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Background
Ethanol precipitation is an important separation and purification process in the traditional Chinese medicine (TCM) industry. However, ethanol precipitation process suffers from loss of active ingredients, low batch-to-batch consistency of supernatant composition, and long standing time. These problems are mainly caused by low efficient equipment and imperfect control strategy.
Methods
In the present study, a membrane dispersion ethanol precipitation device which can achieve rapid cooling was developed for Astragali radix ethanol precipitation. Ethanol precipitation process was optimized according to Quality by design concept. To identify critical material attributes (CMAs), ten batches of Astragali radix was used to prepare concentrates. Definitive screening design was used to investigate the relationships among critical process parameters, CMAs, and process critical quality attributes (CQAs).
Results
Calycosin-7-O-β-D-glucoside content, the sucrose content, and the electrical conductivity were found to be CMAs after the correlation analysis and stepwise regression modelling. Quadratic models were developed and design space was calculated according to the probability of attaining process CQA standards. A material quality control strategy was proposed. High quality and low quality Astragali radix concentrates can be discriminated by the inequalities. Low quality Astragali radix concentrates should not be released for ethanol precipitation process directly. Verification experiment results indicated accurate models and reliable design space.
Conclusions
The temperature control method and control strategy in this study are effective and promising for ethanol precipitation process of other TCMs or foods.
Keywords
Ethanol precipitation, Micromixer, Astragali radix, Quality control strategy
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This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Research
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
History
CURRENT STATUS: Posted
View the published article at Scientific Reports.
Version 1
Posted 21 Jul, 2020
No community comments so far
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at Scientific Reports.
Background
Ethanol precipitation is an important separation and purification process in the traditional Chinese medicine (TCM) industry. However, ethanol precipitation process suffers from loss of active ingredients, low batch-to-batch consistency of supernatant composition, and long standing time. These problems are mainly caused by low efficient equipment and imperfect control strategy.
Methods
In the present study, a membrane dispersion ethanol precipitation device which can achieve rapid cooling was developed for Astragali radix ethanol precipitation. Ethanol precipitation process was optimized according to Quality by design concept. To identify critical material attributes (CMAs), ten batches of Astragali radix was used to prepare concentrates. Definitive screening design was used to investigate the relationships among critical process parameters, CMAs, and process critical quality attributes (CQAs).
Results
Calycosin-7-O-β-D-glucoside content, the sucrose content, and the electrical conductivity were found to be CMAs after the correlation analysis and stepwise regression modelling. Quadratic models were developed and design space was calculated according to the probability of attaining process CQA standards. A material quality control strategy was proposed. High quality and low quality Astragali radix concentrates can be discriminated by the inequalities. Low quality Astragali radix concentrates should not be released for ethanol precipitation process directly. Verification experiment results indicated accurate models and reliable design space.
Conclusions
The temperature control method and control strategy in this study are effective and promising for ethanol precipitation process of other TCMs or foods.
Figure 1
Figure 2
Figure 3
Figure 4
Figure 5
Figure 6
Figure 7
This is a list of supplementary files associated with this preprint. Click to download.
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