时珍国医国药2026，Vol.37Issue(16)：3062-3068,7.DOI:10.70976/j.1008-0805.SZGYGY-2026-1609
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
Identification of the quality attributes affecting the dispersibility of Chinese medicinal com-pound granules prepared by the water-alcohol double extraction process
摘要
Abstract
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.关键词
粉体学/水醇双提/溶化性/相关性/多元统计分析Key words
Pharmaceutical powder micromeritics/Water-alcohol double extraction/Dispersibility/Correlation/Multivariate statistical analysis分类
医药卫生引用本文复制引用
汪盛华,王书娟,闫明,周恩丽,章晨峰,王振中..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[J].时珍国医国药,2026,37(16):3062-3068,7.基金项目
国家长三角科技创新共同体联合攻关项目(2023CSJGG1700) （2023CSJGG1700）
