Abstract: OBJECTIVE To research the protective effect of Xiaohuaqingfengteng capsule on acute liver injury mice induced by CCl4 and D-galactosamine (D-Gal), and to detect its acute toxicity. METHODS Mice were divided into 6 groups(n=10): normal group, positive drug group, model group and the high, medium and low dose groups. Acute liver injury mice model were induced by CCl4 or D-Gal. Then blood from eyeball was used to examine serum ALT, AST, SOD, and MDA. The liver index was determined, and the pathologic section of the liver was stained for HE expression. The mice were randomly divided into the treatment group and the normal group in acute toxicity experiment. The mortality, changes of the body weigh and feed intake of animals were measured. After 14 days, all animals were killed and grossly anatomized, then the internal organs were observed. RESULTS In each group Xiaohuaqingfengteng capsule could decrease serum ALT, AST, MDA levels and liver index and increase serum SOD level (P<0.05 or P<0.01). Pathologic examination showed liver injury had significantly improved in each treatment groups. The mortality was 0 in the treatment group of acute toxicity test. Compared with the normal group, the changes of food intake and behavioral activity have no significant different in treatment group except a slight decrease in body weight. After the gross anatomy, the appearance of organs were not abnormal. CONCLUSION Xiaohuaqingfengteng capsule has a protective effect on acute liver injury. And there did not exist the acute toxicity in treatment mice with maximum dose.