高效液相色谱多成分定量联合化学计量学和熵权优劣解距离法评价舒美宁胶囊质量

Quality evaluation of Shumeining Capsules by high performance liquid chromatography multicomponent quantitative combined with chemometrics and entropy weight solution distance method

建立高效液相色谱法测定舒美宁胶囊中的4种大豆异黄酮成分,并综合评价不同厂家、不同批号舒美宁胶囊的质量。舒美宁胶囊样品经ThermoHypersil-KeystoneC18色谱柱分离,以乙腈-水溶液为流动相梯度洗脱,柱温为40℃,检测波长为254nm。通过化学计量学、熵权优劣解距离法对其大豆异黄酮成分差异性进行研究。大豆苷、染料木苷、大豆苷元、染料木素的质量浓度分别在各自的线性范围内与色谱峰面积线性关系良好,相关系数均大于0.9995。样品平均回收率为97.57%~98.15%,测定结果的相对标准偏差为0.88%~1.47%(n=6)。化学计量学研究表明15批舒美宁胶囊聚类为3类,大豆苷、染料木苷是影响舒美宁胶囊质量的特征性成分。该方法可用于舒美宁胶囊的质量评价,并为其内在质量的有效控制提供了参考依据。

A high performance liquid chromatography method was established for the determination of four soybean isoflavones in Shumeining Capsules,and the quality of Shumeining Capsules from different manufacturers and different batches was comprehensively evaluated.The samples of Shumeining capsules were separated by Thermo Hypersil-Keystone C18 chromatographic column with acetonitrile-water solution as mobile phase for gradient elution.The column temperature was 40°C and the detection wavelength was 254 nm.The differences of soybean isoflavone components were studied by chemometrics and entropy weight solution distance method.The mass concentrations of daidzin,genistin,daidzein and genistein had a good linear relationship with the chromatographic peak area in their respective linear ranges,and the correlation coefficients were all greater than 0.9995.The average recovery of the samples was 97.57%-98.15%,and the relative standard deviation of the determination results was 0.88%-1.47%(n=6).Chemometric studies showed that 15 batches of Shumeining capsules were clustered into 3 categories,and daidzin and genistin were the characteristic components affecting the quality of Shumeining capsules.This method can be used for the quality evaluation of Shumeining Capsules and provides a reference for the effective control of its intrinsic quality.