Chinese Journal of Pharmacovigilance ›› 2022, Vol. 19 ›› Issue (5): 498-504.
DOI: 10.19803/j.1672-8629.2022.05.06

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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   

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

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

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