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ID:34275983
大小:45.00 KB
页数:5页
时间:2019-03-04
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1、1、Digitalisisoneofthemostfrequentlyusedmedicationsinthetreatmentofheartfailureandarrhythmia.Itincreasesthecontractilityoftheheartmuscleandmodifiesvascularresistance.Italsoslowsconductionthroughtheatrioventricularnodeintheheart,makingitusefulinthetreatmentofatrialfibrillationa
2、ndotherrapidheartrhythms洋地黄是其中一个最常用的药物治疗心力衰竭和心律失常。它增加了的心肌收缩血管阻力和修改。它也减慢传导通过传导节点的心使它有用的治疗房颤和其他快速心律2、Theformulationofaparenteralproductinvolvesthecombinationofoneormoreingredientswithamedicinalagenttoenhancetheconvenience,acceptability,oreffectivenessoftheproduct.Rarelyisitpref
3、erabletodispenseadrugsinglyasasteriledrypowderunlesstheformulationofastableliquidpreparationisnotpossible非肠道用产品的配方涉及一个或者更多组成部分间的结合,这些组成部分(各自)都含有一种用以提高产品方便性、可接受性或者疗效的有效成分。(人们)很少愿意把药物仅仅以一种无菌的、干燥的粉末(的形式)配售,除非(把它做成)稳定的液体制剂的配方是行不通的。3、Production生产Theproductionprocessincludesallofth
4、estepsfromtheaccumulationandcombiningoftheingredientsoftheformulatotheenclosingoftheproductintheindividualcontainerfordistribution.Intimatelyassociatedwiththeseprocessesarethepersonnelwhocarrythemoutandthefacilitiesinwhichtheyareperformed.Themostideallyplannedprocessescanbere
5、nderedineffectivebypersonnelwhodonothavetherightattitudeortraining,orbyfacilitiesthatdonotprovideanefficientlycontrolledenvironment.生产过程包括从配方的各个组成部分的积聚和结合到产品封装入用于分售的单个包装内的所有步骤。和这些过程有紧密联系的是搬运人员和执行这些步骤的设备。计划出来的最理想的过程也会因为没有正确态度或没有接受正确培训的人员或者不能提供一个有效的控制环境的设备而变得无效。Toenhancetheassu
6、ranceofsuccessfulmanufacturingoperation,allprocessstepsmustbecarefullyreducedtowritingafterbeingshowntobeeffective.Thesewrittenprocessstepsareoftencalledstandard.operatingprocedures(SOPs)⑥.Noextemporaneouschangesarepermittedtobemadeintheseprocedures;anychangemustgothroughthes
7、ameapprovalstepsastheoriginalwrittenSOP.Further,extensiverecordsmustbekepttogiveassuranceattheendoftheproductionprocessthatallstepshavebeenperformedasprescribed,anaspectemphasizedintheFDA'sGoodManufacturingPractices.Suchin-processcontrolisessentialtoassuringthequalityofthepro
8、duct,sincetheseassurancesareevenmoresignificantthanthosefromproductr
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