Acute and Long-term Toxicity Test of Brucea Javanica Oil Subnanoemulsion Injections / 中国药师

ABSTRACT

Objective: To study the acute and long-term toxicity of brucea javanica oil subnanoemulsion injections ( BJOSI ) . Methods:The mice were given BJOSI by intravenous injection. The acute toxicity was observed and LD50 in mice was calculated by Bliss method. To observe the long-term toxicological effects, Beagle dogs were injected intravenously BJOSI once a day for 8-week du-ration with the dose of 20, 10 and 6 ml·kg-1 , respectively followed by 3-week recovery period. Results:LD50 of BJOSI in mice was 7. 388 g·kg-1 with 95% confidence limits of 6. 306-8. 656 g·kg-1 . The long term toxicity test showed that all the detected indices were within normal range in all groups, including general state, weight changes,hematological indices,biochemical indices,EEG,organ coefficients, morphological and histological changes, while there was an upward tendency of ALT and Cr in every BJOSI group without dose-effect correlation. The dogs could completely recover in three weeks after the administration. Conclusion:The results suggest that BJOSI has low toxicity,while the pathological changes are reversible, and attention should be paid to the function of liver and kidney.