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目的建立枣仁安神胶囊HPLC指纹图谱,通过化学模式识别的方法全面评价其内在质量。方法采用高效液相色谱法(HPLC),确定12批次安神胶囊指纹图谱的15个共有峰,鉴定其中3个共有峰的化学成分。采用指纹图谱相似度评价,结合主成分分析和聚类分析对不同生产厂家12批枣仁安神胶囊的质量进行评价。结果 12批枣仁安神胶囊样品图谱与对照图谱比较,不同厂家相似度差距较大,质量不稳定。主成分分析与聚类分析均可将不同生产厂家的枣仁安神胶囊分为3类,且分类结果基本一致。结论所建立的HPLC指纹图谱分析方法高效、稳定,结合化学模式识别研究可有助于枣仁安神胶囊的整体质量控制及质量评价。
Objective To establish HPLC fingerprinting of Zaoren Anshen Capsule, to evaluate its intrinsic quality through chemical pattern recognition. Methods High-performance liquid chromatography (HPLC) was used to determine 15 common peaks of fingerprints of 12 batches of Anshen Capsules. The chemical constituents of 3 common peaks were identified. The similarity of fingerprints was evaluated, and the quality of 12 batches of Zaoren Anshen capsules from different manufacturers was evaluated by principal component analysis and cluster analysis. Results 12 batches of Zaoren Anshen capsule map compared with the control pattern, the similarity between different manufacturers a large gap, the quality is unstable. The principal component analysis and cluster analysis can be divided into three categories Zaoren Anshen capsules from different manufacturers, and the classification results are basically the same. Conclusion The established method of HPLC fingerprint analysis with high efficiency, stability and combined with chemical pattern recognition can contribute to the overall quality control and quality evaluation of Zaoren Anshen capsule.