退白汤的急性毒性实验研究

Acute Toxicity Test for Anti-Vitiligo Tang

目的:观察小鼠灌胃退白汤后的急性毒性反应,评价其安全性。方法:采用经口给药测定小鼠口服退白汤的急性毒性反应,以1 360 g(生药)·(kg·d)-1剂量的退白汤(相当于成人临床每日用量的480倍)给小鼠灌胃,给药后观察14d,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、粪便颜色棕褐色外,其他一般情况均正常,未出现小鼠死亡,解剖检查内脏器官无异常;给药前正常组摄食量、体质量、体温分别为(3.2±0.3)g·d^(-1)、(23.1±1.4)g、(37.2±0.5)℃,退白汤组分别为(3.3±0.4)g·d^(-1)、(22.9±1.2)g、(37.4±0.4)℃,两组摄食量、体质量、体温比较,差异均无统计学意义(P>0.05);给药后正常组摄食量、体质量、体温分别为(5.5±0.8)g·d^(-1)、(33.8±3.7)g、(37.1±0.5)℃,退白汤组分别为(5.4±0.6)g·d^(-1)、(34.2±3.9)g、(37.2±0.4)℃,两组摄食量、体质量、体温比较,差异均无统计学意义(P>0.05)。结论:退白汤毒性较低,安全性好,为临床应用提供了实验依据。

Objective：To observe the acute toxicity of mice by intragastric infusion for Anti-vitiligo Tang,and the evaluation of its safety.Methods：The acute toxic reaction of mice was measured after oral administration of Anti-vitiligo Tang,with the dose of1 360 g crude drug/（kg·d）-1（equivalent to 480 times the adult clinical daily dosage）by intragastric infusion,14 days were observed after administration,and the toxic reaction and death status of mice were recorded in detail.Results：Except some mice decreased appetite and the color of stool was brown,other status were all normal,with no animal death and no abnormal visceral organs after anatomical examination.Before medication,food intakes,body mass,body temperatures of normal group were（3.2 ±0.3） g·d^（-1）,（23.1 ± 1.4） g,（37.2 ± 0.5） ℃,and in Anti-vitiligo Tang group were（3.3 ± 0.4） g·d^（-1）,（22.9 ± 1.2） g,（37.4 ± 0.4） ℃.Comparing two groups with each other,there were no statistical significance（P 0.05）;After medication,food intakes,body mass and body temperatures of normal group were（5.5 ± 0.8） g·d^（-1）,（33.8 ± 3.7） g,（37.1 ± 0.5）℃,and in Anti-vitiligo Tang group were（5.4 ± 0.6） g·d^（-1）,（34.2 ± 3.9） g,（37.2 ± 0.4）℃.Comparing two groups with each other,there were also no statistical significance（P 0.05）.Conclusion：Anti-vitiligo Tang has low toxicity,and good safety,providing the experimental basis for clinical application.