Regional Ayurveda Research Institute for Drug Development, Gwalior, Madhya Pradesh, India.
School of Pharmaceutical Technology, Adamas University, Kolkata, West Bengal, India.
Drug Chem Toxicol. 2022 Sep;45(5):1986-1994. doi: 10.1080/01480545.2021.1894725. Epub 2021 Mar 8.
is an important classical polyherbal formulation used in Ayurvedic system of medicine for the treatment of various chronic diseases like kidney stones and diabetes. However, no scientific attempts were made to evaluate its oral toxicity. Hence, the present study evaluated the acute and 28 days repeated dose sub-acute oral toxicities of in rats. was tested for its compliance using physicochemical and analytical parameters as per standards prescribed in Ayurvedic Pharmacopeia of India. In acute oral toxicity study, Wistar rats were orally administered a single dose of (2700 mg/kg) and clinical signs and mortality or moribund stage were observed for 14 days along with weekly body weight. On day 15, the rats were euthanized and the gross morphology was carried out during necropsy. In sub-acute (repeated dose) oral toxicity study, the rats were orally administered (270, 1350 and 2700 mg/kg) once daily up to 28 days. Clinical signs and mortality or moribund stage, weekly body weight, weekly feed and water consumptions, biochemical and hematological investigations, urine analysis, and major organ weights and histopathology were carried out. In acute and sub-acute toxicity studies, administration did not show any alteration in parameters or any adverse effect as compared to vehicle treated group. There was no mortality or moribund state observed in any group in both studies. Administration of in acute and 28 days repeated doses did not exhibit any toxicity or adverse effect at the doses used and NOAEL was found to be 2700 mg/kg.
是一种重要的经典复方草药制剂,用于治疗肾结石和糖尿病等各种慢性疾病,是印度阿育吠陀医学体系的药物。然而,目前尚未有科学研究尝试评估其口服毒性。因此,本研究评估了 在大鼠中的急性和 28 天重复剂量亚急性口服毒性。 根据印度阿育吠陀药典规定的标准,对 进行了物理化学和分析参数的合规性测试。在急性口服毒性研究中,Wistar 大鼠口服给予 (2700mg/kg)单次剂量,并在 14 天内观察临床症状和死亡率或濒死阶段,同时每周测量体重。第 15 天,对大鼠进行安乐死,并在解剖时进行大体形态学检查。在亚急性(重复剂量)口服毒性研究中,大鼠每天口服 (270、1350 和 2700mg/kg)一次,持续 28 天。进行了临床症状和死亡率或濒死阶段、每周体重、每周饲料和水消耗、生化和血液学检查、尿液分析、主要器官重量和组织病理学检查。在急性和亚急性毒性研究中,与对照组相比, 给药未显示任何参数改变或任何不良反应。在这两项研究中,任何组均未观察到死亡或濒死状态。在急性和 28 天重复剂量给药时, 在所用剂量下未表现出任何毒性或不良反应,NOAEL 为 2700mg/kg。