R&D Center, Natural Remedies Private Limited, Bengaluru, Karnataka, India.
Sa-FORD, Navi Mumbai, Maharashtra, India.
Biomed Res Int. 2021 Jul 14;2021:6671853. doi: 10.1155/2021/6671853. eCollection 2021.
NR-INF-02 is a standardized extract containing turmerosaccharides from that has anti-inflammatory, analgesic, and chondroprotective potential. In view of its potential uses, NR-INF-02 was evaluated for its safety in Wistar rats at an oral dose of 250, 500, and 1000 mg/kg in a 90-day repeated dose subchronic toxicity study. NR-INF-02 administered at 250, 500, and 1000 mg/kg for 90 days did not show any mortality or clinical signs of toxicity. Body weight gain, food consumption, ocular and neurological examination, and hematological, blood biochemical, hormone, and urine analysis revealed no evidence of toxicity of NR-INF-02 treatment in rats. Absolute and relative organ weights were comparable to control rats. The study did not reveal any major treatment related gross pathological and histopathological alterations in the tissues or organs examined. Thus, based on study observations, the no-observed adverse effect level (NOAEL) was found to be 1000 mg/kg body weight in albino Wistar rats.
NR-INF-02 是一种标准化提取物，含有姜黄中的姜黄三糖，具有抗炎、镇痛和软骨保护作用。鉴于其潜在用途，在一项为期 90 天的重复剂量亚慢性毒性研究中，以 250、500 和 1000mg/kg 的口服剂量评估 NR-INF-02 在 Wistar 大鼠中的安全性。NR-INF-02 连续给药 90 天，剂量为 250、500 和 1000mg/kg，未出现任何死亡或毒性的临床症状。体重增加、食物消耗、眼科和神经检查以及血液学、血液生化学、激素和尿液分析均未显示 NR-INF-02 治疗大鼠存在毒性。绝对和相对器官重量与对照组大鼠相当。研究未发现检查的组织或器官有任何与治疗相关的主要大体病理和组织病理学改变。因此，根据研究观察结果，在白化 Wistar 大鼠中，NR-INF-02 的无观察到不良效应水平（NOAEL）为 1000mg/kg 体重。
