退银汤急性毒性试验

Acute Toxicity Test of Anti-Psoriasis Decoction

目的:对退银汤进行小鼠灌胃的急性毒性试验,评价其安全性。方法:先进行预试验,采用退银汤灌胃的最大给药剂量800g生药/(kg·d)和最大灌胃体积0.4 m L/10 g体质量小鼠一次性灌胃,无法测出退银汤的半数致死量(LD50)。改为最大耐受量试验,采用退银汤200、400、800 g生药/(kg·d)剂量组分别给予小鼠灌胃,给药后观察14 d,详细记录小鼠的毒性反应和死亡情况。结果:除用药前2 d部分小鼠食欲减退、粪便稀薄外,其它情况均正常,未出现动物死亡,解剖检查内脏器官无异常,体质量、脏器指数与对照组比较,差异无统计学意义(P>0.05)。小鼠对本品口服最大耐受量(MTD)>800 g生药/(kg·d),约相当于成人临床推荐剂量的240倍。结论:退银汤毒性较低,安全性好,为临床应用提供了实验依据。

Objective：To evaluate the safety of Anti-Psoriasis Decoction according to acute toxicity tests in mice. Methods：Intragastric administration of Anti-psoriasis decoction was used in the pre-experiment, and the maximum perfusion dose is 800 g crude drug/（kg·d） and the maximum volume of perfusion is 0.4 m L/10 g. Half lethal dose（LD50） of Anti-psoriasis decoction could not be determined. Maximum tolerance test were used instead with Anti-psoriasis decoction groups of 200, 400 and 800 g crude drug（kg·d）. The groups were given intragastric administration and were observed in 14 days after administration. Toxicity reactions and death conditions were recorded in detail. Results：Except at the beginning of 2 days after administration,some mice lost appetite with loose stool, and other conditions were normal with no death. Autopsy examination indicated visceral organs were without exception, and that body weight and organ index showed no statistical significance（P〉0.05）,comparing with the control group. Maximum tolerated dose of mice（MTD）〉800 g crude drug/（kg·d）, roughly equivalent to 240 times the recommended clinical dose of adult. Conclusion：Anti-psoriasis decoction shows low toxicity, with good safety, which provides the experimental basis for clinical application.