荆防颗粒浸膏对大鼠胚胎-胎仔发育毒性研究

doi:10.19803/j.1672-8629.2022.05.05

中国药物警戒 ›› 2022, Vol. 19 ›› Issue (5): 493-497.
DOI: 10.19803/j.1672-8629.2022.05.05

• 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胚胎-胎仔发育毒性研究

郑成成, 王会萍, 徐百卉, 徐娇艳, 李贝贝, 张晓红, 张伟, 孙颖, 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:2022-01-19 出版日期:2022-05-15 发布日期:2022-05-18
通讯作者: *王恩力,男,硕士,研究员,新药临床前药理毒理学。E-mail：13864947620 @163.com
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 embryo-fetal developmental of rats

ZHENG Chengcheng, WANG Huiping, XU Baihui, XU Jiaoyan, LI Beibei, ZHANG Xiaohong, ZHANG Wei, SUN Ying, 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:2022-01-19 Online:2022-05-15 Published:2022-05-18

摘要/Abstract

摘要： 目的探讨荆防颗粒浸膏对动物胚胎-胎仔发育的影响,为其药用价值的进一步开发提供参考。方法 112只受精雌鼠分为空白对照组和荆防颗粒浸膏高、中、低剂量（10、3、1 g·kg^-1·d^-1）组,每组28只。全部动物于妊娠第6天（GD₆）开始给药,每天灌胃给药1次,连续给药至GD₁₅,停药至GD₂₀解剖检查。试验期间,每天观察动物一般状态,定期检测动物体质量和摄食量,解剖时计数卵巢黄体数量、检查着床数和活胎数,测量活胎顶臀长和尾长,检查活胎外观、内脏和骨骼。结果给药期间,动物未见异常体征变化;与空白对照组比较,荆防颗粒浸膏未引起大鼠体质量异常增长;母本动物受孕率、平均黄体数量和受精卵着床丢失率也未见异常改变;窝均活胎率、死胎率和吸收胎率,胎仔顶臀长和尾长也未见明显改变;未见受试物导致胎仔外观、内脏和骨骼畸形。结论荆防颗粒浸膏未见潜在的大鼠胚胎-胎仔发育毒性,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, 灌胃, 胚胎, 发育毒性, 畸形, 妊娠

Abstract: Objective To explore the developmental toxicities of Jingfang granule extract on embryo-fetal of rats, so as to provide reference for the further development of its medicinal value. Methods Totally 112 fertilized rats were divided randomly into control group, Jingfang granule extract 1, 3, and 10 g·kg^-1·d^-1 groups, 28 in each group. Animals were intragastrical administered with Jingfang granule extract from day 6 of pregnancy (GD₆) once daily;; Rats were treated until GD₁₅ and sacrificed on GD₂₀. The clinical manifestation of animals was observed every day during test period, feed take and bodyweight were detected regularly. Corpora lutea number, implantation number, and living fetus number were counted. Lengths of fetus Crown-Rump and tail were measured and the appearance, skeleton, and viscera of fetus were detected. Results With the exception, no apparent toxic reaction in pregnant animals was shown in all groups. Compared with control group, rats treated with Jingfang granule extract had no abnormal change on maternal pregnancy rate, average corpora lutea number, average implantation loss rate, and average living fetus rate, and likewise, average lengths of fetus Crown-Rump and tail were normal. Moreover, rats treated with Jingfang granule extract had no malformation in fetus appearance, skeleton, and viscera compared with vehicle control. Conclusion Jingfang granule extract has no potential developmental toxicities on embryo-fetal of rats. Under the experimental conditions, the no observed adverse effect level (NOAEL) of Jingfang granule extract on developmental toxicity of rats is 10 g·kg^-1·d^-1.

Key words: Jingfang granule extract, intragastric administration, fetus, developmental toxicity, malformation, gestation

中图分类号:

R994.1

郑成成, 王会萍, 徐百卉, 徐娇艳, 李贝贝, 张晓红, 张伟, 孙颖, 王恩力. 荆防颗粒浸膏对大鼠胚胎-胎仔发育毒性研究[J]. 中国药物警戒, 2022, 19(5): 493-497.

ZHENG Chengcheng, WANG Huiping, XU Baihui, XU Jiaoyan, LI Beibei, ZHANG Xiaohong, ZHANG Wei, SUN Ying, WANG Enli. Toxicity of Jingfang granule extract on embryo-fetal developmental of rats[J]. Chinese Journal of Pharmacovigilance, 2022, 19(5): 493-497.

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荆防颗粒浸膏对大鼠胚胎-胎仔发育毒性研究

Toxicity of Jingfang granule extract on embryo-fetal developmental of rats

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