Abstract: ObjectiveEvaluation on the safety of veterinary concentracted Shuanghuanglian oral liquid was conduct-ed to provide reference for its clinical application.MethodTaking Kunming mice as experimental subjects,the main toxicity and toxicological target organs of clinical application were determined by carrying out the acute toxicity and sub-chronic toxicity tests for concentrated Shuanghuanglian oral liquid. Acute toxicity test set five dose groups(20.00,10.00, 5.00,2.50 and 1.25 g/kg). Mice were intragastrically administered for 2-3 times within 24 h on test day. The maximum tolerated dose was 240.00 g/kg,and mice were intragastrically administered twice a day for 24 h with 0.80 mL each at the start of the experiment. The mice in the subchronic toxicity test were treated with the drug at dose of 0.16,0.08 or 0.04 mL each mice a day for 28 d by continuous intragastric administration.ResultFor mice in acute toxicity test,within 30 min after intragastric administration,mice were apathetic,quiet and their slowed down breath,but returned to normal state after 30 min. No symptoms of poisoning and death were presented,and median lethal dose(LD50)was failed to detect. The maximum tolerated dose of veterinary concentrated Shuanghuanglian oral liquid to mice is more than 240.00 g/kg. During the subchronic toxicity test,body weight,organs(liver,spleen and kidney)indexes,serology indexes(glu-tamic pyruvic transaminase,glutamic oxalacetic transaminase,urea nitrogen and creatinine content) in mice of each group were not significantly different when compared with those in the blank control group(P>0.05). Histopathological examination showed that only the high dose group had liver injury,a little necrosis in liver cells,messy liver cell lines, unclear cell boundaries,weakened nuclear staining,but no abnormal changes in other organs were detected.ConclusionThe veterinary concentracted Shuanghuanglian oral liquid has no acute toxicity to mice,and long-term medication does not pose subchronic toxicity to mice. Therefore it is safe.