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企业动态

蛋白质药品冷冻干燥技术研究进展
发布时间:2019-04-11   点击次数:134次

1 引言

 

彩搜网YOUYUDONGGANYAOPINCHENGDUOKONGZHUANG、NENGZHANGSHIJIANWENDINGZHUCUN、BINGYIZHONGXINFUSHUIERHUIFUHUOXING,YINCILENGDONGGANZAOJISHUGUANGFANYINGYONGYUZHIBEIGUTIDANBAIZHIYAOWU、KOUFUSURONGYAOWUJIYAOWUBAOMAIJIZHIZHITIDENGYAOPIN。

彩搜网CONGGUOJIAYAOPINJIANDUGUANLIJUSHUJUKUDEZHI,MUQIANGUONEIYIYOUZHUSHEYONGZHONGZURENLIXIBAOJUSHIXIBAOJILUOCIJIYINZI、ZHUSHEYONGZHONGZURENGANRAOSUα2b、DONGGANSHUBIAOPISHENGZHANGYINZI、WAIYONGDONGGANZHONGZURENBIAOPISHENGZHANGYINZI、ZHUSHEYONGZHONGZULIANJIMEI、ZHUSHEYONGZHONGZURENBAIJIESU-2、ZHUSHEYONGZHONGZURENSHENGZHANGJISU、ZHUSHEYONGAQUNLIANQIUJUN、ZHUSHEYONGZHONGZURENGANRAOSUα2b、DONGGANRENNINGXUEYINZIVⅢ、DONGGANRENXIANWEIDANBAIYUAN、JIANBEN3FENKOUFUDONGGANPIANDENGDONGGANYAOPINHUOZHUNSHANGSHI。JIEZHI2000NIAN2YUE,MEIGUOFDAYIPIZHUNDESHENGWUJISHUYAOGONGJI76GE。

 

LENGDONGGANZAOJISHUZAOYU1813NIANYOUYINGGUORENWollastonFAMING。1909NIANShsckellSHIYANYONGGAIFANGFADUIKANGDUSU、JUNZHONG、KUANGQUANBINGDUJIQITASHENGWUZHIPINJINXINGDONGGANBAOCUN,QUDELEJIAOHAOXIAOGUO。ZAIDIERCISHIJIEDAZHANZHONG,DUIXUEYEZHIPINDEDALIANGXUQIUDADACIJILELENGDONGGANZAOJISHUDEFAZHAN,CONGCIGAIJISHUJINRULEGONGYEYINGYONGJIEDUAN。

彩搜网CIHOU,ZHILENGHEZHENKONGSHEBEIDEFEISUFAZHANWEIKUAISUFAZHANLENGDONGGANZAOJISHUTIGONGLEQIANGYOULIDEWUZHITIAOJIAN。JINRUSHANGGESHIJIDE***SHINIANDAI,KEXUEJISHUDEXUNMENGFAZHANHERENMINQUNZHONGDUIJIANKANGBAOZHANGDEXUQIUWEIYAOPINLENGDONGGANZAOJISHUDEFEISUFAZHANTIGONGLEQIANGDADEDONGLI,ZAIYAOPINDONGGANSUNSHANGHEBAOHUJILI、YAOPINDONGGANGONGYI、YAOPINLENGDONGGANZAOJIDENGFANGMIANQUDELEJUDADECHENGJI。DANYAOPINLENGDONGGANZAOJISHUSHIYIMENBIANYUANXUEKE,XUYAOSHENGWUXUE、YAOXUE、ZHILENG、ZHENKONGHEKONGZHIDENGZHISHIDEJIAOCHAHEZONGHE,YINCIRENGCUNZAIJIDAIJIEJUEDEWENTI。

 

 

 

2 药品冷冻干燥原理及特点

 

YAOPINLENGDONGGANZAOSHIZHIBAYAOPINRONGYEZAIDIWENXIADONGJIE,RANHOUZAIZHENKONGTIAOJIANXIASHENGHUAGANZAO,CHUQUBINGJING,DAISHENGHUAJIESHUHOUZAIJINXINGJIEXIGANZAO,CHUQUBUFENJIEHESHUIDEGANZAOFANGFA。GAIGUOCHENGZHUYAOKEFENWEI:YAOPINZHUNBEI、YUDONG、YICIGANZAO(SHENGHUAGANZAO)HEERCIGANZAO(JIEXIGANZAO)、MIFENGBAOCUNDENGWUGEBUZHOU。YAOPINANSHANGSHUFANGFADONGGANHOU,KEZAISHIWENXIABIGUANGZHANGQIZHUCUN,XUYAOSHIYONGSHI,JIAZHENGLIUSHUIHUOSHENGLIYANSHUIZHICHENGXUANFUYE,JIKEHUIFUDAODONGGANQIANDEZHUANGTAI。YUQITAGANZAOFANGFAXIANGBI,YAOPINLENGDONGGANZAOFAJUYOUFEICHANGTUCHUDEYOUDIANHETEDIAN:

 

a)YAOYEZAIDONGJIEQIANFENZHUANG,JILIANGZHUNQUE;

 

b)ZAIDIWENXIAGANZAO,NENGSHIBEIGANZAOYAOPINZHONGDEREMINWUZHIBAOLIUXIALAI;

 

c)ZAIDIYAXIAGANZAO,BEIGANZAOYAOPINBUYIYANGHUABIANZHI,TONGSHINENGYINQUEYANGERMIEJUNHUOYIZHIMOUXIEXIJUNDEHUOLI;

 

d)DONGJIESHIBEIGANZAOYAOPINKEXINGCHENG"GUJIA",GANZAOHOUNENGBAOCHIYUANXING,XINGCHENGDUOKONGJIEGOUERQIEYANSEJIBENBUBIAN;

 

e)FUSHUIXINGHAO,DONGGANYAOPINKEXUNSUXISHUIHAIYUANCHENGDONGGANQIANDEZHUANGTAI;

 

彩搜网f)TUOSHUICHEDI,SHIHEZHANGTUYUNSHUHEZHANGQIBAOCUN。

 

SUIRANYAOPINLENGDONGGANZAOJUYOUSHANGSHUYOUDIAN,DANSHIGANZAOSULVDI、GANZAOSHIJIANZHANG、GANZAOGUOCHENGNENGHAOGAOHEGANZAOSHEBEITOUZIDADENGRENGSHIGAIJISHUDETUCHUQUEDIAN。

 

3 药品冻干损伤和保护机理

 

彩搜网YAOPINLENGDONGGANZAOSHIYIGEDUOBUZHOUGUOCHENG,HUICHANSHENGDUOZHONGYINGLISHIYAOPINBIANXING,RUDIWENYINGLI、DONGJIEYINGLIHEGANZAOYINGLI。QIZHONGDONGJIEYINGLIYOUKEFENWEIZHIZHUANGBINGJINGDEXINGCHENG,LIZINONGDUDEZENGJIA,PHZHIDEGAIBIANHEXIANGFENLIDENGQINGKUANG。

 

YINCI,WEILEBAOHUYAOPINDEHUOXING,TONGCHANGZAIYAOPINPEIFANGZHONGTIANJIAHUOXINGWUZHIDEBAOHUJI。TAXUYAOJUBEISIGETEXING:BOLIHUAZHUANBIANWENDUGAO、XISHUIXINGCHA、JIEJINGLVDIHEBUHANHAIYUANJI。

 

CHANGYONGDEBAOHUJIYOURUXIAJILEIWUZHI:

 

彩搜网a)TANGLEI/DUOYUANCHUN:ZHETANG、HAIZAOTANG、GANLUCHUN、RUTANG、PUTAOTANG、MAIYATANGDENG;

 

b)JUHEWU:HES、PVP、PEG、PUJUTANG、BAIDANBAIDENG;

 

彩搜网c)WUSHUIRONGJI:YIXIYIERCHUN、GANYOU、DMSO、DMFDENG;

 

d)BIAOMIANHUOXINGJI:Tween 80DENG;

 

e)ANJISUAN:L-SIANSUAN、GUANSUANNA、BINGANSUAN、GANANSUAN、JIANSUANDENG;

 

f)YANHEAN:LINSUANYAN、CUSUANYAN、NINGMENGSUANYANDENG;

 

彩搜网YOUYULENGDONGGANZAOGUOCHENGCUNZAIDUOZHONGYINGLISUNSHANG,YINCIBAOHUJIBAOHUYAOPINHUOXINGDEJILIYESHIBUTONGDE,KEYIFENWEIDIWENBAOHUHEDONGGANBAOHU。

 

DUIYUDIWENBAOHU,MUQIANBEIGUANGWEIJIESHOUDEYETIZHUANGTAIXIADANBAIZHIWENDINGDEJILIZHIYISHIYOUXIANZUOYONGYUANLI。YOUXIANZUOYONGSHIZHIDANBAIZHIYOUXIANYUSHUIHUOSHUIRONGYEZHONGDEBAOHUJIZUOYONG。ZAIYOUQIWENDINGZUOYONGDEBAOHUJICUNZAIDETIAOJIANXIA,DANBAIZHIYOUXIANYUSHUIZUOYONG(YOUXIANSHUIHE),ERBAOHUJIYOUXIANBEIPAICHIZAIDANBAIZHIQUYUWAI(YOUXIANPAICHI)。

彩搜网ZAIZHEIZHONGQINGKUANGXIA,DANBAIZHIBIAOMIANJIUBIQINEIBUYOUJIAODUODESHUIFENZIHEJIAOSHAODEBAOHUJIFENZI。YOUXIANZUOYONGYUANLITONGYANGSHIYONGYULENGDONG-RONGJIEGUOCHENG。DANBAIZHIBAOHUJI,ZAIRONGYEZHONGBEICONGDANBAIZHIBIAOMIANPAICHI,ZAIDONGJIEGUOCHENGZHONGNENGGOUWENDINGDANBAIZHI。DANSHIYOUXIANZUOYONGJILIBUNENGWANQUANJIESHIYONGJUHEWUHUODANBAIZHIZISHENZAIGAONONGDUSHIBAOHUDANBAIZHIDEXIANXIANG。

 

ZAIDONGGANGUOCHENGZHONG,YOUYUDANBAIZHIDESHUIHECENGBEICHUQU,YOUXIANZUOYONGJILIBUZAISHIYONG。DUIYUDONGGANBAOHUJILI,RENGZAIYANJIUTANTAOZHIZHONG,MUQIANZHUYAOYOULIANGZHONG:

 

a)SHUITIDAIJIASHUO。

XUDUOYANJIUZHERENWEIYOUYUDANBAIZHIFENZIZHONGCUNZAIDALIANGQINGJIAN,JIEHESHUITONGGUOQINGJIANYUDANBAIZHIFENZILIANJIE。DANGDANBAIZHIZAILENGDONGGANZAOGUOCHENGZHONGSHIQUSHUIFENHOU,BAOHUJIDEQIANGJINENGTIDAIDANBAIZHIBIAOMIANDESHUIDEQIANGJI,SHIDANBAIZHIBIAOMIANXINGCHENGYICENGJIADINGDESHUIHUAMO,ZHEIYANGKEBAOHUQINGJIANDELIANJIEWEIZHIBUZHIJIEBAOLUZAIZHOUWEIHUANJINGZHONG,WENDINGDANBAIZHIDEJIEGOU,FANGZHIDANBAIZHIYINDONGGANERBIANXING,SHIQIJISHIZAIDIWENLENGDONGHEGANZAOSHISHUIDEQINGKUANGXIA,RENGBAOCHIDANBAIZHIJIEGOUYUGONGNENGDEWANZHENGXING。

 

b)BOLITAIJIASHUO。

YANJIUZHERENWEIZAIHANBAOHUJIRONGYEDEGANZAOGUOCHENGZHONG,DANGNONGDUZUGOUDAQIEBAOHUJIDEJIEJINGBUHUIFASHENGSHI,BAOHUJI-SHUIHUNHEWUJIUHUIBOLIHUA。YANJIUFAXIANZAIBOLITAIXIA,WUZHIJIANYOUGUTIHELIUTIDEXINGWEI,ZHANDUJIGAO,BURONGYIXINGCHENGJIEJING,QIEFENZIKUOSANXISHUHENDI,YINERJUYOUZHANXINGDEBAOHUJIBAOWEIZAIDANBAIZHIFENZIDEZHOUWEI,XINGCHENGYIZHONGZAIJIEGOUSHANGYUBOLIZHUANGDEBINGXIANGSIDETANSHUIHUAHEWUBOLITI,SHIDAFENZIWUZHIDELIANDUANYUNDONGSHOUZU,ZUZHIDANBAIZHIDESHENZHANHECHENDIAN,WEICHIDANBAIZHIFENZISANWEIJIEGOUDEWENDING,CONGERQIDAOBAOHUZUOYONG。

 

MUQIANDABUFENXUEZHEZANTONG"SHUITIDAIJIASHUO",YINWEIKEYITONGGUOSHIYANJIANCEDAODANBAIZHIHEBAOHUJIZHIJIANDEQINGJIAN,WEILILUNTIGONGZHENGJU。SHISHISHANG,WULUNSHI"SHUITIDAIJIASHUO"HAISHI"BOLITAIJIASHUO",TAMENDEJICHUDOUSHIJIYUYAOYESHIXIANLEBUFENHUOQUANBUBOLIHUADONGJIE。

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