ReinhardWeidhase--国际血浆代用品市场的发展趋势

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1、ParenteralDrugCongress2013MedicinalProductsforPlasmaSubstitution–Experiences,Peculiarities,MarketTrendsNanjing,June21st2013Prof.Dr.ReinhardWeidhaseSerumwerkBernburgAG,GermanyParenteralDrugCongress2013MainTopicsGeneralRemarksTheActivePharmaceuticalIngred

2、ientsGelatineandHydroxyethylStarchTheCharacteristicsofHydroxyethylstarchClinicalParticularsandMarketTrendsParenteralDrugCongress2013HistoryofPlasmasubstitutionYearSourceInvestigators1878SalineSANDER1881SalineLANDERER1915GelatineHOGAN1937PV-AlcoholBRAUN/

3、JORNSPV-PyrrolidoneREPPE/WEESE/HECHT1944DextraneGRÖNWALL/INGELMANNParenteralDrugCongress2013HistoryofPlasmasubstitutionYearSourceInvestigators1951/52modifiedGELCAMPBELL/TOURTELOTTE1957OxyethylstarchWIEDERSHEIM1962Urea-linkedGELSCHMIDT-THOME1962HESTHOMPS

4、ON/WALTONSince1970severalvariationsofHESbydifferentcompanies2011MonographforHESofPharm.Eur.ParenteralDrugCongress2013DevelopmentsinSerumwerkBernburgAGYearSource1959DextranesforclinicaluseModifiedGelatineinsaline1991ModifiedGelatineinbalancedsolutionHES2

5、00/0.5basedonpotatostarchHES130/0,42basedonpotatostarchinsalineandinbalancedsolutionaswell2008NewplantforManufacturingofHESParenteralDrugCongress2013SubstancesforcolloidalvolumereplacementSourcesBiologicalOriginNon-BiologicalOriginSyntheticPolymersPVPHu

6、manOriginOtherBiologicalOriginDextran(Microbes)Gelatine(Animal)Starch(Plants)HumanPlasmaHSAParenteralDrugCongress2013RequirementsforVolumeReplacementProductsIsooncoticandisoosmoticpropertiesAdequatevolumeefficacySafeeliminationMetabolizationandnostorage

7、intissuesNoadditionalpharmacologicaleffectsSterileandfreeofpyrogensNoInfluenceonplasmaviscosityStabiletotemperaturechangesLongshelflifeAcceptable(low)pricetocustomersParenteralDrugCongress2013ParenteralDrugCongress2013SolutionsforInfusionBasedonGelatine

8、–PeculiaritiesconcerningManufacturing,StructureandAdministrationParenteralDrugCongress2013ParenteralDrugCongress2013ParenteralDrugCongress2013ParenteralDrugCongress2013SubstancesforcolloidalvolumereplacementSourcesBiologicalOrigi