辅酶Q10软胶囊的急性毒性、遗传毒性和亚急性毒性研究

Study of Acute Toxicology,Inheritance Toxicology and Sub-acute Toxicology of Coenzyme Q10

目的:研究辅酶Q10软胶囊的急性毒性、遗传毒性和亚急性毒性。方法:按《保健食品检验与评价技术规范》2003年版要求进行小鼠急性经口毒性试验、Ames试验、小鼠骨髓嗜多染红细胞微核试验和小鼠精子畸形试验及大鼠灌胃给药30 d的亚急性毒性观察。结果:该辅酶Q10软胶囊对雌雄小鼠LD50均大于20 000 mg·kg-1;Ames试验中受试物各剂量组回变菌落数均未超过自发回变菌落数的2倍,亦无剂量-反应关系;小鼠骨髓嗜多染红细胞微核试验和小鼠精子畸形试验中各剂量组微核率、精子畸形率与阴性对照组之间无显著性差异,为阴性。在30 d灌胃给药的亚急性毒性试验期内各实验组动物生长发育良好,体重增重、食物利用率、脏器质量和脏器系数等各项指标均在本实验室正常值范围内。实验组血常规及血生化各指标均在本实验室正常值范围内。病理组织学检查实验组被检脏器未见有意义的病理改变。结论:该辅酶Q10软胶囊为无毒级物质,在所测剂量及检测指标范围内未见明显遗传毒性和亚急性毒性。

Objective： To study the acute toxicity, inheritance toxicity and sub-acute toxicity of coenzyme Q10. Method： The acute oral toxicity test, inheritance toxicity test including Ames test, polychromatic erythrocytes micronucleus test and sperm malformation test of coenzyme Q10 were carried out in mice＇and 30-day feeding test in rats was also conducted according to 〈〈technical standards for testing ＆ assessment of health food〉〉. Result： The result of acute toxicity in mice exceeded 20 000 mg · kg^-1 and all the results of inheritance toxicity test were negative. During the 30-day feeding experiment the rats grew well and there were no significant differences in body weight and food consumption compared with the control group. At the end of the experiment, compared with the control group, there were also no significant differences in blood and biochemical examination, The histopathological changes in liver, kidney, stomach, intestines, spleen, testicle and ovawy were not observed in every group. Conclusion： Coenzyme Q10 is in non-toxic class; no inheritance toxicity and sub-acute toxicity were observed.