关键词: 质量源于设计, 总生物碱, 苦参碱, 氧化苦参碱, 优化, 提取工艺

Abstract: A design space of the reflux extraction process of Sophora Flavescentis Radix-Glycyrrhizauralensis was established and verified following the concept of "quality by design (QbD)". The extraction ratios of total alkaloids of Sophora flavescens(TASF),matrine(MT),and oxymatrine(OMT) were set as the critical quality attributes(CQAs). Based on the single factor experiment,the high and low levels of different parameters used in Plackeet-Burmann design were identified. The amount of Glycyrrhizauralensis and ethanol concentration and extraction temperature were identified as critical parameters(CPPs) using Plackeet-Burmann design. The central composite design was used for experimental arrangements,and the design space of ethanol extraction process was established based on the quadratic polynomial regression model. According to the verification results,the robustness of the reflux extraction process of the active ingredients of Sophora Flavescentis Radix can be guaranteed by operating within the design space parameters. The recommended operation space of parameters were:Glycyrrhizauralensis mass of 10.00g-10.50g,ethanol concentration of 65%-68% and extraction temperature of 94.5-95.0℃.

Key words: quality by design(QbD), total alkaloids, matrine, oxymatrine, optimization, extraction process