盐酸氟桂利嗪口腔崩解片的制备及质量评价.doc

盐酸氟桂利嗪口腔崩解片的制备及质量评价盐酸氟桂利嗪口腔崩解片的制备及质量评价2011年4月第8卷第12期?制剂与技术?盐酸氟桂利嗪口腔崩解片的制备及质量评价王景翔,常明,曹德英,,河北石家庄050035;,河北石家庄050017【摘要】目的:研究盐酸氟桂利嗪口腔崩解片的处方及制备工艺,:通过考察辅料种类及不同用量对制剂崩解时限和口感的影响,用正交试验筛选最优处方;直接压片制备口腔崩解片,:通过筛选的优化处方为:,微晶纤维素36甘露醇60g,,PVPP12g,,:过筛次数为3次,硬度控制在30,40N,制备的口腔崩解片口感良好,体内外崩解时限均小于30S,在3rain内累积溶出度达95%以上,含量均匀度小于15%.结论:处方合理,制备工艺简便,测定方法可靠,结果准确.【关键词】盐酸氟桂利嗪;口腔崩解片:正交设计【中图分类号】【文献标识码】A【文章编号】1673—7210(2011)04(c)一071—03ThepreparationandthequalityOrallyDisintegratingTabletsevaluationofFlunarizineHydr0chlOrideWANGJingxiangl'%CHANGMinf,CA0De/a~,,ShijiazhuangUniversity,Shijiazhuang050035,China;,HebeiMedicalUniversity,Shijiazhuang050017,China【Abstract】0bjiective:TostudytheprescriptionandpreparationofFlunarizineHydrochlorideOrallyDisintegratingTablets,:,theorthogonaltestwasusedtogettheoptimumformulation,inwhichtheorallydis—pressionandtherelevant?::,mieroerystallinecellulose36g,,PVPP12g,,,,,invivodisintegrationtimewaslessthan30S,3mincumulativedissolutionWasmorethan95%.contentuniformitywas1eSSthan15%.:Theprescriptionisreasonablewithsimplepreparation,urateresults.【Keywords】Flunarizinehydroehloride;Orallydisintegratingtablet;Orthogonaldesign盐酸氟桂利嗪(FlunarizineHydroehloride)为选择性的钙通道阻断剂,对血管平滑肌有扩张作用,能显着改善脑循环和冠脉循环,,脑栓塞,脑动脉硬化,脑出血恢复期,脑外伤后遗症,内耳眩晕症,,本品口服用药只有胶囊剂市售,考虑到脑血管疾[作者简介】王景翔(1963一),男,内蒙通辽人,硕士,高级工程师;研究方向:药物新剂型病急性发作期及老年患者的服用,后研制了口腔崩解片,不用水或用极少量水就可将药物服下[