【摘要】 目的:研究鸦胆子油亚纳米乳注射液的急性毒性和长期毒性。方法:以小鼠静脉注射,采用Bliss法计算其半数致死量(LD50)。Beagle犬静脉注射鸦胆子油亚纳米乳注射液,分高、中、低三个剂量组(20,10,6 ml·kg-1),qd,连续8周,停药后恢复期3周,观察其对beagle犬的长期毒性反应及其程度。结果:小鼠静脉注射鸦胆子油亚纳米乳注射液的LD50为7.388 g·kg-1,95%可信限为6.306~8.656 g·kg-1。长期毒性试验中,三个剂量组的一般状况、体质量、血液学检查、血液生化学指标、心电图检查、脏器系数、脏器的肉眼观察和组织形态检查与对照组比较均无明显差异,但ALT和Cr值三个剂量组均有升高趋势,但无明显量效关系,停药3周复查,可完全恢复。结论:鸦胆子油亚纳米乳注射液毒性较低且病理变化具有可逆性,临床使用安全;但在用药期间应注意对肝肾功能的观察。更多还原

【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 LD50in 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 duration with the dose of 20,10 and 6 ml·kg- 1,respectively followed by 3-week recovery period. Results: LD50of BJOSI in mice was7. 388 g·kg- 1with 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.更多还原