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目的建立安敏胶囊的HPLC指纹图谱,为有效控制药物质量提供依据。方法采用HPLC法建立安敏胶囊指纹图谱,SPSS 16.0软件对不同批次的样品进行主成分分析和聚类分析。色谱条件:Diamonsil(钻石)C_(18)色谱柱(250mm×4.6mm,5μm);流动相:甲醇-水(0.4%磷酸),梯度洗脱;流速:1.0 ml·min~(-1);柱温:30℃;检测波长:210nm。结果 10批安敏胶囊指纹图谱具有22个主要共有特征峰,10批安敏胶囊相似度结果为0.983~0.994,与对照指纹图谱的相似度结果均在0.983以上,聚类分析均在距离标尺为5时将样品分为3类,主成分分析确认了3个主成分为安敏胶囊的主要质量评价指标。结论所建立的HPLC指纹图谱测定安敏胶囊的方法简单易行、快速准确,且重复性好,结合化学模式识别研究,可为安敏胶囊的质量评价和临床安全用药提供参考和依据。
Objective To establish HPLC fingerprints of Amin capsules to provide evidence for effective control of drug quality. Methods The fingerprint of Anmin capsule was established by HPLC. The principal components analysis and cluster analysis were performed on different batches of samples by SPSS 16.0 software. Chromatographic conditions: Diamonsil (diamond) C_ (18) column (250 mm × 4.6 mm, 5 μm); mobile phase: methanol- water with 0.4% phosphoric acid; gradient elution; flow rate: 1.0 ml · min -1; Column temperature: 30 ℃; detection wavelength: 210nm. Results Ten batches of Amin capsule fingerprint had 22 major characteristic peaks. The similarity of ten batches of Amin Capsules was 0.983-0.994, and the similarity with the control fingerprints was above 0.983. The clustering analysis showed that when the distance scale was 5 The samples were divided into three categories, principal component analysis confirmed that the three main components of the main quality evaluation of Anmin capsule. Conclusion The established HPLC fingerprinting method for determination of Amin capsules is simple, rapid and accurate, and has good repeatability. Combined with the study of chemical pattern recognition, it can provide a reference and basis for the quality evaluation and clinical safety of Amin capsules.