Abstract
A support vector regression (SVR) method was introduced to improve the robustness and predictability of the design space in the implementation of quality by design (QbD), taking the extraction process of Pueraria lobata as a case study. In this paper, extraction time, number of extraction cycles, and liquid–solid ratio were identified as critical process parameters (CPPs), and the yield of puerarin, total isoflavonoids, and extracta sicca were the critical quality attributes (CQAs). Models between CQAs and CPPs were constructed using both a conventional quadratic polynomial model (QPM) and the SVR algorithm. The results of the two models indicated that the SVR model had better performance, with a higher R2 and lower root-mean-square error (RMSE) and mean absolute deviation (MAD) than those of the QPM. Furthermore, the design space was predicted using a grid search technique. The operational range was extraction time, 24–51 min; number of extraction cycles, 3; and liquid–solid ratio, 14–18 mL/g. This study is the first reported work optimizing the design space of the extraction process of P. lobata based on an SVR model. SVR modeling, with its better prediction accuracy and generalization ability, could be a reliable tool for predicting the design space and shows great potential for the quality control of QbD.
Highlights
Radix puerariae (RP) is the root of Pueraria lobata, known as ‘Gegen’ in Chinese
The entire dataset obtained using Box–Behnken design was considered as the training set and adopted to establish the quadratic polynomial model (QPM) and support vector regression (SVR) fitted models
The results indicate that the SVR model performs better, with higher
Summary
Radix puerariae (RP) is the root of Pueraria lobata, known as ‘Gegen’ in Chinese. Classic” and classified as middle grade for the prevention and treatment of fever, diabetes, diarrhea, and cardiovascular and cerebrovascular diseases. Modern studies have shown that RP extract exhibits potential bioactivity for the treatment of several immune disorders, such as atopic dermatitis [1], osteoporosis [2], and Alzheimer’s disease [3]. Isoflavonoids are believed to be the major active components in RP. Puerarin is the major and most important component in RP with extensive pharmacological activities such as hepatoprotection [4], anti-atherogenic effects [5], and anti-cancer effects [6]. The content of puerarin (≥2.4%) is regarded as the quality indicator of RP according to the Pharmacopeia of the People’s Republic of China
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