安敏胶囊的HPLC指纹图谱研究

Fingerprints of Anmin Capsules by HPLC

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 an HPLC fingerprint forAnmin capsules in order to provide refer- ence for quality control of Anmin capsules.Methods HPLC was used to establish the standard fingerprint of An rnin capsules.Principal component analysis and cluster analysis of different batches of samples were car- ried out with SPSS 16 software.C18 column （250 min×4.6 mm,5 μm） was used at 30 ℃ with acetonitrile and water （ 0.4% TFA） as the mobile phase in a grading mode.the flow rate was 1.0 ml ·min^-1 ,and the detection wavelength was 210 nm.Results There were 22 characteristic peaks in HPLC spectra of Anrnin capsules.The similarity of the ten batches of An rain capsules determined was 0.983--0.994.Compared with the standard fingerprint,the similarity of the ten batches of samples was above 0.983.When the distance scale of cluster analysis was 5, the samples fell into three categories. Principal component analysis con- firmed the main quality evaluation indexes of the three principal components of the capsule.Conclusion This fingerprint method is simple, fast and accurate, which shows good reproducibility.Combined with chemical pattern recognization it may provide reference for quality evaluation and clinical safety of An min capsules.