Canh Pham Em, Van Lenh Vo, Nguyen Cuong Viet, Duong Ngoc Thoi Nguyen, Le Thi Tuong Vi, Truong Tuyen Ngoc
Department of Medicinal Chemistry, Faculty of Pharmacy, Hong Bang International University, 700000, Ho Chi Minh City, Viet Nam.
Department of Pharmaceutics - Pharmaceutical Industry, Faculty of Pharmacy, Lac Hong University, 810000, Dong Nai Province, Viet Nam.
Toxicon. 2023 May;227:107093. doi: 10.1016/j.toxicon.2023.107093. Epub 2023 Mar 25.
The acute and sub-acute toxicity studies were performed in male and female Swiss albino mice as per the guidelines mentioned in OECD. The oral administration of M. tridentata stem extract (MSE) showed no treatment-related mortality and body weight change in mice up to the single dose of 30,000 mg/kg body weight in the acute toxicity study and up to a dose of 30,000 mg/kg/day body weight in the sub-acute toxicity study. Moreover, the clinical signs, body weight, gross pathology, organ weight, hematology (except for platelet count), biochemical analysis, and histopathology did not show significant variation at a medium dose of 15,000 mg/kg/day body weight compared to the control group. However, toxicological signs in behavior, very mild interstitial nephritis, as well as significant variation in platelet count and total protein parameters were observed at a dose of 30,000 mg/kg/day in the 28-day oral toxicity study. Thus, the no-observed-adverse-effect level was determined at a dose of 15,000 mg/kg/day body weight. Based on study results, it is concluded that MSE showed LD of greater than 5000 mg/kg/day body weight. Hence, this could be a potential candidature as a future safe pharmaceutical product.
按照经合组织(OECD)提及的指南,在雄性和雌性瑞士白化小鼠身上进行了急性和亚急性毒性研究。在急性毒性研究中,高达单剂量30000毫克/千克体重,以及在亚急性毒性研究中,高达剂量30000毫克/千克/天体重时,给予三叉苦茎提取物(MSE)进行口服给药,小鼠未出现与治疗相关的死亡和体重变化。此外,与对照组相比,在中等剂量15000毫克/千克/天体重时,临床体征、体重、大体病理学、器官重量、血液学(血小板计数除外)、生化分析和组织病理学均未显示出显著差异。然而,在为期28天的口服毒性研究中,在剂量为30000毫克/千克/天时,观察到行为方面的毒理学体征、非常轻微的间质性肾炎,以及血小板计数和总蛋白参数的显著变化。因此,未观察到有害作用水平被确定为15000毫克/千克/天体重。根据研究结果,得出结论:MSE的半数致死量大于5000毫克/千克/天体重。因此,这可能是一种未来安全药品的潜在候选物。