含二十八烷醇油胶囊安全性毒理学评价

Safety and Toxicology Assessment of Cereal Germ Oil Capsule Containing Octacosanol

油胶囊的主要成分为二十八烷醇、VE和亚油酸,作者对其安全性毒理学进行评价。结果表明:油胶囊对SD大鼠、昆明小鼠的急性经口LD50均大于10 g/(kg.bw),判属实际无毒类;A-mes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等3项遗传毒性试验均为阴性,表明该受试物无致突变作用;在大鼠30 d喂养试验中未见动物健康状况、生化、血液学指标和器官组织形态的异常变化,据此初步估计该产品的最大无作用剂量大于2.5 g/(kg.bw)(人体推荐摄入量的150倍)。

The main components of cereal germ oil capsule were octacosanol, tocopherols and linoleic acid. The safety and toxicology of cereal germ oil capsule was assessed in this paper. The results showed that the oil capsule was nonpoisonous in reality with oral LD50〉 10 g/（kg · bw） to SD rats and kunming mice. The results of Ames test, mice bone marrow micronucleus test and mice sperm malformation test are of negative active, which means no inducing effect of pathological changes and mutation. After 30 days feeding experiment to SD rats, there were no abnormal changes in the terms of health status, biological chemical indexes, hematology indexes, as well as organ and tissue morphology. The no-observed-adverse-effect level of the product is bigger than 2.5 g/（kg · bw）（150 times of recommended to human being）.