Acute and Repeated Dose 28-day Oral Toxicity Studies of Ich Tri Hadiphar Capsules

Nguyen Thi Lien, Nguyen Thi Hang
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Abstract

Abstract:  Ich tri Hadiphar capsules used for dementia treatment were evaluated for acute and repeated dose toxicities in mice and rabbits, respectively. The acute toxicity results indicated that LD50 of Ich tri Hadiphar capsules in mice according to the method of Behrens is greater than 30 g/kg body weight. In the repeated dose toxicity study, rabbits were administrated Ich tri Hadiphar with doses of 186.5 and 560.0 mg/kg/day for 28 days (equivalent to the dose used on humans and the dose of 3 times more than one used on humans). Blood samples were taken on day 0, day 14, and day 28 of the experiment for hematological and biochemical analysis. Liver and kidney samples were taken on day 28 for histopathological determinations. The repeated dose toxicity results revealed that there were no significant differences in hematological and serum biochemical values between control and treatment animals. Furthermore, no histopathological changes in the liver and kidney of rabbits treated with Ich tri Hadiphar capsules were observed. Keywords: Acute toxicity, repeated dose toxicity, Ich tri Hadiphar.     
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Ich三Hadiphar胶囊急性和重复剂量28天口服毒性研究
摘要:本研究分别在小鼠和家兔实验中评价了用于治疗痴呆的Ich tri Hadiphar胶囊的急性毒性和重复剂量毒性。急性毒性实验结果表明,按Behrens法给药的小鼠LD50大于30 g/kg体重。在重复给药毒性研究中,家兔以186.5和560.0 mg/kg/天的剂量连续28天(相当于人用剂量,是人用剂量的3倍以上)给予Ich trihadiphar。于实验第0天、第14天、第28天采血,进行血液学和生化分析。第28天取肝、肾标本进行组织病理学检查。重复剂量毒性试验结果显示,对照动物和处理动物的血液学和血清生化指标无显著差异。此外,Ich tri Hadiphar胶囊对家兔肝脏和肾脏未见组织病理学改变。关键词:急性毒性,重复剂量毒性,Ich tri Hadiphar。
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