质量源于设计在银杏叶片制粒工艺中应用颗粒粉体学性质综合评价.docVIP

质量源于设计在银杏叶片制粒工艺中应用颗粒粉体学性质综合评价 　　[摘要]该文以银杏叶片湿法制粒工艺中颗粒中间体为研究对象，采用粉体学评价方法表征颗粒的堆积性、均一性、流动性、可压性和稳定性。建立了由松装密度、振实密度、颗粒分布宽度、粒径范围、相对均齐度指数、纵横比、豪斯纳比、休止角、流动时间、颗粒间孔隙率、卡尔指数、比表面积、孔体积、孔径分布、干燥失重和吸湿性16个指标构成的颗粒物理指纹谱。通过可压性参数（参数指数、参数轮廓指数和良好可压性指数）分析颗粒压缩特性。运用主成分分析从不同批次颗粒物理指纹谱信息中提取出2个主成分：第一主成分代表颗粒尺寸参数，第二主成代表颗粒形态参数。中药颗粒物理指纹谱可帮助评价不同批次颗粒质量一致性，分析颗粒质量属性对产品质量的潜在影响，为中药颗粒控制和工艺研发提供指导。 　　[关键词]银杏叶片； 物理指纹谱； 颗粒工程； 质量源于设计； 多变量分析Application of 　　[Abstract]In this paper， the granules intermediate prepared from the wet granulation process of ginkgo leaf tablet were taken as the research object， and then the stackability， homogeneity， flowability， compressibility and stability of granules were characterized by using micromeritics evaluation method The physical fingerprint of granules were constructed by 16 indexes including bulk density， tapped density， span， width， relative homogeneity index， aspect ratio， Hausner ratio， angle of repose， granule flow time， interparticle porosity， Carr index， specific surface area， pore volume， pore size distribution， loss on drying and hygroscopicity Furthermore， compressibility parameters （ie index of parameter， index of parametric profile and index of good compression） were employed to analyze the compressibility characteristics of the granules Two principal components （first principal component representing dimension parameter and second principal component representing morphology parameter）， could be extracted from the physical fingerprint by the principal component analysis （PCA） The granules′ physical fingerprint is of great importance to evaluate the batchtobatch quality consistency of Ginkgo biloba granules and analyze the potential impacts of granules′ quality attributes on product quality， which can provide guidance for the granules′ quality control and process development 　　[Key words]ginkgo leaf tablet； physical fingerprint； particle engineering； quality by design； multivariate analysis 　　“安全有效、稳定可控”是药品研发和生产首要遵循原则。人用药品注册技术标准国际协调会（ICH）在2009 年发布的ICH Q8（R2）中