Objective To study the drug safety of Rongzhi granules via an acute toxicity experi-ment.Methods Forty BALB/c mice(half male and half female)were randomly divided into the blank group and the administration group.Before administration,the rats were fasted for 6 h but were given drinking water.On the first day,Rongzhi granules were administrated with 28.6 mg·g-1 twice in the ad-ministration group while the blank group was administrated with the same volume of sterilized water.After intragastric administration,mice in each group were fasted for 3 h and free to eat and drink water(after the second administration).The changes of behavior,weight,delayed drug reaction and toxic reac-tions of mice in each group were observed within 14 days before the blood routine test was conducted and indexes of liver and kidney function of mice were detected.The organ indexes were recorded and the patho-logical manifestations of mice were observed.Results During the experiment,the activities of mice were normal,including food and water intake,urination,respiratory rate and depth.The mice had smooth fur,free movement,normal defecation,good sleep and none of them died.There was no significant difference in results of blood routine tests,liver and kidney function indexes or organ indexes between the two groups(P>0.05).There were no pathological changes in histopathological examinations.Conclusion Rongzhi granules cause no acute toxicological reactions after oral administration.