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

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