中国中药杂志

2020, v.45(19) 4633-4642

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基于QbD理念的红花提取液浓缩工艺及物性参数模型的建立
Establishment of concentration process and physical property parameter model of Carthami Flos extract based on quality by design

邓莉莉;陈柽;王永洁;王华翔;赵馨雨;刘玉娟;郭子右;吴清;
DENG Li-li;CHEN Cheng;WANG Yong-jie;WANG Hua-xiang;ZHAO Xin-yu;LIU Yu-juan;GUO Zi-you;WU Qing;School of Chinese Materia Medica, Beijing University of Chinese Medicine;

摘要(Abstract):

基于质量源于设计(QbD)理念,探讨浓缩环节应用过程分析技术(PAT)时以"物性模型"为导向的潜能。以红花为模型药,该研究首先以浓缩液总黄酮保留率及羟基红花黄色素A(HSYA)保留率为指标,确定红花提取液浓缩温度范围;然后在优选浓缩温度下制备不同浓度红花提取液,并测定其不同浓度(C)、温度(T)下对应的黏度(η)和电导率(σ),采用Excel,1stOpt,SPSS,MATLAB等数据处理软件,建立红花提取液ρ-C,η-C,η-T,η-C-T,σ-T,σ-C-T的物性参数数学模型。结果表明,红花温浸提取液最佳浓缩温度不宜超过60℃,基于其物性参数所建立的指数方程、Arrhenius方程等R~2均大于0.9,表明模型具有较好预测能力。其中数学模型:η=14.465 1exp(-0.019 8T+0.771 1C-0.058 3C~2),σ=4.061 0+0.004 3T+(-1.104 1+0.950 9T)C-0.556 9TC~2可用来反映浓度、温度对黏度或电导率的综合影响,可为在浓缩环节建立在线监测提取液黏度或电导率体系,以快速预测浓缩状态,控制浓缩终点奠定基础。该研究初步证明了将PAT用于中药浓缩环节质量智能控制时,以物性模型为核心的研究思路的可行性,为中药提取液浓缩环节在线智能监测提供了参考。
To explore the potential of "physical property model" based on the concept of quality by design(QbD),during the application of process analysis technology(PAT) in the concentration process. The Carthami Flos was used as a model drug. Firstly, the total flavonoid retention rate and the hydroxysafflor yellow A(HSYA) retention rate of the concentrated solution were used as indicators to determine the concentration temperature range of the Carthami Flos extract. Then different concentrations were prepared at the optimal concentration temperature, and the corresponding viscosity(η) and electrical conductivity(σ) at different concentrations and temperatures were measured. Data processing software such as Excel, 1 stOpt, SPSS, and MATLAB were used to establish Carthami Flos extract′s mathematical model of physical parameters: ρ-C, η-C, η-T, η-C-T, σ-T, σ-C-T. The results showed that the best concentration temperature of the Carthami Flos extract should not exceed 60 ℃, and the R~2 of the exponential equation and Arrhenius equation established based on physical parameters was all greater than 0.9, indicating that such model had better predictive ability. The mathematical model:η=14.465 1 exp(-0.019 8T+ 0.771 1C-0.058 3C~2), σ=4.061 0 + 0.004 3T +(-1.104 1 +0.950 9T)C-0.556 9TC~2 can be used to reflect the comprehensive effect of concentration and temperature on viscosity or conductance, laying foundation for the establishment of an online monitoring system for the viscosity or conductivity of the extraction liquid in the concentration step, rapid prediction of the concentration status, and control of the concentration endpoint. This study has initially proved the feasibility of using the physical property model as the core of the research idea in application of PAT for intelligent quality control of traditional Chinese medicine concentration links, providing a reference for the online intelligent monitoring of concentration steps of traditional Chinese medicine extracts.

关键词(KeyWords): 质量源于设计(QbD);过程分析技术;提取液;浓缩;物性参数;数学模型
quality by design(QbD);process analytical technology;extract;concentrate;physical parameters;mathematical model

Abstract:

Keywords:

基金项目(Foundation): 北京市科技计划“十病十药”研发项目(Z161100001816015)

作者(Author): 邓莉莉;陈柽;王永洁;王华翔;赵馨雨;刘玉娟;郭子右;吴清;
DENG Li-li;CHEN Cheng;WANG Yong-jie;WANG Hua-xiang;ZHAO Xin-yu;LIU Yu-juan;GUO Zi-you;WU Qing;School of Chinese Materia Medica, Beijing University of Chinese Medicine;

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DOI: 10.19540/j.cnki.cjcmm.20200706.302

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