OBJECTIVE： To study the acute toxicity of Compound lujiao cream. METHODS： A total of 40 SPF Kunming mice were divided into blank control group （constant volume of sodium carboxymethylcellulose）， Compound lujiao cream low-dose， medium-dose and high-dose groups （extract suspension， 6， 14， 34 g/kg， as 192， 448， 1 088 folds of recommended human clinical daily dose， respectively）， with 10 mice in each group， male and female in half. They were given medicine intragastrically once.Before medication and within 14 d after medication，the survival， toxic reaction were observed.Body weights of mice were measured before medication， during medication and 2，3，7，14 d after medication. The mice was scarified 14 d after medication. The pathological changes of body surface， administration site and natural channels， the external surface of the cranial cavity and brain， thoracic cavity， abdominal cavity， pelvic cavity and visceral organs were also observed. RESULTS： All mice survived. No abnormality was found in blank control group and Compound lujiao cream low-dose group. In Compound lujiao cream medium-dose group， no significant abnormality was found in male mice； 4 female mice suffered eye closure 20-23 min after medication， and then began to recover 27 min after medication and returned to normal 29 min after medication. In Compound lujiao cream high-dose group， mice suffered from eye closure， activity reduction， arched back and hair shaft 8-29 min after medication， but recovered 1 h after medication. Compared with blank control group， there was no significant difference in body weight of mice in Compound lujiao cream low-dose， medium-dose and high-dose groups （P＞0.05）. There was no significant lesion in body surface， administration site and natural channels， the external surface of the cranial cavity and brain， thoracic cavity， abdominal cavity， pelvic cavity and visceral organs [adrenaline （bilateral）， brain （brain， cerebellum， brain stem）， esophagus， heart， kidney （bilateral）， large intestine （cecum， colon and rectum）， small intestine， liver， lung， pancreas， spleen， thymus， stomach， bladder]. CONCLUSIONS： After using Compound lujiao cream of the intragastric dose of 34 g/kg， the mice suffer from acute toxicity reaction； by the dose of 14 g/kg， some female mice suffer from mild acute toxic reaction； by the dose of 6 g/kg， no obvious acute toxicity reaction was found.