克糖养心口服液食品安全性毒理学试验研究

Research on the test of food safety toxicology of oral KTYX

目的对克糖养心口服液进行食品安全性毒理学评价。方法依据GB15193-94《食品安全性毒理学评价程序和方法》进行急性毒性试验、三项遗传毒性试验(Ames、小鼠骨髓嗜多染红细胞微核试验、小鼠精子畸形试验)和30 d喂养试验。结果克糖养心口服液对昆明种小鼠经口毒性两周内动物未见明显中毒症状,无动物死亡。三项遗传毒性试验结果均为阴性。30 d喂养试验结果表明:该受试物对W istar大鼠的临床检查,血液学、生化学、脏器重量和系数以及病理组织多样指标无明显影响,未发现该受试物有明显的毒性作用。结论克糖养心口服液既无毒也无任何副作用。

Objective To appraise the food safety toxicology of oral KTYX.Methods The tests of acute toxicity,three terms of hereditary toxicity(Ames,the test of micronucleus of polychromatic erythrocytphilic of young,the test of abnormal sperm of young mouse),and feeding for 30 days according to GB15193-94 《Appraisal Process and Methods of Toxicology of Food Safety》.Results There isn' t evident poisoning symptom and there isn't any death for animals after the test on the young mouse which have eaten oral KTYX.Three terms of hereditary toxicity are all negative.The result of test on feeding for 30 days states that: there is no evident influence on hematology,biochemistry,the weight and coefficient of visceral organ and several indexes of pathological on Wistar adult mouse.Conclusion There is neither poisoning nor side effect for oral KTYX.