Objective: To study the safety and efficacy of compound moxiflocacin ear drops to experimental animals. Methods:In skin irritation testing, 20 rabbits were divided into 2 groups: the normal skin group and the damaged skin group (10 rabbits in each group). Compound moxifloxacin ear drops 1 ml and normal saline 1 ml were applied to the right and left sides in the one and same rabbit once daily for 7 days, respectively. The skin reactions were observed and scored.In skin allergy testing, 30 guinea pigs were divided into the following three groups: the compound moxifloxacin ear drops group, the 1% 2,4dinitrochlorobenzene group, and the normal saline group (10 guinea pigs in each group). The depilated areas of guinea pigs in the three groups were applied with 0.5 ml of abovementioned three medications, respectively. Allergic skin reactions were observed 6, 24, 48, and 72 hours after administration. In acute toxicity testing, 100 mice were devided into 2 groups: the subcutaneous injection group and the intraperitoneal injection group (50 mice in each group). Every group was redivided into 5 variable dosage groups: 40, 32, 26, 20, and 16 ml/kg in the subcutaneous injection group, and 32, 26, 21, 16, and 13 ml/kg in the intraperitoneal injection group. The mortality of the mice was observed for 7 days. LD50 and 95% confidence interval were calculated. In the efficacy study, 30 rabbit models of otitis media were randomly divided into 5 groups as fellows: the three variable dosage of compound moxifloxacin ear drops treatment groups, the ofloxacin ear drops positive control group, and the blank control group (6 rabbits in each group). In the three variable dosage of compound moxifloxacin ear drops treatment group, 0.8, 0.5, and 0.2 ml of compound moxifloxacin ear drops were applied into the ear three time daily, respectively. In the ofloxacin ear drops positive control group, 0.5 ml of ofloxacin was applied into the ear three times daily. In blank control group, nothing was applied. The efficacy to otitis media was evaluated one week after treatment. Results: No compound moxifloxacin ear dropsinduced erythema, swelling, and allergy were found. The subcutaneous and intraperitoneal LD50 were 25.55 ml/kg and 22.58 ml/kg for mice, respectively. The rate of high efficacy to the three variable dosages of compound moxifloxacin ear drops and the ofloxacin ear drops were 83.3%~100% and 666%, respectively, compared with the blank control group. Conclusion: Compound moxifloxacin ear drops is a safe and effective agent in treatment of otitis media.