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首页> 外文期刊>The Journal of toxicological sciences >Genetic, acute and subchronic toxicity studies of matured hop extract produced by extraction from heat-treated hops
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Genetic, acute and subchronic toxicity studies of matured hop extract produced by extraction from heat-treated hops

机译：用热处理啤酒花产生的成熟煤炭提取物的遗传学，急性和亚温度毒性研究

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It has been demonstrated that successive ingestion of matured hop extract (MHE), produced by extraction from heat-treated hops, results in body fat reduction in animals and humans; however, preclinical safety studies have not been reported. In this study, we conducted in vitro and in vivo safety studies for MHE. Genotoxicity was evaluated using the Ames test, in vitro chromosomal aberration test, and in vivo micronucleus test. To assess acute safety, a single, oral administration of MHE to rats was monitored. Subchronic safety was assessed by repeated feeding with MHE for 90 days. The in vitro chromosomal aberration test was positive at 3,330 mu g/mL and 5,000 mu g/mL without metabolic activation. However, MHE did not induce any reverse mutation with or without metabolic activation in the Ames test, and no abnormalities were observed at a dose of 2,000 mg/kg body weight in the rat micronucleus test. In the acute and subchronic safety studies, no deaths or toxicological signs were recorded during the observation period. In addition, no changes in body weights, feed/water consumption, clinical signs, ophthalmoscopy, urinalysis, hematology, blood biochemistry, organ weights, or histopathology were observed after repeated administration of MHE. Therefore, the no-observed-adverse-effect-level (NOAEL) of MHE was considered to be over 3,484 and 4,022 mg/kg body weight/day in males and females, respectively. These results indicate that there is no safety concern for MHE in the present preclinical safety study.
机译：已经证明，通过从热处理的啤酒花产生的成熟啤酒花提取物（MHE）的连续摄入，导致动物和人体的体脂减少;然而，尚未报告临床前安全性研究。在这项研究中，我们在体外进行了对MHE的体内安全性研究。使用AMES测试，体外染色体畸变试验和体内微核试验评估基因毒性。为了评估急性安全性，监测单一的口服MHE对大鼠。通过用MHE重复进料来评估次级安全性90天。体外染色体畸变试验在3,330μg/ ml和5,000μg/ ml的情况下为阳性，没有代谢活化。然而，MHE在ames试验中没有诱导或没有代谢活化的任何反向突变，并且在大鼠微核试验中以2,000mg / kg体重观察到异常。在急性和次级安全性研究中，在观察期间没有记录死亡或毒理迹象。此外，在重复施用MHE后，没有对体重，饲料/耗水，临床症状，眼科检查，尿液分析，血液学，血液化学，器官重量或组织病理学的变化没有变化。因此，MHE的无观察到的不良效应级（NOAEL）分别被认为是雄性和女性的3,484和4,022mg / kg体重/天。这些结果表明，在本临床前安全性研究中，MHE对MHE没有安全担忧。

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