山泽减肥食品的毒理学安全性评价

Toxicological assessment of Shanze weight-reducing food

目的 评价山泽减肥食品的安全性 ,为其应用提供毒理学安全依据。方法 依据国标进行大鼠经口急性毒性试验、遗传毒性试验、30天喂养试验及传统致畸试验。结果 ①大鼠经口急性毒性试验 ,雌、雄大鼠经口LD50 均大于2 0 .0 g·kg-1(相当于推荐人体用量的 4 76倍 ) ,属无毒级。②遗传毒性试验。小鼠骨髓微核试验、小鼠精子畸形试验及Ames试验结果均为阴性。③大鼠 30天喂养试验。未发现其对试验大鼠的生长发育、血液学、生化、脏体比及组织病理学有明显不良影响。④大鼠传统致畸试验。未发现对试验大鼠有致畸作用。结论 在试验剂量 1.0 5 g·kg-1～4 .2 0 g·kg-1范围内 。

Objective To evaluate the toxicological safety of Shanze weight-reducing food in order to provide some toxicological data for its application. Methods According to the national standard of safety evaluation, the following experiments of acute toxicity test through mouth in rats, the genetic toxicity test, thirty days feeding test and teratogenicity test in mice were performed. Results LD 50 was more than 20.0 g·kg -1, equivalent to 467 times of the recommended dosage, in acute toxicity test through mouth in both male and female rats, which fell into the scale of non-toxicity. Under the dosage range of 1.05 g·kg -1 to 4.20 g·kg -1, equivalent to 100 times of the recommended, the negative results were observed in the genetic toxicity test of micronucleus test of bone marrow cells, sperm shape abnormality test in mice and the Ames test. The negative impacts on the growth, development, hematology, biochemistry, histology and the ratio of organ to whole body were not found on the experimental rats of thirty days feeding. Under the same dosage range, no teratogenic effects were found in the experiments of teratogenicity test. Conclusions Shanze can be used as a kind of health weight-reducing food with toxicological safety under the experimental dosage range of 1.05 g·kg -1 to 4.20 g·kg -1.