Study on the application of model transfer technology in the extraction process of Xiao'er Xiaoji Zhike oral liquid
10.16438/j.0513-4870.2023-0239
- VernacularTitle: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
- Author:
Xiu-hua XU
1
;
Lei NIE
1
;
Xiao-bo MA
1
;
Xiao-qi ZHUANG
1
;
Jin ZHANG
1
;
Hai-ling DONG
1
;
Wen-yan LIANG
1
;
Hao-chen DU
2
;
Xiao-mei YUAN
2
;
Yong-xia GUAN
2
;
Lian LI
1
;
Hui ZHANG
1
;
Xue-ping GUO
1
,
3
;
Heng-chang ZANG
1
Author Information
1. NMPA Key Laboratory for Technology Research and Evaluation of Drug Products, School of Pharmaceutical Sciences, Shandong University, Ji'nan 250012, China
2. State Key Laboratory of Generic Manufacture Technology of Chinese Traditional Medicine, Lunan Pharmaceutical Group Co. Ltd., Linyi 276006, China
3. Bloomage Biotechnology Co. Ltd., Ji'nan 250012, China
- Publication Type:Research Article
- Keywords:
near-infrared spectroscopy;
model transfer technique;
Xiao'er Xiaoji Zhike oral liquid;
extraction process;
synephrine
- From:
Acta Pharmaceutica Sinica
2023;57(10):2900-2908
- CountryChina
- Language:Chinese
-
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.
