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

关键词:  QbD  AHP-熵权法  挥发油提取工艺  挥发油包合工艺

Key words:  QbD  AHP-entropy weight method  Volatile oil extraction process  Volatile oil encapsulation process

摘要:

目的 基于质量源于设计理念(QbD)结合AHP-熵权法优化筛选陈皮、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FMEA确定挥发油提取的关键工艺参数(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(CQAs),基于单因素实验,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,单因素实验筛选CPPs水平范围,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：5.3-6h,加水倍数：9-10倍,浸泡时间：0.6-1h；挥发油最佳包合工艺为投料比1:8,包合温度40℃,包合时间2.5h。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, optimize and screen the extraction process of volatile oil from tangerine peel and ginger β- Cyclodextrin encapsulation process. METHOD Using fishbone diagram and FMEA to determine the key process parameters (CPPs) for volatile oil extraction: heating time, solid-liquid ratio, soaking time, volatile oil extraction rate, D-limonene γ- The content of terpenes and citral were used as key quality attributes (CQAs). Based on single factor experiments, Box Behnken response surface methodology was used to optimize the extraction process of volatile oil. The AHP-entropy weighting method was used to calculate the comprehensive score of CQAs, and a design space was established and validated. The study of volatile oil encapsulation process using saturated aqueous solution method, single factor experiment to screen the level range of CPPs, orthogonal experiment to optimize the encapsulation process, AHP-entropy weight method to calculate the comprehensive score of CQAs, and obtain the best encapsulation process for process validation. RRULTS The operating space of the volatile oil extraction process is heating time: 5.3-6h, water addition ratio: 9-10 times, soaking time: 0.6-1h; The optimal encapsulation process for volatile oil is a feeding ratio of 1:8, encapsulation temperature of 40 ℃, and encapsulation time of 2.5 hours. 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.