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急性和重复剂量(28 天)口服 ALIBIRD 在大鼠中的安全性研究。

Acute and repeated dose (28 days) oral safety studies of ALIBIRD in rats.

机构信息

Departamento de Toxicología y Farmacología, Facultad de Veterinaria, Universidad Complutense de Madrid, 28040 Madrid, Spain.

出版信息

J Food Prot. 2013 Jul;76(7):1226-39. doi: 10.4315/0362-028X.JFP-13-032.

DOI:10.4315/0362-028X.JFP-13-032
PMID:23834798
Abstract

ALIBIRD, a test substance composed of oligosaccharides derived from lactulose, a hydrolysate of a whey protein concentrate, and a supercritical extract of rosemary (1:0.5:0.05), was prepared in the laboratory and evaluated for its safety as a multifunctional food additive. In oral toxicity studies (acute and 28 days repeated dose) using Wistar rats, ALIBIRD was administered in a single oral gavage dose of 2,000 mg/kg of body weight and resulted in no adverse events or mortality; a daily dose of 2,000 mg/kg of body weight for 28 days by gavage also resulted in no adverse effects or mortality. No abnormal clinical signs, behavioral changes, body weight changes, or changes in food and water consumption occurred in either study. There were no changes in hematological and serum chemistry values, organ weights, or gross or histological characteristics. Based on test results, it is concluded that ALIBIRD is well tolerated in rats at an acute and subchronic (28 days) dose of 2,000 mg/kg of body weight.

摘要

ALIBIRD 是一种由乳果糖衍生的低聚糖、乳清蛋白浓缩物的水解产物和迷迭香的超临界提取物(1:0.5:0.05)组成的测试物质,在实验室中制备并评估其作为多功能食品添加剂的安全性。在使用 Wistar 大鼠进行的口服毒性研究(急性和 28 天重复剂量)中,ALIBIRD 以 2000mg/kg 体重的单次口服灌胃剂量给予,没有不良事件或死亡;28 天每天以 2000mg/kg 体重的剂量灌胃也没有不良影响或死亡。在这两项研究中,均未观察到异常的临床症状、行为变化、体重变化或食物和水消耗的变化。血液学和血清化学值、器官重量或大体和组织学特征均无变化。根据测试结果,可得出结论,ALIBIRD 在大鼠的急性和亚慢性(28 天)剂量为 2000mg/kg 体重时具有良好的耐受性。

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