Dataset Information

Critical process parameter identification of manufacturing processes of Astragali Radix extract with a weighted determination coefficient method.

ABSTRACT:

Objective

Critical process parameters (CPPs) identification is an important step of the implementation of quality by design (QbD) concept. There are many CPP identification methods, such as risk analysis method, sensitivity analysis method, multiple linear regression method, standard partial regression coefficient (SPRC) method, and so on. The SPRC method can consider multiple process critical quality attributes (CQAs) simultaneously, but the determination of CPP number is subjective. Therefore, new CPP identification method is still required.

Methods

The manufacturing process of Astragali Radix extract, which contained water reflux extraction, concentration, and ethanol precipitation, was used as an example. First, the multiple process CQAs were determined to be the yield of pigment, dry matter, sugars, and active ingredients. Second, the potential CPPs were determined by a knowledge organization method. Plackett-Burman designed experiments were then performed. A weighted determination coefficient ( Rw2 ) method was presented to identify CPPs. In this method, the importance of different CQAs was considered. Process parameters were removed one-by-one according to their importance index. The decrease in Rw2 was used to characterize the importance of the removed parameter. If the decrease of Rw2 was less than a preset threshold, the removed parameter was not a CPP.

Results

During the manufacturing process of Astragali Radix extract, the potential CPPs determined by the knowledge organization method were water consumption, reflux extraction time, extraction frequency, ethanol content, ethanol consumption, and concentration endpoint. Reflux extraction time, the first ethanol consumption, the second ethanol consumption, and the second ethanol precipitation refrigeration temperature were found to be CPPs using the weighted determination coefficient method with the threshold of 10%.

Conclusion

Using the weighted determination coefficient method, CPPs can be determined with all the CQAs considered based on their importance. The determination of CPP number is more objective compared with the SPRC method.

SUBMITTER: Sun MF

PROVIDER: S-EPMC9476637 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Publications

Critical process parameter identification of manufacturing processes of <i>Astragali Radix</i> extract with a weighted determination coefficient method.

Sun Min-Fei MF Yang Jing-Yi JY Cao Wen W Shao Jing-Yuan JY Wang Guo-Xiang GX Qu Hai-Bin HB Huang Wen-Hua WH Gong Xing-Chu XC

Chinese herbal medicines 20191116 2

<h4>Objective</h4>Critical process parameters (CPPs) identification is an important step of the implementation of quality by design (QbD) concept. There are many CPP identification methods, such as risk analysis method, sensitivity analysis method, multiple linear regression method, standard partial regression coefficient (SPRC) method, and so on. The SPRC method can consider multiple process critical quality attributes (CQAs) simultaneously, but the determination of CPP number is subjective. Th ...[more]

PMID: 36119791

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