中草药2026，Vol.57Issue(13)：5069-5081,13.DOI:10.7501/j.issn.0253-2670.2026.13.011
基于"功效物质-物性参数-工艺参数"关联性分析的桂枝茯苓胶囊制药过程浓缩工序质量控制研究
Research on quality control in concentration process of manufacturing of Guizhi Fuling Capsules based on correlation of effective components,physical properties and process parameters
摘要
Abstract
Objective This study focused on the concentration process in the manufacturing of Guizhi Fuling Capsules(GFC,桂枝茯苓胶囊).By analyzing the correlations among effective components,physical properties,and process parameters,it aimed to identify critical quality attributes(CQAs)and critical process parameters(CPPs),explore quality control indicators and their acceptable ranges,and assess the potential for using physical properties of intermediate to guide its quality control.Methods The variations in process parameters(temperature,relative density at endpoint),physical properties(particle size,polydispersity index,ζpotential,conductivity,pH value,viscosity and refractive index),and effective components and total solid content during the concentration process were systematically investigated.Chemometric methods,including Pearson correlation coefficient,grey relational analysis,and partial least squares regression,were applied.Linear models between effective components and physical properties under different process parameters were established to elucidate the correlations among them.Results Analysis of effective component content and physical properties revealed strong correlations between effective components and ζ potential,conductivity,viscosity,and total solids content.For instance,viscosity was positively correlated with total solids,and the contents of amygdalin and paeoniflorin were both positively correlated with total solid content.Analysis of the active ingredients and physical property parameters of samples under various process parameters revealed that the concentration temperature is a key factor influencing the correlation between active ingredients and physical property parameters.Conclusion Correlation analysis of process parameters,physical properties,and effective components revealed interactive and dynamically linked relationships among these variables.Precise control of the concentration temperature during the manufacturing is essential to improve the quality and batch-to-batch consistency of the extract.To a certain extent,parameters such as viscosity,relative density,refractive index and pH value can reflect the quality of intermediates during concentration,providing a reference for the development of online intelligent monitoring in the concentration process of traditional Chinese medicine extracts.关键词
桂枝茯苓胶囊/功效物质/物性参数/工艺参数/浓缩工艺/相关性分析/苦杏仁苷/芍药苷Key words
Guizhi Fuling Capsules/effective components/physical properties/process parameters/concentration process/correlation analysis/amygdalin/paeoniflorin分类
医药卫生引用本文复制引用
王佩,孔祥文,张晶宇,刘文君,曹亮,王振中,王团结,肖伟,牛雪妮..基于"功效物质-物性参数-工艺参数"关联性分析的桂枝茯苓胶囊制药过程浓缩工序质量控制研究[J].中草药,2026,57(13):5069-5081,13.基金项目
国家长三角科技创新共同体联合攻关项目(2023CSJGG1700) （2023CSJGG1700）
中药制药过程控制与智能制造技术全国重点实验室定向课题(SKL2023D02002) （SKL2023D02002）
江苏省基础研究计划——青年基金项目(BK20250552) （BK20250552）
连云港市重点研发计划(CG2320) （CG2320）
