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首页> 外文期刊>Journal of Pharmaceutical and Biomedical Analysis: An International Journal on All Drug-Related Topics in Pharmaceutical, Biomedical and Clinical Analysis >Application of near infrared spectroscopy for rapid analysis of intermediates of Tanreqing injection.
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Application of near infrared spectroscopy for rapid analysis of intermediates of Tanreqing injection.

机译：近红外光谱法在痰热清注射液中间体快速分析中的应用。

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摘要

A method for rapid quantitative analysis of four kinds of Tanreqing injection intermediates was developed based on Fourier transform near infrared (FT-NIR) spectroscopy and partial least squares (PLS) algorithm. The NIR spectra of 120 samples were collected in transflective mode. The concentrations of chlorogenic acid, caffeic acid, luteoloside, baicalin, ursodesoxycholic acid (UDCA), and chenodeoxycholic acid (CDCA) were determined with the HPLC-DAD/ELSD as reference method. In the PLS calibration, the NIR spectra were pretreated with different methods and the number of PLS factors used in the model calibration was optimized by leave-one-out cross-validation. The performance of the final PLS models was evaluated according to the root mean square error of calibration (RMSEC), root mean square error of cross-validation (RMSECV), root mean square error of prediction (RMSEP), BIAS, standard error of prediction (SEP), and correlation coefficients (R). The R values in the prediction sets were all higher than 0.93, and the SEPs for the 6 compounds are 1.18, 6.02, 2.71, 155, 126, 30.0mg/l, respectively. The established models were used for the liquid preparation process analysis of Tanreqing injection in three batches, and a model updating method was proposed for the long-term usage of the established models. This work demonstrated that NIR spectroscopy is more rapid and convenient than the conventional methods to analyze the intermediates of Tanreqing injection, and the presented method is helpful to the implementation of process analytical technology (PAT) in pharmaceutical industry of Chinese Medicines Injections.
机译：基于傅立叶变换近红外光谱（FT-NIR）和偏最小二乘（PLS）算法，开发了一种快速定量分析4种谭热青注射剂中间体的方法。以透反射模式收集了120个样品的近红外光谱。以HPLC-DAD / ELSD作为参考方法测定绿原酸，咖啡酸，黄体苷，黄ical苷，熊去氧胆酸（UDCA）和鹅去氧胆酸（CDCA）的浓度。在PLS校准中，采用不同的方法对NIR光谱进行预处理，并通过留一法交叉验证对模型校准中使用的PLS因子数进行了优化。根据校准的均方根误差（RMSEC），交叉验证的均方根误差（RMSECV），预测的均方根误差（RMSEP），BIAS，预测的标准误差来评估最终PLS模型的性能（SEP）和相关系数（R）。预测集中的R值均高于0.93，这6种化合物的SEP分别为1.18、6.02、2.71、155、126、30.0mg / l。将建立的模型用于三批痰热清注射液的液体制备过程分析，并提出了模型更新方法，以长期使用。这项工作表明，近红外光谱法比常规方法更容易，更方便地分析痰热清注射液的中间体，并且该方法有助于中药注射剂行业过程分析技术的实施。

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