中药颗粒剂制剂工艺

2012★Vol.14No.6〔WorldScienceandTechnology/ModernizationofTraditionalChineseMedicineandMateriaMedica〕2012-03-092012-12-12＊[e-mail]。□611930＊610083611930。、。。。doi:10.3969/j.issn.1674-3849.2012.06.021、、、[1]。。。。。、。。、。1.“”10~14[1]。2212—★〔WorldScienceandTechnology/ModernizationofTraditionalChineseMedicineandMateriaMedica〕。。、、、、、、、[2]。[3]、、、、、。[4]。。。2010GMP。。2.[5]。、、。、、、。、、、、、、、、、[6~8]。。3.2080。、、、、。、、、、、、[9]。3、、、、、[10]。、、、、、、。。22132012★Vol.14No.6〔WorldScienceandTechnology/ModernizationofTraditionalChineseMedicineandMateriaMedica〕、[11]。[12]、。1.37262mL、∶=10.8∶14.2、、5s、75%55%。[13]、。0.2%／210s。、、[11]。。。。。∶∶=1∶10∶512~5091.96%、、。、。、、、、、、、、、、、。4、。[14]。3%~4%+2∶315%[15]。。9%4%20℃[16]。、K30。0.03、0.05、0.03K30[17]。4。、、、、、、。2214—★〔WorldScienceandTechnology/ModernizationofTraditionalChineseMedicineandMateriaMedica〕[14]。。。、。。、OTC、。、、、、。、、、、。。、。。。1..:,2003∶394~394.2,,,..,2006,15(5)∶47~48.3,,,..,2002,22(2)∶90~92.4,,,..2009.2009.5..,2005,16∶10~17．6,,,..,2008,28(17)∶1460~1461.7..,2006,26(8)∶1043~1044.8,..,2010,22(1)∶27~28.9VANDENDRIESK,DEVEGTOM,GIRARD,etal.Granulebreakagephenomenainahighshearmixer;influenceofprocessandformulationvariablesandconsequencesongranulehomogeneity.PowderTechnol,2003,133(1-3)∶228~236.10K.GIRY,M.GENTY,M.VIANA,etal.MultiphaseversusSinglePotGranulationProcess:InfluenceofProcessandGranulationParametersonGranulesProperties.DrugDevelopmentandIndustrialPharmacy,2006,32(5)∶509~530.11JAMESSWARBRICK.HandbookofPharmaceuticalGranulationTechnology.2nded,BocaRaton:Taylor&FrancisGroup,2005∶191~228.12,..,2001,23(3)∶230~231.13,..,2008,32(4)∶348~350.14YueTeng,ZhihuiQiu,HongWen.Systematicalapproachofformulationandprocessdevelopmentusingrollercompactionlation.EurJPharmandBiopharm,2009,73(2)∶219~229.15,,,．．,2002,19(4)∶66.16..,2000,22(5)∶38.17,,,..,2008,30(4)∶616~618.CurrentStatusandProspectofGranulationTechnologyofGranulesofChineseMedicineHuQifei1,YangJidong1,ChenMan2,LanHong1,OuyangXu1(1.SichuanGuangdaPharmaceuticalCo.,Ltd.ofLivzonPharmaceuticalGroupInc.,Pengzhou611930,China;2.LaboratoryMedicineDepartment,ChengduMedicalCollege,Chengdu610083,China)Abstract:ThisstudywasaimedtointroducecurrentstatusandprospectofgranulationtechnologyofgranulesofChinesemedicine.Relatedliteratureshadbeensearched,retrieved,analyzedandsummarized.Inthispaper,thecurrentstatusofgranulationtechnologyofgranulesofChinesemedicinewasmainlyreviewedfromthewet22152012★Vol.14No.6〔WorldScienceandTechnology/ModernizationofTraditionalChineseMedicineandMateriaMedica〕granulationanddrygranulation.TheresultsshowedthatrotatingextrudinggranulationwithhighsheargranulationandrollcompactiongranulationarebeneficialforthepreparationofgranulesofChinesemedicine.Itwasconcludedthattherotatingextrudinggranulationwithhighsheargranulationandrollcompactiongranulationhaveapromisingfuture.Keywords:GranulesofChinesemedicine,granulationtechnology,currentstatus,prospect2216