A model consisting of quantitative fingerprinting integrated with fundamental statistical analysis was established to carry out quality control analysis of Shuang-huang-lian (SHL) oral liquid. The quantitative fingerprinting approach was developed by systematic investigation of the chromatographic condition and optimization of a gradient using a complex sample analysis software system (CSASS). Five pivotal components from three traditional Chinese medicines of SHL oral liquid were determined at dual wavelengths, including phillyrin, baicalin, chlorogenic acid, neochlorogenic acid and cryptochlorogenic acid. Among them, neochlorogenic acid and cryptochlorogenic acid were quantified by quantitative analysis of multi-components with a single marker (QAMS) method. Further, the developed quantitative fingerprinting approach was validated. Good linearity with correlation coefficients (R²) higher than 0.9999 were achieved for phillyrin, baicalin and chlorogenic acid. Recoveries of the three analytes were between 96% and 108%. Relative standard deviation (RSD) values were below 3% regarding the stability and intra-day and inter-day precision. Besides, the feasibility of the QAMS method was verified by an external standard method (ESM) using 18 batches of SHL oral liquid. Fifty-nine batches of SHL oral liquid from nine manufacturers were then analyzed. Effective distinction was realized based on a linear principal component analysis (linear-PCA) model by the combination of the quantitative data and chromatographic fingerprinting. The linear-PCA model based on quantitative chromatographic fingerprinting exhibited great advantage over conventional similarity analysis to distinguish between different samples. The strategy provided a particularly simple and effective approach for quality evaluation of SHL oral liquid from various manufacturers.

建立了定量指纹图谱与基本统计分析相结合的模型，对双黄连口服液进行了质量控制分析。定量指纹图谱方法是通过使用复杂的样品分析软件系统（CSASS）对色谱条件进行系统研究和优化梯度来开发的。在两个波长下测定了三种SHL口服液中药的5个关键成分，分别是phillyrin，黄ical苷，绿原酸，新绿原酸和隐绿原酸。其中，新绿原酸和隐绿原酸通过单标记法（QAMS）对多组分进行定量分析来定量。此外，开发的定量指纹图谱方法得到了验证。R ²phillyrin，黄ical苷和绿原酸均高于0.9999。三种分析物的回收率在96％至108％之间。关于稳定性以及日内和日间精度，相对标准偏差（RSD）值低于3％。此外，采用18批次SHL口服液，通过外标法（ESM）验证了QAMS方法的可行性。然后分析了来自9家制造商的59批SHL口服液。通过将定量数据和色谱指纹图谱相结合，基于线性主成分分析（linear-PCA）模型实现了有效的区分。与传统的相似度分析相比，基于定量色谱指纹图谱的线性PCA模型具有很大的优势，可以区分不同的样品。