Abstract: Objective To observe the long-term toxicity of the Brucea Jananica Oil Injection by repeated intravenous injection. Methods Daily doses of Brucea Jananica Oil Injection(content of acid by means of olegic acid) at 1000 mg ·kg^-1·d^-1, 330mg·kg^-1·d^-1 and 100mg·kg^-1·d^-1 for 26 week were used for high, mid and low dose group, respectively. Examinations including haematological indexes, biochemical indexes and histopathology were performed on the 13th week, on the 26th week during the administration, and on the 6th week after the withdrawal, respectively. Results The rats in high dose group appeared diarrhea, depressed and the fur lacked luster during the administration. Three animals died and appeared face lying, breathlessness, blood excretion at the angulus oris in extremis. The mortality was 7.5% in high dose group. The high and mid doses inhibited the animals'body weight growth. The levels of ALT, AST, BUN and CR in blood serum in high dose group were significantly higher than those in control group on the 26th weeks after administration(P<0.05 ). Those changed indexes of hematology and blood biochemistery regained normal on the 6th weeks after withdrawal. The lung of dead rats in high dose group appeared pathological changes, micrangium in alveolar wall displayed distension and congestion, and there was considerable erythroic fluid in alveolar space.Conclusion Repeated administration of the Brucea Jananica Oil Injection at high dose could lead to damage to liver and kidney function and acute pulmonary edema. The no observed adversed effect level (NOAEL) of the Brucea Jananica Oil Injection on rats was 100mg·kg^-1·d^-1.

Key words: Brucea Jananica Oil, rat, long-term toxicity