Chinese Journal of Pharmacovigilance ›› 2022, Vol. 19 ›› Issue (5): 505-509.
DOI: 10.19803/j.1672-8629.2022.05.07

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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*   

  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 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

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