中英文版欧盟药典EP明胶

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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