基于液相指纹图谱结合多成分含量测定的小儿肺热咳喘颗粒质量评价

Quality evaluation of Xiaoer Feire Kechuan granules based on liquid fingerprint combined with multi-component content determination

目的采用指纹图谱结合多组分含量测定方法对市售小儿肺热咳喘颗粒进行质量评价。方法采用Waters Sunfire C18色谱柱(4.6 mm×250 mm,5μm)以乙腈-0.1%磷酸水溶液梯度洗脱,流速1.0 mL·min^(-1);柱温55℃;检测波长254 nm。采用《中药色谱指纹图谱相似度评价系统(2012版)》对24批小儿肺热咳喘颗粒样品进行相似度评价,确定共有峰,使用SIMCA-P(V 14.1)软件对24批样品数据进行偏最小二乘判别分析(PLS-DA)和正交偏最小二乘判别分析(OPLS-DA)。结果不同厂家小儿肺热咳喘颗粒指纹图谱上存在差异,总体相似度0.889~0.985。采用PLS-DA、OPLS-DA可明显区分,8种组分平均加样回收率在95.57%~103.97%,RSD在1.0%~2.7%。结论指纹图谱结合多组分含量测定可用来评价不同来源小儿肺热咳喘颗粒质量,方法准确可靠,重现性良好,可为一致性评价与生产工艺均一性研究提供理论依据。

Objective To evaluate the quality of Xiaoer Feire Kechuan granules by fingerprint and multicomponent content determination.Methods Waters Sunfire C18 column(4.6 mm×250 mm,5μm)was used.Gradient elution was performed with acetonitrile-0.1%phosphoric acid aqueous solution at the flow rate of 1.0 mL·min^(-1).The column temperature was 55℃;and the detection wavelength was 254 nm.The similarity evaluation system of TCM Chromatographic Fingerprint(2012 edition)was used to evaluate the similarity of 24 batches of test granules to determine the common peaks.Partial least squares discriminant analysis(PLS-DA)and orthogonal partial least squares discriminant analysis(OPLS-DA)were performed on 24 batches of sample data with SIMCA-P(V 14.1)software.Results There were differences in the fingerprints of granules from different manufacturers,and the overall similarity was 0.889~0.985.PLS-DA and OPLS-DA clearly distinguished the difference,and the average recoveries were 95.57%~103.97%,with RSD of 1.0%~2.7%.Conclusion Fingerprint combined with multi-component content determination can be used to evaluate the quality of Xiaoer Feire Kechuan granules from different sources.The method is accurate,reliable and reproducible,which provides theoretical basis for the consistency evaluation and uniformity of production.