The development of Fructus corni quality standard considering the effects of processing

doi:10.1016/j.cjche.2020.04.006

中国化学工程学报 ›› 2021, Vol. 29 ›› Issue (1): 77-84.DOI: 10.1016/j.cjche.2020.04.006

• Separation Science and Engineering • 上一篇下一篇

The development of Fructus corni quality standard considering the effects of processing

Xingchu Gong^1,2,3, Junlin Guo², Jingjing Pan³, Zhenfeng Wu¹

1 Key Laboratory of Modern Preparation of TCM, Ministry of Education, Jiangxi University of Traditional Chinese Medicine, Nanchang 330004, China;
2 Tianjin University of Traditional Chinese Medicine, Graduate College, Tianjin 300193, China;
3 Pharmaceutical Informatics Institute, College of Pharmaceutical Science, Zhejiang University, Hangzhou 310058, China

收稿日期:2020-02-18 修回日期:2020-04-05 出版日期:2021-01-28 发布日期:2021-04-02
通讯作者: Xingchu Gong, Jingjing Pan, Zhenfeng Wu
基金资助:
This Study was Supported by the Open Fund of Key Laboratory of Modern Chinese Medicine Preparations, Ministry of Education, Jiangxi University of Traditional Chinese Medicine and First-class Discipline Construction Project of Jiangxi Province (JXSYLXK-ZHYAO009, JXSYLXK-ZHYAO010).

The development of Fructus corni quality standard considering the effects of processing

Xingchu Gong^1,2,3, Junlin Guo², Jingjing Pan³, Zhenfeng Wu¹

1 Key Laboratory of Modern Preparation of TCM, Ministry of Education, Jiangxi University of Traditional Chinese Medicine, Nanchang 330004, China;
2 Tianjin University of Traditional Chinese Medicine, Graduate College, Tianjin 300193, China;
3 Pharmaceutical Informatics Institute, College of Pharmaceutical Science, Zhejiang University, Hangzhou 310058, China

Received:2020-02-18 Revised:2020-04-05 Online:2021-01-28 Published:2021-04-02
Contact: Xingchu Gong, Jingjing Pan, Zhenfeng Wu
Supported by:
This Study was Supported by the Open Fund of Key Laboratory of Modern Chinese Medicine Preparations, Ministry of Education, Jiangxi University of Traditional Chinese Medicine and First-class Discipline Construction Project of Jiangxi Province (JXSYLXK-ZHYAO009, JXSYLXK-ZHYAO010).

摘要/Abstract

摘要： The quality standards for Fructus Corni have been established based on the effects of the manufacturing processes. Three critical process parameters (CPPs) of extraction, filtration, and concentration to prepare Fructus Corni concentrate were identified by Plackett-Burman design with a single batch of Fructus Corni, which were heating medium temperature, extraction time, and water addition. Morroniside yield, loganin yield, and dry matter yield were process critical quality attributes (CQAs). CPPs arranged with a Box-Behnken design were applied to treat different batches of Fructus Corni. After constructing a model that included CPPs, material properties, and process CQAs, loganin content was found to be the critical material attribute (CMA). The design space was calculated with a probability method. According to the limits of process CQAs, the minimum content of loganin in Fructus Corni was calculated with an error propagation method, which was 6.92 mg·g^-1. When the content of loganin in Fructus Corni reaches up to 6.92 mg·g^-1, the material is considered high-quality and is most suitable for the process. High-quality material can be used for production of Fructus Corni concentrate. This method can also be used to set material quality standards for other Chinese medicines.

关键词: Material quality standard, Critical process parameters, Control strategy, Loganin, Formulated granules

Abstract: The quality standards for Fructus Corni have been established based on the effects of the manufacturing processes. Three critical process parameters (CPPs) of extraction, filtration, and concentration to prepare Fructus Corni concentrate were identified by Plackett-Burman design with a single batch of Fructus Corni, which were heating medium temperature, extraction time, and water addition. Morroniside yield, loganin yield, and dry matter yield were process critical quality attributes (CQAs). CPPs arranged with a Box-Behnken design were applied to treat different batches of Fructus Corni. After constructing a model that included CPPs, material properties, and process CQAs, loganin content was found to be the critical material attribute (CMA). The design space was calculated with a probability method. According to the limits of process CQAs, the minimum content of loganin in Fructus Corni was calculated with an error propagation method, which was 6.92 mg·g^-1. When the content of loganin in Fructus Corni reaches up to 6.92 mg·g^-1, the material is considered high-quality and is most suitable for the process. High-quality material can be used for production of Fructus Corni concentrate. This method can also be used to set material quality standards for other Chinese medicines.

Key words: Material quality standard, Critical process parameters, Control strategy, Loganin, Formulated granules

Xingchu Gong, Junlin Guo, Jingjing Pan, Zhenfeng Wu. The development of Fructus corni quality standard considering the effects of processing[J]. 中国化学工程学报, 2021, 29(1): 77-84.

Xingchu Gong, Junlin Guo, Jingjing Pan, Zhenfeng Wu. The development of Fructus corni quality standard considering the effects of processing[J]. Chinese Journal of Chemical Engineering, 2021, 29(1): 77-84.

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The development of Fructus corni quality standard considering the effects of processing

The development of Fructus corni quality standard considering the effects of processing

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