世界科学技术-中医药现代化2025，Vol.27Issue(7)：2050-2062,13.DOI:10.11842/wst.20240905002
基于物性表征的黄精大蜜丸质量评价模型的建立及在处方工艺优化中的应用
Establishment of A Quality Evaluation Model of Huangjing Dami Pills Based on Physical Properties Characterization and Its Application in Formulation Process Optimization
摘要
Abstract
Objective Based on the holistic view of traditional Chinese medicine,a more objective and comprehensive quality evaluation model for Huangjing Dami pills was established by combining external traits and internal qualities,and was applied to the optimization of the prescription process to verify its feasibility and applicability,so that it can provide reference for the optimization of the preparation process of other honey pills.Methods The texture characterization information of Huangjing Dami pills was collected based on the texture meter,and the water content and chemical composition information were collected based on the 2020 edition of the Chinese Pharmacopoeia.Given that the hardness and other texture characterization indexes are moderate indexes,the quality evaluation model established by the polar value method and principal component analysis(PCA)was used to quantify the values of the characterization evaluation indexes,which can be used to screen the significance of the influencing factors in the Plackett-Burman(PB)test;The quality evaluation model based on the optimal value method,the polar value method and the Analytic Hierarchy Process(AHP)-CRITIC method was used to characterize the quantification of the actual values of the evaluation indexes,and it can be used to optimize the process and derive the optimal process parameters for the steepest hill-climbing test,the response surface test and the validation test.Results The quality evaluation model based on the extreme value method-PCA was used in the PB test to screen out the three significant influencing factors of the ratio of honey to medicine,drying temperature and mesh number;the quality evaluation model based on the optimal value,extreme value method-AHP-CRITIC method was used in the steepest climb test,response surface test and validation test,which resulted in the optimal prescription process parameters of Huangjing Dami pills,namely,the ratio of medicine to honey was 1:0.64,the honey temperature was 60℃,the mesh number was 100 mesh,the drying temperature was 50.8℃,the drying time was 3 h,the sweating time was 1 day.Conclusion It was verified that the feasibility and applicability of the qualitative attributes guiding the optimization of prescriptions,and that the established quality evaluation model could guarantee the quality of the final product by taking into account the physical attributes and the chemical attributes during the optimization of the prescription,which showed a better prospect of application in the optimization of the process of honey pills and the method for the evaluation of the quality of honey pills preparation.关键词
大蜜丸/质构表征/指标性质/主成分分析法/AHP-CRITIC权重赋值法/极值法/最优值法Key words
Big honey pill/Physical attributes/Index nature/Principal component analysis/AHP-CRITIC weight evaluation method/Extreme value method/Optimal value method分类
医药卫生引用本文复制引用
徐悦媛,吴鑫雨,梁泽华..基于物性表征的黄精大蜜丸质量评价模型的建立及在处方工艺优化中的应用[J].世界科学技术-中医药现代化,2025,27(7):2050-2062,13.基金项目
国家级大学生创新训练计划项目(202410344055):黄精九蒸九晒设备数字化改良,负责人:徐悦媛 （202410344055）
浙江中医药大学校级科研项目(2024GJYY19):黄精调控PI3K/AKT通路改善慢性支气管炎炎症损伤及黏液高分泌的作用机制研究,负责人:梁泽华 （2024GJYY19）
重药(浙江)中药有限公司企事业委托项目(2024-HT-651):大健康产品的设计、开发及评价研究,负责人:梁泽华. （浙江）
