EP检测-欧洲药典3.2.9

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1、3.2.9.注射用粉针和冻干粉末容器胶塞标准3.2.9.RUBBERCLOSURESFORCONTAINERSFORAQUEOUSPARENTERALPREPARATIONS,FORPOWDERSANDFORFREEZE-DRIEDPOWDERS粉和冻干粉水肠外制剂胶塞材料通过高分子物质（弹性体）硫化（交联），加入合适的添加剂获得。该规范也适用于粉和冻干粉在使用前立即被溶解在水中的封闭容器。该规范不适用于硅橡胶制成的胶塞（在3.1.9处理，不封和油管的有机硅弹性体），夹层封闭或漆封。弹性体由天然胶或合成物质的聚合，加聚或缩聚产生。主要组成部

2、分和各种添加剂的性质（例如硫化剂、促进剂、稳定剂、色素）取决于成品所需的属性。Rubberclosuresforcontainersforaqueousparenteralpreparationsforpowdersandforfreeze-driedpowdersaremadeofmaterialsobtainedbyvulcanisation(cross-linking)ofmacromolecularorganicsubstances(elastomers),withappropriateadditives.Thespecificat

3、ionalsoappliestoclosuresforcontainersforpowdersandfreeze-driedproductstobedissolvedinwaterimmediatelybeforeuse.Thespecificationdoesnotapplytoclosuresmadefromsiliconeelastomer(whicharedealtwithin3.1.9.Siliconeelastomerforclosuresandtubing),tolaminatedclosuresortolacqueredcl

4、osures.Theelastomersareproducedfromnaturalorsyntheticsubstancesbypolymerisation,polyadditionorpolycondensation.Thenatureoftheprincipalcomponentsandofthevariousadditives(forexamplevulcanisers,accelerators,stabilisers,pigments)dependsonthepropertiesrequiredforthefinishedarti

5、cle.胶塞材料可以分为两类：Ⅰ类胶塞符合严格要求，是首选；Ⅱ类胶塞有着适用于特殊用途（如多孔冲孔）的机械性能，但因为它们的化学组成，不能满足第一类那样的需求。Rubberclosuresmaybeclassifiedin2types:typeIclosuresarethosewhichmeetthestrictestrequirementsandwhicharetobepreferred;typeIIclosuresarethosewhich,havingmechanicalpropertiessuitableforspecialuses

6、(forexample,multiplepiercing),cannotmeetrequirementsassevereasthoseforthefirstcategorybecauseoftheirchemicalcomposition.供特殊制备使用选择的胶塞如：—与胶塞相关的制备部件不能吸附到胶塞的表面，不能迁移或通过胶塞的表面而影响制备。—胶塞成批的不屈服的准备物质的数量足以影响其稳定性或目前的毒性风险。Theclosureschosenforusewithaparticularpreparationaresuchthat:—the

7、componentsofthepreparationincontactwiththeclosurearenotadsorbedontothesurfaceoftheclosureanddonotmigrateintoorthroughtheclosuretoanextentsufficienttoaffectthepreparationadversely,—theclosuredoesnotyieldtothepreparationsubstancesinquantitiessufficienttoaffectitsstabilityort

8、opresentariskoftoxicity.胶塞与它们使用其整个有效期的准备兼容。该制剂的制造商必须从供应商获得保证，胶塞的组成不发生变化，这是相同的兼容性测试期间使用的封闭