根据《保健食品检验与评价技术规范》对茶多酚西洋参制剂安全性进行了评价。急性毒性试验结果表明,制剂内容物经口LD50>10.0 g/kg·Bw;3项致突变试验结果均为阴性;大鼠30 d喂养试验中,各剂量组动物生长发育良好,对体重、食物利用率无不良影响;各剂量组血常规,血清生化测定结果与对照组比较无显著差异;脏器比值与对照差异不明显。肝、心、脾、肾、胃肠、睾丸、卵巢等器官外观和组织切片与对照比均未发现实质性病理改变。结果表明茶多酚西洋参制剂无毒,无遗传毒性,使用安全性高。
The edible safety of the compound of Tea-polyphenols and American ginseng was investigated according to “the Standard of Health Food Test and Assesment”. Acute toxicity test in mice showed that LD50 was higher than 10.0 g/kg.Bw, all three genetic tests showed negative results, 30 days feeding test showed that the physical appearance, behaviors, weights, organ coefficients, the indexes of hematology and biochemistry in rats have no significant difference comparing with the control group, also, no significant external appearance and pathological changes of various organs including liver, heart, spleen, kidney, stomach, intestines, testicle, and ovary were discovered. All results suggested that the compound has no acute toxicity, no genotoxicity, and high in edible safety.
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