【摘要】 目的:通过对啮齿动物进行急性和长期毒性实验研究,观察番石榴叶颗粒对大、小鼠的毒性反应,为临床安全用药提供实验依据。方法:急性毒性实验:用小鼠以口服给药,测定其最大耐受量(MTD),并推算出相当于临床人用量的倍数,以观察动物在短时间内出现的毒性反应。长期毒性实验:SD大鼠80只,雌雄各半,随机分成高(62.5 g/kg)、中(25 g/kg)、低(10 g/kg)3个剂量组和空白对照组,连续灌胃给药1个月,观察大鼠一般状态、饮食、体重,于给药1个月后及停药2周后分别处死1/2的动物,取血测定血常规、血液生化指标,并取出主要脏器组织做病理组织学的检查,以观察连续用药对动物产生的毒性反应,以及停药后组织和功能损害的发展和恢复情况,了解毒性反应的可逆程度和可能出现的延迟性毒性反应。结果:急性毒性实验结果表明:番石榴叶颗粒的最大耐受量为562.5 g/kg,相当于临床人用剂量的1125倍。长期毒性实验结果表明:大鼠体重逐周增长,各主要血象及血生化指标均未见异常,主要脏器病理组织学检查未见异常。结论:番石榴叶颗粒对大、小鼠无明显毒性反应,在临床推荐用量下口服连续给药安全可靠。更多还原

【Abstract】 Objective:To observe toxicity effects,target organs and NOAEL(no observed adverse effect level)of Psidium guajava L Granule,acute toxicity study and long term toxicity study were conducted.These studies would be a guidance on clinical studies.Method:Acute toxicity study:(20 males,20 females)40 mice were randomized into 2 groups(10 mals,10 females,20 rats a group),oral maximal tolerance dose(MTD) were determined,and the times equal to human were calculated accordingly.Long term toxicity study:80 SD rats(40 males,40 females)were randomized into four groups(10 males and 10 females,20 rats a group).Animals in each group were daily administered Psidium guajava L Granule once on dose levels of 62.5、25、10 g/kg for 30 days and monitored the toxicity effects.Results:Acute toxicity study:no rat died,MTD=562.5g/kg,equal to 1125 times dosage in human.Long term toxicity study:all animals survived,Psidium guajava L Granule had no interfere on the weight of the animals.Conclusion:The present studies show that it is safe to take Psidium guajava L Granule for oral administration.更多还原