Keywords
SD rats
Subchronic toxicity
Chronic toxicity
Body weight
Organ coefficient
Blood routine
Liver function biochemical indexes
Urine routine
Submitted : 2025-05-06
Accepted : 2025-05-21
Published : 2025-06-05
Abstract
To evaluate the subchronic and chronic toxicity of Fuyanxiao capsules, Sprague-Dawley (SD) rats were used in toxicity studies. In the subchronic toxicity study, 50 female rats were randomly divided into a high-dose group (5.4g/kg/day) and a control group, with 15 rats in each, and medium (2.7g/kg/day) and low (1.35g/kg/day) dose groups, with 10 rats in each. The test substance was administered orally (mixed with feed, twice daily) for 90 consecutive days. In the chronic toxicity study, 40 female rats were randomly divided into high, medium, and low dose groups and a control group, with 10 rats in each. The test substance was administered orally in the same manner for 180 consecutive days. Clinical signs, body weight, and food consumption were observed and recorded daily. At the end of the terminal phase (the first 10 rats from each group, 1 day after the last dose) and the recovery phase (the last 5 rats from the control group and the high-dose group, observed for an additional 28 days after the last dose), blood and urine samples, as well as organs, were collected. Organ coefficients were calculated, and various hematological and urinary indicators were detected, followed by pathological analysis. The results showed that there were no significant differences in body weight, food consumption, or organ coefficients between any of the dose groups and the control group in both subchronic and chronic toxicity studies (P > 0.05). Histopathological examination revealed no lesions, suggesting no tissue or organ damage in any of the dose groups. The rats exhibited good mental status, and hematological and urinary physiological indicators were within normal ranges, indicating stable liver and kidney function, hematopoietic system of the bone marrow, and internal environment in all dose groups. Therefore, Fuyanxiao capsule has no obvious subchronic or chronic toxicity in SD rats, and it is safe and reliable to use at reasonable dosage in clinical practice.
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