ORIGINAL RESEARCH article

Front. Vet. Sci.

Sec. Veterinary Pharmacology and Toxicology

Volume 12 - 2025 | doi: 10.3389/fvets.2025.1645372

This article is part of the Research TopicNatural Compounds in Veterinary TherapeuticsView all 6 articles

Pharmacokinetics and Safety Evaluation of anemoside B4 in Healthy Beagle Dogs

Provisionally accepted
JiJinzhao  JiJiJinzhao Ji1,2Yuqiao  MaYuqiao Ma2,3Shaobing  WanShaobing Wan2,3Xiaoqing  DingXiaoqing Ding2,3Jingyu  WangJingyu Wang2,3Yongcheng  ZhongYongcheng Zhong2,3Yangyang  SongYangyang Song4junqing  Zhaojunqing Zhao5Zhetong  SuZhetong Su5Kun  JiaKun Jia2,3Shoujun  LiShoujun Li2,3*
  • 1College of Veterinary Medicine, South China Agricultural University,, Guangzhou, China
  • 2Guangdong Technological Engineering Research Center for Pet, Guangzhou, China
  • 3College of Veterinary Medicine, South China Agricultural University, Guangzhou, China
  • 4Guangxi Innovate Pharmaceutical Co., Ltd,, Guangxi, China
  • 5Guangxi Innovate Pharmaceutical Co., Ltd, Guangxi, China

The final, formatted version of the article will be published soon.

Anemoside B4 (AB4), a pentacyclic triterpenoid saponin isolated from the traditional Chinese medicinal herb Pulsatilla chinensis, has demonstrated potent anti-inflammatory and immunomodulatory effects in both preclinical studies and clinical trials. However, data on the pharmacokinetics and safety of AB4 in dogs remain lacking. A comprehensive understanding of its pharmacokinetic profile, bioavailability, and safety margin in dogs is essential to support its future study.This study included three parts: (1) A randomized parallel-controlled study was conducted in 40 Beagle dogs, which received single subcutaneous injections of AB4 at low (10 mg/kg), medium (20 mg/kg), or high (40 mg/kg) doses, or intravenous injection bolus at 20 mg/kg. Plasma concentrations were analyzed using a validated HPLC-MS/MS method to establish concentrationtime profiles and determine pharmacokinetic parameters, including absolute bioavailability, dose proportionality, and sex-based differences. (2) In a multiple-dose study, 10 Beagle dogs were administered 20 mg/kg AB4 subcutaneously once daily for 7 consecutive days to assess drug accumulation and degree of fluctuation. (3) In a target animal safety study, 32 healthy Beagle dogs were randomly assigned to receive 20, 60, or 100 mg/kg of AB4, or saline, by daily subcutaneous injection for 7 days. Clinical signs, hematology, serum biochemistry, gross necropsy, and histopathology were evaluated.In the safety study, no mortality or near-death events occurred in dogs receiving 20-100 mg/kg AB4. Dogs exhibited normal clinical signs throughout the study period, with no observable toxic reactions or adverse effects. No significant effects were observed on liver and kidney function, hematopoiesis, coagulation, or related physiological parameters. Histopathological analysis revealed no consistent or target-organ specific lesions.These findings provide fundamental pharmacokinetic and safety data to support the rational clinical use of AB4 in veterinary medicine.

Keywords: Anemoside B4, pharmacokinetics, Safety, dog, Veterinary Medicine

Received: 11 Jun 2025; Accepted: 07 Jul 2025.

Copyright: © 2025 Ji, Ma, Wan, Ding, Wang, Zhong, Song, Zhao, Su, Jia and Li. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence: Shoujun Li, Guangdong Technological Engineering Research Center for Pet, Guangzhou, China

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