Design space method for optimizing extraction process of Carthami Flos / 中草药

ABSTRACT

Objective To establish and verify the design space for the extraction process of Carthami Flos (CF) based on the concept of quality by design (QbD). Methods The safflower was used as a model drug. The critical evaluation indicators were determined through literature and previous research experience. Fishbone diagram and Failure Mode Effect Analysis (FMEA) were carried out to determine the critical process parameters (CPPs). The mathematical models of CPPs and critical evaluation indicators were established using the Box-Behnken experimental design method. Results The critical evaluation indicators were the extraction amount of total flavonoid, hydroxysafflor yellow A (HSYA), and total solids. The water-adding amount, extraction temperature, extraction time, and extraction times were determined as the CPPs by the fishbone diagram and FMEA. The variance analysis results of Box-Behnken experiments showed that the P values of established models were less than 0.000 1, indicating that the models have good prediction ability. The recommended operating space were as follows the extraction times were twice and 2.5 h for each time, the water-adding amount was 23.5-25 mL/g crude drug and the temperature was 65-71 ℃. Conclusion The establishing of design space for CF extraction improves the correlation between the extraction process parameters and extract quality, which provides a reference for the applicability of the design space approach in the field of CMM.