毕业论文-头孢丙烯分散片的制备及质量考察

泰山医学院毕业设计（论文）题目头孢丙烯分散片的制备及质量考察院（部）系药学院所学专业制药工程年级、班级完成人姓名指导教师姓名专业技术职称年月日摘要目的研制头孢丙烯分散片，通过减少药物崩解时间，提高药物的吸收度。方法通过头孢丙烯分散片辅料相容性试验，筛选制剂的最佳处方，从溶出度、含量测定等实验对制剂进行质量检查。结果筛选出最佳处方为微晶纤维素、低取代羟丙基纤维素、预胶化淀粉、8PVP50乙醇溶液、阿司帕坦、交联聚维酮、二氧化硅、硬脂酸镁、并进行方法学考察，样品的溶出度、含量测定与上市药品相似。结论按本处方工艺所制得的分散片分散均匀性符合规定，全部崩解时间约在1分钟，溶出度较高，含量测定符合要求。关键词分散片；溶出度；含量测定ABSTRACTOBJECTIVETOSTUDYOFCEFPROZILDISPERSIBLETABLET,BYREDUCINGDRUGDISINTEGRATIONTIME,ENHANCINGDRUGABSORPTIONMETHODSTHROUGHCEFPROZILDISPERSIBLETABLETEXCIPIENTCOMPATIBILITYTESTING,SCREENINGTHEBESTPRESCRIPTIONPREPARATION,FROMTHEDISSOLUTION,ASSAYEXPERIMENTONTHEPREPARATIONOFQUALITYINSPECTIONRESULTSSCREENINGOUTTHEBESTPRESCRIPTIONFORTHEMICROCRYSTALLINECELLULOSE,LOWSUBSTITUTEDHYDROXYPROPYLCELLULOSE,PREGELATINIZEDSTARCH,8PVP50ETHANOLSOLUTION,ASPARTAME,PVPP,SILICONDIOXIDE,MAGNESIUMSTEARATE,ANDMETHODOLOGICALSTUDY,SAMPLEDISSOLUTION,CONTENTDETERMINATIONANDMARKETEDDRUGSSIMILARTOCONCLUSIONACCORDINGTOTHEPRESCRIPTIONANDPROCESSOFTHEPREPAREDDISPERSIONTABLETSUNIFORMITYINACCORDANCEWITHTHEREGULATIONS,ALLTHEDISINTEGRATIONTIMEINABOUT1MINUTES,HIGHLEACHINGRATE,DETERMINATIONMEETSTHEREQUIREMENTSKEYWORDSDISPERSIBLETABLETSDISSOLUTIONCONTENTDETERMINATION目录正文X前言X仪器与试剂X实验方法与结果X讨论X结论X参考文献X文献综述X致谢X附录X头孢丙烯分散片的制备及质量考察学生张俊洋指导教师曹明亮（泰山医学院药学院，泰安271016）1前言头孢丙烯CEFPROZIL为白色至淡黄色结晶性粉末。在水中微溶，在甲醇或二甲基甲酰胺中极微溶，在丙酮、三氯甲烷或乙醚中几乎不溶。头孢丙烯是1991年年底美国FDA批准上市的第二代头孢菌素，为高效、低毒、耐酶的广谱抗生素，对革兰氏阳性菌、革兰氏阴性菌、厌氧菌活性强，其中对革兰氏阳性菌活性突出。临床用于轻、中度感染。我国药品监管部门于1999年10月批准中美上海施贵宝制药有限公司生产和销售头孢丙烯片剂和混悬剂。目前国内市场头孢丙烯有多种剂型，如片剂、胶囊剂、混悬剂等，由于头孢丙烯在水中微溶，给药途径为口服，根据各剂型特点，我们选择了分散片，其优点如下（1）速崩、速效分散片系指在水中能迅速崩解并均匀分散的片剂。分散片中的药物应是难溶性的，分散片加水分散后口服，也可将分散片含于口中吮服或吞服。普通片剂或胶囊剂存在着崩解速度慢的缺点，对药物的吸收有一定的影响。分散片在1921水中一般3分钟内完全崩解，大大提高了药物的吸收度。分散片速崩是由于所选择的崩解剂具有不溶于水与吸湿性强的特点，水分子通过毛细管作用或膨胀作用用渗透进入片剂之中，吸水后粉粒膨胀二倍溶解，不形成胶体溶液，不至于阻碍水分子的继续渗入而影响片剂的进一步崩解。分散片使药物的达血药浓度峰高度增加，达峰时间缩短，这些将会带来临床疗效上的优势。（2）服用方便普通片剂、胶囊剂的体积较大，或一次常需用多片（粒），服用不方便，特别对给老、幼和有吞咽障碍的病人治疗有一定困难。分散片崩解速度快，放入水中可分散成均匀的混悬液，服用方便。（3）制备工艺简单，稳定性强分散片与泡腾片放入水中均可迅速崩解成均匀的混合物溶液。但泡腾片不适合与泡腾剂酸碱溶液相互作用的药物，辅料要选择泡腾剂和水溶性辅料，在生产过程中需控制室温和相对湿度，生产工艺复杂，且对贮藏条件要求高。而分散片崩解后形成可通过710M孔径筛的清澈或略带乳色的水溶液或混悬液，对辅料的选择不要求选择泡腾剂和水溶性辅料，生产条件无特殊要求，水中分散后口服或吞服水中溶解后口服。（4）高效分散片由于其崩解形成均一的混悬液，所以吸收较快、充分，可提高药物的生物利用度。基于以上分散片特点，我们选择研究头孢丙烯分散片，有利于临床使用。具有良好的市场前景。2、临床中头孢丙烯用于治疗敏感菌所致的下列轻、中度感染上呼吸道感染、下呼吸道感染、皮肤和皮肤软组织。把本品做成分散片，携带方便，给药途径简单，且有利于吸收。3、参照头孢丙烯分散片上市制剂的规格与用法用量，确定其规格为025G2仪器与试剂21仪器热风循环烘箱GT005南京马渡药机厂高效湿法混合制粒机GSL250江苏范群干燥设备厂粉末分装机DXDF60B北京清华丰公司岛津高效液相色谱仪（SPD20A紫外检测器、LC20AT泵）ZRS6G智能溶出试验仪CP225D电子天平F2104N电子天平22材料和试剂头孢丙烯齐鲁安替制药有限公司微晶纤维素曲阜市药用辅料有限公司低取代羟丙纤维素曲阜市药用辅料有限公司预胶化淀粉曲阜市药用辅料有限公司阿司帕坦湖南尔康制药有限公司交联聚维酮INTERNATIONLSPECIALTYPRODUCTSINC二氧化硅安徽山河药用辅料股份有限公司硬脂酸镁曲阜市药用辅料有限公司聚维酮K30湖州展望药业有限公司乙醇山东广源医药酒精有限公司23溶液配制231。232。3实验方法与结果31。311。图1表11XXXXXXXXXXXX2XXXXXXXXXXXX3XXXXXXXXXXXX4XXXXXXXXXXXX5XXXXXXXXXXXX6XXXXXXXXXXXX4讨论41。42。5结论。参考文献1纪莉莲柿叶抗菌活性的研究及活性成分的分离鉴定J营养卫生,2003,2431291312杨建雄,原江峰,李发荣柿叶黄酮的体外抗氧化作用研究J营养学报,2003,252215217引用参考文献标示方式应全文统一，用上标的形式置于所引内容最末句的右上角，用“小四号宋体”。如“科学技术1”。参考文献的序号用数字加方括号表示，如1，2等，每一参考文献条目的最后均以“”结束。作者姓名写到第三位，余者写“，等”以英文大写字母方式标识各种参考文献类型专著M,论文集C,报纸文章N,期刊文章J,学位论文D,报告R,标准S,专利P。（1）期刊序号作者题名刊名，出版年，卷号期号起止页码1伊廷夫，徐相连实验室一级管理体制的改革与实践J实验室研究与探索，2003，22（5）8286（2）专著序号著者书名其他责任者如编者译者版本出版地出版者，出版年起止页码2霍斯尼RK谷物科学与工艺学原理李庆龙译M第一版北京中国食品出版社，19892030（3）论文集序号作者题名文集编者姓名会议文集名，出版地出版者，出版年起止页码3司宗国，王群重子湮没快度关联的研究赵维勤，高崇寿编第五届高能粒子产生和重离子碰撞理论研讨会文集C，北京中国高等科学技术中心出版，1996105107（4）国际、国家标准序号标准编号，标准名称4GB/T161591996，汉语拼音正词法基本规则S（5）专利序号专利申请者题名专利国别专利号，出版日期5姜锅洲一种温热外敷药制备方案P中国专利881056073，19890726（6）电子文献序号主要责任者题名电子文献的出处或可获得地址，发表或更新日期/引用日期任选6王明亮关于中国学术期刊标准化数据库系统工程的进展HTTP/WWWCAJCDEDUCN/PUB/WMLTEX/9808102HTML,19980816/19981004综述柿叶的研究进展摘要。关键词；。参考文献1纪莉莲柿叶抗菌活性的研究及活性成分的分离鉴定J营养卫生，2003，24（3）1291312杨建雄，原江峰，李发荣柿叶黄酮的体外抗氧化作用研究J营养学报，2003，25（2）215217致谢。XXXX年X月X日附录对于一些不宜放在正文中、但又是毕业设计中不可缺少的部分，或有重要参考价值的内容，可编入附录中。论文的附录用大写字母A，B，C等连续编号，如附录A。附录中的图、表、公式等用阿拉伯数字另行编序号，但在数码前冠以附录序码，如图A1；表B2；式B3等。您好，为你提供优秀的毕业论文参考资料，请您删除以下内容，O_O谢谢ALARGEGROUPOFTEAMERCHANTSONCAMELSANDHORSESFROMNORTHWESTCHINASSHAANXIPROVINCEPASSTHROUGHASTOPONTHEANCIENTSILKROAD,GANSUSZHANGYECITYDURINGTHEIRJOURNEYTOKAZAKHSTAN,MAY5,2015THECARAVAN,CONSISTINGOFMORETHAN100CAMELS,THREEHORSEDRAWNCARRIAGESANDFOURSUPPORTVEHICLES,STARTEDTHETRIPFROMJINGYANGCOUNTYINSHAANXIONSEPT19,2014ITWILLPASSTHROUGHGANSUPROVINCEANDXINJIANGUYGURAUTONOMOUSREGION,ANDFINALLYARRIVEINALMATY,FORMERLYKNOWNASALMAATA,THELARGESTCITYINKAZAKHSTAN,ANDDUNGANINZHAMBYLPROVINCETHETRIPWILLCOVERABOUT15,000KILOMETERSANDTAKETHECARAVANMORETHANONEYEARTOCOMPLETETHECARAVANISEXPECTEDTORETURNTOJINGYANGINMARCH2016THENTHEYWILLCOMEBACK,CARRYINGSPECIALTYPRODUCTSFROMKAZAKHSTANASMALLARTTROUPEFOUNDEDSIXDECADESAGOHASGROWNINTOAHOUSEHOLDNAMEINTHEINNERMONGOLIAAUTONOMOUSREGIONINTHE1950S,ULANMUQIRARTTROUPEWASCREATEDBYNINEYOUNGMUSICIANS,WHOTOUREDREMOTEVILLAGESONHORSESANDPERFORMEDTRADITIONALMONGOLIANMUSICANDDANCESFORNOMADICFAMILIESTHE54YEAROLDWASBORNINTONGLIAO,INEASTERNINNERMONGOLIAANDJOINEDTHETROUPEIN1975HESAYSTHEREARE74BRANCHTROUPESACROSSINNERMONGOLIAANDACTORSGIVEAROUND100SHOWSEVERYYEARTOLOCALNOMADICPEOPLE“ICANSTILLRECALLTHEDAYSWHENITOUREDWITHTHETROUPEINTHEEARLY80SWESATONTHEBACKOFPICKUPTRUCKSFORHOURSTHESKYWASBLUE,ANDWECOULDNTHELPB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