根据 OECD 425 TG 标准，使用 Wistar 大鼠和瑞士白化小鼠对新型多草药制剂进行急性口服毒性研究

Q3 Pharmacology, Toxicology and Pharmaceutics

Phytomedicine Plus Pub Date : 2024-11-08 DOI:10.1016/j.phyplu.2024.100672

Ramkishan Jatoth , S.P Dhanabal , V. Senthil , T. Ganesh , Jubie Selvaraj , P.S. Venkatesan

{"title":"根据 OECD 425 TG 标准，使用 Wistar 大鼠和瑞士白化小鼠对新型多草药制剂进行急性口服毒性研究","authors":"Ramkishan Jatoth , S.P Dhanabal , V. Senthil , T. Ganesh , Jubie Selvaraj , P.S. Venkatesan","doi":"10.1016/j.phyplu.2024.100672","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Hydaljss08 is a new semisolid fermented hydroalcoholic polyherbal formulation containing crude drug substances. Immunoboost Tab is a novel polyherbal dosage form that is incorporated isolated, and fractionated phytochemical substances. Acute oral toxicity is a primary safety profile of the novel polyherbal formulations. As a part of our study, we estimated acute toxicity safety profile of novel dosage forms by a Swiss albino mice and Wistar rats.</div></div><div><h3>Aim</h3><div>According to the OECD 425 test guideline., the study aims to estimate acute toxicity tests of the “Hydaljss08, and Immunoboost Tab” dosage forms in rats and mice to assess the safety profile. Mice and rats are normally used in safety studies because of their susceptibility to toxic challenges, tumor induction, and carcinogenicity.</div></div><div><h3>Material and Methods</h3><div>1 % CMC, Hydaljss08, Immunoboost-Tab polyherbal formulations, female rats, and albino mice. Animals were divided into the control groups, and treated groups with test dosage forms. At the end of the study, animals were euthanized by using the CO<sub>2</sub> asphyxiation technique and subjected to gross pathological examinations.</div></div><div><h3>Results</h3><div>According to the assessment of the experimental data, the single-dose acute toxicity study of Hydaljss08 and Immunoboost-Tab formulations in mice and rats was fine. No signs of toxicity were observed in the animals treated at (2000 mg/kg.b. wt, Po), and revealed dullness, causing lethargy, and piloerections, which only persisted on the 1st day. At the end of the study, mild congestion in the liver, and lungs was observed in animals, treated with “Hydaljss08 formulation” compared to the vehicle control groups.</div></div><div><h3>Conclusions</h3><div>The estimated LD<sub>50</sub> of Hydaljss08, and Immunoboost-Tab polyherbal formulations in rats and mice by oral route was found >2000 mg/kg, b.wt.</div></div>","PeriodicalId":34599,"journal":{"name":"Phytomedicine Plus","volume":"5 1","pages":"Article 100672"},"PeriodicalIF":0.0000,"publicationDate":"2024-11-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Acute oral toxicity study of novel polyherbal formulations by using wistar rats and Swiss albino mice as per OECD 425 TG\",\"authors\":\"Ramkishan Jatoth , S.P Dhanabal , V. Senthil , T. Ganesh , Jubie Selvaraj , P.S. Venkatesan\",\"doi\":\"10.1016/j.phyplu.2024.100672\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><div>Hydaljss08 is a new semisolid fermented hydroalcoholic polyherbal formulation containing crude drug substances. Immunoboost Tab is a novel polyherbal dosage form that is incorporated isolated, and fractionated phytochemical substances. Acute oral toxicity is a primary safety profile of the novel polyherbal formulations. As a part of our study, we estimated acute toxicity safety profile of novel dosage forms by a Swiss albino mice and Wistar rats.</div></div><div><h3>Aim</h3><div>According to the OECD 425 test guideline., the study aims to estimate acute toxicity tests of the “Hydaljss08, and Immunoboost Tab” dosage forms in rats and mice to assess the safety profile. Mice and rats are normally used in safety studies because of their susceptibility to toxic challenges, tumor induction, and carcinogenicity.</div></div><div><h3>Material and Methods</h3><div>1 % CMC, Hydaljss08, Immunoboost-Tab polyherbal formulations, female rats, and albino mice. Animals were divided into the control groups, and treated groups with test dosage forms. At the end of the study, animals were euthanized by using the CO<sub>2</sub> asphyxiation technique and subjected to gross pathological examinations.</div></div><div><h3>Results</h3><div>According to the assessment of the experimental data, the single-dose acute toxicity study of Hydaljss08 and Immunoboost-Tab formulations in mice and rats was fine. No signs of toxicity were observed in the animals treated at (2000 mg/kg.b. wt, Po), and revealed dullness, causing lethargy, and piloerections, which only persisted on the 1st day. At the end of the study, mild congestion in the liver, and lungs was observed in animals, treated with “Hydaljss08 formulation” compared to the vehicle control groups.</div></div><div><h3>Conclusions</h3><div>The estimated LD<sub>50</sub> of Hydaljss08, and Immunoboost-Tab polyherbal formulations in rats and mice by oral route was found >2000 mg/kg, b.wt.</div></div>\",\"PeriodicalId\":34599,\"journal\":{\"name\":\"Phytomedicine Plus\",\"volume\":\"5 1\",\"pages\":\"Article 100672\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-11-08\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Phytomedicine Plus\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2667031324001465\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"Pharmacology, Toxicology and Pharmaceutics\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Phytomedicine Plus","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2667031324001465","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"Pharmacology, Toxicology and Pharmaceutics","Score":null,"Total":0}

引用次数: 0

摘要

背景Hydaljss08 是一种含有粗制药物物质的新型半固体发酵水醇多草药制剂。Immunoboost Tab 是一种新型多草药制剂，含有分离和分馏的植物化学物质。急性口服毒性是新型多草药制剂的主要安全性特征。作为研究的一部分，我们通过瑞士白化小鼠和 Wistar 大鼠对新型剂型的急性毒性安全性进行了评估。小鼠和大鼠通常用于安全性研究，因为它们容易受到毒性挑战、肿瘤诱导和致癌。动物分为对照组和试验剂型处理组。根据实验数据评估，Hydaljss08 和 Immunoboost-Tab 制剂对小鼠和大鼠的单剂量急性毒性研究结果良好。以（2000 毫克/千克体重，Po）剂量给药的动物未观察到中毒症状，但出现了乏力、嗜睡和肢体僵硬等症状，这些症状仅持续了 1 天。研究结束时，与药物对照组相比，使用 "Hydaljss08 配方 "的动物肝脏和肺部出现轻度充血。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

Acute oral toxicity study of novel polyherbal formulations by using wistar rats and Swiss albino mice as per OECD 425 TG

Background

Hydaljss08 is a new semisolid fermented hydroalcoholic polyherbal formulation containing crude drug substances. Immunoboost Tab is a novel polyherbal dosage form that is incorporated isolated, and fractionated phytochemical substances. Acute oral toxicity is a primary safety profile of the novel polyherbal formulations. As a part of our study, we estimated acute toxicity safety profile of novel dosage forms by a Swiss albino mice and Wistar rats.

Aim

According to the OECD 425 test guideline., the study aims to estimate acute toxicity tests of the “Hydaljss08, and Immunoboost Tab” dosage forms in rats and mice to assess the safety profile. Mice and rats are normally used in safety studies because of their susceptibility to toxic challenges, tumor induction, and carcinogenicity.

Material and Methods

1 % CMC, Hydaljss08, Immunoboost-Tab polyherbal formulations, female rats, and albino mice. Animals were divided into the control groups, and treated groups with test dosage forms. At the end of the study, animals were euthanized by using the CO₂ asphyxiation technique and subjected to gross pathological examinations.

Results

According to the assessment of the experimental data, the single-dose acute toxicity study of Hydaljss08 and Immunoboost-Tab formulations in mice and rats was fine. No signs of toxicity were observed in the animals treated at (2000 mg/kg.b. wt, Po), and revealed dullness, causing lethargy, and piloerections, which only persisted on the 1st day. At the end of the study, mild congestion in the liver, and lungs was observed in animals, treated with “Hydaljss08 formulation” compared to the vehicle control groups.