Journal of Southern Medical University ›› 2026, Vol. 46 ›› Issue (10): 2518-2535.doi: 10.12122/j.issn.1673-4254.2026.10.20

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Comparison of Pulsatilla decoction formula granules versus its standard decoction for consistency of chemical components and bioequivalence in mice with ulcerative colitis

Jiana ZHANG1,2,4,5,6(), Xia ZHANG2, Weixuan HUANG2, Dandan YE2, Zhuowen HUANG2, Jinhao HUANG2, Xiaoya WENG2, Lin PENG3, Weibo DAI3(), Xiaoqi HUANG2()   

  1. 1.Department of Pharmacy, First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510405, China
    2.School of Pharmaceutical Sciences, Guangzhou University of Chinese Medicine, Guangzhou 510006, China
    3.Zhongshan Hospital of Traditional Chinese Medicine, Guangzhou University of Chinese Medicine, Zhongshan 528400, China
    4.Guangdong Provincial Clinical Research Academy of Chinese Medicine, Guangzhou 510405, China
    5.Guangdong Provincial Engineering Research Center of Commercialization of Medical Institution Preparations and Traditional Chinese Medicines, Guangzhou 510405, China
    6.Guangdong Provincial Engineering Technology Research Center of Commercialization of Lingnan Special Medical Institution Preparations, Guangzhou 510405, China
  • Received:2026-04-16 Online:2026-10-20 Published:2026-10-26
  • Contact: Weibo DAI, Xiaoqi HUANG E-mail:2440585936@qq.com;daiweibo007@163.com;huangxiaoqi@gzucm.edu.cn

Abstract:

Objective To investigate the consistency of chemical composition between commercially available formula granules (FG) and standard decoction (SD) of Pulsatilla Decoction and their pharmacodynamic effects in mice with dextran sulfate sodium (DSS)-induced ulcerative colitis (UC). Methods Ultra-high performance liquid chromatography coupled with Fourier transform electrostatic field orbitrap high-resolution mass spectrometry (UHPLC-Orbitrap HRMS) combined with mzCloud database and analyisis of literature and reference substances was used to compare the chemical profiles and major components of the two preparations, whose fingerprints and index components were determined with HPLC. Chemical components consistency of the two preparations was assessed by evaluating the number and total area of common peaks, fingerprint similarity, extraction rate, and index component contents. A mouse model of DSS-induced UC was used to to compare the therapeutic effects of the two preparations. Results Chemical composition analysis showed basically consistent number and retention times of chromatographic peaks of FG and SD in both positive and negative ion modes with only differences in response intensity, and identified a total of 39 major components. FG and SD showed identical fingerprint common peaks with a similarity >0.99. Compared with SD, FG exhibited significantly higher relative total common peak area ratios (1.24, 1.34, and 1.20), a higher mean extraction rate (18.09% vs 13.71%), higher pulchinenoside B5 and jatrorrhizine contents, but lower obaculactone content with comparable contents of the other 10 components. In the UC mouse models, FG and SD showed similar therapeutic effects and both significantly ameliorated macroscopic signs, promoted colonic tissue repaire, increased anti-inflammatory and decreased pro-inflammatory cytokines, and enhanced mucosal barrier protein expression. Conclusion Pulsatilla Decoction SD and FG have basically consistent chemical composition with only minor differences and show pharmacodynamic equivalence in mice with DSS-induced UC.

Key words: Pulsatilla Decoction, formula granules, standard decoction, chemical composition, bioequivalence