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三波长融合指纹图谱结合六种成分定量测定及主成分分析对银翘解毒片的质量评价

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

作者信息

Ma Didi, Gong Dandan, Sun Guoxiang, Yang Fangliang

机构信息

School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, China.

出版信息

Se Pu. 2017 Jul 8;35(7):741-747. doi: 10.3724/SP.J.1123.2017.01015.

Abstract

The fusion high performance liquid chromatographic fingerprint combined with quantification 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 chromatography. 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 manufacturers 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 comprehensive and reliable, which could be used for a valuable reference to scientifically evaluate and effectively control the quality of YQJDT.

摘要

成功开发了融合高效液相色谱指纹图谱结合定量分析和主成分分析(PCA)的方法,并将其应用于评估25批银翘解毒片(YQJDTs)的质量一致性。采用分离度指标I作为评价色谱条件的目标函数。通过反相高效液相色谱法建立色谱指纹图谱。波长分别设置为230、279和327nm。然后,采用多波长融合指纹图谱技术建立了三波长融合指纹图谱。该方法的线性、精密度、重复性、稳定性和准确性均符合指纹图谱分析标准。随后,应用系统定量指纹图谱方法从定性和定量两个角度对YQJDTs进行综合质量判别。结果表明,两个厂家的25批YQJDTs质量均完全合格且有明显差异。同时测定了六种成分的含量并结合指纹图谱分析。从整体和局部两个角度对YQJDT的质量进行评价。此外,对融合指纹图谱数据进行PCA得到得分图。可以清晰地区分两个厂家的25批YQJDT样品。本研究提出的方法全面可靠,可为科学评价和有效控制YQJDT的质量提供有价值的参考。

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