| 胡维稳,杨玲欢,字桂成,等.高效液相色谱法同时测定三十九味骨愈贴中 4种成分的含量及其指纹图谱研究[J].安徽医药,2026,30(2):276-282. |
| 高效液相色谱法同时测定三十九味骨愈贴中 4种成分的含量及其指纹图谱研究 |
| Simultaneous determination of four components and fingerprint analysis of sanjiu bone healing plaster by HPLC |
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| DOI：10.3969/j.issn.1009-6469.2026.02.012 |
| 中文关键词: 主成分分析 三十九味骨愈贴 凝胶贴膏 高效液相色谱指纹图谱 聚类分析 多指标成分含量测定 |
| 英文关键词: Principal component analysis Sanjiu bone healing plaster Gel plaster Fingerprint analysis Cluster analysis Quantification of multiple components |
| 基金项目:云南中医药大学校院联合基金( YXLH202101) |
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| 中文摘要: |
| 目的建立三十九味骨愈贴的 HPLC指纹图谱，测定蛇床子素、异欧前胡素、二氢欧山芹醇当归酸酯和大黄酚这 4种成分的含量。方法 2023年 8―12月采用 Agilent ZORBAX Extend-C18色谱柱(250 mm×4.6 mm，5 μm)和 Agilent Extend-C18保护柱(12.5 mm×4.6 mm，5 μm)，流动相为乙腈 -水溶液，梯度洗脱，流速为 1.0 mL/min，柱温为 25 ℃，检测波长为 250 nm与 330 nm，样量为 15 μL。运用《中药色谱指纹图谱相似度评价软件系统》进行相似度评价和 OriginPro软件对共有峰校正峰面积进行层进次聚类分析( HCA)和主成分分析( PCA)并对指认的 4种成分进行定量测定。结果在建立的 HPLC指纹图谱中共标定 16个共有峰，与对照品比对出 4个成分，各批次样，品的相似度均大于 0.90，HCA结果将样品分为了 2个主群组， PCA结果显示前 2个主成分共解释了 93.7%的总方差。定量分析的 4种成分在各自浓度范围内线性关系良好，其决定系数( R2)均大于 0.999 9，平均加样回收率为 89.46%～100.79%。10批样品中 4种成分的含量基本一致。结论该研究建立的 HPLC指纹图谱及含量测定方法准确度高、重复性好，适用于该制剂的质量评价与控制； HCA与 PCA结果揭示了批次间的质量差异，为质量控制与批间一致性评估提供了重要依据。 |
| 英文摘要: |
| Objective To establish an HPLC fingerprint for Sanjiu Bone Healing Plaster and quantify four components: osthole, im-peratorin, columbianadin, and chrysophanol. Methods From August to December 2023, Agilent ZORBAX Extend-C18 column and guard column were used, with acetonitrile-water as the mobile phase in a gradient elution, a flow rate of 1.0 mL/min, and a column tem-perature of 25 ℃. UV detection was at 250 nm and 330 nm with an injection volume of 15 μL. The HPLC fingerprint was establishedusing the Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine. Hierarchical cluster analysis(HCA) and principal component analysis (PCA) were performed on the common peak areas using OriginPro software, and the four com-ponents were quantified using an external standard method.Results The HPLC fingerprint identified 16 common peaks, with a simi-larity index over 0.90 across all batches. HCA segregated the samples into two main clusters, while PCA showed that the first two prin-cipal components accounted for 93.7% of the total variance. The four components exhibited excellent linearity (R2>0.999 9) with recov-ery rates of 89.46%-100.79%. The content of the four components was consistent across all batches.Conclusions The HPLC finger-printing and quantitative analysis methods developed in this study are accurate and reliable, suitable for the quality assessment andcontrol of Sanjiu Bone Healing Plaster. HCA and PCA provided essential insights into batch-to-batch quality variations, supporting quality control and consistency evaluation. |
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