复方盐酸伪麻黄碱口腔速崩片的研究

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1、沈阳药科大学硕士学位论文复方盐酸伪麻黄碱口腔速崩片的研究姓名：闫学文申请学位级别：硕士专业：药剂学指导教师：崔福德2003.5.1沈阳药科太学醐士学位论文摘蔡摘要零文耀盐羧魏瓣黄碱靼麴蠓黢笨海控明作为模型药，考察了敷接聪片法制铸口腔逋崩片的处方和工艺。本文用盐酸苯海拉髓合成稳橼酸辈海控碉，制备彳鞫橼酸苯海羧筏熬EudragitE100露体分数体。建立了擒臻羧苯海拉骥含量戆俸终硷测方法；测定了搀橼黢苯海拉明的油水分鞭己系数和溶解度，初步稳定性实验表明，枸橼酸苯海挝明原料药对黼温、离湿和光照都很稳定，加迷实验和长期实验缩采证明枸橼酸苯海拉明性质稳定。／奁单霞褰考察瓣基旗上，往纯徽球影硅胶嘏

2、辩盐酸镄麻莛碱静条终。影响因褰试验表明暖簿镦球澎硅胶药物含薰和释放废不交。雨溶液屡积工琶进一步掇高暖药微球形醵胶的载药霪。糟Surelease礓0水分散体帮EudragitE100作为包农材料黼备薤酸锈寐黄碱静掩睬徽囊，魁衣粒子增重20％M，可运至#较好鹣燕绦熬栗，Eudragit嚣1t30瓣撼昧效莱不薅怒。j鼽，零交考察了A种糖醇类辅瓣游溶辩性煞鞫压缩成形性，靛串选爨出絮耱裙赤藓糖佟为口整邃麓嚣戆耋簧辕耩。鼷多元疆是方戆、效疯菇驽嚣耨等嚣线黧考察我涨攀帮娃方筑成每强睦速臻冀豹挽张强度霸壤麟瓣蠲熟芙系，在藕勰瓣阕等嵩绞黧中爨熬捷张强发帮攘鼹对溜鼹含逮区域，蝴交的嚣域戈处方秘王芝条传熬馁

3、纯嚣。按j毙续聚剃餐曩睃速潮姥，髑解黪润魏魏张强度郝能这劐设嚣要求。俸终游蹬实验缭暴表雳，蹲腔遮照片审嚣耱药躲静港魄速璇要魄普暹片中骜耪耱港窭遽度捷。／稳定蛙试验表明零鼹褒40±2*0，RH75％+5％的加速嶷验袋{牛下，保存三个月，农25"0±2℃，RH60％±t0％的条4牛下，长期实验观察兰个月，棒懿幢状、髑解时鼹、含鬃溜来笈燕明显交纯，说鲷鹣獠羧苯海被鞠翻盐酸赞潦羹碱嚣耱鞭辩势凝掰选辘凝挂纛强寇。盖。如—一关键词：口腔遮崩彤抗张强度，崩解时间；多元嘲峰盐酸伪麻黄碱；沈阳药科大学硕士学位论文A8s

4、I融(?r1疆王i置S董∥粼娃0FCC翘艘OUNDPSEUDOEPHEDRINEHC

5、LFASTBUCCALIXS矗《]旺iGRATINGTABLETYahXuewen(Pharmaceuties)CuiFude，ABSTRACfTheaimofthisstudywastodevelopafastbuccaldisintegratingtabletwithasimpleandlowcostmanufacturingprocess。ThemodeldrugswerePseudoephedrineHclandDiphanhydrmninecitrate,andtheywereverywatersolvableandverybitter．Inthiscasetwofactor

6、swouldbeclarified．Theywerehowtoimprovethedissolvingrateofthetabletsandhowtomaskefficientlyunpleasanttasteoftheactivecomponents．Therefore,thestudiesasfollowswerecarriedout：First,formulationdesignincludingselectionofexcipientsthatwerefastsoluableandhadgoodcompaetability；Seeond,seleetionofoptimized

7、preparationconditions；Third，Sometaste-maskingmethodswereusedtomasktheirbittertaste．Firstly,inordertoprepareintrabuccallydisintegratingtabletswhichquicklydisintegrateanddissolveinthebuccalcavityandhaveadequatehardness，severalcrystallinesugaralcoholsWereexplored．Theexperimentalresultsshowedthatsor

8、bitolhadexcellentsolubilityandcompactabilitypropertiesandErythritolhadafastdissolutecharacter,．So．SorbitolandErythritolWeresdeetedasthebasicexcipientsofbuooaldisintegratingtablet．1lladdition,10％ofmierocrystallinecelluloseWas