Abstract: The safety of the acute and subacute toxicity of aqueous extract of the Alpinia japonica (Thunb.) Miq rhizome (AAR) is studied.In acute toxicity test,ICR mice were divided into AAR group (maximum tolerated dose:5 g/kg) and control group.In subacute toxicity test,ICR mice were divided into low-dose AAR group (1.3 g/kg),high-dose AAR group (2.6 g/kg) and control group,and the drugs were administered by gavage once a day for 15 consecutive days.After administration,the behavior characteristics and weight changes of mice were observed,and the organ coefficients were recorded.The content of urea nitrogen and creatinine in plasma,and the activity of alanine aminotransferase and aspartate aminotransferase in serum were detected.Histopathological examination of liver tissues were performed by H&E staining.In the acute toxicity test,there was no significant difference between the experimental group of mice in AAR group and the control group.In the subacute toxicity test,compared with the control group,the creatinine content of the high dose group was low (P<0.05),and the liver coefficient of the high dose group was high (P<0.05);the remaining organs' coefficients,the content of urea nitrogen and creatinine,and the activity of alanine aminotransferase and aspartate aminotransferase did not significantly differ from those of the control group;the liver histopathology showed no abnormality.There was no obvious acute toxicity and subacute toxicity in the aqueous extract of the Alpinia japonica rhizome.

Key words: Alpinia japonica, aqueous extract, acute toxicity, subacute toxicity