【正文】 湖北民族學(xué)院制藥工程課程設(shè)計 1 年產(chǎn) 億粒膠囊生產(chǎn)車間工藝設(shè)計 專業(yè) :化工與制藥 班級 :0412408 學(xué)號 :041240836 姓名 :吉波莫日牛 摘要 : 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)計為年產(chǎn) 億粒膠囊車間生產(chǎn)工藝的設(shè)計。在 GMP 的相關(guān)規(guī) 定指導(dǎo)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 ：工藝設(shè)計、膠囊劑、工藝流程、廠房車間設(shè)計 Abstract: Hard capsule system refers to a certain amount of drug and excipients into uniform powder or granules, or directly filled the drug powder into empty capsules, is currently most widely used as a solid dosage forms in addition to tablets. The drug loaded into the plastic shell can be divided into powder, pellet, pellet, tablet and capsule, even liquid or semi solid paste. The bioavailability of hard capsule is high, and can reach many purposes such as rapid release, slow release or controlled release, etc. In addition, the capsule production process is relatively simple, and can make up for the lack of other solid dosage forms. Because the adhesive shell has the mask effect, it can effectively isolate the bad smell of the medicine. The design is the annual output of 350000000 capsules workshop production process design. The design is under the guidance of GMP related regulations, according to the needs of production, carrying out material balance, plete the design of workshop, equipment layout, general layout, the clean level and the Character flow trends. 湖北民族學(xué)院制藥工程課程設(shè)計 2 目 錄 第一章 工藝概述 ............................................................................................................ 4 膠囊劑的概述 ..................................................................................................... 4 設(shè)計目的 ............................................................................................................. 4 設(shè)計原則 ............................................................................................................. 5 設(shè)計要求及內(nèi)容： ............................................................................................... 5 設(shè)計依據(jù) ............................................................................................................. 5 第二章 工藝流程及 凈化區(qū)域劃分 ................................................................................... 6 產(chǎn)品類型及生產(chǎn)規(guī)模 ........................................................................................... 6 生產(chǎn)工藝 ............................................................................................................. 6 第三章 物料衡算 ............................................................................................................. 8 ．基本物料衡算 .................................................................................................... 8 ．物料損耗計算 .................................................................................................... 8 包裝材料計算 ..................................................................................................... 8 第四章 工藝設(shè)備選型說明 ............................................................................................. 10 生產(chǎn)設(shè)備選型說明 ............................................................................................. 10 選型原則 ........................................................................................................... 10 設(shè)備的主要參數(shù)選擇 .......................................................................................... 10 設(shè)備的可靠性和維修性 ...................................................................................... 11 制藥企業(yè)設(shè)備選型 ..........