Fu Shaohua, Xu Siyuan, Pei Dong, Qu Wen, Qu Jingjing, Tian Jie
Hubei Provincial Center for Disease Control and Prevention Key Laboratory of Application Toxicology, Wuhan 430079, China.
Key Laboratory of Chemistry of Northwest Plant Resources, Chinese Academy of Sciences, Lanzhou 730000, China.
Wei Sheng Yan Jiu. 2019 Jan;48(1):104-108.
To observe the sub-chronic toxicity of songaria cynomorium herb aqueous extract in rat at different oral dose levels.
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.
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.
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.
观察锁阳水提取物在不同口服剂量水平下对大鼠的亚慢性毒性。
按照《食品安全毒理学评价程序和方法》（GB 15193.13 - 2015）中大鼠亚慢性毒性研究方案进行试验。选取80只体重60 - 80 g的SPF级Wistar大鼠，按体重随机分为4组，每组10只（雌雄各半）。第1至4组大鼠分别每天灌胃给予锁阳水溶性提取物1次，剂量分别为0、2.83、5.66和8.49 g/kg体重，连续90天。给药体积为13 mL/kg。监测或检测动物的临床症状、体重、摄食量、食物利用率、血液学指标、血清生化指标及组织病理学变化。
整个研究过程中未观察到明显的中毒症状，也无动物死亡。对照组与各给药组在体重、摄食量、食物利用率方面无显著差异。虽然个别剂量组的一些血液学和血清生化参数有明显变化，但仍在本实验室正常范围内。因此，上述所有变化均未被视为不良反应。然而，雄性中、高剂量组的凝血酶原时间（PT）显著延长（P < 0.05）。此外，与对照组相比，中剂量组睾丸指数显著升高，高剂量组脾脏指数、睾丸指数、附睾指数升高。各给药组均未检测到明显的组织病理学变化。
在本实验条件下，锁阳水溶性提取物对大鼠亚慢性毒性研究的未观察到有害作用剂量（NOAEL）为2.83 g/kg体重，最低观察到有害作用剂量（LOAEL）为5.66 g/kg体重。
