三波长融合指纹图谱结合6组分定量和主成分分析评价银翘解毒片的质量

Quality evaluation of Yinqiaojiedu tablets by three wavelength fusion fingerprint combined with six components quantitative determination and principal component analysis

建立了三波长融合高效液相色谱指纹图谱,并结合6组分定量和主成分分析(PCA)评价25批银翘解毒片的质量一致性。采用反相高效液相色谱法(RP-HPLC)分别于230、279、327 nm下检测。运用多波长融合指纹图谱技术建立银翘解毒片三波长融合指纹图谱,采用系统指纹定量法对其进行定性和整体定量评价。结果鉴别出25批银翘解毒片样品完全合格且区分良好。同时测定6组分含量,与指纹图谱结合,从整体和局部角度评价银翘解毒片质量。此外,运用PCA法对融合指纹图谱进行分析,通过主成分得分图可以明显区分来自两个厂家的25批银翘解毒片样品。方法综合性较强且有效,为科学评价与有效控制银翘解毒片的质量提供了可靠的参考。

The fusion high performance liquid chromatographic fingerprint combined with quan-tification and principal component analysis （PCA） was successfully developed,which was applied to assess the quality consistency of 25 Yinqiaojiedu tablets （YQJDTs）. The resolution index I was employed as an objective function to evaluate chromatographic conditions. The chromatographic fingerprints were established by reversed-phase high performance liquid chro-matography. The wavelengths were set at 230,279 and 327 nm,separately. Then,the three wavelength fusion fingerprint was developed by the technique of multi-wavelength fusion fingerprint. The linearity, precision, repeatability, stability and accuracy of the method were proved to meet the fingerprint analysis criteria. Subsequently, the systematic quantified fingerprint method was applied for integrative quality discrimination of YQJDTs from both qualitative and quantitative perspectives. The results showed that the quality of 25 YQJDTs from the two manu-facturers were completely qualified and well differentiated. The contents of six components were determined simultaneously and combined with fingerprint analysis. It was used to evaluate the quality of YQJDT from the overall and partial points of view. In addition,the PCA of the fusion fingerprint data was applied to get the score plot. It can be clearly distinguished the 25 YQJDT samples from the two manufacturers. The method proposed in this study was compre-hensive and reliable, which could be used for a valuable reference to scientifically evaluate and effectively control the quality of YQJDT.