The scale-up of traditional Chinese medicine (TCM) extraction processes is a crucial step in transitioning from laboratory research to industrial production. With the rapid development of the TCM industry, the scale-up of TCM extraction processes faces numerous key challenges, such as parameter fluctuations caused by multi-factor coupling, instability in cross-scale amplification due to unclear kinetic mechanisms, and quality variations resulting from the failure of traditional scaling-up theories. In recent years, with the rapid advancement of process analytical technology (PAT), its application in the scale-up of TCM extraction processes has garnered increasing attention. PAT enhances the efficiency and stability of TCM extraction process scale-up by real-time monitoring and analyzing key parameters during the extraction process, optimizing extraction techniques, establishing precise models, and implementing dynamic regulation and feedback control. This provides robust data support for process scale-up. This review summarizes the application of PAT in extraction process scale-up, systematically elaborates on the current research status of data acquisition, process modeling, and dynamic feedback techniques, and analyzes the current problems and challenges faced by extraction process scale-up. It aims to provide insights for promoting the application of PAT in the TCM manufacturing industry, therebyfacilitating the intelligent transformation, upgrading, and high-quality development of the TCM industry.
Key words
process analytical technology
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extraction process scale-up
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intelligent regulation and control
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data acquisition
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process modeling
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dynamic feedback techniques
GUAN Yongmei, LIU Leling, YANG Ming, ZHENG Qin, WU Zhenfeng, WANG Danfeng, WU Yangming, ZHONG Guangde, ZANG Zhenzhong.
Key issues and application progress in scaling up traditional Chinese medicine extraction processes based on process analytical technology[J].
Chinese Traditional and Herbal Drugs,
2026
, 57
(2)
: 767
-777
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DOI: 10.7501/j.issn.0253-2670.2026.02.033
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