三维打印复方丹参口腔崩解片的制备工艺及初步评价.docxVIP

三维打印复方丹参口腔崩解片的制备工艺及初步评价 　　[摘要]目的采用三维（3d）打印技术制备复方丹参口腔崩解片（odt）及其初步评价。方法以丹参、三七、冰片、乳糖、pvpk30、甘露醇、阿斯巴甜、微粉硅胶作为铺层粉末，以含2%pvpk30的乙醇水溶液为粘结剂。通过3d打印技术，制备复方丹参口腔崩解片，设定odt半径5mm，铺粉喷涂层高0.1mm，打印层数30层。并检测口腔崩解片的崩解时限、硬度、质量、外观口感及内部结构特征等指标。结果打印的复方丹参odt半径为（5.1±0.1）mm，厚度为（3.2±0.2）mm。药片的平均质量为167.6mg（rsd=3.40%），药片硬度为（1.72±0.20）kg。所制得片剂在1min以内崩解，孔隙度高，外观及口感良好，微甜。扫描电镜观察结果提示，药片内部微观结构较均匀。结论3d打印的复方丹参odt孔隙度高，载药量高，工艺简易，崩解时限短，口感及外观良好。3d打印复方丹参口腔崩解片具有一定的可行性。 　　[关键词]3d打印；复方丹参；口腔崩解片；崩解时限；硬度 　　[中图分类号]r932[文献标识码]a[文章编号]1674-4721（2019）4（c）-0048-04 　　preparationtechnologyandpreliminaryevaluationoforallydisintegratingtabletsofcompoundsalviamiltiorrhizabythreedimensionsprinting 　　liyue-zhong1tangliang1yangya-dong2zhangwen-yuan2▲ 　　1.instituteofhealthfood，zhejiangacademyofmedicalsciences，zhejiangprovince，hangzhou310013，china；2.instituteofbioengineering，zhejiangacademyofmedicalsciences，zhejiangprovince，hangzhou310013，china 　　[abstract]objectivetoprepareorallydisintegratingtablets（odt）ofcompoundsalviamiltiorrhizabythreedimensions（3d）printingtechnologyandmakeapreliminaryevaluation.methodssalviamiltiorrhiza，panaxnotoginseng，borneol，lactose，povidonek30，mannitol，aspartame，andsilicondioxideweremixedandusedastheprintingpowders，andalcoholaqueoussolutioncontaining2%pvpk30wasusedasthebinder.odtofcompoundsalviamiltiorrhizawaspreparedby3dprintingtechnology.theodtwasset5mminradius，0.1mmincoatinglayerheight，and30layersinlayernumber.thenthedisintegrationtime，hardness，weight，taste，appearance，andinternalstructureoftheodtweredetected.resultstheodtradiusofcompoundsalviamiltiorrhizawasabout（5.1±0.1）mminradius，thethicknesswas（3.2±0.2）mm.theaveragemassofthetabletswas167.6mg（rsd=3.40%）andthehardnessofthetabletswas（1.72±0.20）kg.thepreparedtabletsdisintegratedwithin1min，withhighporosity，goodappearanceandtaste，slightlysweet.theresultsofscanningelectronmicroscopyindicatedthatthemicrostructureofthetabletswasuniform.conclusionthe3dprintedodtofcompoundsalviamiltiorrhizahashighporosity，simpleprocess，shortdisintegrat