南方医科大学学报 ›› 2026, Vol. 46 ›› Issue (10): 2518-2535.doi: 10.12122/j.issn.1673-4254.2026.10.20

• • 上一篇    

白头翁汤配方颗粒与标准汤剂化学成分基本一致且对溃疡性结肠炎小鼠具有生物等效性

张佳娜1,2,4,5,6(), 张霞2, 黄伟轩2, 叶丹丹2, 黄卓文2, 黄锦豪2, 翁晓雅2, 彭林3, 戴卫波3(), 黄晓其2()   

  1. 1.广州中医药大学第一附属医院药学部,广东 广州 510405
    2.广州中医药大学中药学院,广东 广州 510006
    3.广州中医药大学附属中山中医院,广东 中山 528400
    4.广东省中医临床研究院,广东 广州 510405
    5.医疗机构中药制剂与中药新药转化广东省工程研究中心,广东 广州 510405
    6.广东省岭南特色医院制剂转化工程技术研究中心,广东 广州 510405
  • 收稿日期:2026-04-16 出版日期:2026-10-20 发布日期:2026-10-26
  • 通讯作者: 戴卫波,黄晓其 E-mail:2440585936@qq.com;daiweibo007@163.com;huangxiaoqi@gzucm.edu.cn
  • 作者简介:张佳娜,硕士,E-mail: 2440585936@qq.com
  • 基金资助:
    广东省基础与应用基础研究基金项目(2023A1515220035);广东省基础与应用基础研究基金项目(2023A1515140115);广东省普通高校生物医药与健康重点领域专项(2023ZDZX2017);广东省科技创新战略专项资金(大学生科技创新培育)项目(pdjh2025bk057);中山市中医药传承创新发展科研专项(2024B3003)

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

摘要:

目的 研究白头翁汤市售配方颗粒(FG)与标准汤剂(SD)的化学成分种类、含量及对DSS诱导的溃疡性结肠炎(UC)小鼠药效的一致性,为该配方颗粒的临床应用提供参考。 方法 通过超高效液相色谱-傅里叶变换静电场轨道阱高分辨质谱(UHPLC-Orbitrap HRMS)分析技术,结合mzCloud数据库、文献比对及对照品验证,对二者化学成分大致组成进行初步对比,并鉴定其主要化学成分;采用高效液相色谱技术建立白头翁汤指纹图谱和测定指标成分含量的液相色谱方法,以共有峰数量与总面积、指纹图谱相似度、出膏率、指标成分含量为评价指标,分析FG与SD的化学成分一致性;同时,将雄性Balb/c小鼠随机分为9组,每组8只:正常对照组,模型组,阳性药组(5-ASA,200 mg/kg),标准汤剂低、中、高剂量组(SDL,5 g/kg;SDM,10 g/kg;SDH,15 g/kg),配方颗粒低、中、高剂量组(FGL,5 g/kg;FGM,10 g/kg;FGH,15 g/kg)。各组自由饮食,除正常对照组自由饮用无菌水外,其余各组小鼠自由饮用3% DSS溶液,持续7 d以建立DSS诱导UC小鼠模型。通过评估小鼠宏观体征、结肠组织病理学、血清炎性因子水平及肠道黏膜屏障相关蛋白表达,综合评价二者药效。 结果 化学成分分析显示,FG和SD在正、负离子模式下的色谱峰数量、保留时间基本吻合,仅部分色谱峰的响应强度存在差异,共鉴定出39个主要成分;FG与SD指纹图谱共有峰种类与数目一致,相似度>0.99;FG共有峰总面积显著提高的相对比值分别为1.24、1.34、1.20,显著高于SD(P<0.05);FG的出膏率均值(18.09%)显著高于SD(13.71%);FG中白头翁皂苷B5、药根碱的含量显著高于SD(P<0.05),而黄柏内酯含量显著低于SD(P<0.05),其余10个指标成分二者无明显差异。药效学结果显示,FG与SD均能显著改善DSS诱导UC小鼠的宏观体征,修复结肠组织结构,提高抗炎因子水平,同时显著降低促炎因子水平以及提高黏膜屏障蛋白的表达,且两者药效差异无统计学意义。 结论 白头翁汤标准汤剂与配方颗粒在化学成分组成上基本一致,仅存在个别化学成分含量差异,且二者在改善DSS诱导的溃疡性结肠炎小鼠症状中表现出生物等效性。

关键词: 白头翁汤, 配方颗粒, 标准汤剂, 化学成分, 生物等效性

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