参金口服液大鼠亚慢性毒性试验研究

摘要

To evaluate the safety of Shenjin oral liquid (SJ) in animal model,we performed the subchronic toxicity test using Sprague Dawley rats.A total of 120 rats were randomly divided into 4 groups (experimental groups:high,medium,low dose groups,and control group).For experimental groups the SJ was administrated once daily by oral gavage at doses of 16,32 and 64 g/kg,while distilled water was given to rats in the control group.Administration was consecutive for 28 d.The main outcome measures including reversibility,persistence,or delayed occurrence of toxic effects were observed during the period of administration and within 14 d after withdrawal.Compared with the control group,ALT was significant increased (P＜0.05) in the high dose group,while other parameters were normal.The effect of toxicity would recover after drug withdrawal.Our results indicated that administration of SJ was safe in SD rats,suggesting potential safe use in clinic.%为评价参金口服液的安全性,采用Sprague Dawley (SD)大鼠开展了亚慢性毒性试验.120只SD大鼠(雌雄各半)随机分为高、中、低剂量和空白对照组,药物组分别按64、32、16 g/kg体重灌胃给药,空白对照组给予同体积蒸馏水,连续给药28 d,停药后观察14 d.结果表明,高剂量组出现谷丙转氨酶升高,停药后可恢复正常,其余相关检测指标均未见异常.表明参金口服液在临床应用是安全的.