水醇双提工艺制备中药复方颗粒溶化性的质量属性辨识研究OA
Identification of the quality attributes affecting the dispersibility of Chinese medicinal com-pound granules prepared by the water-alcohol double extraction process
目的 以水醇双提工艺制备的3种中药复方制剂为研究对象,探讨中间体粉末对颗粒溶化性的影响因素,以期筛选出潜在关键物料属性(pCMAs).方法 对水醇双提工艺制备的杏贝止咳颗粒、腰痹通胶囊与参乌益肾片3个品种各25批中间体物料进行测定,采用物理指纹图谱与二维矩阵热图对各品种中间体物料属性进行相关性分析,同时基于粉体性质建立主成分分析(PCA)与偏最小二乘回归(PLS)预测模型,初步筛选出影响水-醇双提下制剂颗粒溶化性的关键因素.结果 各品种物理指纹图谱结果显示,杏贝止咳颗粒混合粉批次间相似度范围为86.39%～99.99%;腰痹通胶囊喷干细粉批次间相似度范围为95.65%～99.99%;参乌益肾片干膏粉批次间相似度为93.52%～99.97%.各品种物性指标间相关性分析结果表明,Dc、UN、Span与Da等呈显著相关.以18个粉体学指标建立的PCA与PLS模型显示,主成分1与主成分2的方差贡献率分别为66.98%、19.68%,对模型累积解释率达86.66%;通过对次变量的剔除及模型的重构优化,最后筛选出α、%HR与%H是pCMAs.结论 该研究从中药粉体学角度出发,通过对多个品种制剂中间体粉末与颗粒溶化性进行测定分析,初步筛选出水醇双提工艺制备的颗粒溶化性的影响因素,为解决实际生产中出现的沉淀、焦屑等溶化性问题提供参考.
Objective This study focused on three Chinese medicinal compound preparations prepared by the water-alcohol double extraction process to investigate the influencing factors of intermediate powders on the dispersibility of granules,aiming to screen out potential critical material attributes(pCMAs).Methods For each of the three preparations,Xingbei Zhike Granule(杏贝止咳颗粒,XBZKG),Yaobitong Capsule(腰痹通胶囊,YBTC),and Shenwu Yishen Tablet(参乌益肾片,SWYST),25 batches of intermediate materials were measured.Physical fingerprints and two-dimensional matrix heatmaps were used to analyze the correlations among mate-rial attributes for each variety.Based on powder properties,principal component analysis(PCA)and partial least squares regression(PLS)prediction models were established to preliminarily identify the key factors affecting the dispersibility of granules prepared by the water-alcohol double extraction process.Results The physical fingerprint of each variety showed that the similarity between batches of XBZKG mixed powder ranged from 86.39%to 99.99%;the similarity between batches of YBTC spray-dried fine powder ranged from 95.65%to 99.99%;and the similarity between batches of SWYST dry extract powder ranged from 93.52%to 99.97%.Correlation analysis among material attributes indicated that Dc,UN,Span,and Da were significantly correlated.PCA and PLS models based on 18 powder indicators showed that the variance contribution rates of principal component 1 and principal component 2 were 66.98%and 19.68%,respectively,with a cumulative interpretation rate of 86.66%.After eliminating secondary variables and reconstructing and optimizing the model,α,%HR,and%H were finally screened out as pCMAs.Conclusion Based on the perspective of pharmaceutical powder micromeritics of Chinese medicinals,this study evaluated the intermediate powders and final preparations of multiple varieties.The factors affecting the dispersibility of preparations prepared via the water-alcohol double extraction process were preliminarily identi-fied,aiming to provide a reference for resolving practical production issues such as sediments and scorched particles.
汪盛华;王书娟;闫明;周恩丽;章晨峰;王振中
中药制药过程控制与智能制造技术全国重点实验室,江苏 连云港 222001||江苏省海洋药物和现代中药创制重点实验室,江苏 连云港 222001||江苏康缘药业股份有限公司,江苏 连云港 222001江苏省海洋药物和现代中药创制重点实验室,江苏 连云港 222001||江苏康缘药业股份有限公司,江苏 连云港 222001江苏省海洋药物和现代中药创制重点实验室,江苏 连云港 222001||江苏康缘药业股份有限公司,江苏 连云港 222001江苏省海洋药物和现代中药创制重点实验室,江苏 连云港 222001||江苏康缘药业股份有限公司,江苏 连云港 222001江苏省海洋药物和现代中药创制重点实验室,江苏 连云港 222001||江苏康缘药业股份有限公司,江苏 连云港 222001中药制药过程控制与智能制造技术全国重点实验室,江苏 连云港 222001||江苏康缘药业股份有限公司,江苏 连云港 222001
医药卫生
粉体学水醇双提溶化性相关性多元统计分析
Pharmaceutical powder micromeriticsWater-alcohol double extractionDispersibilityCorrelationMultivariate statistical analysis
《时珍国医国药》 2026 (16)
3062-3068,7
国家长三角科技创新共同体联合攻关项目(2023CSJGG1700)
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