锁阳水提物大鼠亚慢性毒性试验研究

目的研究锁阳水提物对大鼠的亚慢性毒性作用。方法按《食品安全性毒理学评价程序和方法》(GB 15193.13—2015)大鼠亚慢性经口毒性试验方法。选取SPF级Wistar大鼠80只,雌雄各半,按体重随机分为对照组及锁阳水提物低、中、高剂量组(2.83、5.66、8.49 g/kg)。大鼠经口灌胃给药,每日一次,连续90 d,灌胃容量13 mL/kg,阴性对照组给予等容量蒸馏水。检测指标包括大鼠的一般临床症状、体重、进食量及食物利用率,血液学及血液生化学检查,组织病理学检查。结果试验期间动物未见明显的中毒症状和死亡。与阴性对照组比较,锁阳水提物各剂量组大鼠体重、进食量、食物利用率差异均无统计学意义(P>0.05);个别剂量组动物血液学及血液生化学检查指标与阴性对照组相比,虽然差异有统计学意义(P<0.05),但值均在实验室正常范围内且无剂量-反应关系,无毒理学意义;雄鼠中、高剂量组血浆凝血酶原时间(prothrombin time,PT)偏高,差异均有统计学意义(P<0.05);雄鼠中剂量组睾丸脏器系数,高剂量组脾脏器系数、睾丸脏器系数、附睾脏器系数偏高,差异均有统计学意义(P<0.05)。组织病理学检查未发现明显异常变化。结论本次试验条件下,锁阳水提物使雄鼠中、高剂量组血浆PT明显增高,使雄鼠中、高剂量组睾丸脏器系数以及高剂量组附睾脏器系数明显增加,大鼠亚慢性经口毒性最大未观察到有害作用剂量(no observed adverse effect level,NOAEL)为2.83 g/kg,最小观察到的有害作用剂量(lowest observed adverse effect level,LOAEL)为5.66 g/kg。

Subchronic toxicity test of songaria cynomorium herb aqueous extract in rat

OBJECTIVE To observe the sub-chronic toxicity of songaria cynomorium herb aqueous extract in rat at different oral dose levels.METHODS The study was conducted according to the protocol of sub-chronic toxicity study in rat in Procedures and Method for Toxicolohical Assessment on Food Safety (GB 15193.13-2015).Total 80 SPF grade Wistar rats,weighing 60-80 g,were randomized into 4 groups of 10/sex/group based on their body weight.The animals from groups 1 to 4 were orally dosed once daily with songaria cynomorium herb aqueous-soluble extract at 0,2.83,5.66 and 8.49 g/kg BW respectively for continuous 90 days.And the dose volume was 13 mL/kg.The clinical signs,body weight,food consumption,food utilization rate, hematology,serum chemistry and histopathology were monitored or tested.RESULTS No obvious toxic signs were observed and no animals were found dead during the whole study.There were no significant differences between the control and test article groups in the body weight,food consumption,food utilization rate.Although some hematology and serum chemistry parameters in a single dose group changed significantly,their values were still in the normal ranges of our laboratory.Therefore,all the above changes were not considered as adverse effects.However,the prothrombin time (PT)at male middle and high dose group prolonged significantly (P<0.05).In addition,Compared with that of control,significantly increased testes index was observed in the mid-dose group,while increased spleen index,testes index,epididymis index were observed in high-dose group. no obvious histopathology changes were detected in all test article groups.CONCLUSION Under the condition of this experiment,the No-observed-adverse-effect-level (NOAEL) was 2.83 g/kg BW and the lowest-observed-adverse-effect-level (LOAEL)was 5.66 g/kg BW for songaria cynomorium herb aqueous-soluble extract in the rat sub-chronic toxicity study.