Chinese Journal of Pharmacovigilance ›› 2022, Vol. 19 ›› Issue (5): 493-497.
DOI: 10.19803/j.1672-8629.2022.05.05

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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*   

  1. 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

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

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