RESUMO
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.
RESUMO
Objective To optimize the prescription and technology of Brucea javanica oil subnanoemulsion injection. Methods Using superfine Brucea javanica oil as oil phase,yolk lecithin and poloxamer 188 as the complex emulsifying agents. The dosage of oil,emulsifier and stabilizer were optimized and the preparation was optimized by orthogonal experiments. Results The optimum precription was 10% oil phase,1.2% emulsifier and 0.1% stabilizer. The optimum technology was that aqueous phase and oil phase mixed at 70 ℃,sheared 20 min by high speed shearing machine and then passed the ultra-high pressure nano homogenizer 6 times under the pressure of 900 bar. Conclusion The physical stability of Brucea javanica oil subnanoemulsion injection is good.