Pre-Clinical Department, Cadila Pharmaceuticals Ltd., Dholka 387 810, India.
Food Chem Toxicol. 2011 Aug;49(8):1834-42. doi: 10.1016/j.fct.2011.05.001. Epub 2011 May 6.
Curcumin, a polyphenol, is obtained from turmeric, the ground rhizomes of Curcuma longa L. Extensive research over the past half century has revealed several health benefits of curcumin. The objective of the present study was to investigate potential adverse effects, if any, of a novel solid lipid curcumin particle (SLCP) preparation in rats following acute and subchronic administration. The oral LD₅₀ of the preparation in rats as well as in mice was found to be greater than 2000 mg/kg body weight (bw). In the subchronic toxicity study, Wistar rats (10/sex/group) were administered via oral gavage 0 (control), 180, 360, and 720 mg/kg bw/day of SLCP preparation for 90 days. Administration of the curcumin preparation did not result in any toxicologically significant treatment-related changes in clinical (including behavioral) observations, ophthalmic examinations, body weights, body weight gains, feed consumption, and organ weights. No adverse effects of the curcumin preparation were noted on the hematology, serum chemistry parameters, and urinalysis. Terminal necropsy did not reveal any treatment-related gross or histopathology findings. Based on the results of this study, the No Observed-Adverse-Effect Level (NOAEL) for this standardized novel curcumin preparation was determined as 720 mg/kg bw/day, the highest dose tested.
姜黄素是一种多酚，从姜黄，即姜黄属的根茎中提取得到。在过去的半个世纪中，大量研究揭示了姜黄素对健康的多种益处。本研究的目的是调查在大鼠中急性和亚慢性给药后，新型固体脂质姜黄素颗粒（SLCP）制剂是否存在任何潜在的不良影响。该制剂在大鼠和小鼠中的口服 LD₅₀大于 2000mg/kg 体重（bw）。在亚慢性毒性研究中，Wistar 大鼠（每组 10 只，雌雄各半）经口灌胃给予 0（对照）、180、360 和 720mg/kg bw/day 的 SLCP 制剂，连续 90 天。姜黄素制剂的给予未导致临床（包括行为）观察、眼科检查、体重、体重增加、饲料消耗和器官重量出现任何毒理学上显著的与处理相关的变化。姜黄素制剂对血液学、血清化学参数和尿液分析也没有任何不良影响。终端剖检未显示任何与处理相关的大体或组织病理学发现。基于这项研究的结果，确定该标准化新型姜黄素制剂的无观察到不良作用水平（NOAEL）为 720mg/kg bw/day，即最高测试剂量。
