复方红花滴丸的制备工艺与质量控制.研究

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1、垡趔浚丝笾趁空二、英文摘要ABSTRACTTheresearchincludethepreparationandqualitystandardbyHPLCandTLCmethod，whichisbasedontheanalysisoftheprescriptionandactiveconstituents．accordingto‘吐emethodofthenewdrugsapproval’’．Thisdissertationisthemainlypartof“TheresearchingofnewdrugfromCompoundSafflowerD

2、ruppmgPills'’．InthecouI‘seofstudy，accordingtothetechnicalclaimofexaminationandapprovalmethodofnewdrugwhichwasissuedbydosageformandqualitystandardwasstudiedinorder．1．TheeffectiveconstituentinSafflowerisqualified，whichisuptothestandardof2005editionSChinesepharmacopoeia．Observedt

3、hepollengrainsofSafflowerfirstbySea／lningelectronmicroscope(SEM)．Thepollen目面nsareellipsoidorsubspheroidal，Thepollensurfacesticksout、】vitllspines．andhasthreeapel'tu／es．Studiesofextraxrttechnology：Accordingt0theeffectofprescriptionmadcha／aet盯ofcomponent,theextractingtechniqueofS

4、afflowerisstudied，whichisbasedonthepaxamcteroftheHydroxysaffloryellowAExtinction．Usingt434)orthogonaltesttoselectthebestprocessofextractionofHydroxysaffloryellowAinSafflower,determinedbyUVspecllophotometer．TheoptimizedextractingtechniqueisexuactingthecrudedrugsbyUltrasomcwavei

5、n35℃．andextmctin49twicefor20minwith20％ethan01．2．SelectthePEG-6000aspedestal．theoptimalratioofextractionandPEG-6000is1：5．Thepreparationconditions,suchasthedifferentkindsofprmarysubstance．cooltagagent,theproportionbetxve部ltheextractsandprimarysubstanceetc．werestudiedtoestablisht

6、heoptimumpreparationprocessforCompoundSafflowerDroppingPills．3．ResearchedthequalitycontrolmethodoftheCompoundSafflowerDroppingPillsformulation．IndentifiedanddeterminedHydroxysaffloryellowAinCompoundSafflowerDroppingPillsbyTLCandHPLC蒯drawuptheclaimofcrudedrugandthequalitystanda

7、rdsofpreparation，IdentifiedHydroxysaffloryellowAbyTLC，SetupthequalitycontrolmethodofHydroxysaffloryellowAbyHPLC．Throughstudiesoftechnologicalprocess，it2丝五堂丛：堂煎±堂笸丝奎canbecertificatedthattechniqueofthenewdrugisstable，qualitystandardiscontrollable，effectisreliable．4．Tostudytheacu

8、tetoxicityofCompoundSafflowerDroppingPills．Thestudiesalsoshow