tolerance dose（MTD） was used to detect the acute toxicity. 60,90,120 times of recommen- ded dose of the Tuibai decoction were given continuously for 26 weeks to detect the long-term toxicity, and then observe the effects on blood cytology indexes, blood biochemical indexes, weight coefficient of organs, histopathology examination, routine examinations and reversibility study. RESULTS There was no obvious toxic symptom in the acute toxicity trial （the acute tox- icity of the different sexual mice, MTD^120. 0 g,kg-＇ dose o{ Tuihai decoction）. The results of long-term toxicity trial indica- ted that there were no significant differences in appearance, behavior, body weight, food exploitation rate, blood cytology inde- xes, blood biochemical indexes, organ^body ratio, and pathematotogy examination in the rats of the three dosage groups as compared to the control group. The reversibility study demonstrated that there was no delayed toxicity in the rats of the three dosage groups as compared to the control group （P〉0. 05）. CONCLUSION Tuibai decoction is a nontoxic drug and it is safe to long-term use. The study also provides an experimental foundation for the clinical application.