Đánh giá độc tính cấp và độc tính bán trường diễn của viên nén MED001 trên mô hình thực nghiệm

Abstract

Objective: To evaluate the acute and sub-chronic toxicities of MED001 tablets in experimental animals.

Subjects and methods: An experimental study was conducted using Swiss albino mice to assess the acute toxicity and LD₅₀ of MED001 according to the Litchfield–Wilcoxon method. Sub-chronic toxicity was evaluated in Wistar rats, which were divided into groups receiving MED001 orally at a human-equivalent dose (81 mg/kg/day) and a threefold higher dose (243 mg/kg/day) for 90 consecutive days. Parameters monitored included body weight, hematological indices, liver and kidney biochemical markers, and histopathological changes.

Results: No mortality or clinical signs of acute toxicity were observed in Swiss albino mice at the maximum tested dose of 50 tablets/kg. After 90 days of administration in Wistar rats, body weight, hematological indices, serum ALT, AST, and creatinine levels, as well as the histological morphology of the liver and kidneys, remained within physiological ranges across all treatment groups, with no statistically significant differences compared to controls (p>0.05).

Conclusion: MED001 tablets exhibited no signs of acute or sub-chronic toxicities in the experimental models.