消炎片的指纹图谱分析及多指标成分含量测定

    Fingerprint and Multi-Component Quantification Analysis of Xiaoyan Tablets by HPLC

    • 摘要: 目的 采用HPLC建立消炎片的指纹图谱分析方法,并测定秦皮乙素、黄芩苷、蒙花苷、黄芩素、汉黄芩素的含量,为其质量控制提供依据。方法 采用ACE C18色谱柱(4.6 mm×250 mm,5 μm),以乙腈-0.1%甲酸溶液为流动相,梯度洗脱,检测波长为321 nm。运用“中药色谱指纹图谱相似度评价软件”(2004 A版)对11批消炎片进行相似度评价。结果 11批消炎片相似度均>0.90,确定25个共有峰,指定秦皮乙素、黄芩苷、蒙花苷、黄芩素、汉黄芩素为特征峰并测定其含量。结论 该方法建立的消炎片HPLC指纹图谱特征性强、多指标成分含量测定方法重复性好、方法简便、准确,可为产品综合评价和质量控制提供依据。

       

      Abstract: OBJECTIVE To establish HPLC fingerprint of Xiaoyan tablets and simultaneously determine 5 chemical compositions (aesculetin, baicalin, linarin, baicalein, wogonin), provide evidence for quality control.METHODS The analytical column was ACE C18(4.6 mm×250 mm, 5 μmm). The mobile phase was acetonitrile-water(containing 0.1% formic acid) with gradient elution, and the detection wavelength was set at 321 nm. "Chromatographic fingerprint similarity evaluation software" (version 2004 A) was used to evaluate similarity for the 11 batches Xiaoyan tablets.RESULTS The similarity among the 11 batches was all >0.90, and 25 common peaks were defined in the HPLC fingerprint, and 5 characteristic peaks were earmarked 5 characteristic peaks (aesculetin, baicalin, linarin, baicalein, wogonin) were earmarked and determined.CONCLUSION The HPLC fingerprint method is high characteristics, and the determination of multi-index components is repeatability, accurate and simple, which can be used efficiently in the quality control composite evaluation of Xiaoyan tablets.

       

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