| 朱和平,李有伟.麻黄汤传统汤剂与配方颗粒剂化学成分一致性及差异标志物研究[J].安徽医药,待发表. |
| 麻黄汤传统汤剂与配方颗粒剂化学成分一致性及差异标志物研究 |
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| 投稿时间：2026-08-21 录用日期：2026-11-02 |
| DOI： |
| 中文关键词: 麻黄汤 传统汤剂 配方颗粒剂 高效液相色谱 化学计量学 差异标志物 |
| 英文关键词: |
| 基金项目:2023年安徽省教育厅研究项目(编号:2023AH053196) |
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| 摘要点击次数: 19 |
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| 中文摘要: |
| 目的：系统比较麻黄汤传统汤剂与配方颗粒剂的化学成分组成及整体化学轮廓差异，筛选差异标志物，为临床剂型选择提供化学层面参考，并为后续生物等效性研究奠定基础。方法：采用HPLC法测定6种指标成分（盐酸麻黄碱、盐酸伪麻黄碱、苦杏仁苷、甘草苷、桂皮醛、甘草酸铵）的含量，结合指纹图谱相似度分析；引入PCA、PLS-DA和HCA进行化学轮廓判别与差异标志物筛选。结果：传统汤剂中盐酸麻黄碱、盐酸伪麻黄碱、苦杏仁苷、甘草苷含量显著高于配方颗粒剂（P<0.01），桂皮醛与甘草酸铵无组间差异（P>0.05）。配方颗粒剂组内相似度为0.802～0.944，传统汤剂组内相似度为0.749～0.928，两组间交叉相似度为0.601～0.822。PCA提取2个主成分（累计贡献率99.62%），PLS-DA（R²Y=0.998，Q²=0.998）实现完全组间分离；筛选出VIP>1的标志物4个：甘草苷（1.196）、苦杏仁苷（1.166）、盐酸麻黄碱（1.155）、盐酸伪麻黄碱（1.011），HCA验证一致。结论：两种制剂化学成分种类基本一致，但水溶性及部分挥发性成分含量存在显著差异；化学计量学可有效揭示剂型间化学差异，筛选的标志物可为质量控制提供参考。本研究仅从化学层面进行比较，不能等同于生物等效性或临床等效性评价；后续需开展药效学与临床研究验证生物等效性。 |
| 英文摘要: |
| Objective: To systematically compare the chemical composition and overall chemical profile between Mahuang Tang traditional decoction and formula granules, and to provide evidence for clinical dosage form selection. Methods: HPLC was employed to determine the contents of six marker components (ephedrine hydrochloride, pseudoephedrine hydrochloride, amygdalin, liquiritin, cinnamaldehyde, and ammonium glycyrrhizinate), combined with fingerprint similarity analysis. Chemometric methods including PCA, PLS-DA and HCA were introduced for overall chemical profile discrimination and differential marker screening. Results: The contents of ephedrine hydrochloride, pseudoephedrine hydrochloride, amygdalin, and liquiritin in the traditional decoction were significantly higher than those in the granules (P<0.01), while no statistical differences were observed for cinnamaldehyde and ammonium glycyrrhizinate (P>0.05). Intra-group similarities ranged from 0.802 to 0.944 for formula granules and from 0.749 to 0.928 for traditional decoction, while inter-group cross-similarities ranged from 0.601 to 0.822. PCA extracted two principal components with a cumulative variance contribution of 99.62%; PLS-DA (R²Y=0.998, Q²=0.998) achieved complete inter-group separation. Four core differential markers with VIP>1 were identified: liquiritin (1.196), amygdalin (1.166), ephedrine hydrochloride (1.155), and pseudoephedrine hydrochloride (1.011), with HCA results fully consistent with PCA and PLS-DA. Conclusion: The two preparations are generally consistent in chemical composition types, but significant differences exist in certain water-soluble components. Chemometric methods can effectively reveal the chemical differences at a holistic level, and the screened markers may serve as references for quality control and process optimization. This study only provides a chemical-level comparison and cannot be regarded as a bioequivalence or clinical equivalence assessment. Further pharmacodynamic and clinical studies are warranted to verify bioequivalence. |
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