【摘要】 为了提高草苁蓉颗粒的均一性和稳定性，本试验对其提取和成型工艺进行优化，以提取时间、料液比和提取次数作为关键工艺参数，以浸膏得率为关键质量属性，通过Box-Behnken设计响应面法建立模型，考察关键工艺参数与关键质量属性之间的交叉作用，优化草苁蓉提取工艺的设计空间。以填充剂配比、浸膏用量和润湿剂浓度为考察因素，以颗粒合格率、溶化性、吸湿率和感官评价的总评归一值(OD值)作为评价指标，采用单因素试验结合Box-Behnken设计响应面法优化草苁蓉颗粒成型工艺。结果显示，草苁蓉最佳提取工艺为：提取时间60 min,液料比10∶1,提取次数2次。最佳成型工艺为：辅料乳糖∶糊精=3∶1,浸膏用量为7%,润湿剂为75%乙醇。该方法稳定可行且重复性好，可用于草苁蓉颗粒的提取和成型工艺。更多还原

【Abstract】 In order to improve the uniformity and stability of Boschniakia rossica granules, the extraction and forming processes were optimized in this study. Extraction time, liquid-to-material ratio, and extraction frequency were taken as key process parameters, with the yield of extract as the critical quality attribute. A model was established using the Box-Behnken design-response surface methodology to investigate the interactions between key process parameters and critical quality attributes, aiming to optimize the design space of Boschniakia rossica extraction process. With filler ratio, extract dosage, and moistening agent concentration as factors, and the granule qualification rate, dissolvability, hygroscopicity, and the overall desirability normalization(OD value) of sensory evaluation as evaluation indicators, the forming process of Boschniakia rossica granules was optimized using single-factor experiments combined with the Box-Behnken design-response surface methodology. The results showed that the optimal extraction process for Boschniakia rossica was as follows: extraction time of 60 minutes, liquid-to-material ratio of 10∶1, and extraction frequency of 2 times. The optimal forming process was: excipient lactose∶dextrin = 3∶1, extract dosage of 7%, and moistening agent of 75% ethanol. The proposed method is stable, feasible, and repeatable, making it suitable for the extraction and forming processes of Boschniakia rossica granules.更多还原