Safety evaluation of a polyherbal formulation: Acute and sub-acute toxicity study using Wistar Albino rats

Vaibhav Tripathi, Chandra Kishore Tyagi, Wasim Raja
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Abstract

Vatrog Nashak Churna (VNC) is a traditional polyherbal formulation for musculoskeletal diseases. Although the safety and mechanism of toxicity of the individual herbs have been explored, the formulation remains undocumented in the literature. Research into its sub-acute toxicity will strengthen its pharmacological outline and encourage its investigation as a potential future treatment. Rats were split into three groups (n¼12) by OECD TG 407 (OECD, 2008). The limit test determined the necessary amount of VNC. The control groups were given an identical volume of vehicle, while the dosing and monitoring groups were given VNC (1000 mg/kg/day, p.o. for 14 days). The duration of the post-treatment surveillance period was extended by 14 days in order to evaluate reversibility. Deaths, toxic reactions, and weight shifts were all recorded. On days 15 and 29, the rats were killed while under anaesthesia so that blood samples could be collected to analyze for haematological and biochemical markers. Histopathological studies and evaluation of a wide range of biochemical and hematological parameters indicated that VNC has no appreciable harmful effect on body weight, erythropoiesis, or leucopoiesis. This study may assist scientists in determining appropriate levels for longer-term sub-chronic investigations so that VNC may be considered safe for short-term use. Sub-chronic and chronic toxicity tests must also assess long-term safety.
复方制剂的安全性评价:Wistar白化大鼠急性和亚急性毒性研究
Vatrog Nashak Churna (VNC)是一种用于肌肉骨骼疾病的传统多草药配方。虽然安全性和毒性机制的个别草药已被探索,配方仍未在文献中记录。对其亚急性毒性的研究将加强其药理学概述,并鼓励其作为潜在的未来治疗方法的研究。采用OECD TG 407 (OECD, 2008)将大鼠分为三组(n / 12)。限制测试确定了VNC的必要数量。对照组给予等量载药,给药组和监测组给予VNC (1000 mg/kg/d, p.o.,连用14 d)。治疗后监测时间延长14 d,以评估可逆性。死亡、中毒反应和体重变化都有记录。在第15天和第29天,在麻醉状态下杀死大鼠,以便收集血液样本进行血液学和生化标志物分析。组织病理学研究和广泛的生化和血液学参数的评估表明,VNC对体重、红细胞生成或白细胞生成没有明显的有害影响。这项研究可以帮助科学家确定长期亚慢性调查的适当水平,以便VNC可以被认为是短期使用的安全。亚慢性和慢性毒性试验还必须评估长期安全性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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