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ORIGINAL RESEARCH article

Front. Pharmacol.
Sec. Ethnopharmacology
Volume 15 - 2024 | doi: 10.3389/fphar.2024.1424940

Toxicological evaluation of porcine bile powder in Kunming mice and Sprague-Dawley rats

Provisionally accepted
Lirong Wu Lirong Wu 1Jieyi Wang Jieyi Wang 1Jing Lei Jing Lei 2Kun Ge Kun Ge 1Chun Qu Chun Qu 1Jiajian Liu Jiajian Liu 1Fengjie Huang Fengjie Huang 2Dongnan Sun Dongnan Sun 1XiaoWen Chao XiaoWen Chao 1Tianlu Chen Tianlu Chen 1Zhao Aihua Zhao Aihua 1Wei Jia Wei Jia 1Xiaojiao Zheng Xiaojiao Zheng 1Guoxiang Xie Guoxiang Xie 2*
  • 1 Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China
  • 2 Human Metabolomics lnstitute lnc., Shenzhen, China

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

    Porcine bile powder (PBP) is a traditional Chinese medicine that has been used for centuries in various therapeutic applications. However, PBP has not previously undergone comprehensive component analysis and not been evaluated for safety through standard in vivo toxicological studies. In the present study, the component of PBP were characterized and acute and subchronic oral toxicity studies of PBP were designed and conducted in Kunming mice and Sprague-Dawley (SD) rats. The chemical analysis of PBP by liquid chromatography-mass spectrometry showed that the main components of PBP were bile acids, especially glycochenodeoxycholic acid. There were no signs of toxicity observed in the acute oral test and the subchronic test. In the genotoxicity tests, no positive results were observed in the bacterial reverse mutation test. Additionally, in the mammalian micronucleus test and mouse spermatocyte chromosomal aberration test, no abnormal chromosomes were observed. In the teratogenicity test, no abnormal fetal development was observed. These results demonstrate that PBP, composed mainly of bile acids, is non-toxic and safe based on the conditions tested in this study.

    Keywords: porcine bile powder, chemical composition, acute oral toxicity, subchronic oral toxicity, genotoxity, teratogenicity Abbreviations BALF, bronchoalveolar lavage fluid, BW, body weight, CDCA, chenodeoxycholic acid, CP, cyclophosphamide, GCDCA, glycochenodeoxycholic acid, GHCA, glycohyocholic acid, GHDCA, glycohyodeoxycholic acid, GLP-1, glucagon-like peptide 1

    Received: 02 May 2024; Accepted: 17 Jun 2024.

    Copyright: © 2024 Wu, Wang, Lei, Ge, Qu, Liu, Huang, Sun, Chao, Chen, Aihua, Jia, Zheng and Xie. 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: Guoxiang Xie, Human Metabolomics lnstitute lnc., Shenzhen, China

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.