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目的:建立心可舒系列制剂的UPLC特征图谱,为全面评价其内在质量提供参考。方法:采用Thermo Syncronis C_(18)(2.1mm×150 mm,5μm)色谱柱;以乙腈-0.1%甲酸溶液为流动相,梯度洗脱,流量为0.3 m L·min~(-1);柱温30℃;检测波长287nm。结果:心可舒系列制剂特征图谱共有12个特征峰,采用对照品及质谱信息推断,指认了10个特征峰;采用《中药色谱指纹图谱相似度评价系统(2012版本)》对特征图谱进行相似度分析,以特征峰峰面积为变量,采用SIMCA-P软件进行主成分分析,很好地区分了各剂型与各企业产品。结论:建立的特征图谱专属性强,重现性好,可用于心可舒系列制剂的质量评价。
OBJECTIVE: To establish the UPLC characteristic map of XKK series preparations and to provide a reference for the comprehensive evaluation of its intrinsic quality. Methods: A column with a Thermo Syncronis C18 (2.1 mm × 150 mm, 5 μm) column was used. The mobile phase consisted of acetonitrile and 0.1% formic acid with gradient elution at a flow rate of 0.3 mL · min -1. Temperature 30 ℃; detection wavelength 287nm. Results: There were 12 characteristic peaks in the XKK profiles, and 10 peaks were identified by reference and mass spectrometry information. The similarity of the chromatograms was similar to that of the traditional Chinese medicine chromatographic fingerprint similarity evaluation system (2012 version) Degree analysis, the characteristic peak area as a variable, the use of SIMCA-P software for principal component analysis, a good distinction between the various dosage forms and various enterprise products. Conclusion: The established characteristic map is strong in specificity and reproducibility, and can be used for the quality evaluation of XKH preparations.