基于危害及可操作性分析的设计空间法优化红参醇提工艺

基于质量源于设计理念,采用危害及可操作性分析法与设计空间法对红参醇提工艺进行优化。首先采用危害及可操作性分析法结合实际生产对醇提工艺进行风险评估,确定乙醇浓度、醇料比和提取时间为关键工艺参数,然后采用Box-Behnken设计法建立关键工艺参数和工艺评价指标间的数学模型,在此基础上计算设计空间,最终选取的操作空间为:醇浓度90.3%~90.7%,醇料比2.5~3.1 mL·g~(-1),每次提取时间124~130 min。结果表明,该研究方法能降低红参醇提工艺各参数的风险水平,为提高工艺控制水平提供了新思路。

Optimization of ethanol reflux extraction process of red ginseng using a design space approach based on hazard and operability analysis

Quality by design principle was used as a guideline in this study to optimize ethanol reflux extraction of red ginseng. Firstly, hazard and operability analysis(HAZOP) was used as a risk assessment tool to evaluate the hazard degree of process parameters.Ethanol concentration, the ratio of alcohol and herbal material (A/M ratio), and extraction time were identified as the critical process parameters(CPPs) according to HAZOP method.Secondly, Box-Behnken experimental design was applied to establish theregression models between CPPs and the process indices. Finally, the design space was calculated. The recommended operation space of parametersis as follows:alcohol concentration of 90.3%-90.7%, A/M ratio of 2.5-3.1 mL·g^-1 and extraction time of 124-130 min. The study shows that the design space approach combined with the risk assessment using HAZOP has the potential to reduce the risk of red ginseng extraction process, which might ultimately improve the process control.