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[摘要]
评价赶黄草总黄酮(Total Flavonoids of Penthorum chinense Pursh, TFPCP)的安全性。参照GB 15193-2014《食品安全毒理学评价程序》及《保健食品及其原料安全性毒理学检验与评价技术指导原则(2020年版)》,对赶黄草总黄酮进行急性经口毒性试验、三项遗传毒性试验及大鼠28 d喂养试验的安全性评价。急性经口毒性试验中,赶黄草总黄酮对小鼠的半数致死量(Median Lethal Dose, LD50)大于10 g/(kg··BW),属无毒级;细菌回复突变 (Bacterial Reverse Mutation, Ames) 试验各剂量组结果呈阴性,且菌落数未超过TA97A、TA98、TA100溶剂对照的2倍,TA1535溶剂对照的3倍(P>0.05);2.4、1.2、0.6 g/(kg·BW) 的赶黄草总黄酮灌胃小鼠,与阴性对照相比,哺乳动物红细胞微核率及小鼠精母细胞染色体畸变率无显著性差异(P>0.05);大鼠在2.4、1.2、0.6 g/(kg·BW)剂量下连续灌胃28 d,受试物各剂量组对大鼠体重、尿常规、血常规指标、血液生化学指标及主要脏器系数与对照组相比均无显著性差异(P>0.05),肝肾组织学检查未发现明显病理变化。赶黄草总黄酮在本试验条件下无急性毒性、遗传毒性、亚急性毒性,赶黄草总黄酮具有较好的安全性。本试验为把赶黄草总黄酮开发为保健食品和功能性食品提供了实验依据。
[Key word]
[Abstract]
To evaluate the safety of total flavonoids of Penthorum chinense Pursh (TFPCP). An oral toxicity test, three genotoxicity tests, and a 28-day feeding test in rats were used to demonstrate the toxicological safety of TFPCP according to GB 15193-2014 Procedures for Toxicological Evaluation of Food Safety and Technical Guidelines for Toxicological Examination and Evaluation of Health Food and its Raw Materials (2020 Edition). The results showed that the median lethal dose (LD50) of the TFPCP was greater than 10 g/(kg·BW) for oral acute toxicity in mice, belonging to non-toxic grade; and 2-fold of the solvent control for TA97A, TA98, and TA100, and 3-fold for TA1535, were not exceeded by TFPCP for each dose group (P > 0.05), no mutagenic effect was observed in Ames test. Gavage of TFPCP in mice at doses of 2.4, 1.2, and 0.6 g/(kg·BW) showed no significant difference in the rate of erythrocyte micronuclei in mammals and chromosomal aberrations in spermatocytes in mice when compared with the negative control (P > 0.05). Three different dosages (2.4, 1.2, and 0.6 g/(kg·BW)) were administered via gavage once daily for 28 days in rats, the body weight, urinary, hematology, biochemical analysis, and coefficient of major organs did not show significant variation compared to the control group (P > 0.05), and liver and kidney histopathology revealed no significant pathological changes. Therefore, TFPCP has no acute toxicity, genotoxicity, or subacute toxicity under the conditions of this test, and TFPCP has high safety, which provides a scientific basis for its development into healthy food and functional food.
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