WANG Chunliu, LONG Kaihua, YANG Jie, TANG Tao, ZANG Qiaozhen, LI Tonghui, XIN Yongjie, LI Ye
Objective To test long-term toxicity of self-microemulsifying granules of Brucea javanica oil on SD rats . Methods The SD rats were divided into blank control group, high-, medium- and low-dose (144, 72 and 36 folds of dosage for human, respectively) of self-microemulsifying granules of Brucea javanica oil groups randomly (n=30 each group).The weight, appetite, haematological indexes, blood biochemical indexes, visceral index and histopathologic changes of organs of rats were measured at time point after 3, 6 months treatment and 4 weeks after drug withdrawal, respectively. Results Compared with blank control group, the drug groups showed no significant differences in the appearance and weight of rats.With haematological indexes, the level of lymphocyte rate (LY) in high dose group was lower while the levels of monor (MO) in high dose group was higher, MO and basic cells rate(BA)in medium dose group were significantly higher than those in blank control group (P<0.01) after 3-month long treatment.Hematocrit (HCT) in high dose group was lower, neut (NE) in medium dose group was higher than those in blank control group(P<0.01) after 6-month long treatment.Those changed indexes recovered to be blank on the 4th week after withdrawal.No significant difference was obtained compared with blank control group(P>0.05).In blood biochemical indexes, the levels of total protein (TP), albumin (G), glutamic-pyruvic transaminase (ALT) in high dose group and TP in medium dose group were higher than those in blank control group (P<0.05).Glutamic-oxalacetic transaminase (AST) in high dose group was significantly higher than that in blank control group (P<0.01) after 3 months.After 6 months treatment , compared with blank control group, the level of glutamic-oxalacetic transaminase (AST) in high dose group was higher while trilaurate glycerin (TG) was lower(P<0.05).The level of creatine kinase (CK) was lower(P<0.05) and the level of TG was significantly lower (P<0.01).The level of glucose (Glu) was significantly lower (P<0.01).Those changed indexes recovered to be blank on the 4th week after withdrawal.In haematological indexes,delayed enlargements of liver and testis occurred after withdrawal.No rat died in the process of experiment.No obvious histopathologic changes of organs of rats were observed . Conclusion Self-microemulsifying granules of Brucea javanica oil have no apparent toxicity.It is worthy of further research.