【正文】 ... XXXIX ....................................................................................................................................................... XL ..................................................................................................................................................... LVI 車間布置設(shè)計(jì) .......................................................................................................................................................... LVIII .......................................................................................................................................................... LVIII .............................................................................................................................................................LIX 第 II 頁 ......................................................................................................................................... LX ......................................................................................................................................... LX ........................................................................................................................................LXI 第三章 非工藝設(shè)計(jì) ......................................................... LXI 通風(fēng)、空調(diào)和空氣凈化設(shè) 計(jì) ................................................................................................................................. LXI 設(shè)計(jì)依據(jù) ..........................................................................................................................................................LXI 設(shè)計(jì)參數(shù) ..........................................................................................................................................................LXI 制劑車間及提取車間 30 萬級(jí)潔凈空調(diào)系統(tǒng)的設(shè)計(jì) 方案 ...................................................................... LXIII 設(shè)計(jì)計(jì)算負(fù)荷 ................................................................................................................................................ LXV 潔凈空調(diào)系統(tǒng)流程圖 ................................................................................................................................... LXV 土建設(shè)計(jì) ............................................................................................................................................................... LXVI 工藝對(duì)土建的要求 ...................................................................................................................................... LXVI 工藝對(duì)內(nèi)部裝修材料的要求 ..................................................................................................................... LXVII 環(huán)境保護(hù) ............................................................................................................................................................... LXIX 參照標(biāo)準(zhǔn) ....................................................................................................................................................... LXIX 設(shè)計(jì)說明 ....................................................................................................................................................... LXIX 消防及安全 ............................................................................................................................................................ LXX 防火要求 ........................................................................................................................................................ LXX 勞動(dòng)安全 ....................................................................................................................................................... LXXI 節(jié)能 ........................................................................................................................................................................ LXXI 節(jié)能應(yīng)采取的措施 ...................................................................................................................................... LXXI 參考文獻(xiàn) ................................................................. LXXIII 致謝 ...................................................................... LXXIV 附錄 ....................................................................... LXXV 第 III 頁 年產(chǎn) 億粒復(fù)方降脂膠囊劑 GMP 車間設(shè)計(jì) 摘要 復(fù)方降脂膠囊為治療高血脂癥的特效新藥 。其處方 主要由黃芪、山楂、三七等 12味中藥組成， 有活 血化瘀、化痰利濕、疏通脈絡(luò)的功效， 其能夠在治療高脂血癥的同時(shí)有效改善血液流變性，對(duì)高脂血癥的療效非常顯著。本設(shè)計(jì)從科學(xué)，合理，可行性的原則出發(fā)，對(duì)年產(chǎn) 復(fù)方降脂膠囊劑的工藝流程、產(chǎn)品質(zhì)量標(biāo)準(zhǔn)、廠房車間、設(shè)備選型、人員編制等方面進(jìn)行了GMP 設(shè)計(jì)。在本設(shè)計(jì)中，藥物劑型為硬膠囊劑。生產(chǎn)工藝簡潔，主要由 4個(gè)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。其中，前處理工段有 6個(gè)工序，提取工段有2個(gè)工序，制劑工段有 5個(gè)工序，外包工段有 4個(gè)工序。工藝中最重要的工序?yàn)樘崛『椭屏９ば?。其中，提取工序選用了水提取工藝，制粒工序選用了高效混合制粒工藝。本設(shè)計(jì)中，制粉工藝選用了超微粉碎技術(shù)，能夠達(dá)到細(xì)胞壁破碎的效果，使藥物能更迅速更充分地發(fā)揮。本設(shè)計(jì)選定廠址位于甘肅天水市秦州區(qū)西坪。廠址所在地的地理、能源、交通等方面條件均符合GMP規(guī)范要求。設(shè)計(jì)廠房生產(chǎn)區(qū)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)相應(yīng)的輔助設(shè)施齊全，布置科學(xué)合理。本設(shè)計(jì)嚴(yán)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(jì) Abstracts Fufangjiangzhi capsule is a new proprietary Chinese medicines which has a Special effect for reducing blood lipid. It’s prescription is posed of 12 taste traditional Chinese medicine,including Astragalus membranaceus , hawthorn , pseudoginseng etc. This drug has a notable effect for promoting blood circulation ,removing blood stasis , geting rid of sputum and dehumidification, mediating artery and vein. It is able to have an effect to improve blood stream degeneration while curing design what is base on the principle of Scientificalness , rationality , feasibility is on product quality level , workshop appliance, choose for 第 IV 頁 equipment type and manning quotas for Fufangjiangzhi ’s productive technology,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 , the stage for outside casin