阿司匹林片工藝規(guī)程

1、阿司匹林工藝規(guī)程第1頁共11頁阿司匹林片工藝規(guī)程阿司匹林片工藝規(guī)程目錄目錄1.產(chǎn)品名稱及劑型產(chǎn)品名稱及劑型.............................................................................................................................31.1產(chǎn)品名稱：阿司匹林片............................

2、..........................................................................31.2產(chǎn)品劑型：片劑..................................................................................................................32.產(chǎn)品概述產(chǎn)品概述..........

3、...............................................................................................................................32.1產(chǎn)品名稱.....................................................................................

4、.........................................32.2產(chǎn)品特點..............................................................................................................................33.操作過程及工藝條件操作過程及工藝條件........................

5、.............................................................................................33.1備料.........................................................................................................................

6、.............33.2制粒......................................................................................................................................43.3總混將整粒后的顆粒轉(zhuǎn)入三維運動混合機中，加入1.25kg滑石粉，混合15分鐘。將混合后的顆粒裝入無毒塑料袋，稱量，附上桶簽，轉(zhuǎn)

7、入中間站待驗。................43.4壓片......................................................................................................................................43.5包裝...................................................

8、...................................................................................54.工藝流程圖工藝流程圖............................................................................................................................

9、.......55.質(zhì)量監(jiān)控質(zhì)量監(jiān)控.........................................................................................................................................65.1按生產(chǎn)工序設置監(jiān)控點，不得遺漏。各監(jiān)控點如下：......................................

10、............65.2批投料處方..........................................................................................................................65.3依據(jù)執(zhí)行標準：《中國藥典》2010年版二部....................................................

11、...75.4制法取阿司匹林、淀粉和枸櫞酸置高效濕法制粒機中混合均勻，用淀粉漿制粒；干燥；壓片；瓶內(nèi)包裝及外包裝，制得。....................................................................76主要設備一覽表主要設備一覽表............................................................................

12、..............................................77.生產(chǎn)周期生產(chǎn)周期.........................................................................................................................................88環(huán)境保護環(huán)境保護................

13、.........................................................................................................................89技術安全及勞動保護技術安全及勞動保護...............................................................................

14、...................................89.1技術安全..............................................................................................................................89.2勞動保護...........................................

15、...................................................................................99.3勞動組織定員定崗、生產(chǎn)周期..........................................................................................99.4勞動組織定員定崗..................

16、............................................................................................910.技術經(jīng)濟指標的計算及原料、輔料、包裝材料的消耗定額技術經(jīng)濟指標的計算及原料、輔料、包裝材料的消耗定額...................................................910.1單耗................

17、....................................................................................................................910.2原輔包材的消耗定額及技術經(jīng)濟指標............................................................................910.3偏差

18、處理..........................................................................................................................1011.附錄：附錄：常用理化常數(shù)、換算表常用理化常數(shù)、換算表.................................................................

19、........................1012.附頁：附頁：………………………………………………………………………………………….12阿司匹林工藝規(guī)程第3頁共11頁平衡，并嚴格復核。物料編碼原輔料名稱粉碎目數(shù)過篩目數(shù)阿司匹林100目100目淀粉80目枸櫞酸100目100目滑石粉100目3.1.3配料物料編碼原輔料名稱批配料量（12萬片）阿司匹林50kg淀粉5kg枸櫞酸0.6kg滑石粉1.25kg3.2制粒3.2.1配漿稱取純化

20、水1kg置配漿鍋中，加入1kg淀粉，攪拌使均勻，在攪拌下沖入10kg純化水加熱至糊化，配成10%的淀粉漿作為粘合劑。3.2.2制粒將60kg阿司匹林粉、4kg淀粉和0.6kg枸櫞酸粉投入高速制粒機中，干混4分鐘后，加入上述淀粉漿混合5分鐘，開機制粒。3.2.3干燥將上述濕顆粒吸入沸騰制粒機中，將設定好工藝參數(shù)（進風溫度1205℃，溫度755℃，進風溫度305℃）的冷空氣通過初效中高效過濾器進適入后部加熱室，經(jīng)過加熱器加熱至進風所需溫度后