欢迎来到天天文库
浏览记录
ID:38780248
大小:22.13 KB
页数:8页
时间:2019-06-19
《中英文版欧盟药典EP明胶》由会员上传分享,免费在线阅读,更多相关内容在教育资源-天天文库。
1、欧洲药典7.0DefinitionPurifiedproteinobtainedeitherbypartialacidhydrolysis(typeA),partialalkalinehydrolysis(typeB)orenzymatichydrolysisofcollagenfromanimals(includingfishandpoultry);itmayalsobeamixtureofdifferenttypes.Thehydrolysisleadstogellingornon-gellingproductgr
2、ades.Bothproductgradesarecoveredbythismonograph.Gelatindescribedinthismonographisnotsuitableforparenteraladministrationorforotherspecialpurposes.定义通过酸性水解(A型),部分碱性水解(B型)从动物(包括鱼,家畜)获得的蛋白质通过水解从而得到凝胶或非凝胶类型。两种产品类型都包含在本药典中。本药典中的明胶不适用于注射给药或用于其他用途。形态特征外观:淡黄色或者淡棕黄色,通常为透明
3、的片状,碎片、颗粒状或者粉末水溶性:一般不容易常用有机溶剂,凝胶类型在冷水中膨胀。等电子点是明胶不同用途的相对参考质量指标:A型明胶Ph6.0~9.5,B型明胶pH4.7~5.6,对于不同用途的明胶pH范围可略微不同.不同类型的明胶透明度,色泽不同。CHARACTERSAppearance:faintlyyelloworlightyellowish-brown,solid,usuallyoccurringastranslucentsheets,shreds,granulesorpowder.Solubility:pra
4、cticallyinsolubleincommonorganicsolventsgellinggradesswellincoldwaterandgiveonheatingacolloidalsolutionwhichoncoolingformsamoreorlessfirmgel.Theisoelectricpointisarelevantqualityparameterforuseofgelatinindifferentapplications:fortypeAgelatinitistypicallybetweenp
5、H6.0andpH9.5andfortypeBgelatinistypicallybetweenpH4.7andpH5.6.Theserangescoveravarietyofdifferentgelatinsandforspecificapplicationsanarrowertoleranceisusuallyapplied.Differentgelatinsformaqueoussolutionsthatvaryinclarityandcolour.Foraparticularapplication,asuita
6、blespecificationforclarityandcolourisusuallyapplied.IDENTIFICATIONA.To2mLofsolutionS(seeTests)add0.05mLofcoppersulfatesolutionR.Mixandadd0.5mLofdilutesodiumhydroxidesolutionR.Avioletcolourisproduced.B.To0.5ginatest-tubeadd10mLofwaterR.Allowtostandfor10min,heatat
7、60°Cfor15minandkeepthetubeuprightat0°Cfor6h.Invertthetube;thecontentsimmediatelyflowoutfornon-gellinggradesanddonotflowoutimmediatelyforgellinggrades.鉴别A在2mlS溶液(见下文试验)中添加0.05ml硫酸铜。混匀,然后添加0.5ml稀释的NaOH溶液,产生紫色。B.在试管中添加10ml水,0.5g明胶,让试管竖立10分钟,加热60°C15分钟,同时保持试管在0°C情况下
8、竖立6小时。倒转试管,对于非凝胶类型,试管内物立即流出;对凝胶类型,试管内物不立即流出试验:S溶液在无二氧化碳的水中,55℃温度下溶解1.00g明胶,后用水稀释至100ml,保持溶液在该温度下进行试验pH:S溶液3.8~7.6电导率:≤1mS·cm−1,30±1.0°C1.0%溶液SO2:≤50ppmTest:SsolutionD
此文档下载收益归作者所有