荆防颗粒浸膏对大鼠生育力与早期胚胎发育毒性研究

doi:10.19803/j.1672-8629.2022.05.07

中国药物警戒 ›› 2022, Vol. 19 ›› Issue (5): 505-509.
DOI: 10.19803/j.1672-8629.2022.05.07

• 荆防颗粒安全性研究专栏 • 上一篇下一篇

荆防颗粒浸膏对大鼠生育力与早期胚胎发育毒性研究

郑成成, 王恩力, 徐百卉, 徐娇艳, 李贝贝, 张晓红, 周宗仪, 王永刚, 姚景春^*

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:2022-01-19 出版日期:2022-05-15 发布日期:2022-05-18
通讯作者: * 姚景春,男,硕士,研究员,新药临床前药理毒理学。E-mail：yaojingchun@lunan.cn
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 the reproductive and early embraonic development of Jingfang granule extract in rats

ZHENG Chengcheng, WANG Enli, XU Baihui, XU Jiaoyan, LI Beibei, ZHANG Xiaohong, ZHOU Zongyi, WANG Yonggang, YAO Jingchun^*

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:2022-01-19 Online:2022-05-15 Published:2022-05-18

摘要/Abstract

摘要： 目的观察荆防颗粒浸膏对SD大鼠生育力及早期胚胎发育的影响,为其药用价值的进一步开发提供参考。方法选用SPF级大鼠168只,随机分为4组,即空白对照组,荆防颗粒浸膏1、3、10 g·kg^-1·d^-1 剂量组,每组42只,雌雄各半。全部动物灌胃给予对应药物,每日1次,给药体积15 mL·kg^-1。雌雄大鼠分别给药2周和4周后按照1∶1合笼交配。动物交配期间持续给药,交配成功雌鼠继续给药至妊娠第6天,交配成功雄鼠持续给药直至处死。试验期间检测指标包括一般观察,摄食,体重,雄鼠精子活动度、数量和形态,妊娠雌鼠妊娠情况和着床腺数（活胎、死胎、吸收胎）,主要脏器称量和脏器系数计算。结果试验期间,空白对照组及荆防颗粒浸膏1、3、10 g·kg^-1·d^-1 剂量组动物均未见受试物引起的异常体征。与空白对照组比较,荆防颗粒浸膏1、3、10 g·kg^-1·d^-1剂量组雌、雄大鼠交配前体重、雌鼠妊娠期体重和体重增重以及雌、雄鼠交配前摄食量、雌鼠妊娠期摄食量均未见显著改变;动物交配天数、交配率和雌鼠受孕率、雄鼠精子质量和雌鼠妊娠结局均未见异常改变。结论本实验条件下,荆防颗粒浸膏未见潜在的大鼠生育力与早期胚胎发育毒性,无明显损害作用剂量（NOAEL）为 10 g·kg^-1·d^-1。

关键词: 荆防颗粒浸膏, 大鼠, 发育毒性, 生育力, 早期胚胎

Abstract: Objective To observe the effects of Jingfang granule extract on fertility and early embryonic development of SD rats, so as to provide reference for the further development of its medicinal value. Methods Totally 168 rats were divided randomly into control group and Jingfang Granule Extract 1, 3, 10 g·kg^-1·d^-1 groups, 42 in each group; half male and half female. Prior to mating, male rats were treated for 4 weeks and female rats were treated for 2 weeks respectively by intragastric administration with volume 15 mL·kg^-1 once a day. With each treatment group, the male and female rats were co-housed (1∶1). The clinical manifestation of animals was observed every day during test period, feed taking and bodyweight were detected regularly. Sperm motility, quantity and morphology of male rats, pregnancy of pregnant female rats, corpora lutea number, implantation number, and living fetus number, absorbed fetus number, dead fetus number, main reproductive organs were detected. Results Compared with the control group, there were no significant changes in the pre-mating weight of female and male rats, pregnant weight and weight gain of female rats, pre-mating food intake of female and male rats and pregnant food intake of female rats of all the Jingfang Granule Extract treatment groups. There were no abnormal changes on animal precoital interval, mating index, gestation index, sperm quality of male rats and pregnancy outcome of female rats. During test period, no abnormal signs were found in the control and Jingfang granule extract 1, 3 and 10 g·kg^-1·d^-1groups. Conclusion Under the experimental conditions, Jingfang granule extract has no potential developmental toxicities on embryo-fetal of rats, and the no observed adverse effect levels (NOAEL) is 10 g·kg^-1·d^-1.

Key words: Jingfang granule extract, rats, developmental toxicity, reproductive, early embraonic

中图分类号:

R994.1

郑成成, 王恩力, 徐百卉, 徐娇艳, 李贝贝, 张晓红, 周宗仪, 王永刚, 姚景春. 荆防颗粒浸膏对大鼠生育力与早期胚胎发育毒性研究[J]. 中国药物警戒, 2022, 19(5): 505-509.

ZHENG Chengcheng, WANG Enli, XU Baihui, XU Jiaoyan, LI Beibei, ZHANG Xiaohong, ZHOU Zongyi, WANG Yonggang, YAO Jingchun. Toxicity of the reproductive and early embraonic development of Jingfang granule extract in rats[J]. Chinese Journal of Pharmacovigilance, 2022, 19(5): 505-509.

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荆防颗粒浸膏对大鼠生育力与早期胚胎发育毒性研究

Toxicity of the reproductive and early embraonic development of Jingfang granule extract in rats

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