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ID:40241174
大小:4.84 MB
页数:50页
时间:2019-07-28
《中国药科大学药剂学ControlledSustained-ReleaseDrugDeliverySystems课件》由会员上传分享,免费在线阅读,更多相关内容在教育资源-天天文库。
1、Controlled&Sustained-ReleaseDrugDeliverySystemsPharmaceuticsDepartmentChinaPharmaceuticalUniversityLearningObjectivesTomastertheprincipleofdrugreleasefromDDSTomasterusualmethodstoachievecontrolledreleaseandtheirformuladesignTounderstandtheevaluationofthein-vitro&in-vivoof
2、DDSOutlineDDSdevelopmentIntroductiontoDDSbasicconcept,classification,advantageMechanism5typesFormuladesignCommonprincipleinfluencingfactorsformuladesignexamplesChapter1HistoryofDDSDevelopment1)Original:waxpellets、suspensionsetc2)Developmentatoverseas3)China蜡丸是最早的缓释制剂,其作用缓
3、和而持久研制:1950s上市:1970s规模生产:1980s目前:口服200余种,不同规格余的商品计有400种80年代初开始已有近百种制剂获国家新药证书Nimodipine、Nifedipine、Nitrendipine、Felodipine;Diclofenac、Naproxen、Tramadol、Morphine;Nitroglycerol、Clonidine、IsosorbideMononitrate;TiclopidineHydrochloridc、Aspirin;Acopolamine(patch)、Norgestrel(imp
4、lants)国内部分上市品种Chapter2BasicConcept1、DefinitionSustained-releasepreparation缓释制剂——较长时间内持续释药sustained-release~,extended-release~,prolongedaction~,repeat-action~,retardedpreparationsControlled-releasepreparation控释制剂——以恒定速度药(狭义)。广义:速度、时间、方向(部位)ControlledReleasevs.SustainedRel
5、easeSustainedrelease种类、品种多(约80%)处方工艺简单易于工业化大生产Controlledrelease种类、品种较少处方工艺较复杂质量标准要求高Chapter2BasicConcept2、ClassificationTypesofDrugDeliverySystems1)骨架型(Matrix):Hydrogels、Wax、Insolublematrixesetc.释药过程flash2)膜控型(Membrane):macro-porous、micro-porous、semi-permeablemembraneetc.
6、基本结构picture3)其它(Others):Osmoticpumps、Implanted、Impulsivepreparations、Transdermaltherapeuticsystem(TTS)、Self-regulatedDDSetc.膜控型微丸基本结构聚合物缓释包衣层药物层色衣层基丸骨架型片剂释药示意图Chapter2BasicConcept3、CharacteristicsTheoryofDDS1)Safe:血浓平稳,避免峰谷现象,降低毒副作用;2)Effect:降低胃肠道刺激,提高生物利用度,减少给药总剂量;3)Conv
7、enience:延长给药间隔,减少服药频率,提高服药依从性(Compliance)。Qualitycontrol:成本较高,制造过程复杂,大生产易出现质量问题(特别是膜控型)。CharacteristicsChapter3Mechanism5TypesofSystemRate-controlledmechanismNoyes-WhitneyEquation•DevelopedbyNoyesWhitneyin1897••Ifc<8、ogetextendingAccordingNoyes-WhitneyEquation1)ReducingtheCs2)Reducingthedissolutionrate1)Salifica
8、ogetextendingAccordingNoyes-WhitneyEquation1)ReducingtheCs2)Reducingthedissolutionrate1)Salifica
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