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牛大力亚慢性毒性研究

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目的 通过开展牛大力的亚慢性毒性试验,为其安全性评价提供试验依据。方法 80只SPF级SD种大鼠(雌雄各半)分成4个组,分别为低、中、高3个剂量组[0。86、2。58、7。73 g/(kg·bw)]和阴性对照组,经口灌胃分别给予相应剂量的牛大力,阴性对照组给予纯净水,连续灌胃90 d。实验结束,大鼠经腹腔麻醉后采血检测血液指标,采集脏器称重及计算脏/体比,并进行病理学检查。结果 各剂量组动物生长发育良好,体重、摄食量、食物利用率、血常规、凝血、血生化指标、脏器重,以及脏/体比指标与阴性对照组比较,差异无统计学意义(P>0。05),组织病理学观察未见与受试样品有关的病理改变。结论 在本试验条件下,确定受试样品牛大力对雌、雄性大鼠的未观察到有害作用剂量(NOAEL)均为75。00 g/(kg·bw),未见亚慢性毒性。
Study on Subchronic Toxicity of Millettia Speciosa
Objective To provide experimental basis for safety evaluation of Millettia speciosa by conducting subchronic toxicity test.Methods A total of 80 SPF SD rats(sex in half)were divided into low,medium and high dose groups[0.86、2.58、7.73 g/(kg·bw)]and a negative control group.Rats in the dose groups were orally administered the corresponding doses of millettia speciosa,while rats in the negative control group were given purified water.The oral gavage lasted for 90 days consecutively.At the end of the experiment,blood samples were collected from rats anesthetized by intraperitoneal injection for blood indexes analyses.Major organs were harvested and weighed to calculate organ-to-body weight ratios.Histopathological examinations were also performed on organ tissues.Results The growth and development of the animals in each dose group were good.There was no significant difference in body weight,food intake,food utilization rate,blood routine,blood clotting,blood biochemical index,organ weight,and viscera/body ratio index between each dose group and the negative control group(P>0.05).No pathological changes related to the test samples were observed by histopathological observation.Conclusion Under the conditions of this experiment,the no observed adverse effect level(NOAEL)of the test sample Millettia speciosa on female and male rats is determined to be 75.00 g/(kg·bw),and no subchronic toxicity is observed.

Millettia speciosaSubchronic toxicitySafety assessmentNo observed adverse effect level

汤莉、胡帅尔、陈美芬、张紫虹、李文立、李冬利

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广东省疾病预防控制中心卫生毒理所,广东 广州 511430

五邑大学生物科技与大健康学院,广东 江门 529000

牛大力 亚慢性毒性 安全性评价 有害作用剂量

广东省中医药局科研项目

20221060

2024

医学信息
国家卫生部信息化管理领导小组 中国电子学会中国医药信息学分会 陕西文博生物信息工程研究所

医学信息

影响因子:0.161
ISSN:1006-1959
年,卷(期):2024.37(7)
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