An effective optimization strategy for extracting functional ingredients from Polygonatum cyrtonema Hua based on quality by design principles

Abstract

This study aimed to develop and validate a novel and robust strategy for the simultaneous extraction of the functional ingredients, including phenolic components, polysaccharides, saponins, and amino acids, from Polygonatum cyrtonema Hua using ultrasound-assisted extraction based on quality by design principles. Critical process parameters determined using Ishikawa diagram and systematic risk analyses were investigated through a Box-Behnken design. A Monte-Carlo simulation was subsequently utilized to establish a design space. After verification experiments, chemometric analysis was eventually applied to evaluate the quality consistency of samples from different geographical regions. Models investigating the relationships between process parameters and indicators were successfully established, achieving R² > 0.89. Furthermore, a hypercube design space for process control was successfully established based on constraints of the desired quality attributes. Verification experiments confirmed the accuracy and reliability of both the models and the design space. The validated method effectively extracted active ingredients from P. cyrtonema samples sourced from different geographical regions, allowing their differentiation. This study supports the application of the proposed quality-by-design-optimized extraction method for efficiently recovering active constituents from P. cyrtonema, thus facilitating quality control and providing valuable insights into the sustainable utilization of this traditional Chinese medicine.