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Optimization of the Ethanol Recycling Reflux Extraction Process for Saponins Using a Design Space Approach

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  • Xingchu Gong
  • Ying Zhang
  • Jianyang Pan
  • Haibin Qu

Abstract

A solvent recycling reflux extraction process for Panax notoginseng was optimized using a design space approach to improve the batch-to-batch consistency of the extract. Saponin yields, total saponin purity, and pigment yield were defined as the process critical quality attributes (CQAs). Ethanol content, extraction time, and the ratio of the recycling ethanol flow rate and initial solvent volume in the extraction tank (RES) were identified as the critical process parameters (CPPs) via quantitative risk assessment. Box-Behnken design experiments were performed. Quadratic models between CPPs and process CQAs were developed, with determination coefficients higher than 0.88. As the ethanol concentration decreases, saponin yields first increase and then decrease. A longer extraction time leads to higher yields of the ginsenosides Rb1 and Rd. The total saponin purity increases as the ethanol concentration increases. The pigment yield increases as the ethanol concentration decreases or extraction time increases. The design space was calculated using a Monte-Carlo simulation method with an acceptable probability of 0.90. Normal operation ranges to attain process CQA criteria with a probability of more than 0.914 are recommended as follows: ethanol content of 79–82%, extraction time of 6.1–7.1 h, and RES of 0.039–0.040 min−1. Most of the results of the verification experiments agreed well with the predictions. The verification experiment results showed that the selection of proper operating ethanol content, extraction time, and RES within the design space can ensure that the CQA criteria are met.

Suggested Citation

  • Xingchu Gong & Ying Zhang & Jianyang Pan & Haibin Qu, 2014. "Optimization of the Ethanol Recycling Reflux Extraction Process for Saponins Using a Design Space Approach," PLOS ONE, Public Library of Science, vol. 9(12), pages 1-20, December.
  • Handle: RePEc:plo:pone00:0114300
    DOI: 10.1371/journal.pone.0114300
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    References listed on IDEAS

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    1. Xingchu Gong & Huali Chen & Teng Chen & Haibin Qu, 2014. "Unit Operation Optimization for the Manufacturing of Botanical Injections Using a Design Space Approach: A Case Study of Water Precipitation," PLOS ONE, Public Library of Science, vol. 9(8), pages 1-14, August.
    2. Jieqiang Zhu & Xiaohui Fan & Yiyu Cheng & Rajiv Agarwal & Christine M V Moore & Shaw T Chen & Weida Tong, 2014. "Chemometric Analysis for Identification of Botanical Raw Materials for Pharmaceutical Use: A Case Study Using Panax notoginseng," PLOS ONE, Public Library of Science, vol. 9(1), pages 1-10, January.
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    1. Liangshan Ming & Zhe Li & Fei Wu & Ruofei Du & Yi Feng, 2017. "A two-step approach for fluidized bed granulation in pharmaceutical processing: Assessing different models for design and control," PLOS ONE, Public Library of Science, vol. 12(6), pages 1-25, June.

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