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目的:评价13-甲基肉豆蔻酸(13-MTD)由于积蓄而对Beagle犬机体产生的毒性反应和其严重程度,确定无毒反应剂量,为拟定人用剂量提供参考。方法:Beagle犬12只,随机分为0.4g.kg-1和0.8g.kg-12个剂量组和空白对照组,每组4只,♀♂各半。每天口服1次,连续3个月(每周日停1d)后检查各剂量组犬的一般情况、心电图、血象、肝肾功能、尿常规及病理检验等指标并进行恢复性观察。结果:各剂量组犬的各项指标均无明显异常,停药半个月观察未见13-MTD延迟性不良反应。结论:13-MTD以0.8g.kg-1相当于临床拟用量40倍给予Beagle犬连续口服3个月,无明显毒性反应。
OBJECTIVE: To evaluate the toxicity and severity of 13-methylmyristic acid (13-MTD) due to accumulation in Beagle dogs and to determine the dose of non-toxicity and provide reference for the development of human dose. Methods: Twelve Beagle dogs were randomly divided into 0.4g.kg-1 and 0.8g.kg-12 dose groups and blank control group, with 4 in each group and half in each group. Oral 1 times a day, for 3 consecutive months (1 d per day on weekdays), check the general condition, electrocardiogram, blood picture, liver and kidney function, urine routine, and pathological examination of the dogs in each dose group and perform recovery observations. RESULTS: There was no obvious abnormality in each index of dogs in each dose group, and no delayed adverse reaction of 13-MTD was observed during the half-month withdrawal. Conclusion: The 13-MTD dose of 0.8g.kg-1 is equivalent to 40 times the clinical dose to be administered to Beagle dogs continuously for 3 months without obvious toxicity.