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Safety evaluation of Aloe vera soft capsule in acute, subacute toxicity and genotoxicity study

机译:急性,亚急性毒性和基因毒性研究中芦荟软胶囊的安全评估

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Aloe vera has been widely used in health and nutritional supplements in Chinese herbal medicine. Furthermore, Aloe vera production has been an emerging industry for making cosmetics and functional food. However, the reported adverse effects raised questions as to whether Aloe vera and its products were safe enough to be used in medicine and health care. In view of this, the safety evaluation of Aloe vera products before marketing is very important. The present study aimed to assess the toxicological profile of Aloe vera soft capsule (ASC), through acute, subacute toxicity and genotoxicity tests. Male and female ICR mice were received by oral gavage 15000 mg/kg bodyweight of ASC in the acute toxicity test. Male and female SD rats were fed on diet blended with different doses of ASC (equivalent to 832.5, 1665 and 3330 mg/kg bodyweight of ASC) for the subacute toxicity test. In the acute toxicity study, no mortality or behavioral changes were observed, indicating the LD 50 was higher than 15000 mg/kg bodyweight. In the subacute toxicity test, no significant changes were observed in bodyweight, food consumption, hematological, biochemical or histopathological parameters in the rats exposed. These data suggested that ASC used in this study did not produce any marked subacute toxic effects up to a maximum concentration of 3330 mg/kg bodyweight. In the genotoxicity study, ASC showed no mutagenic activity in the Ames test and no evidence of potential to induce bone marrow micronucleus or testicular chromosome aberrations in ICR mice exposed to 10000 mg/kg bodyweight. Collectively, ASC could be considered safe before it was marketed as a laxative and moistening health food.
机译:芦荟已广泛用于中草药的健康和营养补充剂。此外,芦荟生产是制作化妆品和功能性食品的新兴行业。然而,报告的不利影响提出了芦荟及其产品是否足够安全的问题,以便在医学和医疗保健中使用。鉴于此,销售前芦荟产品的安全评估非常重要。本研究旨在评估芦荟软胶囊(ASC),通过急性亚急性毒性和遗传毒性试验的毒理学曲线。在急性毒性试验中,通过口服Gavage 15000mg / kg体重接受雄性和女性ICR小鼠。雄性和雌性SD大鼠饲喂饮食,用不同剂量的ASC(相当于832.5,1665和3330 mg / kg体重ASC),用于亚急性毒性试验。在急性毒性研究中,没有观察到死亡或行为变化,表明LD 50高于15000mg / kg体重。在亚急性毒性测试中,在暴露的大鼠中,在体重,食物消耗,血液学,生物化学或组织病理学参数中没有观察到显着变化。这些数据表明,本研究中使用的ASC未产生任何明显的亚急性毒性效应,高达3330毫克/千克体重的最大浓度。在遗传毒性研究中,ASC在AMES测试中没有诱导活性,并且没有潜在诱导骨髓微核或睾丸染色体畸变在ICR小鼠中暴露于10000mg / kg体重的证据。在其作为一种泻药和滋润保健食品之前,ASC可以被认为是安全的。

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