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Study on the application of model transfer technology in the extraction process of Xiao'er Xiaoji Zhike oral liquid
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Xiu-hua XU1, Lei NIE1, Xiao-bo MA1, Xiao-qi ZHUANG1, Jin ZHANG1, Hai-ling DONG1, Wen-yan LIANG1, Hao-chen DU2, Xiao-mei YUAN2, Yong-xia GUAN2, Lian LI1, Hui ZHANG1, Xue-ping GUO1, 3, *, Heng-chang ZANG1, *
Acta Pharmaceutica Sinica | 2023, 58(10) : 2900 - 2908
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Acta Pharmaceutica Sinica | 2023, 58(10): 2900-2908
Study on the application of model transfer technology in the extraction process of Xiao'er Xiaoji Zhike oral liquid
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Xiu-hua XU1, Lei NIE1, Xiao-bo MA1, Xiao-qi ZHUANG1, Jin ZHANG1, Hai-ling DONG1, Wen-yan LIANG1, Hao-chen DU2, Xiao-mei YUAN2, Yong-xia GUAN2, Lian LI1, Hui ZHANG1, Xue-ping GUO1, 3, *, Heng-chang ZANG1, *
Affiliations
  • 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
Published: 2023-10-12 doi: 10.16438/j.0513-4870.2023-0239
Outline
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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.

near-infrared spectroscopy  /  model transfer technique  /  Xiao'er Xiaoji Zhike oral liquid  /  extraction process  /  synephrine
Xiu-hua XU, Lei NIE, Xiao-bo MA, Xiao-qi ZHUANG, Jin ZHANG, Hai-ling DONG, Wen-yan LIANG, Hao-chen DU, Xiao-mei YUAN, Yong-xia GUAN, Lian LI, Hui ZHANG, Xue-ping GUO, Heng-chang ZANG. Study on the application of model transfer technology in the extraction process of Xiao'er Xiaoji Zhike oral liquid[J]. Acta Pharmaceutica Sinica, 2023 , 58 (10) : 2900 -2908 . DOI: 10.16438/j.0513-4870.2023-0239
Year 2023 volume 58 Issue 10
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Article Info
doi: 10.16438/j.0513-4870.2023-0239
  • Receive Date:2023-03-01
  • Online Date:2025-11-21
  • Published:2023-10-12
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History
  • Received:2023-03-01
  • Revised:2023-04-26
Funding
Affiliations
    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
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表12种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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