Chinese Journal of Pharmacovigilance ›› 2017, Vol. 14 ›› Issue (11): 653-656.

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Experimental Study on Acute and Repeated Dose Toxicity of Traditional Chinese Medicine Kangguan Granule on Juvenile Rats

LIN Xiao-qi1, GUO Xin-miao1, ZHANG Ying-xue1, WEI Jin-feng1,2, JIN Hong-tao1,2,*   

  1. 1 Beijing Union-Genius Pharmaceutical Technology Development Co., Ltd., Beijing 100176, China;
    2 New Drug Safety Evaluation Center, Institute of Materia Medica, Chinese Academy of Medical Sciences, Beijing 100050, China
  • Received:2017-12-26 Revised:2017-12-26 Online:2017-11-20 Published:2017-12-26

Abstract: Objective To observe the acute and repeated dose toxicity of Kanggan granule on juvenile rats. Methods The acute toxicity study was conducted with the maximum dose method by oral dose of 36 g·kg-1. For the repeated dose toxicity study, Kanggan granule suspended in 0.5% methylcellulose vehicle was administered via oral gavage, once daily, at doses of 1, 3, 9 g·kg-1 for 30 days and with 4 weeks recovery period.Parameters included daily clinical signs, periodic hematology, clinical chemistry and urinalysis determinations, hormone, histopathology and neurobehavioral examination. Results In acute toxicity study, body weight of female rat increased slowly at the dose of 36 g·kg-1. In repeated dose toxicity study, slightly decreased RBC, HGB and HCV, mild increased reticulocytes were observed at the dose of 9 g·kg-1, while reversible at the end of recovery period. Conclusion In acute toxicity study, the maximum tolerance dose was greater than 36 g·kg-1, for repeated toxicity, the NOEAL was 3 g·kg-1 of Kanggan granule on juvenile rats.

Key words: Kanggan granule, juvenile rat, acute toxicity, repeated dose toxicity

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