Waghmare Chaitali S, Bidve Shivcharan R, Gudi Ramacharya V, Nalawade Megha L, Chawda Mukesh B
Shree Dhootapapeshwar Ayurvedic Research Foundation, Veer Savarkar Chowk, Panvel, Maharashtra, India.
Shree Dhootapapeshwar Limited, Veer Savarkar Chowk, Panvel, Maharashtra, India.
J Pharmacopuncture. 2022 Dec 31;25(4):354-363. doi: 10.3831/KPI.2022.25.4.354.
This study aimed to assess the adverse effects of Rasaraj Rasa tablets after repeated oral administration for 180 days in Wistar rats.
Wistar rats were divided into five groups, of which three were treated with 54, 162, and 270 mg/kg body weight of Rasaraj Rasa, respectively, which correspond to one, three, and five times the proposed human therapeutic dose, for 180 days consecutively. The fifth group (satellite) also received 270 mg/kg body weight of Rasaraj Rasa for 180 days. Body weight and food intake were measured weekly. At the end of the study, all rats were sacrificed, and their blood, serum, and organs were collected and examined using hematology, serum biochemistry, gross pathology, and histopathology tests. In contrast, the satellite group was kept for 4 weeks after treatment.
No significant treatment-related toxicological findings were observed in the clinical features, body weight, laboratory findings, and pathological findings of the high-dose treated groups, when compared to those of the control group.
The no-observed-adverse-effect-level for Rasaraj Rasa in Wistar rats is set at 270 mg/kg body weight.
本研究旨在评估Rasaraj Rasa片对Wistar大鼠连续口服给药180天后的不良反应。
将Wistar大鼠分为五组，其中三组分别给予54、162和270mg/kg体重的Rasaraj Rasa，分别相当于人用治疗剂量的1倍、3倍和5倍，连续给药180天。第五组（卫星组）也给予270mg/kg体重的Rasaraj Rasa，持续180天。每周测量体重和食物摄入量。研究结束时，处死所有大鼠，收集其血液、血清和器官，并通过血液学、血清生物化学、大体病理学和组织病理学检查进行检测。相比之下，卫星组在治疗后饲养4周。
与对照组相比，高剂量治疗组的临床特征、体重、实验室检查结果和病理检查结果均未观察到与治疗相关的显著毒理学发现。
Rasaraj Rasa在Wistar大鼠中的未观察到不良反应水平设定为270mg/kg体重。
