畢業(yè)論文頭孢丙烯分散片的制備及質(zhì)量考察

1、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，通過減少藥物崩解時(shí)間，提高藥物的吸收度。方法 通過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、8%PVP 50%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，

2、溶出度較高，含量測定符合要求。關(guān)鍵詞：分散片；溶出度；含量測定AbstractObjective: To study of cefprozil dispersible tablet, by reducing drug disintegration time, enhancing drug absorption.Methods: Through cefprozil dispersible tablet excipient compatibility testing, screening the best prescription preparation, from the dissolution

3、, assay experiment on the preparation of quality inspection.Results: Screening out the best prescription for the microcrystalline cellulose, low-substituted hydroxypropyl cellulose, pregelatinized starch, 8%PVP 50% ethanol solution, aspartame, PVPP, silicon dioxide, magnesium stearate, and methodolo

4、gical study, sample dissolution, content determination and marketed drugs similar to.Conclusion: According to the prescription and process of the prepared dispersion tablets uniformity in accordance with the regulations, all the disintegration time in about 1 minutes, high leaching rate, determinati

5、on meets the requirements. Key words: Dispersible tablets; Dissolution; Content determination.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FDA批準(zhǔn)上市的第二代頭孢菌素，為高效、低毒、耐酶的廣

6、譜抗生素，對(duì)革蘭氏陽性菌、革蘭氏陰性菌、厭氧菌活性強(qiáng)，其中對(duì)革蘭氏陽性菌活性突出。臨床用于輕、中度感染。我國藥品監(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。目前國內(nèi)市場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

7、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

8、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，給藥途徑簡單

9、，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：0.25g2 儀器與試劑2.1 儀器熱風(fēng)循環(huán)烘箱GT-005南京馬渡藥機(jī)廠高效濕法混合制粒機(jī)GSL-250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（SPD-20A紫外檢測器、LC-20AT泵）ZRS-6G智能溶出試驗(yàn)儀CP225D電子天平F2104N電子天平2.2 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：Internationl Spe

10、cialty Products Inc.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2.3 溶液配制2.3.1 。 2.3.2 。3 實(shí)驗(yàn)方法與結(jié)果3.1 。3.1.1 。圖1 表1 1xxxxxxxxxxxx2xxxxxxxxxxxx3xxxxxxxxxxxx4xxxxxxxxxxxx5xxxxxxxxxxxx6xxxxxxxxxxxx4 討論4.1 。4.2 。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.營養(yǎng)衛(wèi)生,2003,24(3):129-131.2 楊建雄,原江峰,李

11、發(fā)榮.柿葉黃酮的體外抗氧化作用研究J.營養(yǎng)學(xué)報(bào),2003,25(2):215-217.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))：起止頁碼.1 伊廷夫，徐相連.實(shí)驗(yàn)室一級(jí)管理體

12、制的改革與實(shí)踐J.實(shí)驗(yàn)室研究與探索，2003，22（5）：82-86（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：起止頁碼    2 霍斯尼R K.谷物科學(xué)與工藝學(xué)原理.李慶龍譯M第一版北京：中國食品出版社，1989：20-30（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：起止頁碼3 司宗國，王群重子湮沒快度關(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：中國高等科學(xué)技術(shù)中心出版，1996：105-107（4）國際、國家標(biāo)準(zhǔn)序號(hào) 標(biāo)準(zhǔn)編號(hào)，標(biāo)準(zhǔn)名稱.4 GB/T 16159-1

13、996，漢語拼音正詞法基本規(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.中國專利：881056073，1989-07-26.（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)于中國學(xué)術(shù)期刊標(biāo)準(zhǔn)化數(shù)據(jù)庫系統(tǒng)工程的進(jìn)展http：/ 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.營養(yǎng)衛(wèi)生，2003，24（3）：129-131.2 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.營養(yǎng)學(xué)報(bào)，2003，25（2）：215

14、-217.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(qǐng)您刪除以下內(nèi)容，O(_)O謝謝！A large group of tea merchants on camels and horses from Northwest China's Shaanxi province pass t

15、hrough a stop on the ancient Silk Road, Gansu's Zhangye city during their journey to Kazakhstan, May 5, 2015. The caravan, consisting of more than 100 camels, three horse-drawn carriages and four support vehicles, started the trip from Jingyang county in Shaanxi on Sept 19, 2014. It will pass th

16、rough Gansu province and Xinjiang Uygur autonomous region, and finally arrive in Almaty, formerly known as Alma-Ata, the largest city in Kazakhstan, and Dungan in Zhambyl province. The trip will cover about 15,000 kilometers and take the caravan more than one year to complete. The caravan is expecte

17、d to return to Jingyang in March 2016. Then they will come back, carrying specialty products from Kazakhstan A small art troupe founded six decades ago has grown into a household name in the Inner Mongolia autonomous region. In the 1950s, Ulan Muqir Art Troupe was created by nine young musicians, wh

18、o toured remote villages on horses and performed traditional Mongolian music and dances for nomadic families. The 54-year-old was born in Tongliao, in eastern Inner Mongolia and joined the troupe in 1975.He says there are 74 branch troupes across Inner Mongolia and actors give around 100 shows every

19、 year to local nomadic people. "I can still recall the days when I toured with the troupe in the early '80s. We sat on the back of pickup trucks for hours. The sky was blue, and we couldn't help but sing the folk songs," Nasun says. The vastness of Inner Mongolia and the lack of en

20、tertainment options for people living there, made their lives lonely. "The nomadic people were very excited about our visits," Nasun recalls. "We didn't have a formal stage. The audience just sat on the grass. Usually, the performances became a big party with local people joining

21、in." For him, the rewarding part about touring isn't just about sharing art with nomadic families but also about gaining inspiration for the music and dance. Ulan Muqir literally translates as "red burgeon", and today's performers of the troupe still tour the region's vill

22、ages and entertain nomadic families, but their fame has spread around the world. On May 16 and 17, nearly 100 singers and dancers from the troupe performed at Beijing's Poly Theater. Their show, titled Ulan Muqir on the Grassland, depicted the history and development of the art troupe. "Bei

23、ng from the region allowed me to embrace the culture of Inner Mongolia and being a member of the troupe showed me where I belonged," Nasun, the art troupe's president, who is also a renowned tenor, tells China Daily. During a tour in 1985, he went to a village and met an elderly local man,

24、who told him a story about his friendship with a solider from Shenyang, capital of Northeast China's Liaoning province, decades ago. The solider gave the old man a handmade saddle when they bid farewell. The story inspired Nasun to write Carved Saddle, a song that later became one of his most po

25、pular numbers. Now, every year, Nasun recruits young singers and dancers for the troupe. The troupe has also designed a new repertoire, which is mostly based on the daily lives of Mongolian people, especially the lives of nomadic families, and has combined contemporary musical elements with folk son

26、gs of the region. Haimu, a 25-year-old khoomei (a local variant of overtone singing) singer, joined the troupe three years ago. Along with a six-member band, he performs fast songs and soft ones that he writesall while playing the horse-head fiddle."Although I learned the piano since childhood

27、and grew up listening to various kinds of music, to me, the folk music of Inner Mongolia is the root," he says. "Performing in remote villages is pleasant. I feel at home on the boundless grasslands, and the warm people there make me feel fulfilled." The first round of spring auction

28、season in Beijing ended last week, but it failed to create much spring in the art market. Although two pieces of Chinese painting fetched more than 100 million yuan, the decline in trading volume and sale rate showed a downturn this year. In the “Grand View: Chinese Painting Highlight” session at Ch

29、ina Guardian 2015 spring auctions, Pan Tianshous representative work Eagle, Rock and Flora hit a record auction price of 279 million yuan, while Li Kerans masterwork Jinggang Mountain fetched 126.5 million yuan, an unexpected high in recent years. However, the trading volume fells to 1.87 billion yu

30、an from 2.22 billion yuan in the same period the year before. The Huangchen 2015 Spring Auctions, which recorded 42.5 million yuan in total sales, experienced the same. The section number went down to 5 from 12 compared to last year. According to expert Shao Jianwu, the art market did not attract mu

31、ch excitement this year due to the booming stock market and the persistent problems of forgery and fake deals. The two pieces of Chinese painting notched up high price this spring due to their own value not due to a revival in the market. "The successful transaction of two works with a hammer p

32、rice of more than 100 million yuan once again confirms that valuable and rare works of high quality always earn the long-lasting high price. Chinese painting and calligraphy is still the pillar of the market. However, the overall sales rate has dropped slightly, which reflects the demand for the ord

33、inary auction goods has weakened,” said the president of China Guardians Hu Yanyan. "Besides, the entry of new buyers also makes certain changes to the direction of purchasing. In a word, the overall market trend is very unpredictable. Although China Guardian 2015 Spring Auctions has achieved r

34、emarkable results, it does not mean that the market has walked out of the predicament. We still have to wait for the big economic boom to invigorate the art market.” Even so, the hot pursuit of some special items appeared this spring. A special session of China Guardian Spring Auctions titled “Fine

35、GiltBronze Buddhist Images” achieved a great deal with total sales volume of 41.89 million yuan and 92 percent sale rate. The 5th Shamar Rinpoche Statue from 16-17th century of Tibet was sold for 5.06 million yuan. The Beijing Chengxuan Auctions featured almost 2,800 items of coins and stamps in thr

36、ee sessions with good sale rate. The Huachen Auctions also set a special session of photographs under the condition of large-scale decline of auction sessions. There was a palpable dull thud of disappointment that accompanied the return of the imperial entourage of Zhen Huan to her homeland. It foll

37、owed a couple years of hushed excitement as Chinese fans were fed tidbits about their proud concubine who was supposed to conquer the high ground of the North American market. Zhen Huan is, of course, the title character of The Legend of Zhen Huan, a 2011 television series that swept China off its f

38、eet and later took other Asian countries by storm. Two years ago, it was reported that HBO, a premium cable service headquartered in the United States, was going to air it in North America after some modification. Now, a condensed version that provides English subtitles but no dubbing has finally be

39、en made available on Netflix for online streaming. This version, highly anticipated as a milestone in China's cultural foray overseas, has been widely panned by its home audience. Retitled Empresses in the Palace, the American version has been shortened from its original 76 episodes at 45 minute

40、s each, to six 90-minute episodes. The quick pacing threw off many native viewers, who are accustomed to a more leisurely daytime-soap-style narrative rhythm. (Chinese TV stations would run two or three episodes every day.) I did not finish the full-length version and found the truncated one not dif

41、ficult to follow. What's lost, I believe, are the interesting setups and pauses that illuminate the Chinese art of storytelling. Much of the plot is still there. It is the flavor that was sacrificed. The American edition uses the framework of the Empress Dowager in her senior years reminiscing a

42、t the beginning and the end of each episode, hinting at what's to come and recapping the key points. This device, not used in the original, is culturally understandable but artistically mediocre. What puzzles me is the two new songs for the opening and end credits. They were written in English,

43、but sung by Chinese with an uncomfortable accent. They were obviously designed to appeal to an English-speaking base, but do not jibe with the Chinese dialogue. Speaking of the dialogue, the English translation, picked apart by some Chinese, is too literal for my taste. I can imagine a typical Ameri

44、can hit by a flurry of royal ranks, addresses and greetings, even multiple names and titles for the same person. The first half hour must be a swamp to wade through, very much like my experience of getting through a Tolstoy tome with its endless inflections of names transliterated into lengthy Chine

45、se. I see the choice of verbatim translation as an effort for conveying exotica. It is fairly competent, with no error that I could detect, but fails to rise above words or capture the essence of the language. A cultural product usually crosses over to a foreign territory first by an emphasis on the

46、 commonalities. But whether inside or outside China, the temptation to sell it for the differences is just too great. Sure, the sumptuous sets and costumes are a big attraction, but the narrative technique has becomehow shall I put it?a bit anglicized, which is necessary for cultural export. Judging

47、 by the responses, this legend, which, contrary to the claim of the English trailer, is totally fictitious, has departed from China but not yet landed on American shores. I am a big fan of Ralph Waldo Emerson's essay titled Self-Reliance. If you've not yet read it, I strongly encourage you t

48、o do so. In this essay, the venerable Emerson talks about eschewing the trappings of society and finding one's own path. He urges the reader to find rectitude and lead a moral life. He professes that, only by being self reliant, as opposed to relying on the government and being dictated to by so

49、ciety, can one begin leading a decent and purposeful life. He avers that such a life is the only life worth living. I agree with him. This essay was written during a time of social upheaval in America, and it is rather odd that Emerson authored it, as he was a part of the upper crust of society at t

50、he time. It just so happened that he looked around him, at the indolence and the wantonness of the people in his circle; he wondered how in the world he came to belong there. Indeed his penning and publishing this essay caused his excommunication from high society and also caused him a lot of legal trouble. The legal trouble came as a result of the fact that he was speaking out against the government. I like to reference such texts from time t