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一种阿育吠陀药用油制剂经皮肤暴露后的全身毒性评估。

Assessment of the systemic toxicity of , an Ayurvedic medicated oil formulation after dermal exposure.

作者信息

Wanjari Manish M, Yadav Mahendra, Dey Yadu Nandan, Sharma Deepti, Srivastava Bhavana, Jamdagni Shrirang B, Gaidhani Sudesh N, Jadhav Ankush D, Gautam Manish

机构信息

Regional Ayurveda Research Institute for Drug Development, Gwalior 474009, India.

Regional Ayurveda Institute for Fundamental Research, Pune 411038, India.

出版信息

Toxicol Res (Camb). 2021 Dec 7;11(1):32-41. doi: 10.1093/toxres/tfab104. eCollection 2022 Feb.

Abstract

(LVT) is a medicated oil preparation used in the Ayurvedic system of medicine and applied topically for the treatment of painful musculoskeletal and inflammatory disorders. It contains some mildly poisonous phytoconstituents which may show untoward effects upon application. The present study evaluated the toxicity of LVT in the acute, subacute, and subchronic dermal toxicity study in Wistar rats. LVT was tested for its compliance using physicochemical and analytical parameters as per standard methods prescribed in Ayurvedic Pharmacopoeia of India, while acute, subacute, and subchronic toxicity studies were carried out as per OECD 402, 410, and 411 guidelines, respectively. In the acute dermal toxicity study, a single dose of LVT (2000 mg/kg) was applied topically to rats, while in subacute and subchronic dermal toxicity study, the rats were topically applied LVT (1000 mg/kg) up to 28 and 90 days, respectively. LVT did not cause any alterations in clinical signs and no mortality or moribund stage was observed. The change in weekly body weight was insignificant compared with the vehicle control group. In subacute and subchronic dermal toxicity study, there were no significant changes in behavior, body weight, feed consumption, biochemical and hematological parameters, organ weight, and histological parameters compared with vehicle control rats. Topical application of single and repeated doses of LVT in rats did not exhibit adverse effects and suggests that the LD of LVT is more than 2000 mg/kg in the acute dose and NOAEL is more than 1000 mg/kg/day in repeated dose application.

摘要

(LVT)是一种在阿育吠陀医学体系中使用的药用油制剂,用于局部治疗疼痛性肌肉骨骼疾病和炎症性疾病。它含有一些轻度有毒的植物成分,应用时可能会产生不良影响。本研究在Wistar大鼠中进行了LVT的急性、亚急性和亚慢性皮肤毒性研究。根据《印度阿育吠陀药典》规定的标准方法,使用理化和分析参数对LVT进行了合规性测试,而急性、亚急性和亚慢性毒性研究分别按照经合组织402、410和411指南进行。在急性皮肤毒性研究中,将单剂量的LVT(2000毫克/千克)局部应用于大鼠,而在亚急性和亚慢性皮肤毒性研究中,大鼠分别局部应用LVT(1000毫克/千克),持续28天和90天。LVT未引起任何临床症状改变,未观察到死亡或濒死阶段。与赋形剂对照组相比,每周体重变化不显著。在亚急性和亚慢性皮肤毒性研究中,与赋形剂对照大鼠相比,行为、体重、饲料消耗、生化和血液学参数、器官重量和组织学参数均无显著变化。在大鼠中局部应用单剂量和重复剂量的LVT均未表现出不良反应,表明LVT在急性剂量下的LD大于2000毫克/千克,在重复剂量应用中的无观察到有害作用水平大于1000毫克/千克/天。

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