Majeed Muhammed, Natarajan Sankaran, Pandey Anjali, Bani Sarang, Mundkur Lakshmi
Sami Labs Limited, Karnataka, India.
Toxicol Res. 2019 Jan;35(1):65-74. doi: 10.5487/TR.2019.35.1.065. Epub 2018 Jan 15.
Tetrahydrocurcumin (THC) is a major metabolite of curcumin, which is obtained from . THC has various benefits and overcomes the bioavailability issue of curcumin. To establish it as a pharmacologically active molecule, its safety profile has to be determined. Thus, the present study aimed to determine the preclinical safety profile of THC in a 90-day subchronic and reproductive/developmental toxicity study in Wistar rats. THC at oral doses of 100, 200, and 400 mg/kg was administered daily for 90 days. Rats in the recovery group were kept for 14 days after treatment termination. The animals were observed for treatment-related morbidity, mortality, and changes in clinical signs, clinical pathology, and histopathology. In the reproductive/developmental toxicity study, THC at 100, 200, and 400 mg/kg was administered orally to rats and the reproductive/developmental parameters in adult male and female rats and pups were observed. THC at up to 400 mg/kg/day of did not have any significant effect on all parameters in male and female rats in both toxicity studies. Thus, 400 mg/kg/day can be considered as the no-observed-adverse-effect-level of THC in rats.
四氢姜黄素（THC）是姜黄素的主要代谢产物，姜黄素可从……中获得。THC具有多种益处，并克服了姜黄素的生物利用度问题。为了将其确立为一种具有药理活性的分子，必须确定其安全性。因此，本研究旨在通过对Wistar大鼠进行为期90天的亚慢性毒性研究以及生殖/发育毒性研究来确定THC的临床前安全性。每天口服给予100、200和400mg/kg剂量的THC，持续90天。恢复期组的大鼠在治疗结束后饲养14天。观察动物的治疗相关发病率、死亡率以及临床体征、临床病理学和组织病理学的变化。在生殖/发育毒性研究中，对大鼠口服给予100、200和400mg/kg的THC，并观察成年雄性和雌性大鼠以及幼崽的生殖/发育参数。在两项毒性研究中，高达400mg/kg/天的THC对雄性和雌性大鼠的所有参数均无显著影响。因此，400mg/kg/天可被视为大鼠中THC的未观察到有害作用水平。
