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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 Yin-Yin-Tang decoction in mice by intragastric administration. Methods: The pre-test was carried out. The maximum dose of 800g crude drug / (kg · d) and the maximum gavage volume of 0.4 m L / Half the lethal dose of silver soup (LD50). To the maximum tolerated dose test, 200,400,800 g crude drug / (kg · d) dose group were given intragastric administration, the mice were observed for 14 days after administration, and the toxicity and death of mice were recorded in detail Happening. Results: Except for 2 days before treatment, the appetite of some mice was decreased and the excrement was thin, the other cases were normal, no animals died, no abnormality was found in the organs of the internal organs, the body weight and organ index were not significantly different from the control group (P> 0.05). Mice on the oral maximum tolerated dose (MTD)> 800 g crude drug / (kg · d), equivalent to about 240 times the clinical recommended dose adult. Conclusion: The silver decoction is less toxic and safe, which provides the experimental evidence for clinical application.