PRADO, Preclinical Research and Development Organization Pvt. Ltd., Pune, India.
Phytoveda Pvt. Ltd., Mumbai, India.
Drug Metab Pers Ther. 2024 Oct 2;39(3):145-158. doi: 10.1515/dmpt-2024-0056. eCollection 2024 Sep 1.
(WS) is a valuable medicinal plant that has been used against several ailments. The medicinal properties of WS are ascribed to existence of secondary metabolites which are in great demand in herbal nutraceutical industry. Despite well-known therapeutic effects of WS, it is necessary to assess preclinical toxicity of WS plant on rats and further explore its potential application against treatment of various disorders in humans. The existing study assessed oral acute and sub-chronic toxicities of WS root extract in Sprague Dawley (SD) rats (male and female) for 14 and 90 days, respectively under OECD-423 and -408 guidelines as well as GLP compliance.
In acute toxicity, rats of either sex were orally fed a dose of 2,000 mg/kg. In sub-chronic toxicity, animals were orally administered repeated doses of WS root extract at 250, 500, 1,000 mg/kg for 90 days with an additional 14-day recovery period. Two more groups (n=5 animals each) receiving vehicle and 1,000 mg/kg of WS root extract for 90 days were also observed.
In acute toxicity, the results revealed that LD of WS root extract in SD rats was higher than 2,000 mg/kg. In sub-chronic toxicity, oral administration of extract for 90 days showed no significant toxicological changes in rats. Haematological and serum chemistry markers were found within normal range. Terminal necropsy showed no gross or histopathological outcomes.
The no-observed-adverse-effect level (NOAEL) of WS root extract was 1,000 mg/kg body weight, and safe to use at this dose in rats.
（WS）是一种有价值的药用植物，已被用于治疗多种疾病。WS 的药用特性归因于存在次生代谢产物，这些产物在草药营养保健品行业中有很大的需求。尽管 WS 具有众所周知的治疗效果，但有必要评估 WS 植物对大鼠的临床前毒性，并进一步探索其在治疗人类各种疾病方面的潜在应用。本研究根据 OECD-423 和 -408 指南以及 GLP 法规，评估了 WS 根提取物对 Sprague Dawley（SD）大鼠（雄性和雌性）的口服急性和亚慢性毒性，分别为 14 天和 90 天。
在急性毒性试验中，雌雄大鼠口服给予 2000mg/kg 的剂量。在亚慢性毒性试验中，动物口服给予 WS 根提取物重复剂量，剂量分别为 250、500、1000mg/kg，共 90 天，随后有 14 天恢复期。还观察了另外两组（每组 5 只动物），分别接受赋形剂和 1000mg/kg 的 WS 根提取物，持续 90 天。
在急性毒性试验中，结果表明 WS 根提取物在 SD 大鼠中的 LD 高于 2000mg/kg。在亚慢性毒性试验中，连续 90 天口服给予提取物未显示大鼠出现显著的毒理学变化。血液学和血清化学标志物均在正常范围内。终端尸检未显示明显的大体或组织病理学结果。
WS 根提取物的无观察不良效应水平（NOAEL）为 1000mg/kg 体重，在该剂量下大鼠使用是安全的。
