【文章內(nèi)容簡介】 rds ………………………………… ………………… 2 致謝 ………………………………………………………… 26 參考文獻 …………………………………………………… 34 1 億粒 /年阿莫西林硬膠囊車間工藝設(shè)計 學生署名：劉小蘭 指導老師署名：詹利之 湖北醫(yī)藥學院藥藥護學院 摘要 阿莫西林膠囊 為新型半合成青霉素類藥， 具有 吸收快 、 血藥濃度高 、 殺菌力強 、 毒性極低 、 副作用小 以及 廣泛的抗菌譜，對多種細菌的殺菌作用迅速而強 等特點 。 硬膠囊劑系將一定量的藥物加輔料制成均勻的粉末或顆粒，充填與空膠囊中，或?qū)⑺幬锓勰┲苯犹畛渑c空膠囊中制成，是目前除片劑之外應(yīng)用最為廣泛的一種固體劑型。裝入膠殼的藥物可分為粉末、顆粒、微丸、片劑及膠囊，甚至液體或半固體糊狀物。硬膠囊的生物利用度高，能夠達到速釋、緩釋或控制釋藥等多種目的。此外，膠囊生產(chǎn)工藝過程相對簡單，且能夠彌補其他固體劑型的不足。由于膠殼具有掩味作用，因此能夠有效地隔離藥物的不良氣味。 本設(shè)計為 1 億粒 /年阿莫西林硬膠囊車間生產(chǎn)工藝的設(shè)計。在GMP的相關(guān)規(guī)定指導下，根據(jù)生產(chǎn)需要，進行物 料衡算，完成工藝流程設(shè)計，廠房車間的設(shè)計，設(shè)備平面布置的設(shè)計，總平面布置設(shè)計，潔凈級別設(shè)計，人物流走向設(shè)計。 關(guān)鍵詞： 阿莫西林 硬膠囊劑 車間設(shè)計 Study On The Quality Standard Of 100 million/year hard capsules amoxicillin Process Design Workshop Abstract Amoxicillin is a new semisynthetic penicillin drugs, with the absorption of fast, high plasma concentration, bactericidal ability, low toxicity, side effects and wide antibacterial spectrum, bactericidal action of bacteria on a variety of quick and strong features. Department of hard capsules will be a certain amount of drug plus percipients into a homogeneous powder or granules, filled with empty capsules, or directly to the drug powder into capsules filled with air, is the most widely used than tablets outside a kinds of solid dosage forms. Drugs into the plastic shell can be divided into powder, granules, pellets, tablets and capsules, liquid or semisolid or paste. Hard capsule bioavailability, can achieve rapid release, sustained release or controlled release, and other purposes. In addition, capsule production process is relatively simple, and can make up for lack of other solid dosage forms. The plastic shell with a taste masking effect, so the drug can effectively isolate the bad smell. The design for the 100 million / year hard capsules amoxicillin workshop production process design. The relevant provisions of the GMP guidance, based on production needs, the material balance, plete the process design, plant design, equipment layout design, general layout design, cleanlevel design, logistics to human designs Keywords: amoxicillin hard capsules Workshop Design 年產(chǎn) 100 噸克拉霉素中間體 5181 車間工藝設(shè)計 摘要： 本設(shè)計是按年產(chǎn) 100 噸 (2′ , 4″O雙三甲基硅烷基 )紅霉素A9[O(1乙氧基 1甲乙基 )]肟 (5181)的量進行的車間工藝設(shè)計。該物質(zhì)是合成克拉霉素的關(guān)鍵中間體?？死顾厥切乱淮蟓h(huán)內(nèi)酯類抗生素，臨床應(yīng)用廣泛。 本次設(shè)計采用的工藝路線為：以硫氰酸紅霉素肟為原料、氨水為堿、二氯甲烷為有機溶劑進行游離反應(yīng)后得到紅霉素 A 肟，然后以紅霉素 A 肟為原料，通過 2乙氧基丙烯進行醚化反應(yīng)保護肟羥基，再用三甲基氯硅烷進行硅烷化反應(yīng)，經(jīng)離心、干燥后得到克拉霉素關(guān)鍵中間體，整個工藝過程總收率可以達到 86%。 設(shè)計內(nèi)容主要包括車間工藝設(shè)計依據(jù)、工藝流程設(shè)計、物料衡算、能量衡算、工藝設(shè)備選型與計算、車間布置設(shè)計、三廢處理、勞動保護、安全生產(chǎn)、工程經(jīng)濟等內(nèi)容。設(shè)計所得成果主要有設(shè)計說明書和相應(yīng)的圖紙，其中圖紙包括反應(yīng)釜裝配圖、工藝流程圖、設(shè)備一覽表、車間平面布置圖及剖面圖。 關(guān)鍵詞： 克拉霉素； 5181 中間體；紅霉素肟；車間工藝設(shè)計 年產(chǎn) 億粒復(fù)方降脂膠囊劑 GMP 車間設(shè)計 摘要 復(fù)方降脂膠囊為治療高血脂癥的特效新藥。設(shè)計從科學，合理，可行性的原則出發(fā)，主要對年產(chǎn) ，工藝流程、廠房車間、設(shè)備選型等方面進行了 GMP 設(shè)計。設(shè)計中產(chǎn)品的生產(chǎn)工藝簡潔，由 4個工段組成，分別為前處理工段，提取工段，制劑工段和外包工段。設(shè)計的工藝技術(shù)在充分運用國內(nèi)現(xiàn)有技術(shù)的同時對某些工藝步驟做了較科學合理的創(chuàng)新，比如制粉工藝選用了超微粉碎技術(shù)等。設(shè)計選定廠址于甘肅天水市秦州區(qū)西坪。設(shè)計生產(chǎn)區(qū)廠房主要由制劑車間和前處理提取車間組成，制劑車間為一層框架結(jié)構(gòu)，前處理提取車間為兩層框架結(jié)構(gòu)。廠區(qū)內(nèi)設(shè)置了相應(yīng)的輔助設(shè)施，布置科學合理。同時，設(shè)計還在 GMP規(guī)范基礎(chǔ)上對工廠的人員編制，組織機構(gòu)等當面做了比較合理的設(shè)置。本設(shè)計嚴格執(zhí)行國家 GMP規(guī)范及相關(guān)規(guī)定。 關(guān)鍵詞 復(fù)方降脂膠囊，工藝，車間，設(shè)計 GMP process design of Fufang Jiangzhi preparation workshop with annual output of 120 million capsules Abstracts Fufangjiangzhi capsule is a new proprietary Chinese medicines which has a special effect for reducing blood lipid .This paper based on the principle of Scientificalnes,rationality,feasibility is on process ,workshop appliance etc. It’s productive technology is very concise,which is made up of 4 Project stage including the treatment for the earlier stage,the stage for extracting and separationis,the stage for preparation and the stage for outside casing. This paper not only made good use of the available technology in china today but also did some foak necessary such as the AMD technology. According the request of GMP standard ,the factory site of the design is located in the city of Tian Shui,GanSu province. The workshop building for producing is mainly made up of 2 sections: the workshop for the treatment of the earlier stage and the workshop for preparation section of construction factory of this design has auxiliary facilities all in readiness and it’s arrangement is rational as well as scientifical. blood lipid. This paper based on the principle of Key words Fufang Jiangzhi, ,process,Workshop, Design 年產(chǎn) 1000 萬支 10ml 糖漿劑生產(chǎn)車間工藝設(shè)計 第一章 概述 錯誤 !未定義書簽。 糖漿劑介紹 錯誤 !未定義書簽。 糖漿劑的特點 錯誤 !未定義書簽。 糖漿劑劑的分類 錯誤 !未定義書簽。 糖漿劑的規(guī)格和質(zhì)量 錯誤 !未定義書簽。 糖漿劑 在制備與貯 藏過程中易出現(xiàn)的問題 錯誤 !未定義書簽。 磷酸可待因糖漿簡介