I摘要研究背景：在FDA的要求下，QbD（QualitybyDesign，质量源于设计）已成为制药行业提高药品质量的发展方向。研究目的：用QbD方法对现有产品LP片的包衣工艺进行技术改进，解决工艺问题。同时借鉴国外先进经验，结合国内现状，梳理分析现行政策下QbD的具体做法，并就如何实施提出意见和建议。研究方法：使用DOE（DesignofExperiment）方法在包衣工艺改进过程中进行QbD实施。通过正交实验设计来找出影响包衣工艺的关键因素以及因素间关系，再用全析因设计对部分参数进行小范围的优化。国情特点和国内外相关经验，结合本次QbD实施结果，总结归纳QbD实施的难点和可行性。研究结果和结论：实施QbD虽然前期投入成本较高，但是其可以降低生产成本，提高企业的产品质量和市场竞争力。关键词：工艺改进；QbD实施；实验设计；药品质量IIQbDApplicationtoProcessImprovement-ACaseofCoatingProcessforLPTabletAbstractBackground:UndertheFDA'srequirements,theQbD(QualitybyDesign)hasbecomethedevelopmenttrendforpharmaceuticalindustrydevelopmenttoimprovetheproductquality.Objective:QbDmethodswereusedintheimprovementofthecoatingprocessforthelegendLPtablestosolvetheprocessproblem.AndtherecommendationsandtheproposalswereputforwardbyscrutinizingthepracticalpathwayunderthecurrentpolicieswiththeadvancedexperiencesinforeigncountriesincombinationwiththecurrentconditionsinChina.Methods:TheQbDmethodwasemployedintheimprovementofthecoatingprocessthroughDOE(designofexperiment)method.Thecriticalfactorsthathaveimpactsoncoatingprocessandtheinterrelationsbetweenthesefactorswerescreenedoutthroughorthogonaldesign,andsomeparameterswereoptimizedwithfullfactorialdesign.BasedontheresultsoftheQbDimplementation,thedifficultiesandthefeasibilityfortheimplementationofQbDweresummarizedwiththeconsiderationofthedomesticconditionsandtherelevantabroadexperiences.ResultsandConclusion:theupfrontcostfortheimplementationofQbDwashigher,buttheimplementationofQbDcouldreducethemanufacturingcostandimprovetheproductqualityandmarketcompetiveness.Keywords:Processimprovement;QbDimplementation;DesignofExperiment;PharmaceuticalqualityIII目录HYPERLINK\l"_TOC_250015"第1章引言1HYPERLINK\l"_TOC_250014"1.1研究背景1HYPERLINK\l"_TOC_250013"1.2研究目的与意义2HYPERLINK\l"_TOC_250012"1.3相关概念确定2HYPERLINK\l"_TOC_250011"第2章研究设计32.1数据来源3HYPERLINK\l"_TOC_250010"2.2研究方法3HYPERLINK\l"_TOC_250009"第3章研究结果4HYPERLINK\l"_TOC_250008"3.1对现有工艺的工艺理解5HYPER