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

• Published in: Chinese journal of chemical engineering Vol. 29; no. 1; pp. 77 - 84
• Main Authors: Gong, Xingchu, Guo, Junlin, Pan, Jingjing, Wu, Zhenfeng
• Format: Journal Article
• Language: English
• Published: Elsevier B.V 01-01-2021; Key Laboratory of Modern Preparation of TCM, Ministry of Education, Jiangxi University of Traditional Chinese Medicine, Nanchang 330004, China; Tianjin University of Traditional Chinese Medicine, Graduate College, Tianjin 300193, China; Pharmaceutical Informatics Institute, College of Pharmaceutical Science, Zhejiang University, Hangzhou 310058, China%Tianjin University of Traditional Chinese Medicine, Graduate College, Tianjin 300193, China%Pharmaceutical Informatics Institute, College of Pharmaceutical Science, Zhejiang University, Hangzhou 310058, China%Key Laboratory of Modern Preparation of TCM, Ministry of Education, Jiangxi University of Traditional Chinese Medicine, Nanchang 330004, China
• Subjects: Control strategy; Critical process parameters; Formulated granules; Loganin; Material quality standard; Formulated granules; Loganin; Control strategy; Critical process parameters; Material quality standard
• ISSN: 1004-9541; 2210-321X
• DOI: 10.1016/j.cjche.2020.04.006

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.
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•A method to identify critical material attributes of herbal materials was presented.•A method to set herbal material quality standards was presented.•Process parameters were optimized with a design space approach.