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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 toxicity and long-term toxicity of Decoction and evaluate its safety. Methods: Acute toxicity test was conducted on the maximum tolerated dose (MTD) test. Long-term toxicity test was given to three groups of low, medium and high doses (60, 90 and 120 times of the recommended dose) Hematology, blood biochemistry, organ weight coefficient, histopathology, routine examination and reversible observation. Results: Acute toxicity test showed no obvious symptoms of poisoning. The acute toxicity MTD of different sex mice> 120.0g crude drug / kg. The long-term toxicity test showed that the appearance signs, behavioral activities, body weight, Food utilization, hematology, blood biochemistry, visceral ratio and histopathological examination showed no abnormalities, reversible observation showed that retreated soup did not cause delayed toxicity in rats, compared with the control group, no significant difference (P> 0.05). Conclusion: Decoction has no toxic reaction and is safe for long-term use, providing experimental basis for clinical application.