Object:To observe the acute and sub-acute toxic effects of Bai-xiao-san(BXS).Method:we adopted maximally tolerated dosage in acute toxicity tests in mice and successive administration 30d for sub-acute toxicity tests in rats.Result:The acute toxicity showed a dose-dependent increase after oral administration of BXS in mice.The LD50 was observed at 10.8 g/kg and 9.26 g/kg,respectively.sub-acute toxic effects shows that after given dosage above0.35 g/kg a week,the movement of mice reduced,weight increased slowly,skin showed no smooth.The weight and increased weight,food availability,spleen/body-mass index,adrenal/body-mass index,thymus/ body-mass index,WBC,WGB,ALT,TP,ALB,TC had significant difference compared to control group(P0.01);TG,CRE showed no differece to control group(P0.05).Accrementition of flat cell was seen through histopathologic examination at gastric mucosa cardia,scarfskin cuticularizate obviously,part of membrana mucosa had Inflammatory reaction.Conclusion:The study shows that at common dosage BXS would not cause drug interaction.However,at high dosages it exhibited marked damage to all the major organs of the body.