荆防颗粒浸膏大鼠灌胃给药围产期发育毒性研究

doi:10.19803/j.1672-8629.2022.05.06

中国药物警戒 ›› 2022, Vol. 19 ›› Issue (5): 498-504.
DOI: 10.19803/j.1672-8629.2022.05.06

• 荆防颗粒安全性研究专栏 • 上一篇下一篇

荆防颗粒浸膏大鼠灌胃给药围产期发育毒性研究

郑成成, 徐百卉, 徐娇艳, 王会萍, 李贝贝, 张晓红, 孙颖, 姚景春, 王恩力

鲁南制药集团股份有限公司新药安评中心, 中药制药共性技术国家重点实验室,临沂市天然药物免疫药理毒理重点实验室,山东临沂 273400

收稿日期:2022-02-28 出版日期:2022-05-15 发布日期:2022-05-18
通讯作者: ^*王恩力,男,硕士,新药临床前药理毒理学。
作者简介:郑成成,女,硕士,工程师,新药临床前药理毒理学。
基金资助:
国家重点研发计划（2019YFC1711205）

Toxicity of Jingfang granule extract on perinatal rats

ZHENG Chengcheng, XU Baihui, XU Jiaoyan, WANG Huiping, LI Beibei, ZHANG Xiaohong, SUN Ying, YAO Jingchun, WANG Enli

Center For Drug Safety Evaluation of Lunan Pharmaceutical Group Corporation, State Key Laboratory of Generic Manufacture Technology of Chinese Traditional Medicine, Linyi Key Laboratory of Immunopharmacology and Toxicology of Natural Drugs, Linyi Shandong 273400, China

Received:2022-02-28 Online:2022-05-15 Published:2022-05-18

摘要/Abstract

摘要： 目的检测自胚胎着床到幼仔离乳给予荆防颗粒浸膏,评价其对妊娠及哺乳雌性大鼠及F1代大鼠和F2代大鼠生长发育的影响,为其临床安全应用提供依据。方法妊娠大鼠96只,随机分为空白对照组和荆防颗粒浸膏低剂量组(1 g·kg^-1·d^-1)、中剂量组(3 g·kg^-1·d^-1)、高剂量组(10 g·kg^-1·d^-1)。各组妊娠大鼠于妊娠6 d至离乳,每日给予雌性大鼠不同剂量的荆防颗粒浸膏。观察F0代妊娠大鼠体质量、摄食量、分娩情况和泌乳情况。F1代大鼠及F2代大鼠分娩后观察出生仔鼠的外观、体质量、生长发育指标、神经反射指标、行为学指标等。结果荆防颗粒浸膏10 g·kg^-1·d^-1及以下剂量无母体毒性;对F1代大鼠和F2代哺乳期新生仔鼠无毒性;F1代和F2代大鼠的体质量增长及摄食、生长发育、神经反射及学习记忆功能与空白组比较无显著性差异（P>0.05）,不影响F1代大鼠脏器发育及生殖功能。结论在本实验条件下,荆防颗粒浸膏对SD大鼠围产期发育的无毒性反应剂量（NOAEL）为10 g·kg^-1·d^-1。

关键词: 荆防颗粒浸膏, 灌胃, 大鼠, 发育毒性

Abstract: Objective To investigate the effect of Jingfang granule extract giving from embryo to cub on pregnant and lactating female rats as well as F1 and F2 rats. Methods A total of 96 rats were divided into solvent control group, Jingfang granule extract low dose group (1 g·kg^-1·d^-1) , medium dose group (3 g·kg^-1·d^-1) , and high dose group (10 g·kg^-1·d^-1). Jingfang granule extract were given from the day 6 of gestation through weaning. F0 pregnant rats were observed for body weight, food intake, childbirth and lactation. The appearance, body weight, growth and development index, nerve reflex index and behavioral index of the newborn rats were observed in F1 and F2 rats. Results Jingfang granule extract had no toxic effects on F1 generation and F2 generation offspring rats. Compared with solvent control group, Jingfang granule extract groups had no significant effects on body weight, feeding, growth, nerve reflex, learning and memory ability in F1 and F2 generation rats (P>; 0.05). In addition, no effect on the development of the organs or reproductive function of the F1 generation rats was observed. Conclusion Under the experimental conditions, Jingfang granule extract has no toxicities on perinatal of rats, and the no observed adverse effect levels (NOAEL) is 10 g·kg^-1·d^-1.

Key words: Jingfang granule extract, intragastric administration, rats, developmental toxicity

中图分类号:

R994.1

郑成成, 徐百卉, 徐娇艳, 王会萍, 李贝贝, 张晓红, 孙颖, 姚景春, 王恩力. 荆防颗粒浸膏大鼠灌胃给药围产期发育毒性研究[J]. 中国药物警戒, 2022, 19(5): 498-504.

ZHENG Chengcheng, XU Baihui, XU Jiaoyan, WANG Huiping, LI Beibei, ZHANG Xiaohong, SUN Ying, YAO Jingchun, WANG Enli. Toxicity of Jingfang granule extract on perinatal rats[J]. Chinese Journal of Pharmacovigilance, 2022, 19(5): 498-504.

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荆防颗粒浸膏大鼠灌胃给药围产期发育毒性研究

Toxicity of Jingfang granule extract on perinatal rats

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