年產(chǎn)5000萬粒奧美拉唑腸溶膠囊生產(chǎn)車間工藝設(shè)計


摘    要
奧美拉唑是一個國內(nèi)外臨床上廣泛應(yīng)用的質(zhì)子泵抑制劑，是作用機制不同于H2受體拮抗劑的全新抗消化性潰瘍藥，比H2受體拮抗劑具有更強的抑制胃酸分泌作用，對潰瘍的治愈率更高，速度更快。
消化性潰瘍包括胃潰瘍及十二指腸潰瘍是一種常見病、多發(fā)病，總發(fā)病率約占人口總數(shù)的10％～20％。而藥物治療依舊是主要的治療手段，奧美拉唑，可以特異性的作用于胃粘膜的壁細胞,降低壁細胞中的H+-K+-ATP酶的活性,使胃壁細胞內(nèi)的氫離子不能轉(zhuǎn)移到胃腔中,由于氫離子的缺乏而使胃酸的生成減少,從而起到治療潰瘍的作用。奧美拉唑劑量小，起效快，治愈率高，耐受性好，將其制成膠囊劑型，具有成分穩(wěn)定，不易被污染 生物利用度高，密封性好，遮蓋不良氣味；崩解后在腸道直接吸收，無需溶解過程，吸收快等特點。已被有關(guān)刊物列入2000年時期的暢銷藥之一，具有廣闊的市場前景。
本文參照國內(nèi)制藥現(xiàn)有水平，對奧美拉唑腸溶膠囊的生產(chǎn)車間進行設(shè)計，包括工藝流程設(shè)計、物料衡算、生產(chǎn)設(shè)備的選型、車間布置設(shè)計等。

關(guān)鍵詞  奧美拉唑；腸溶膠囊；工藝流程；生產(chǎn)車間設(shè)計

Annual production capacity of 50 million omeprazole capsules production workshop process design
Abstract
Omeprazole is a widely used proton pump inhibitor in domestic and foreign clinical, and it is also a new anti-ulcer drugs which is different fr-om H2-recetor blockers in mechanism. Compared with H2-recetor blockers, it has a much stronger effect on inhibiting gastric acid secretion, higher recovery rate and faster.
Peptic ulcer which includes gastric ulcer and duodenal ulcer is a co-mmonly encountered disease and frequently-occurring disease. The disease rate is 10%～20% of the total population.However, the pharmacotherapy is still the main cure measures. Omeprazole can make a specific effect on the parietal cell of gastric mucosa , cutting down the activity of H+-K+-ATPase which is in parietal cell. And the hydrogen ions in the gastric pa-rietal cells cannot transfer to thegastral cavity. As lack of the hydrogen  ions, the generation of gastric acid dec-rease, and then achieve the object of curing the ulcer.
Omeprazole has lots of characters, such as small doses, work fast,   high recovery rate, and so on. And if make it into capsules, it will have much more characters, such as stable ingredient, hard to be polluted, high bioavailability, good leak tightness, covering the bad smell, absorbing in intestines directly and fast.It was list on some publication as a bestselling drugs in 2000 times. It has a wide market prospect.
In this paper, according to the current level of pharmaceutical, it was carri-ed by on Omeprazole Enteric-Coated Capsules production process  design and the design of its GMP production workshop, including process design, the calculation concerning the matierial balance, the selection of production equipment, the designing of the workshop and so on .

Key words: Omeprazole; Enteric-Coated Capsules; Technology process;            workshop design
目    錄
摘    要 I
Abstract II
目    錄 III
第1章 緒論 1
1.1 課題背景 1
1.2 抗?jié)兯幬镅芯窟M展 1
1.2.1 抑制攻擊因子類藥物 2
1.2.2 促進防御因子類藥物 4
1.2.3 抗HP(幽門螺桿菌)感染的藥物 5
1.2.4 聯(lián)合用藥 5
1.3 產(chǎn)品概述 6
1.3.1 產(chǎn)品名稱、化學(xué)結(jié)構(gòu)、理化性質(zhì)、臨床應(yīng)用及藥代動力學(xué) 6
第2章 生產(chǎn)工藝流程設(shè)計 7
2.1 生產(chǎn)工藝介紹 7
2.2 奧美拉唑腸溶膠囊制備工藝 8
2.2.1 丸芯制備 8
2.2.2 包衣 8
2.2.3 膠囊的充填 9
2.2.4 內(nèi)包工序 10
第3章 物料衡算及設(shè)備選型 11
3.1 物料衡算 11
3.1.1 配制工序物料平衡 11
3.1.2 充填工序物料平衡 12
3.1.3 鋁包工序物料平衡 12
3.1.4 奧美拉唑腸溶膠囊總物料衡算 13
3.2 生產(chǎn)設(shè)備選型 14
3.2.1 選擇設(shè)備的原則 14
3.3 設(shè)備選型 15
3.3.1 粉碎 15
3.3.2 過篩 15
3.3.3 濕法制粒 15
3.3.4 包衣設(shè)備 16
3.3.5 充填設(shè)備 16
3.3.6 鋁塑包裝 17
第4章 生產(chǎn)車間設(shè)計 18
4.1 車間設(shè)計概述 18
4.1.1 設(shè)計目的 18
4.1.2 設(shè)計依據(jù) 18
4.1.3 膠囊劑車間GMP設(shè)計要點 20
4.1.4 設(shè)計原則 22
4.1.5 生產(chǎn)規(guī)模及生產(chǎn)制度 22
4.2 車間布置設(shè)計 22
4.2.1 基礎(chǔ)資料 22
4.2.2 車間生產(chǎn)線布置 23
4.3 管道布置設(shè)計 23
4.3.1 管道設(shè)計的基礎(chǔ)資料 23
4.3.2 管道設(shè)計的基本要求 24
第5章 工程建筑設(shè)計 25
5.1 車間建設(shè)對環(huán)境的影響 25
5.2 電力系統(tǒng) 25
5.3 采暖通風(fēng)及空調(diào)凈化系統(tǒng) 26
5.4 建筑具體細節(jié)要求的確定 26
5.5 相關(guān)工序特殊要求 27
5.5.1 備料室的設(shè)置 27
5.5.2 產(chǎn)塵的處理 27
5.5.3 關(guān)于車間排熱、排濕及臭味的處理 27
5.5.4 參觀走廊的設(shè)置 28
5.5.5 安全門的設(shè)置 28
結(jié)    論 29
致    謝 30
參考文獻 31
附錄A 32
附錄B 41