芝麻素胶囊的毒理学安全性评价

Study on toxicological security of sesamin capsules

目的 评价芝麻素胶囊的毒理学安全性。 方法 应用小鼠急性经口毒性试验评价芝麻素胶囊的急性毒性；通过Ames试验、骨髓细胞微核试验和小鼠睾丸染色体畸变试验评价其遗传毒性；采用大鼠30 d喂养试验评价其亚急性毒性。 结果 雌、雄小鼠急性经口试验的最大耐受量＞15 g/kg ·b.wt.，毒性等级为无毒级。Ames试验为阴性，无致基因突变作用。与对照组比较，各剂量组小鼠细胞微核率、睾丸染色体畸变细胞率差异均无统计学意义（ P 值均＞0.05）。雌、雄大鼠经30 d喂养后总增重、总食物利用率、脏体比差异均无统计学意义（ P 值均＞0.05），大鼠血常规指标、血生化指标均在正常范围内，主要脏器无病变。 结论 在本实验条件下，该芝麻素胶囊无急性毒性、遗传毒性、亚急性毒性，具有较高安全性。

Objective To evaluate the toxicological security of sesamin capsules. Methods Acute toxicity of sesamin capsules was evaluated by acute oral toxicity test on mice. Genetic toxicity was evaluated by Ames test, bone marrow micronucleus test and mice testicle cells chromosome aberration test. 30 d feeding test on rats was conducted to study sub-acute toxicity. Results The oral MTD was 〉15 g/kg ·b.wt. for both male and female mice, the toxic level was non-toxic. Ames test showed negative results, mutagenic effect was not detected among samples. Compared with the control group, the results of mice bone marrow micronucleus test and testicle cells chromosome aberration test were both negative（all P 〉0.05）.The results of 30 d feeding test on rats demonstrated no significant difference for total weight gain, total food utilization or body mass ratio （all P 〉0.05）. The blood routine indices and biochemical indices of rats were within the historical normal range, the main organs were free of lesions. Conclusion Under the experimental conditions, sesamin capsules was safe for no acute,mutagenic effect or sub-acute toxicity.