本文主要研究内容
作者蒋芳蓉（2019）在《右布洛芬口服液体缓释给药系统的构建及体内外评价》一文中研究指出：右布洛芬（S-ibuprofen,S-IB）为非甾体抗炎药布洛芬的右旋体,是WHO、美国FDA唯一共同推荐的、首选儿童退烧和抗炎药。但右布洛芬是难溶性药物,在体液中的溶解度非常小,故给药剂量大,常规剂型不便于儿童服用。并且右布洛芬的半衰期仅有1-2小时,患者每天需要服药34次才能维持治疗浓度,频繁给药会导致血药浓度波动过大,增加对胃肠道的刺激性和不良反应。为了克服以上问题,本课题以S-IB为模型药物,ZB-2型阴离子交换纤维作为药物载体,围绕右布洛芬药物纤维缓释混悬液的制备及体内外释药行为进行了系统的研究,主要可分为以下五个部分:一、药物纤维复合物的制备首先将难溶性药物右布洛芬制备成易溶性的右布洛芬钠盐以便于进行离子化载药,然后以ZB-2强碱性阴离子交换纤维作为药物载体,分别采用静态交换法和动态交换法制备右布洛芬药物纤维复合物（Drug-fiber complex,DFC）;同时通过研究纤维粒径、药物浓度等各关键因素对于载药过程的影响,考察不同条件下药物与纤维发生离子交换反应的速率和反应平衡情况,从而确立制备DFC的最佳工艺。二、药物与纤维的结合机制与体外释放通过SEM、DSC确定S-IB与纤维是通过离子交换反应形成的药物纤维复合物,而不是物理吸附。本章考察了释放介质的pH、离子类型、离子强度、温度和转速对DFC释放过程的影响。采用?2相似因子法对DFC的体外释放行为进行分析评价,为进一步制备缓释混悬液提供理论和实验基础。三、DFC的包衣工艺及处方研究首先对DFC进行浸渍处理,避免DFC在水性混悬液中溶胀而造成药物突释,再采用乳化溶剂挥干法进行包衣。参照中国药典关于布洛芬缓释胶囊溶出度测定方法,对包衣过程中的处方及工艺因素进行优化,最终确定了增塑剂的种类与用量、包衣囊材的种类与用量、固化温度和时间等因素,制备出具有明显缓释效果的DFC包衣微囊。DFC包衣微囊的释药行为遵循一级动力学过程,即以膜控为主,粒扩散为辅。四、S-IB缓释混悬液的制备以沉降体积比和再分散性为考察指标,筛选出制备混悬液的处方和工艺。分别测定S-IB包衣微囊及缓释混悬液的体外释放行为,结果表明混悬介质基本不影响药物的释放。同时进行自制缓释混悬液的影响因素试验和加速试验,分别考察了各时间点自制混悬液的药物含量、药物泄漏量、再分散性、沉降体积比、体外释放行为,将检查结果与0天的数据进行对比,结果显示自制缓释混悬液的稳定性良好且符合要求。五、S-IB缓释混悬液大鼠体内药动学研究本章建立了S-IB缓释混悬液的SD大鼠体内分析方法,考察了方法的专属性、精密度、方法回收率和提取回收率,结果均符合要求。市售S-IB混悬液和自制S-IB缓释混悬液分别大鼠灌胃给药,采用非房室模型计算其药动学参数。由药动学参数可知自制缓释混悬液与普通混悬液相比,Cmax有所降低,Tmax有所延长,t1/2分别为6.926h和2.356h,表明自制S-IB缓释混悬液可以有效平稳血药浓度,体内缓释效果明显。自制S-IB缓释混悬液相对市售普通混悬液的相对生物利用度为114.70%,生物等效。
Abstract
you bu luo fen （S-ibuprofen,S-IB）wei fei zai ti kang yan yao bu luo fen de you xuan ti ,shi WHO、mei guo FDAwei yi gong tong tui jian de 、shou shua er tong tui shao he kang yan yao 。dan you bu luo fen shi nan rong xing yao wu ,zai ti ye zhong de rong jie du fei chang xiao ,gu gei yao ji liang da ,chang gui ji xing bu bian yu er tong fu yong 。bing ju you bu luo fen de ban cui ji jin you 1-2xiao shi ,huan zhe mei tian xu yao fu yao 34ci cai neng wei chi zhi liao nong du ,pin fan gei yao hui dao zhi xie yao nong du bo dong guo da ,zeng jia dui wei chang dao de ci ji xing he bu liang fan ying 。wei le ke fu yi shang wen ti ,ben ke ti yi S-IBwei mo xing yao wu ,ZB-2xing yin li zi jiao huan qian wei zuo wei yao wu zai ti ,wei rao you bu luo fen yao wu qian wei huan shi hun xuan ye de zhi bei ji ti nei wai shi yao hang wei jin hang le ji tong de yan jiu ,zhu yao ke fen wei yi xia wu ge bu fen :yi 、yao wu qian wei fu ge wu de zhi bei shou xian jiang nan rong xing yao wu you bu luo fen zhi bei cheng yi rong xing de you bu luo fen na yan yi bian yu jin hang li zi hua zai yao ,ran hou yi ZB-2jiang jian xing yin li zi jiao huan qian wei zuo wei yao wu zai ti ,fen bie cai yong jing tai jiao huan fa he dong tai jiao huan fa zhi bei you bu luo fen yao wu qian wei fu ge wu （Drug-fiber complex,DFC）;tong shi tong guo yan jiu qian wei li jing 、yao wu nong du deng ge guan jian yin su dui yu zai yao guo cheng de ying xiang ,kao cha bu tong tiao jian xia yao wu yu qian wei fa sheng li zi jiao huan fan ying de su lv he fan ying ping heng qing kuang ,cong er que li zhi bei DFCde zui jia gong yi 。er 、yao wu yu qian wei de jie ge ji zhi yu ti wai shi fang tong guo SEM、DSCque ding S-IByu qian wei shi tong guo li zi jiao huan fan ying xing cheng de yao wu qian wei fu ge wu ,er bu shi wu li xi fu 。ben zhang kao cha le shi fang jie zhi de pH、li zi lei xing 、li zi jiang du 、wen du he zhuai su dui DFCshi fang guo cheng de ying xiang 。cai yong ?2xiang shi yin zi fa dui DFCde ti wai shi fang hang wei jin hang fen xi ping jia ,wei jin yi bu zhi bei huan shi hun xuan ye di gong li lun he shi yan ji chu 。san 、DFCde bao yi gong yi ji chu fang yan jiu shou xian dui DFCjin hang jin zi chu li ,bi mian DFCzai shui xing hun xuan ye zhong rong zhang er zao cheng yao wu tu shi ,zai cai yong ru hua rong ji hui gan fa jin hang bao yi 。can zhao zhong guo yao dian guan yu bu luo fen huan shi jiao nang rong chu du ce ding fang fa ,dui bao yi guo cheng zhong de chu fang ji gong yi yin su jin hang you hua ,zui zhong que ding le zeng su ji de chong lei yu yong liang 、bao yi nang cai de chong lei yu yong liang 、gu hua wen du he shi jian deng yin su ,zhi bei chu ju you ming xian huan shi xiao guo de DFCbao yi wei nang 。DFCbao yi wei nang de shi yao hang wei zun xun yi ji dong li xue guo cheng ,ji yi mo kong wei zhu ,li kuo san wei fu 。si 、S-IBhuan shi hun xuan ye de zhi bei yi chen jiang ti ji bi he zai fen san xing wei kao cha zhi biao ,shai shua chu zhi bei hun xuan ye de chu fang he gong yi 。fen bie ce ding S-IBbao yi wei nang ji huan shi hun xuan ye de ti wai shi fang hang wei ,jie guo biao ming hun xuan jie zhi ji ben bu ying xiang yao wu de shi fang 。tong shi jin hang zi zhi huan shi hun xuan ye de ying xiang yin su shi yan he jia su shi yan ,fen bie kao cha le ge shi jian dian zi zhi hun xuan ye de yao wu han liang 、yao wu xie lou liang 、zai fen san xing 、chen jiang ti ji bi 、ti wai shi fang hang wei ,jiang jian cha jie guo yu 0tian de shu ju jin hang dui bi ,jie guo xian shi zi zhi huan shi hun xuan ye de wen ding xing liang hao ju fu ge yao qiu 。wu 、S-IBhuan shi hun xuan ye da shu ti nei yao dong xue yan jiu ben zhang jian li le S-IBhuan shi hun xuan ye de SDda shu ti nei fen xi fang fa ,kao cha le fang fa de zhuan shu xing 、jing mi du 、fang fa hui shou lv he di qu hui shou lv ,jie guo jun fu ge yao qiu 。shi shou S-IBhun xuan ye he zi zhi S-IBhuan shi hun xuan ye fen bie da shu guan wei gei yao ,cai yong fei fang shi mo xing ji suan ji yao dong xue can shu 。you yao dong xue can shu ke zhi zi zhi huan shi hun xuan ye yu pu tong hun xuan ye xiang bi ,Cmaxyou suo jiang di ,Tmaxyou suo yan chang ,t1/2fen bie wei 6.926hhe 2.356h,biao ming zi zhi S-IBhuan shi hun xuan ye ke yi you xiao ping wen xie yao nong du ,ti nei huan shi xiao guo ming xian 。zi zhi S-IBhuan shi hun xuan ye xiang dui shi shou pu tong hun xuan ye de xiang dui sheng wu li yong du wei 114.70%,sheng wu deng xiao 。
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论文详细介绍
论文作者分别是来自江苏大学的蒋芳蓉，发表于刊物江苏大学2019-09-19论文，是一篇关于右布洛芬论文,阴离子交换纤维论文,乳化溶剂挥干法论文,缓释混悬液论文,江苏大学2019-09-19论文的文章。本文可供学术参考使用，各位学者可以免费参考阅读下载，文章观点不代表本站观点，资料来自江苏大学2019-09-19论文网站，若本站收录的文献无意侵犯了您的著作版权，请联系我们删除。
标签：右布洛芬论文; 阴离子交换纤维论文; 乳化溶剂挥干法论文; 缓释混悬液论文; 江苏大学2019-09-19论文;