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泰山醫(yī)學(xué)院畢業(yè)設(shè)計(jì)(論文)題目頭孢丙烯分散片的制備及質(zhì)量考察院(部)系藥學(xué)院所學(xué)專業(yè)制藥工程年級(jí)、班級(jí)完成人姓名指導(dǎo)教師姓名專業(yè)技術(shù)職稱年月日摘要目的研制頭孢丙烯分散片,通過(guò)減少藥物崩解時(shí)間,提高藥物的吸收度。方法通過(guò)頭孢丙烯分散片輔料相容性試驗(yàn),篩選制劑的最佳處方,從溶出度、含量測(cè)定等實(shí)驗(yàn)對(duì)制劑進(jìn)行質(zhì)量檢查。結(jié)果篩選出最佳處方為微晶纖維素、低取代羥丙基纖維素、預(yù)膠化淀粉、8PVP50乙醇溶液、阿司帕坦、交聯(lián)聚維酮、二氧化硅、硬脂酸鎂、并進(jìn)行方法學(xué)考察,樣品的溶出度、含量測(cè)定與上市藥品相似。結(jié)論按本處方工藝所制得的分散片分散均勻性符合規(guī)定,全部崩解時(shí)間約在1分鐘,溶出度較高,含量測(cè)定符合要求。關(guān)鍵詞分散片;溶出度;含量測(cè)定ABSTRACTOBJECTIVETOSTUDYOFCEFPROZILDISPERSIBLETABLET,BYREDUCINGDRUGDISINTEGRATIONTIME,ENHANCINGDRUGABSORPTIONMETHODSTHROUGHCEFPROZILDISPERSIBLETABLETEXCIPIENTCOMPATIBILITYTESTING,SCREENINGTHEBESTPRESCRIPTIONPREPARATION,FROMTHEDISSOLUTION,ASSAYEXPERIMENTONTHEPREPARATIONOFQUALITYINSPECTIONRESULTSSCREENINGOUTTHEBESTPRESCRIPTIONFORTHEMICROCRYSTALLINECELLULOSE,LOWSUBSTITUTEDHYDROXYPROPYLCELLULOSE,PREGELATINIZEDSTARCH,8PVP50ETHANOLSOLUTION,ASPARTAME,PVPP,SILICONDIOXIDE,MAGNESIUMSTEARATE,ANDMETHODOLOGICALSTUDY,SAMPLEDISSOLUTION,CONTENTDETERMINATIONANDMARKETEDDRUGSSIMILARTOCONCLUSIONACCORDINGTOTHEPRESCRIPTIONANDPROCESSOFTHEPREPAREDDISPERSIONTABLETSUNIFORMITYINACCORDANCEWITHTHEREGULATIONS,ALLTHEDISINTEGRATIONTIMEINABOUT1MINUTES,HIGHLEACHINGRATE,DETERMINATIONMEETSTHEREQUIREMENTSKEYWORDSDISPERSIBLETABLETSDISSOLUTIONCONTENTDETERMINATION目錄正文X前言X儀器與試劑X實(shí)驗(yàn)方法與結(jié)果X討論X結(jié)論X參考文獻(xiàn)X文獻(xiàn)綜述X致謝X附錄X頭孢丙烯分散片的制備及質(zhì)量考察學(xué)生張俊洋指導(dǎo)教師曹明亮(泰山醫(yī)學(xué)院藥學(xué)院,泰安271016)1前言頭孢丙烯CEFPROZIL為白色至淡黃色結(jié)晶性粉末。在水中微溶,在甲醇或二甲基甲酰胺中極微溶,在丙酮、三氯甲烷或乙醚中幾乎不溶。頭孢丙烯是1991年年底美國(guó)FDA批準(zhǔn)上市的第二代頭孢菌素,為高效、低毒、耐酶的廣譜抗生素,對(duì)革蘭氏陽(yáng)性菌、革蘭氏陰性菌、厭氧菌活性強(qiáng),其中對(duì)革蘭氏陽(yáng)性菌活性突出。臨床用于輕、中度感染。我國(guó)藥品監(jiān)管部門于1999年10月批準(zhǔn)中美上海施貴寶制藥有限公司生產(chǎn)和銷售頭孢丙烯片劑和混懸劑。目前國(guó)內(nèi)市場(chǎng)頭孢丙烯有多種劑型,如片劑、膠囊劑、混懸劑等,由于頭孢丙烯在水中微溶,給藥途徑為口服,根據(jù)各劑型特點(diǎn),我們選擇了分散片,其優(yōu)點(diǎn)如下(1)速崩、速效分散片系指在水中能迅速崩解并均勻分散的片劑。分散片中的藥物應(yīng)是難溶性的,分散片加水分散后口服,也可將分散片含于口中吮服或吞服。普通片劑或膠囊劑存在著崩解速度慢的缺點(diǎn),對(duì)藥物的吸收有一定的影響。分散片在1921水中一般3分鐘內(nèi)完全崩解,大大提高了藥物的吸收度。分散片速崩是由于所選擇的崩解劑具有不溶于水與吸濕性強(qiáng)的特點(diǎn),水分子通過(guò)毛細(xì)管作用或膨脹作用用滲透進(jìn)入片劑之中,吸水后粉粒膨脹二倍溶解,不形成膠體溶液,不至于阻礙水分子的繼續(xù)滲入而影響片劑的進(jìn)一步崩解。分散片使藥物的達(dá)血藥濃度峰高度增加,達(dá)峰時(shí)間縮短,這些將會(huì)帶來(lái)臨床療效上的優(yōu)勢(shì)。(2)服用方便普通片劑、膠囊劑的體積較大,或一次常需用多片(粒),服用不方便,特別對(duì)給老、幼和有吞咽障礙的病人治療有一定困難。分散片崩解速度快,放入水中可分散成均勻的混懸液,服用方便。(3)制備工藝簡(jiǎn)單,穩(wěn)定性強(qiáng)分散片與泡騰片放入水中均可迅速崩解成均勻的混合物溶液。但泡騰片不適合與泡騰劑酸堿溶液相互作用的藥物,輔料要選擇泡騰劑和水溶性輔料,在生產(chǎn)過(guò)程中需控制室溫和相對(duì)濕度,生產(chǎn)工藝復(fù)雜,且對(duì)貯藏條件要求高。而分散片崩解后形成可通過(guò)710M孔徑篩的清澈或略帶乳色的水溶液或混懸液,對(duì)輔料的選擇不要求選擇泡騰劑和水溶性輔料,生產(chǎn)條件無(wú)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懸液,所以吸收較快、充分,可提高藥物的生物利用度?;谝陨戏稚⑵攸c(diǎn),我們選擇研究頭孢丙烯分散片,有利于臨床使用。具有良好的市場(chǎng)前景。2、臨床中頭孢丙烯用于治療敏感菌所致的下列輕、中度感染上呼吸道感染、下呼吸道感染、皮膚和皮膚軟組織。把本品做成分散片,攜帶方便,給藥途徑簡(jiǎn)單,且有利于吸收。3、參照頭孢丙烯分散片上市制劑的規(guī)格與用法用量,確定其規(guī)格為025G2儀器與試劑21儀器熱風(fēng)循環(huán)烘箱GT005南京馬渡藥機(jī)廠高效濕法混合制粒機(jī)GSL250江蘇范群干燥設(shè)備廠粉末分裝機(jī)DXDF60B北京清華豐公司島津高效液相色譜儀(SPD20A紫外檢測(cè)器、LC20AT泵)ZRS6G智能溶出試驗(yàn)儀CP225D電子天平F2104N電子天平22材料和試劑頭孢丙烯齊魯安替制藥有限公司微晶纖維素曲阜市藥用輔料有限公司低取代羥丙纖維素曲阜市藥用輔料有限公司預(yù)膠化淀粉曲阜市藥用輔料有限公司阿司帕坦湖南爾康制藥有限公司交聯(lián)聚維酮INTERNATIONLSPECIALTYPRODUCTSINC二氧化硅安徽山河藥用輔料股份有限公司硬脂酸鎂曲阜市藥用輔料有限公司聚維酮K30湖州展望藥業(yè)有限公司乙醇山東廣源醫(yī)藥酒精有限公司23溶液配制231。232。3實(shí)驗(yàn)方法與結(jié)果31。311。圖1表11XXXXXXXXXXXX2XXXXXXXXXXXX3XXXXXXXXXXXX4XXXXXXXXXXXX5XXXXXXXXXXXX6XXXXXXXXXXXX4討論41。42。5結(jié)論。參考文獻(xiàn)1紀(jì)莉蓮柿葉抗菌活性的研究及活性成分的分離鑒定J營(yíng)養(yǎng)衛(wèi)生,2003,2431291312楊建雄,原江峰,李發(fā)榮柿葉黃酮的體外抗氧化作用研究J營(yíng)養(yǎng)學(xué)報(bào),2003,252215217引用參考文獻(xiàn)標(biāo)示方式應(yīng)全文統(tǒng)一,用上標(biāo)的形式置于所引內(nèi)容最末句的右上角,用“小四號(hào)宋體”。如“科學(xué)技術(shù)1”。參考文獻(xiàn)的序號(hào)用數(shù)字加方括號(hào)表示,如1,2等,每一參考文獻(xiàn)條目的最后均以“”結(jié)束。作者姓名寫到第三位,余者寫“,等”以英文大寫字母方式標(biāo)識(shí)各種參考文獻(xiàn)類型專著M,論文集C,報(bào)紙文章N,期刊文章J,學(xué)位論文D,報(bào)告R,標(biāo)準(zhǔn)S,專利P。(1)期刊序號(hào)作者題名刊名,出版年,卷號(hào)期號(hào)起止頁(yè)碼1伊廷夫,徐相連實(shí)驗(yàn)室一級(jí)管理體制的改革與實(shí)踐J實(shí)驗(yàn)室研究與探索,2003,22(5)8286(2)專著序號(hào)著者書名其他責(zé)任者如編者譯者版本出版地出版者,出版年起止頁(yè)碼2霍斯尼RK谷物科學(xué)與工藝學(xué)原理李慶龍譯M第一版北京中國(guó)食品出版社,19892030(3)論文集序號(hào)作者題名文集編者姓名會(huì)議文集名,出版地出版者,出版年起止頁(yè)碼3司宗國(guó),王群重子湮沒(méi)快度關(guān)聯(lián)的研究趙維勤,高崇壽編第五屆高能粒子產(chǎn)生和重離子碰撞理論研討會(huì)文集C,北京中國(guó)高等科學(xué)技術(shù)中心出版,1996105107(4)國(guó)際、國(guó)家標(biāo)準(zhǔn)序號(hào)標(biāo)準(zhǔn)編號(hào),標(biāo)準(zhǔn)名稱4GB/T161591996,漢語(yǔ)拼音正詞法基本規(guī)則S(5)專利序號(hào)專利申請(qǐng)者題名專利國(guó)別專利號(hào),出版日期5姜鍋洲一種溫?zé)嵬夥笏幹苽浞桨窹中國(guó)專利881056073,19890726(6)電子文獻(xiàn)序號(hào)主要責(zé)任者題名電子文獻(xiàn)的出處或可獲得地址,發(fā)表或更新日期/引用日期任選6王明亮關(guān)于中國(guó)學(xué)術(shù)期刊標(biāo)準(zhǔn)化數(shù)據(jù)庫(kù)系統(tǒng)工程的進(jìn)展HTTP/WWWCAJCDEDUCN/PUB/WMLTEX/9808102HTML,19980816/19981004綜述柿葉的研究進(jìn)展摘要。關(guān)鍵詞;。參考文獻(xiàn)1紀(jì)莉蓮柿葉抗菌活性的研究及活性成分的分離鑒定J營(yíng)養(yǎng)衛(wèi)生,2003,24(3)1291312楊建雄,原江峰,李發(fā)榮柿葉黃酮的體外抗氧化作用研究J營(yíng)養(yǎng)學(xué)報(bào),2003,25(2)215217致謝。XXXX年X月X日附錄對(duì)于一些不宜放在正文中、但又是畢業(yè)設(shè)計(jì)中不可缺少的部分,或有重要參考價(jià)值的內(nèi)容,可編入附錄中。論文的附錄用大寫字母A,B,C等連續(xù)編號(hào),如附錄A。附錄中的圖、表、公式等用阿拉伯?dāng)?shù)字另行編序號(hào),但在數(shù)碼前冠以附錄序碼,如圖A1;表B2;式B3等。您好,為你提供優(yōu)秀的畢業(yè)論文參考資料,請(qǐ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