OBJECTIVE Based on the quality based design concept(QbD) combined with analytical hierarchy process(AHP) entropy weight method, screen and optimize the extraction process of volatile oil from Zingiberis Rhizoma Recens and Citri Reticulatae Pericarpium, as well as the β-cyclodextrin inclusion process.
METHODS Using fishbone diagram and risk identification tool FMEA, the key process parameters(CPPs) for volatile oil extraction were determined, including heating time, solid-liquid ratio, and soaking time. The key quality attributes(CQAs) were determined based on the extraction rate of volatile oil, D-limonene, γ-terpenoids, and citral content. Based on single factor experiments, the Box Behnken response surface method was used to optimize the volatile oil extraction process, and the AHP entropy weight method was used to calculate the comprehensive score of CQAs. The design space was established and validated. The saturated aqueous solution method was used to study the volatile oil encapsulation process. Based on single factor experiments and orthogonal experiments, the encapsulation process was optimized. The AHP entropy weight method was used to calculate the comprehensive score of CQAs, and the optimal encapsulation process was obtained and validated.
RESULTS The operating space of the volatile oil extraction process was as follows: heating time, 5.3−6 h; water addition ratio, 9−10 times; and soaking time, 0.6−1 h. The optimal encapsulation process for volatile oil was a feeding ratio of 1∶8, encapsulation temperature of 40 ℃, and encapsulation time of 2.5 h.
CONCLUSION The operating space of the volatile oil extraction process based on the QbD concept and AHP-entropy weight method can improve and ensure the extraction rate and effective ingredient content of volatile oil from Zingiberis Rhizoma Recens and Citri Reticulatae Pericarpium. The optimal encapsulation process obtained from the screening can effectively encapsulate the volatile oil from Zingiberis Rhizoma Recens and Citri Reticulatae Pericarpium, providing reference value for industrial production and research on traditional Chinese medicine formulations.