九味羌活丸HPLC指纹图谱建立及质量评价

doi:10.19803/j.1672-8629.20260240

摘要/Abstract

摘要： 目的分析九味羌活丸的潜在指标性成分,研究不同厂家九味羌活丸的差异性,为其质量评价提供参考。方法建立九味羌活丸高效液相色谱（HPLC）指纹图谱,使用中药色谱指纹图谱相似度评价系统计算相似度;采用高效液相色谱-质谱联用（HPLC-MS）法,通过对照品比对及文献检索,指认共有峰,通过比较单味药材和全方制剂,对共有峰进行归属确定其来源。采用网络药理学构建“成分-靶点”网络并富集相关通路,分析关键活性成分。结果指认出指纹图谱中18个共有峰;1、17、18号色谱峰归属于苍术,2、5、7号色谱峰归属于防风,3、8、14号色谱峰归属于羌活,6、9、10、11号色谱峰归属于黄芩,13、16号色谱峰归属于白芷,4号色谱峰归属于地黄,12号色谱峰归属于甘草,15号色谱峰归属于川芎。8批样品的指纹图谱相似度评价结果在0.883~0.971,表明不同样品的质量差异明显。成分与疾病交集靶点有632个,主要通过PI3K-Akt信号通路、MAPK信号通路等治疗风寒感冒;共有5个关键靶点和7种关键活性成分,揭示其可能通过多成分、多靶点、多途径来发挥作用。结论建立的 HPLC 指纹图谱稳定可靠,结合网络药理学预测其发挥药效的潜在活性成分、靶点和通路,为阐明九味羌活丸的药效物质基础和质量控制提供参考。

关键词: 九味羌活丸, 高效液相色谱指纹图谱, 高效液相色谱-质谱联用, 相似度分析, 质量评价, 网络药理学

Abstract: Objective To analyze the potential index components of Jiuwei Qianghuo pills and investigate inter-manufacturer quality differences in order to provide a reference for quality evaluation. Methods The HPLC fingerprint of Jiuwei Qianghuo pills was established, and similarity was calculated using the similarity evaluation system for chromatographic fingerprints of traditional Chinese medicine. Common peaks were identified by HPLC-MS via comparisons with reference substances and literature retrieval while their botanical origins were traced by comparing single medicinal materials with the whole formulation. Network pharmacology was employed to construct a component-target network and perform pathway enrichment analysis to identify key components. Results A total of 18 common peaks were identified in the fingerprint and attributed to their respective medicinal sources: peaks 1, 17, and 18 to Atractylodis Rhizoma, peaks 2, 5, and 7 to Saposhnikoviae Radix, peaks 3, 8, and 14 to Notopterygii Rhizoma et Radix, peaks 6, 9, 10, and 11 to Scutellariae Radix, peaks 13 and 16 to Angelicae Dahuricae Radix, peak 4 to Rehmanniae Radix, peak 12 to Glycyrrhizae Radix et Rhizoma, and peak 15 to Chuanxiong Rhizoma. The similarity of fingerprints for 8 batches of samples ranged from 0.883 to 0.971, indicating considerable quality variations between manufacturers. A total of 632 intersection targets were obtained between components and diseases, with the pills primarily acting against wind chill or common colds through the PI3K-Akt signaling pathway, the MAPK signaling pathway, among others. Five key targets and seven key active components were identified, suggesting that the therapeutic effects of Jiuwei Qianghuo pills were mediated through multiple components, targets, and pathways. Conclusion The established HPLC fingerprint is stable and reliable. Combined with network pharmacology to predict potential active ingredients, targets, and pathways, this study provides a reference for elucidating the pharmacodynamic material basis and quality control of Jiuwei Qianghuo pills.

Key words: Jiuwei Qianghuo Pills, HPLC Fingerprint Spectrum, HPLC-MS, Similarity Analysis, Quality Evaluation, Network Pharmacology

中图分类号:

刘晶晶, 刘树森, 李思琪, 徐蓓蕾, 刘静. 九味羌活丸HPLC指纹图谱建立及质量评价[J]. 中国药物警戒, 2026, 23(8): 867-874.

Liu Jingjing, Liu Shusen, Li Siqi, Xu Beilei, Liu Jing. HPLC fingerprint for Jiuwei Qianghuo pills and quality evaluation[J]. Chinese Journal of Pharmacovigilance, 2026, 23(8): 867-874.

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https://zgywjj.magtechjournal.com/CN/Y2026/V23/I8/867

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