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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references
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