Parameter Optimization Considering the Variations Both from Materials and Process: A Case Study of <i>Scutellaria baicalensis</i> Extract
The Quality by Design (QbD) concept has been widely applied to the optimization of traditional Chinese medicine production processes recently. This work focused on optimizing the critical purification process of <i>Scutellaria baicalensis</i> extract used in the preparation of Zhusheyong...
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2025-06-01
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| author | Xuecan Zhang Zhilong Tang Bo Chen Xingchu Gong |
| author_facet | Xuecan Zhang Zhilong Tang Bo Chen Xingchu Gong |
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| description | The Quality by Design (QbD) concept has been widely applied to the optimization of traditional Chinese medicine production processes recently. This work focused on optimizing the critical purification process of <i>Scutellaria baicalensis</i> extract used in the preparation of Zhusheyong Shuanghuanglian. Considering the impact of noise parameters and changes in herbal properties, an experimental design method was employed for optimization. Multiple batches of <i>Scutellaria baicalensis</i> decoction were prepared in this research, and quantitative models of <i>Scutellaria baicalensis</i> herbal properties, critical process parameters (CPPs), and process evaluation indicators were established. The <i>R</i><sup>2</sup> of the quantitative models were all higher than 0.80. According to the model, the yield of baicalin was identified as a critical material property (CMA). The pH of first acid precipitation (X<sub>1</sub>), first temperature holding time (X<sub>2</sub>), pH of alkalization (X<sub>3</sub>), ethanol amount (X<sub>4</sub>), and end pH of ethanol washing (X<sub>5</sub>) were CPPs. Considering the difficulty in controlling the end pH of the ethanol washing, it was considered to be a noise parameter. The Monte Carlo probability-based method was used to calculate the design space, determining the range of controllable parameters, which was successfully validated through experiments. Normal operation ranges for controllable parameters are recommended as follows: X<sub>1</sub> of 0.8–2.2, X<sub>2</sub> of 25–35 min, X<sub>3</sub> of 6.5–7.5, and X<sub>4</sub> of 0.8–1.2 g/g. |
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| spelling | doaj-art-e8cc76f88cb044c3a874df010877b4d92025-08-20T03:27:26ZengMDPI AGSeparations2297-87392025-06-0112616510.3390/separations12060165Parameter Optimization Considering the Variations Both from Materials and Process: A Case Study of <i>Scutellaria baicalensis</i> ExtractXuecan Zhang0Zhilong Tang1Bo Chen2Xingchu Gong3Pharmaceutical Informatics Institute, College of Pharmaceutical Sciences, Zhejiang University, Hangzhou 310058, ChinaPharmaceutical Informatics Institute, College of Pharmaceutical Sciences, Zhejiang University, Hangzhou 310058, ChinaPharmaceutical Informatics Institute, College of Pharmaceutical Sciences, Zhejiang University, Hangzhou 310058, ChinaPharmaceutical Informatics Institute, College of Pharmaceutical Sciences, Zhejiang University, Hangzhou 310058, ChinaThe Quality by Design (QbD) concept has been widely applied to the optimization of traditional Chinese medicine production processes recently. This work focused on optimizing the critical purification process of <i>Scutellaria baicalensis</i> extract used in the preparation of Zhusheyong Shuanghuanglian. Considering the impact of noise parameters and changes in herbal properties, an experimental design method was employed for optimization. Multiple batches of <i>Scutellaria baicalensis</i> decoction were prepared in this research, and quantitative models of <i>Scutellaria baicalensis</i> herbal properties, critical process parameters (CPPs), and process evaluation indicators were established. The <i>R</i><sup>2</sup> of the quantitative models were all higher than 0.80. According to the model, the yield of baicalin was identified as a critical material property (CMA). The pH of first acid precipitation (X<sub>1</sub>), first temperature holding time (X<sub>2</sub>), pH of alkalization (X<sub>3</sub>), ethanol amount (X<sub>4</sub>), and end pH of ethanol washing (X<sub>5</sub>) were CPPs. Considering the difficulty in controlling the end pH of the ethanol washing, it was considered to be a noise parameter. The Monte Carlo probability-based method was used to calculate the design space, determining the range of controllable parameters, which was successfully validated through experiments. Normal operation ranges for controllable parameters are recommended as follows: X<sub>1</sub> of 0.8–2.2, X<sub>2</sub> of 25–35 min, X<sub>3</sub> of 6.5–7.5, and X<sub>4</sub> of 0.8–1.2 g/g.https://www.mdpi.com/2297-8739/12/6/165Zhusheyong Shuanghuanglian<i>Scutellaria baicalensis</i> extractprocess parameter optimizationdesign space |
| spellingShingle | Xuecan Zhang Zhilong Tang Bo Chen Xingchu Gong Parameter Optimization Considering the Variations Both from Materials and Process: A Case Study of <i>Scutellaria baicalensis</i> Extract Separations Zhusheyong Shuanghuanglian <i>Scutellaria baicalensis</i> extract process parameter optimization design space |
| title | Parameter Optimization Considering the Variations Both from Materials and Process: A Case Study of <i>Scutellaria baicalensis</i> Extract |
| title_full | Parameter Optimization Considering the Variations Both from Materials and Process: A Case Study of <i>Scutellaria baicalensis</i> Extract |
| title_fullStr | Parameter Optimization Considering the Variations Both from Materials and Process: A Case Study of <i>Scutellaria baicalensis</i> Extract |
| title_full_unstemmed | Parameter Optimization Considering the Variations Both from Materials and Process: A Case Study of <i>Scutellaria baicalensis</i> Extract |
| title_short | Parameter Optimization Considering the Variations Both from Materials and Process: A Case Study of <i>Scutellaria baicalensis</i> Extract |
| title_sort | parameter optimization considering the variations both from materials and process a case study of i scutellaria baicalensis i extract |
| topic | Zhusheyong Shuanghuanglian <i>Scutellaria baicalensis</i> extract process parameter optimization design space |
| url | https://www.mdpi.com/2297-8739/12/6/165 |
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