Institute of Toxicology and Risk Assessment, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu, China.
PLoS One. 2021 Mar 26;16(3):e0249356. doi: 10.1371/journal.pone.0249356. eCollection 2021.
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 LD50 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.
库拉索芦荟在中草药的保健品和营养补充剂中被广泛应用。此外，库拉索芦荟的生产已成为制造化妆品和功能性食品的新兴产业。然而，所报道的不良反应引发了人们对库拉索芦荟及其产品是否足够安全，可用于医药和保健领域的质疑。有鉴于此，在上市前对库拉索芦荟产品进行毒理学评价非常重要。本研究旨在通过急性毒性、亚急性毒性和遗传毒性试验评估库拉索芦荟软胶囊（ASC）的毒理学特征。雄性和雌性 ICR 小鼠在急性毒性试验中经口灌胃给予 ASC 15000mg/kg 体重。雄性和雌性 SD 大鼠经口灌胃给予不同剂量 ASC （相当于 ASC 832.5、1665 和 3330mg/kg 体重）的饲料，进行亚急性毒性试验。在急性毒性研究中，未观察到死亡或行为改变，表明 LD50 高于 15000mg/kg 体重。在亚急性毒性试验中，暴露于 ASC 的大鼠的体重、食物消耗、血液学、生化学或组织病理学参数均无显著变化。这些数据表明，在本研究中使用的 ASC 最高浓度达 3330mg/kg 体重时，不会产生任何明显的亚急性毒性作用。在遗传毒性研究中，ASC 在 Ames 试验中没有表现出致突变活性，也没有证据表明暴露于 10000mg/kg 体重的 ICR 小鼠会引起骨髓微核或睾丸染色体畸变。总的来说，ASC 可被认为是安全的，可作为一种通便和滋润健康食品上市。
