英文摘要 |
The 8-week repeated oral dose toxicity study of a preparation of human urine (PHU) was evaluated in both male young rats (1.5 months) and middle-aged rats (15 months). PHU was administrated orally at once-daily doses of 0.3, 1.0, 3.0 g/kg in young rats and 0.3, 1.0 g/kg in middle-aged rats. In hematology, young rats given 3 g/kg and middle-aged rats given 1 mg/kjg showed thrombocytosis. Increased percentages of lymphocyte and decreased percentages of segmented neutrophil were observed in middle-aged rats of the 0.3 and 1.0 g/kg dose groups. In addition, a decreased activated partial thromboplastin time was observed in middle-aged rats of the 1.0 g/kg dose group. In blood chemistry, an increased glucose level was observed in young rats of the 3 g/kg dose group and in middle-aged rats of the 1 g/kg dose group. Young rats given 3 g/kg showed a decrease in K?? level. Middle-aged rats given 1.0 g/kg showed a deceased in Cl?? level. A decreased uric acid level was observed in middle-aged rats of the 0.3 and 1.0 g/kg dose groups. Urinalysis showed an increase in Na?? level in both young rats of 1.0 g/kg dose group. Increased urinary protein was observed in young rats of the 3.0 g/kg dose group and middle-aged rats of 3.0 g/kg dose group and middle-aged rats of 1.0 g/kg dose group. Increased urinary protein was observed in young rats of the 3.0 g/kg dose group and middle-aged rats of 0.3, 1.0 g/kg dose groups. Middle-aged rats given 1.0 g/kg showed an increase in prostate wight. In conclusion, the toxicological no-observed levels in young rats were thought to be 1.0 g/kg or below. |