基于QbD理念和AHP-熵权法优化陈皮、生姜挥发提取工艺及包合工艺

    Optimization of Volatile Extraction and Encapsulation Processes for Tangerine Peel and Ginger Based on QbD Concept and AHP-entropy Weight Method

    • 摘要:
      目的 基于质量源于设计理念(quality based design concept,QbD)结合AHP-熵权法筛选并优化陈皮、生姜挥发油提取工艺及β-环糊精包合工艺。
      方法 借助鱼骨图及风险辨识工具FMEA确定挥发油提取的关键工艺参数(key process parameters,CPPs):加热时间、料液比、浸泡时间,以挥发油提取率、D-柠檬烯、γ-萜品烯和柠檬醛的含量作为关键质量属性(key quality attributes,CQAs),基于单因素试验,采用Box-Behnken响应面法优化挥发油提取工艺,AHP-熵权法计算CQAs的综合评分,建立设计空间并进行验证。饱和水溶液法研究挥发油包合工艺,基于单因素试验,正交试验优化包合工艺,AHP-熵权法计算CQAs的综合评分,得到最佳包合工艺并进行工艺验证。
      结果 挥发油提取工艺的操作空间为加热时间:5.3~6 h,加水倍数:9~10倍,浸泡时间:0.6~1 h;挥发油最佳包合工艺为投料比1∶8,包合温度40 ℃,包合时间2.5 h。
      结论 基于QbD理念与AHP-熵权法筛选出的挥发油提取工艺操作空间可以提高并保证陈皮、生姜挥发油提取率及有效成分的含量,筛选所得的最佳包合工艺能有效包合陈皮、生姜挥发油,可为工业化生产及中药制剂研究提供参考价值。

       

      Abstract:
      OBJECTIVE Based on the quality based design concept(QbD) combined with AHP entropy weight method, screen and optimize the extraction process of volatile oil from tangerine peel and ginger, as well as the β-cyclodextrin inclusion process.
      METHOD 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, gamma 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 is heating time: 5.3−6 h, water addition ratio: 9−10 times, soaking time: 0.6−1 h; The optimal encapsulation process for volatile oil is 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 tangerine peel and ginger. The optimal encapsulation process obtained from the screening can effectively encapsulate the volatile oil from tangerine peel and ginger, providing reference value for industrial production and research on traditional Chinese medicine formulations.

       

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