Chinese Journal of Pharmacovigilance ›› 2019, Vol. 16 ›› Issue (1): 1-5.

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Repeated Dose Toxicity Study of Antexiao Capsules in Beagle Dogs for 39 Weeks

DU Xiao1, WANG Jiannong1,*, HAN Lin2, SUN Caixia1, CAO Xiaoqiang1, SUN Jian1   

  1. 1Research and Development Centre, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China;
    2Guanganmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China
  • Received:2018-08-30 Revised:2019-02-18 Online:2019-01-20 Published:2019-02-18

Abstract: Objective To examine the repeated dose toxicity of Antexiao capsule in Beagle dogs. Methods 48 Beagle dogs were divided into four groups: 120, 320, 800 mg·kg-1 dose of Antexiao capsule groups and solvent control group. The dogs were orally treated with Antexiao capsule for 39 weeks. Clinical observation, body weight, electrocardiogram, hematology, blood biochemistry, organ weights, and histopathological findings were examined. Results Antexiao capsule could induce vomiting, salivation and liquid stools in healthy dogs. The body weight of dogs in 800 mg·kg-1 group decreased significantly (P <0.05). The levels of serum TP, ALB and GLOB changed in dogs treated with 320 and 800 mg·kg-1 Antexiao capsule. No significant drug-related pathological changes were found. Conclusion Antexiao capsule (320 and 800 mg·kg-1) administered intragastrically can induce significant gastrointestinal toxicity in Beagle dogs.

Key words: Antexiao capsule, total steroidal alkaloids from Solanum lyratum, Beagle dogs, repeated dose toxicity

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