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目的研究AF-5对机体产生的中毒反应及其严重程度、主要毒性靶器官以及损害的可逆程度。方法设5、15和50mg/kg,PVP对照组及蒸馏水对照组。按每周给药6次,给Beagle犬经口给予AF-5/PVP共9个月,并经3周恢复期进行毒性研究。结果15和50mg/kg剂量组在给药期间出现血清ALP水平的升高,但是停药后恢复正常;动物体重、进食量、心电图、神经活动状况、尿生化、血液学、以及其他血清生化指标等均未见明显异常。结论血清ALP水平的升高,与经口给予的大剂量的AF-5/PVP固体分散体影响胃肠道有关;Beagle犬经口给药AF-5/PVP固体分散体9个月的无明显毒副反应剂量为5mg/kg。
Objective To study the toxicity and severity of AF-5 to the body, the main toxic target organs and the degree of reversibility of the damage. Methods 5,15 and 50mg / kg, PVP control group and distilled water control group. Administered 6 times a week, Beagle dogs orally administered AF-5 / PVP for 9 months, and after 3 weeks of convalescence toxicity study. Results Serum ALP levels were elevated in the 15 and 50 mg / kg groups, but returned to normal after stopping the treatment. The body weight, food intake, electrocardiogram, nervous activity, urine biochemistry, hematology and other serum biochemical parameters No obvious abnormalities were found. Conclusion The increase of serum ALP level is related to the high dose of AF-5 / PVP solid dispersion orally administered to the gastrointestinal tract. The solid dispersion of AF-5 / PVP orally administered to Beagle dogs was not significantly Toxic side effects dose of 5mg / kg.