二十八烷醇微乳液的毒理学评价

The Toxicological Evaluation of Octacosanol Nanoemulsion

二十八烷醇微乳液是由二十八烷醇、吐温80、乙醇等配制而成的均一透明液体。通过急性毒性经口试验和28 d经口重复毒性试验,判断二十八烷醇微乳液的食品毒性。在急性毒理学试验中,对昆明小鼠一次性经口灌胃10 g/kg bw二十八烷醇微乳液,观察14 d,无中毒或死亡症状,LD50>10 g/kg bw,属于实际无毒级别。在28 d经口重复毒性试验中,设置二十八烷醇高剂量组(5.00 g/kg bw)、中剂量组(2.50 g/kg bw)、低剂量组(1.25 g/kg bw)和阴性对照组,通过临床观察、对比体质量和摄食量变化、进行血液学、血生化及病理学检查得出结论,二十八烷醇微乳液对小鼠最大无作用剂量为2.50 g/kg bw(人体推荐摄入量的100倍)。综上所述,二十八烷醇微乳液无毒。

Octacosanol nanoemulsion,prepared from octacosanol,Tween 80,ethanol and other substances,is a uniform transparent liquid.The acute toxicity test and the 28-day repeated oral toxicity test were conducted to determine the food toxicity of octacosanol nanoemulsion.In the tests of acute toxicity,single oral gavage of 10 g/kg bw octacosanol micro-emulsion was given to Kunming mice.After 14 days of observation,there were no symptom of poisoning or death,LD50>10 g/kg bw,hence,octacosanol nanoemulsion belongs to actually non-toxic grading.In the 28-day repeated oral toxicity experiment,octacosanol high-dose group (5.00 g/kg bw),medium-dose group (2.50 g/kg bw),low-dose group (1.25 g/kg bw) and negative control group were set up.After clinical observation,weight comparison,food intake records,hematology,blood biochemistry and pathological examination,the maximum non-effect dose of octacosanol nanoemulsion on mice is 2.50 g/kg bw (100 times of the recommended intake of human body).Therefore,octacosanol micro-emulsion is non-toxic.