肝素鈉生產(chǎn)工藝翻譯-中英
1、輔料的配置
1）、把150g的蛋白酶（2709）放入規(guī)定的容器按1：1進(jìn)行溶解，待用。
2）、把10kg的無(wú)水氯化鈣放入規(guī)定的容器按1：1進(jìn)行溶解，調(diào)節(jié)PH值至8.5，待用。
3）、把10kg的無(wú)水碳酸氫鈉放入規(guī)定的容器按1：1進(jìn)行溶解，待用。
2、投料、溶解
1）、打開(kāi)溶解罐夾套補(bǔ)水管球閥，將自來(lái)水注滿夾套，關(guān)閉排料閥門，
2）、打開(kāi)內(nèi)膽加水管道球閥，根據(jù)粗品肝素鈉的投料量，按1：10的比例加入蒸餾水至溶解罐中
3）、將粗品肝素鈉投料至溶解罐中，調(diào)PH7.8-8.0
3、升溫、酶解、降溫
1）、打開(kāi)蒸汽閥門升溫，啟動(dòng)攪拌電源，均勻攪拌升溫至50-60℃2）、均勻攪拌至肝素鈉粗品完全溶解
3）、攪拌過(guò)程中溶解液自然冷卻降溫至38-42℃，將已溶解好的蛋白酶（2709）150克加入料液中攪勻PH7.8-8.0，溫控38-42℃間隔攪拌共4小時(shí)
4、加熱升溫、降溫
1）先調(diào)值至PH8.5，加腸衣鹽（15-20KG）3-4%按溶解后體積加，加輔料（無(wú)水碳酸鈉106克，碳酸氫鈉756克，EDTA186克，無(wú)水亞硫酸鈉200克）加水10KG攪勻加入液體中，升溫60℃加氯化鈣10KG（氯化鈣要先溶解調(diào)PH8.5）再升溫85-90℃加無(wú)水碳酸鈉10KG攪50-10分鐘，關(guān)閉蒸汽保溫30分鐘后降溫至60-65℃
5、過(guò)濾
打開(kāi)溶解罐底部排料閥門，排料閥門經(jīng)管道與板框過(guò)濾機(jī)相聯(lián)接，溶解液經(jīng)板框過(guò)濾機(jī)過(guò)濾、去除雜質(zhì)，用泵將液體抽入溶解罐
6、沉淀
按1:2的比例向過(guò)濾液中加入80-90°酒精（過(guò)濾液:酒精=1:2），充分?jǐn)嚢杈鶆�，檢測(cè)波美度在35-40℃按常溫調(diào)節(jié)。保持4小時(shí)溫度在30℃以上
7、脫水
采用自吸泵抽取出上清液后，取出沉淀后的肝素鈉，加入85-95℃度酒精脫水，用濾布進(jìn)一步濾干,然后放入不銹鋼盤中。
8、烘干
1）、 將不銹鋼盤放入烘箱內(nèi),烘箱溫度設(shè)定在50~70℃;
2）、在烘干過(guò)程中操作人員每隔2小時(shí)觀察烘箱溫度,并如實(shí)填寫記錄(日期､時(shí)間､溫度等)。
9、將兩層塑料袋重疊套好并稱重;其重量為皮重.
1)、取出烘干的肝素,用已稱重的兩層塑料袋密封后再稱重,其重量為毛重.按照下列公式計(jì)算出肝素的凈重。
凈重=毛重-皮重
2）、在塑料袋外面貼上標(biāo)簽,標(biāo)簽上寫明工廠名稱､生產(chǎn)批號(hào)､生產(chǎn)日期､凈重､效期等內(nèi)容;包裝后的肝素放入專柜儲(chǔ)存。
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2013.11.9