薏芽健脾凝胶幼龄大鼠的一般毒理学研究

doi:10.19803/j.1672-8629.20220081

中国药物警戒 ›› 2023, Vol. 20 ›› Issue (4): 416-422.
DOI: 10.19803/j.1672-8629.20220081

薏芽健脾凝胶幼龄大鼠的一般毒理学研究

刘欢, 袁慧, 尹晶晶, 刘梦雅, 秦秀军, 李建国^*

中国辐射防护研究院药物安全性评价中心,药物毒理与放射损伤药物山西省重点实验室,中核放射毒理与放射性药物临床前评价重点实验室,山西太原 030006

收稿日期:2022-03-04 出版日期:2023-04-15 发布日期:2023-04-20
通讯作者: ^*李建国,男,博士,研究员,药物临床前安全性评价。E-mail: Ljg2547@163.com
作者简介:刘欢,男,硕士,助理研究员,药物临床前安全性评价。
基金资助:
国防科工局核能开发项目（HH19010201）：山西省科技基础条件平台项目（201805D141007）

General toxicology of Yiya Jianpi jel among juvenile animals

LIU Huan, YUAN Hui, YIN Jingjing, LIU Mengya, QIN Xiujun, LI Jianguo^*

Drug Safety Evaluation Center in China Institute for Radiation Protection, Shanxi Key Laboratory of Drug Toxicology and Drug for Radiation Injury, Key Laboratory of Radiological Toxicology and Radiological Drugs Preclinical Evaluation in China National Nuclear Corporation, Taiyuan Shanxi 030006, China

Received:2022-03-04 Online:2023-04-15 Published:2023-04-20

摘要/Abstract

摘要： 目的通过幼龄SD大鼠急性毒性和长期毒性试验,评价薏芽健脾凝胶的安全性和对生长发育的影响。方法急性毒性试验采用最大耐受量法,幼龄SD大鼠以最大给药量5.2 g·kg-1灌胃给药,每日2次,总给药剂量为10.4 g·kg-1,给药后严密观察大鼠的毒性反应情况。长期毒性试验采用幼龄SD大鼠200只,分为给药高（3.9 g·kg-1）、中（2.6 g·kg-1）、低（1.3 g·kg-1）剂量组和对照组,每组50只大鼠,连续给药90 d,恢复28 d,主要检查指标有体质量、摄食量、血液学、血液生化、生理发育、内分泌、神经行为学、病理等。结果急性毒性试验幼龄SD大鼠灌胃薏芽健脾凝胶最大耐受剂量大于10.4 g·kg-1,且未见明显的毒副反应。长期毒性试验高剂量组（3.9 g·kg-1）部分指标出现一过性改变,未见与药物相关的毒性病理改变。结论在本试验条件下,薏芽健脾凝胶对受试动物未见明显毒性反应。

关键词: 薏芽健脾凝胶, 急性毒性试验, 长期毒性试验, 幼龄动物, 非临床安全性评价, 大鼠

Abstract: Objective To evaluate the safety of Yiya Jianpi jel and its effects on the growth of juvenile SD rats via acute toxicity and long-term toxicity tests. Methods The acute toxicity test was conducted using the maximum tolerable dose (MTD) method. The maximum dose was 5.2 g·kg-1, twice a day, and the total dose was 10.4 g·kg-1. After administration, the toxic reactions of rats were closely observed. The 200 juvenile SD rats used in the long-term toxicity test were divided into the high (3.9 g·kg-1), medium (2.6 g·kg-1), low (1.3 g·kg-1) dose groups and control group, with 50 rats in each. The drug was administered for ninety consecutive days before the rats were allowed to recover for twenty-eight days. The main indexes for examination were body mass, food intake, hematology, blood biochemistry, physiological development, endocrine, neuroethology and pathology. Results The MTD of Yiya Jianpi jel exceeded 10.4 g·kg-1 in juvenile SD rats, and no obvious side effects were observed. In the high dose group, transient changes were observed in some of the indexes during the long-term toxicity test, but no drug-related toxic pathological changes were observed (3.9 g·kg-1). Conclusion Under the conditions used in this experiment, Yiya Jianpi jel causes no obvious toxic reactions to the tested animals and clinical use in children is supported.

Key words: Yiya Jianpi jel, acute toxicity, repeated toxicity, juvenile animal, nonclinical safety evaluation, rats

中图分类号:

R975
R994.11

刘欢, 袁慧, 尹晶晶, 刘梦雅, 秦秀军, 李建国. 薏芽健脾凝胶幼龄大鼠的一般毒理学研究[J]. 中国药物警戒, 2023, 20(4): 416-422.

LIU Huan, YUAN Hui, YIN Jingjing, LIU Mengya, QIN Xiujun, LI Jianguo. General toxicology of Yiya Jianpi jel among juvenile animals[J]. Chinese Journal of Pharmacovigilance, 2023, 20(4): 416-422.

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薏芽健脾凝胶幼龄大鼠的一般毒理学研究

General toxicology of Yiya Jianpi jel among juvenile animals

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