Abstract: With mice as the experimental subject,the safety of the volatile oil of the Alpinia japonica (Thunb.) Miq Rhizome (AJV) was evaluated through acute toxicity test and subacute toxicity test.The acute toxicity test was divided into the AJV group and control group.The acute toxicity test was conducted with a maximum tolerance dose 5 mL/kg of volatile oil.The subacute toxicity test was divided into low-dose AJV group (1.3 g/kg) and high-dose AJV group (2.6 g/kg) and control group,and the drugs were intragastrically administered once a day for 15 consecutive days.After administration,the physical signs of the mice were observed,body weight and organ coefficient were recorded,the contents of urea nitrogen and creatinine in plasma and the activities of alanine aminotransferase and aspartate aminotransferase in serum were detected,and histopathological examination was performed.The results showed that compared with the control group,the physical signs of most mice were normal after administration,and some mice had vertical hair.There were no significant changes in organ coefficient,urea nitrogen content,creatinine content,alanine aminotransferase activity and aspartate aminotransferase activity of mice (P>0.05).Compared with the weight at the beginning of the experiment,the weight of the mice did not decrease at the end of the experiment.One mouse died in the acute toxicity test.In the subacute toxicity test,the alanine aminotransferase level of 1 mouse significantly increased (135.30 U/L).Pathological findings showed that 1 mouse had liver tissue inflammation and 1 mouse had liver fibrosis.The results indicated that the acute toxicity of volatile oil was low,but it may cause some hepatotoxicity with high dosage in clinic.Attention should be paid to its safety.

Key words: Alpinia japonica, volatile oil, acute toxicity, subacute toxicity