Quality assurance for Chinese herbal formulae standardization of IBS-20, a 20-herb preparation 英文参考文献.docVIP

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Quality assurance for Chinese herbal formulae standardization of IBS-20, a 20-herb preparation 英文参考文献.doc

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Quality assurance for Chinese herbal formulae standardization of IBS-20, a 20-herb preparation 英文参考文献

Ipetal.ChineseMedicine2010,5:8 /content/5/1/8 RESEARCH OpenAccess QualityassuranceforChineseherbalformulae: standardizationofIBS-20,a20-herbpreparation Siu-PoIp1,MingZhao1,YanfangXian1,MengliChen1,YuyingZong1,Yung-WuiTjong1,Sam-HipTsai1, JosephJYSung2,AlanBensoussan3,BrianBerman4,HarryHSFong5,Chun-TaoChe1* Abstract Background:Theemploymentofwellcharacterizedtestsamplespreparedfromauthenticated,highquality medicinalplantmaterialsiskeytoreproducibleherbalresearch.Thepresentstudyaimstodemonstrateaquality assuranceprogramcoveringtheacquisition,botanicalvalidation,chemicalstandardizationandgood manufacturingpractices(GMP)productionofIBS-20,a20-herbChineseherbalformulaunderstudyasapotential agentforthetreatmentofirritablebowelsyndrome. Methods:Purityandcontaminanttestsforthepresenceoftoxicmetals,pesticideresidues,mycotoxinsand microorganismswereperformed.Qualitativechemicalfingerprintanalysisandquantitationofmarkercompounds oftheherbs,aswellasthatoftheIBS-20formulawascarriedoutwithhigh-performanceliquidchromatography (HPLC).Extractionandmanufactureofthe20-herbformulawerecarriedoutunderGMP.Chemicalstandardization wasperformedwithliquidchromatography-massspectrometry(LC-MS)analysis.Stabilityoftheformulawas monitoredwithHPLCinrealtime. Results:Qualitycomponentherbs,purchasedfromaGMPsupplierwerebotanicallyandchemicallyauthenticated andquantitativeHPLCprofiles(fingerprints)ofeachcomponentherbandofthecompositeformulawere established.Anaqueousextractofthemixtureofthe20herbswaspreparedandformulatedintoIBS-20,which waschemicallystandardizedbyLC-MS,with20chemicalcompoundsservingasreferencemarkers.Thestabilityof theformulawasmonitoredandshowntobestableatroomtemperature. Conclusion:Aqualityassuranceprogramhasbeendevelopedforthepreparationofastandardized20-herb formulationforuseintheclinicalstudiesforthetreatmentofirritablebowelsyndrome(IBS).Theprocedures developedinthepresentstudywillserveasaprotocolforotherpoly-herbalChinesemedicinestudies. Background (IBS),wehavedevelopedandteste