粉末直接压片常用辅料的粉体学性质评价.docxVIP

粉末直接压片常用辅料的粉体学性质评价陈盛君1，朱家壁2，祁小乐2(1.江阴天江药业有限公司，江苏江阴214434；2.中国药科大学药学院药剂教研室，江苏南京210009)摘要：评价了常用的直接压片辅料：微晶纤维素(Vivapur?PH301、Ceolus?KG-802和Celldone?200)、乳糖(Cellactose?80、Flowlactose?100)和共聚维酮(Plasdone?S-630)的流动性和可压性。采用Hausner比值、Carrs指数、休止角及川北方程参数综合评价粉体的流动性和充填性；采用抗张强度-压力回归方程和川北方程评价粉体的压缩特性。结果表明，Plasdone?S-630和Ceolus?KG-802可压性较佳，但流动性和充填性较差；Cellactose?80和Flowlactose?100的流动性较好，但可压缩性一般；Vivapur?PH301和Celldone?200流动性、充填性和可压缩性均介于前两者之间。充分了解这些辅料的粉体学性质，有助于合理选择直接压片辅料。关键词：直接压片；可压性；流动性；充填性；川北方程；抗张强度中图分类号：R94文献标志码：A文章编号：1001-8255(2013)10-1010-04EvaluationofMicromeriticPropertiesofExcipientsforDirectCompressionCHENShengjun1,ZHUJiabi2,QIXiaole2(1.JiangyinTianjiangPharmaceuticalLtd.,Company,Jiangyin214434;2.SchoolofPharmacy,ChinaPharmaceuticalUniversity,Nanjing210009)ABSTRACT:Thefluidityandcompressibilityofseveralcommonlyusedpharmaceuticalexcipientsfordirectcompression,whichweremicrocrystallinecellulose(Vivapur?PH301,Ceolus?KG-802andCelldone?200),lactose(Cellactose?80andFlowlactose?100)andcopovidone(Plasdone?S-630),hadbeenevaluated.ThefluidityandfillingpropertyoftheseexcipientswerecharacterizedbyHausnerratio,Carrsindex,angleofreposeandKawakitaequationparameters.Thetensilestrength-pressureregressionequationandtheKawakitaequationwereemployedtocharacterizethecompressibility.TheresultsshowedthatcompressibilityofPlasdone?S-630andCeolus?KG-802weregoodamongtheseexcipients,buttheirfluidityandfillingpropertyweregeneral.ThefluidityandfillingpropertyofCellactose?80andFlowlactose?100wereexcellent,buttheircompressibilityweregeneral.Thefluidity,fillingpropertyandcompressibilityofVivapur?PH301andCelldone?200weremoderate.Throughfullyunderstandingofthepowderpropertiesoftheseexcipients,itwasgoodtocontributetoamorereasonablechoicedirectcompressionexcipients.KeyWords:directcompression;compressibility;fluidity;fillingproperty;Kawakitaequation;tensilestrength粉末直接压片技术具有省时节能、工序简单等特点，适合湿热不稳定的药物，应用日益广泛。对于粉末直接压片工艺，物料的流动性、充填性和可压性等粉体学性质直接影响生产过程中物料的混合和传递等环节，影响制剂的装量差异、含量均匀度等质量指标。然而一些药物粉末自身的流动性和可压性欠佳，除了改进设备的饲料装置外，常通过选择流