茶氨酸复合制剂安全性毒理学研究

摘要

The edible safety of theanine was investigated according to Standard of Health Food Test and Assessment.Acute toxicity test in mice showed that the maximum tolerance dose（MTD） was higher than 20 g/kg.All three genetic tests including Ames test,mouse bone marrow micronucleus test and mouse teratospermia test showed negative results.Thirty-day feeding test showed that physical appearance and the indices of hematology,biochemistry and organ coefficients of rats had no significant difference when compared with those in the control group.All these results suggest that compound theanine preparation is highly safe with neither acute toxicity nor genotoxicity.%根据《保健食品检验与评价技术规范》对茶氨酸复合制剂的安全性进行评价。急性毒性实验结果表明,制剂对雌雄小鼠的急性经口的最大耐受剂量（MTD）均大于20g/kg。Ames实验、小鼠骨髓微核实验、小鼠精子畸形实验3项致突变实验结果均为阴性;大鼠30d喂养实验中,实验动物生长情况良好,血液学检查结果、生化学检查结果、主要脏体比及组织学检查结果与对照组相比,均无明显差异。结果表明：茶氨酸复合制剂无毒,无遗传毒性,使用安全性高。