基于Qbd理念和设计空间法的白芍提取工艺研究  

Extraction Process of Radix Paeoniae Alba Based on Qbd Concept and Design Space Method

作　　者：胡若楠 兰青 张兴德[1] 郁红礼 谢辉 狄留庆[1] 陈希宇 HU Ruonan;LAN Qing;ZHANG Xingde;YU Hongli;XIE Hui;DI Liuqing;CHEN Xiyu(Nanjing University of Chinese Medicine,Nanjing 210023,China;Jiangsu Key Laboratory of Chinese Medicinal Processing,Nanjing 210023,China;Jiangsu Engineering Research Center for Classic Formulas,Nanjing 210023,China;Jiangsu Engineering and Technology Research Center of Efficient Chinese Medicinal Delivery System,Nanjing 210023,China)

机构地区：[1]南京中医药大学,江苏南京210023 [2]江苏省中药炮制重点实验室,江苏南京210023 [3]江苏省经典名方工程研究中心,江苏南京210023 [4]江苏省中药高效给药系统工程技术研究中心,江苏南京210023

出　　处：《中医药信息》2023年第6期27-31,共5页Information on Traditional Chinese Medicine

基　　金：全国中医药创新骨干人才培训项目(国中医药办人教函〔2019〕91号)。

摘　　要：目的:基于质量源于设计(Qbd)理念结合设计空间法对白芍提取工艺参数进行优化,建立并验证设计空间。方法:基于质量源于设计理念,以芍药苷、芍药内酯苷、没食子酸的提取率及出膏率为关键质量属性,依据单因素实验结果,确定筛选因素的水平范围,通过Plackett-Burman设计确定关键工艺参数,采用Box-Behnken设计,计算综合评分,构建数学模型,优化关键工艺参数,使用Matlab软件中的蒙特卡洛模拟设计并验证白芍的提取空间。结果:关键工艺参数为提取时间、提取次数和提取温度。设计空间最佳范围为提取1~2次,温度在90~100℃,提取时间60~120 min。结论:基于Qbd理念构建的设计空间,使白芍的提取工艺高效稳固,可提供动态的提取参数范围,扩大容错范围,提高经济效益。Objective:To optimize the extraction process parameters of Radix Paeoniae Alba based on concept of quality by design(Qbd)and design space method,and to establish and verify the design space.Methods:The extraction rate and paste rate of paeoniflorin,albiflorin and gallic acid were taken as the key quality attributes on the basis of Qbd concept.According to the results of single factor experiment,the level range of screening factors was determined.The key process parameters were determined by Plackett-Burman design.The Box-Behnken design was used to calculate the comprehensive score,construct the mathematical model and optimize the key process parameters.The Monte Carlo simulation design in Matlab software was applied to verify the extraction space of Radix Paeoniae Alba.Results:The key process parameters include extraction time,extraction times and extraction temperature.The optimum range of design space was 1-2 times of extraction,the temperature was 90℃-100℃,and the extraction time was 60-120 min.Conclusion:The constructed design space based on Qbd is efficient and stable for the process of Radix Paeoniae Alba,it provides a dynamic range of extraction parameters,expands the fault tolerance range,and improves economic benefits.

关 键 词：QBD 白芍 芍药苷 Box-Behnken 蒙特卡洛模拟 设计空间 

分 类 号：R284.2[医药卫生—中药学]