Abstract Process monitoring is essential for the pharmaceutical industry to control the quality uniformity of final products. In this study, the prompt quantitative methods of geniposide in Lanqin oral solution (LOS) during the process of extraction and concentration were developed by near-infrared spectroscopy (NIRs). Simultaneously, the feasibility of the method for universally monitoring the two processes was investigated. Methods including interval partial least square (iPLS), synergy interval partial least square (siPLS) and competitive adaptive reweighted sampling (CARS) were performed for characteristic variables selection. The single-process models of extraction, concentration and the multi-process model based on the combination of the two processes were constructed and discussed. Results showed that the performance of siPLS models were superior to others. For the extraction, concentration and the combination of these two processes, the Rc values were 0.9486, 0.9746 and 0.9980; while the RSEP values were 10.42 %, 5.41 % and 6.17 %, respectively. Compared with the specific models, the strong accuracy and stability of the multi-process model were also demonstrated. In addition, Pearson correlation analysis and paired t-test were also applied to verify the predictive performance of models. The overall results indicate that NIRs combined with siPLS algorithm is a robust method for predicting the geniposide in the extraction and concentration of LOS. Furthermore, the multi-process model of combination is feasible for the universal supervision of geniposide, which is convenient for industrial production applications.

中文翻译：

---

近红外光谱结合化学计量算法快速测定兰沁口服液提取浓缩过程中栀子苷的含量

摘要 过程监控对于制药行业控制最终产品的质量一致性至关重要。本研究利用近红外光谱 (NIR) 建立了蓝沁口服液 (LOS) 中栀子苷在提取和浓缩过程中的快速定量方法。同时，考察了该方法对两个过程进行普遍监测的可行性。采用区间偏最小二乘法（iPLS）、协同区间偏最小二乘法（siPLS）和竞争性自适应重加权抽样（CARS）等方法进行特征变量选择。构建并讨论了提取、浓缩的单过程模型和基于两个过程组合的多过程模型。结果表明，siPLS 模型的性能优于其他模型。对于提取、浓缩和这两个过程的组合，Rc 值分别为0.9486、0.9746 和0.9980；而 RSEP 值分别为 10.42%、5.41% 和 6.17%。与具体模型相比，也证明了多进程模型具有很强的准确性和稳定性。此外，还应用了 Pearson 相关分析和配对 t 检验来验证模型的预测性能。总体结果表明，NIR 结合 siPLS 算法是预测 LOS 提取和浓缩中栀子苷的稳健方法。此外，多工艺组合模型对于栀子苷的通用监管是可行的，便于工业化生产应用。