许秀华, 聂磊, 马晓博, 庄晓琪, 张晋, 董海玲, 梁文燕, 杜昊忱, 袁晓梅, 关永霞, 李连, 张惠, 郭学平, 臧恒昌. 模型转移技术在小儿消积止咳口服液提取过程中的应用研究J. 药学学报, 2023, 58(10): 2900-2908. DOI: 10.16438/j.0513-4870.2023-0239
引用本文: 许秀华, 聂磊, 马晓博, 庄晓琪, 张晋, 董海玲, 梁文燕, 杜昊忱, 袁晓梅, 关永霞, 李连, 张惠, 郭学平, 臧恒昌. 模型转移技术在小儿消积止咳口服液提取过程中的应用研究J. 药学学报, 2023, 58(10): 2900-2908. DOI: 10.16438/j.0513-4870.2023-0239
XU Xiu-hua, NIE Lei, MA Xiao-bo, ZHUANG Xiao-qi, ZHANG Jin, DONG Hai-ling, LIANG Wen-yan, DU Hao-chen, YUAN Xiao-mei, GUAN Yong-xia, LI Lian, ZHANG Hui, GUO Xue-ping, ZANG Heng-chang. Study on the application of model transfer technology in the extraction process of Xiao'er Xiaoji Zhike oral liquidJ. Acta Pharmaceutica Sinica, 2023, 58(10): 2900-2908. DOI: 10.16438/j.0513-4870.2023-0239
Citation: XU Xiu-hua, NIE Lei, MA Xiao-bo, ZHUANG Xiao-qi, ZHANG Jin, DONG Hai-ling, LIANG Wen-yan, DU Hao-chen, YUAN Xiao-mei, GUAN Yong-xia, LI Lian, ZHANG Hui, GUO Xue-ping, ZANG Heng-chang. Study on the application of model transfer technology in the extraction process of Xiao'er Xiaoji Zhike oral liquidJ. Acta Pharmaceutica Sinica, 2023, 58(10): 2900-2908. DOI: 10.16438/j.0513-4870.2023-0239

模型转移技术在小儿消积止咳口服液提取过程中的应用研究

Study on the application of model transfer technology in the extraction process of Xiao'er Xiaoji Zhike oral liquid

  • 摘要: 中药产业的现代化发展对中药产品质量提出了更高的要求, 提取过程作为中药生产的关键基础环节, 直接关系到产品的最终质量。然而, 目前提取工艺的质量保证主要依靠简单的湿化学分析, 无法达到提取过程的精准控制, 而且存在费时、耗力等诸多弊端。因此, 将近红外光谱技术应用于中药生产环节的过程监控对于中药产品质量控制具有重要意义。本研究以小儿消积止咳口服液的提取过程为研究对象, 利用傅里叶变换近红外光谱仪和便携式近红外光谱仪收集近红外光谱, 监测提取过程中药典规定的质控指标成分辛弗林的浓度变化, 实现提取过程的快速、准确检测。同时创新模型转移方法, 实现两种不同类别(分析级与便携式) 的近红外光谱仪间的模型转移, 解决了便携式仪器分辨率低、性能差、预测精度不足的问题, 以实现对小儿消积止咳口服液进行现场快速筛查和质量分析, 对中药生产过程质量监控具有指导意义。

     

    Abstract: The modernization and development of traditional Chinese medicine has led to higher standards for the quality of traditional Chinese medicine products. The extraction process is a crucial component of traditional Chinese medicine production, and it directly impacts the final quality of the product. However, the currently relied upon methods for quality assurance of the extraction process, such as simple wet chemical analysis, have several limitations, including time consumption and labor intensity, and do not offer precise control of the extraction process. As a result, there is significant value in incorporating near-infrared spectroscopy (NIRS) in the production process of traditional Chinese medicine to improve the quality control of the final products. In this study, we focused on the extraction process of Xiao'er Xiaoji Zhike oral liquid (XXZOL), using near-infrared spectra collected by both a Fourier transform near-infrared spectrometer and a portable near-infrared spectrometer. We used the concentration of synephrine, a quality control index component specified by the pharmacopoeia, to achieve rapid and accurate detection in the extraction process. Moreover, we developed a model transfer method to facilitate the transfer of models between the two types of near-infrared spectrometers (analytical grade and portable), thus resolving the low resolution, poor performance, and insufficient prediction accuracy issues of portable instruments. Our findings enable the rapid screening and quality analysis of XXZOL onsite, which is significant for quality monitoring during the traditional Chinese medicine production process.

     

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