黄芪桑叶玉竹颗粒食用安全性评价

Study on edible safety evaluation of HuangqiSangyeYuzhu granules

中文关键词:  黄芪桑叶玉竹颗粒  保健食品  毒理安全评价

英文关键词:HuangqiSangyeYuzhu granules  health food  toxicological safety evaluation

中文摘要:

      目的 评价黄芪桑叶玉竹颗粒的食用安全性。方法 通过小鼠急性经口毒性试验、3项遗传毒性试验、28 d经口毒性试验综合评估黄芪桑叶玉竹颗粒的食用安全性。结果 小鼠急性经口毒性试验结果显示受试动物未见异常, 且黄芪桑叶玉竹颗粒的最大耐受剂量大于30.0 g/kg·BW, 属实际无毒性物质。细菌回复突变试验、哺乳动物红细胞微核试验及精原细胞染色体畸变试验结果均为阴性, 表明黄芪桑叶玉竹颗粒无遗传毒性。28 d经口毒性试验期间大鼠生长状况良好, 未见中毒体征, 血常规、血生化及病理学等检查指标均未见与黄芪桑叶玉竹颗粒相关的不良影响, 未观察到有害作用剂量为10.0 g/kg·BW。结论 黄芪桑叶玉竹颗粒在本研究剂量范围内具有食用安全性。

英文摘要:

      Objective To evaluate the edible safety of HuangqiSangyeYuzhu granules. Methods The edible safety of HuangqiSangyeYuzhu granules was comprehensively evaluated by acute oral toxicity test, 3 genotoxicity tests, and 28 d oral toxicity test. Results The results of acute oral toxicity test showed no abnormality in the test animals, and the maximum tolerated dose of HuangqiSangyeYuzhu granules was greater than 30.0 g/kg·BW, which was practically non-toxic substance. The results of bacterial reverse mutation test, mammalian erythrocyte micronucleus test and spermatogonial chromosome aberration test were negative, indicating that the HuangqiSangyeYuzhu granules had no genotoxicity. During the 28 d oral toxicity test, the rats growed well, and no signs of toxicity were observed, and no adverse effects associated with HuangqiSangyeYuzhu Granules were seen in blood routine, blood biochemistry, and pathology indices, and the no observed adverse effect level was 10.0 g/kg·BW. Conclusion HuangqiSangyeYuzhu granules have edible safety within the dosage range of this experiment.