Acute toxicity study of 77 herbal formulas according to GLP guidelines in rats

Hyeun-kyoo Shin, Woo-Young Jeon, C. Seo, Mee-Young Lee
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Abstract

Objectives: This study aimed to investigate the acute oral toxicity of 77 herbal formulas and performed in male and female Sprague-Dawley (SD) rats as per the guidelines mentioned in Ministry of Food and Drug Safety.Methods: Each sex of SD rat were administered a single dose (2000 or 5000 mg/kg) of 77 herbal formulas via oral gavage; the control group received vehicle only. After administration, the mortality, clinical signs, gross findings, and body weight were followed up for 15 days.Results: After administration of 77 herbal formulas, mortality, clinical signs, body weight changes, and gross findings related to the test substances were not observed in both male and female groups.Conclusion: Our results demonstrate the single-dose oral administration of 77 herbal formulas produced no mortality indicating the approximate lethal dose is greater than 2000 or 5000 mg/kg body weight.
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77种中药方剂按GLP指南对大鼠急性毒性研究
目的:研究77种中药复方的急性口服毒性,并按照国家食品药品安全部的指导方针对SD大鼠和雄性大鼠进行实验研究。方法:分别给SD大鼠单次灌胃77种中药配方(2000或5000 mg/kg);对照组只接受车辆。给药后随访15 d,观察死亡率、临床症状、大体检查结果及体重。结果:在服用77种中药制剂后,男女两组均未观察到死亡率、临床体征、体重变化和与试验物质相关的总体检查结果。结论:77种中药复方单次口服无死亡,表明近似致死剂量大于2000或5000 mg/kg体重。
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