包裝和儲存條件

麗珠集團福州福興醫(yī)藥有限公司·標準譯文文件出處：USP38頁次：20/20<659>PACKAGINGANDSTORAGEREQUIREMENTS<659>包裝和儲存要求(ChaptertobecomeofficialMay1,2016)（本章節(jié)2016年5月1號正式生效）Deletethefollowing：以下內(nèi)容刪除：EverymonographintheUSPandNFshallhavepackagingandstoragerequirements.Forthepackagingportionofthestatement,thechoiceofcontainersisgiveninthischapter.Fordrugproductpackagingrequirements,definitionsareprovidedtoguideselectionandadaptation.Foractivepharmaceuticalingredients(APIs),thechoicewouldbetight,well-closedor,whereneeded,alight-resistantcontainer.Forexcipients,giventheirtypicalpresentationaslarge-volumecommodityitems(containersrangingfromdrumstotankcars),awell-closedcontainerisanappropriatedefault.在USP和NF的每個專論中應(yīng)要有包裝和儲存的要求。對于包裝的聲明部分，本章節(jié)提供了容器的選擇。對于藥品包裝的要求，定義進行導(dǎo)向篩選和改編。對于API，要選擇密封的、密閉性好的或者根據(jù)需要選擇耐光的容器。對于賦形劑，和大容量商品一樣，鑒于他們的典型性質(zhì)，（容器從圓桶到罐車），默認是一個密閉性好的容器。Wherenospecificdirectionsorlimitationsareprovidedinthearticle’slabeling,articlesshallbeprotectedfrommoisture,freezing,andexcessiveheatand,wherenecessary,fromlightduringshippinganddistribution.Drugsubstancesareexemptfromthisstandard.USP38.在物品的標簽上沒有提供特定的方向或局限性。物品在運輸和配送過程中應(yīng)該防潮、防凍、防過熱，必要時要避光。藥物不受這個標準限制。PACKAGING包裝Packagingmustnotinteractphysicallyorchemicallywithofficialarticlesinanywaythatcausestheirsafety,identity,strength,quality,orpuritytofailtoconformtorequirements.包裝不能以任何方式使物品化學(xué)和物理方面產(chǎn)生相互影響，從而導(dǎo)致他們的安全性、特性、強度、質(zhì)量或純度不符合要求。Packagingcontainerchoicesaregiveninthischapter.Fordrugproductsandactivepharmaceuticalingredients(APIs),thecontainerchoicesaretight,well-closed,or,whereneeded,light-resistant.Forexcipients,giventheirtypicalpresentationaslarge-volumecommodityitems(containersrangingfromdrumstotankcars),awell-closedcontainerisanappropriatedefault.Forarticlesotherthandrugsubstancesanddrugproducts,wherenospecificdirectionsorlimitationsareprovided,articlesshallbeprotectedfrommoisture,freezing,andexcessiveheat,and,wherenecessary,fromlightduringshippinganddistribution.本章節(jié)提供了包裝容器的選擇。對于藥品和API包裝的要求，要選擇密封的、密閉性好的或者根據(jù)需要選著耐光的容器。對于賦形劑，和大容量商品一樣，鑒于他們的典型性質(zhì)，（容器從圓桶到罐車），默認是一個密閉好的容器。沒有提供特定的方向或局限性時，對于除了藥物和藥品外的其他物品，在運輸和配送過程中應(yīng)該防潮、防凍、防過熱，必要時要避光。Thecompendialrequirementsfortheuseofspecifiedcontainersapplyalsotoarticlesaspackagedbythepharmacistorotherdispenser,unlessotherwiseindicatedintheindividualmonograph.USP38使用指定容器的藥典要求對藥劑師或其他分配者包裝物品時同樣適用，除非在專論中另有說明。GENERALDEFINITIONS一般概念Packagingsystem(alsoreferredtoasacontainer–closuresystem):Thesumofpackagingcomponentsthattogethercontainandprotectthearticle.Thisincludesprimarypackagingcomponentsandsecondarypackagingcomponents,ifthelatterisintendedtoprovideadditionalprotection.包裝系統(tǒng)（也稱為容器密封系統(tǒng)）：指共同盛裝和保護物品的所有包裝組件的總和。如果次級包裝組件具有為物品提供額外保護的功能，則容器密封系統(tǒng)包括初級包裝組件和次級包裝組件。Container:Areceptaclethatholdsanintermediatecompound,activepharmaceuticalingredient,excipient,ordosageformandisormaybeUSP38indirectcontactwiththearticles.Theimmediatecontaineristhatwhichisindirectcontactwiththearticleatalltimes.Theclosureisapartofthecontainer.Beforebeingfilled,thecontainershouldbeclean.Specialprecautionsandcleaningproceduresmaybenecessarytoensurethateachcontaineriscleanandthatextraneousmatterisnotintroducedintoorontothearticle.USP38容器：能夠保存中間體、原料藥、輔料或劑型的容器，是或可能是和物品直接接觸。直接包裝的容器會一直直接接觸藥品。密封也是容器的一部分。在填裝之前，容器應(yīng)該干凈。特殊的預(yù)防措施和清潔程序可能是必要的，可以保證每個容器的干凈，異物不會引入或粘到藥品上。Packagingcomponent:Anysinglepartofthepackageorcontainer–closuresystemincludingthecontainer(e.g.,ampuls,prefilledsyringes,vials,bottles);containerliners(e.g.,tubecartridgeliners);closures(e.g.,screwcaps,stoppers);ferrulesandoverseals;closureliners;innerseals;administrationports;overwraps;administrationaccessories;andlabels.包裝組件：容器密封系統(tǒng)或包裝的任何一個部分，包括容器（如：安瓿、預(yù)灌封注射器、西林瓶、瓶子）；容器襯墊（例如管襯）；瓶塞（螺旋蓋、膠塞）；套管和膠塞頂封；瓶塞襯墊；內(nèi)封；輸液口；外包裝；給藥配件和標簽。Primarypackagingcomponent:Packagingcomponentsthatareindirectcontactormaybecomeindirectcontactwiththearticle.初級包裝組件指的是與物品直接接觸或可能變成直接接觸的包裝組件。Secondarypackagingcomponent:Packagingcomponentsthatarenotandwillnotbeindirectcontactwiththearticle.USP38次級包裝組件指的是不與物品直接接觸的包裝組件。Tertiarypackaging:Packagingcomponentsthatarenotindirectcontactwiththearticlebutfacilitatethehandlingandtransportinordertopreventdamagefromphysicalhandlingandstorageconditionstowhichthearticleissubjected.三級包裝：包裝組件不直接接觸物品但是方便操作和運輸，以避免來自物理操作和儲存條件對物品產(chǎn)生的損害。Materialsofconstruction:Referstothematerials(e.g.,glass,plastic,elastomers,metal)usedtomanufactureapackagingcomponent.結(jié)構(gòu)材料：指的是用于生產(chǎn)包裝組件的材料（如：玻璃、塑料、彈性纖維、金屬）。Multiple-dosecontainerUSP38(alsoreferredtoasmulti-dose):Apackagingsystemthatpermitswithdrawalofsuccessiveportionsofanarticleforparenteraladministrationwithoutchangingthesafety,strength,quality,orpurityoftheremainingportion.SeeMulti-DoseContainersinContainerContentforInjections697.USP38多劑量容器（也稱為多劑量）：允許藥品連續(xù)部分取出進行非消化道給藥的一個包裝系統(tǒng)，不改變余下部分的安全、強度、質(zhì)量或純度。見<697>注射劑容器部分的多劑量容器。.Multiple-unitcontainer:USP38Apackagingsystemthatpermitswithdrawalofsuccessiveportionsofanarticlewithoutchangingthesafety,strength,quality,orpurityoftheremainingportion.多單元包裝容器：允許一個藥品連續(xù)部分的取出的包裝系統(tǒng)，不改變余下部分的安全、強度、質(zhì)量或純度。Single-unitcontainer：USP38Apackagingsystemthatholdsaquantityofanarticleintendedforadministrationasasingledoseorasinglefinisheddeviceintendedforusepromptlyafterthecontainerisopened.Preferably,theimmediatecontainerand/ortheoutercontainerorprotectivepackagingshallbesodesignedastoshowevidenceofanytamperingwiththecontents.USP38一次用容器：盛有一定量藥品的包裝系統(tǒng)，打開后能夠作為單劑量或一次性給藥的裝置，在容器打開后能盡快使用。最好，應(yīng)設(shè)計直接包裝和/或外容器或保護性包裝，以作為內(nèi)容有任何篡改的證據(jù)。Single-dosecontainer:Asingle-dosecontainerisacontainerofsterilemedicationforparenteraladministration(injectionorinfusion)thatisnotrequiredtomeettheantimicrobialeffectivenesstestingcriteria.[Note—Forthisdefinitiononly,containerissynonymouswithpackagingsystemandcontainer–closuresystem.]Asingle-dosecontainerisdesignedforusewithasinglepatientasasingleinjection/infusion.1Asingle-dosecontainerislabeledassuchand,whenspacepermits,shouldincludeappropriatediscardinstructionsonthelabel.Examplesofsingle-dosecontainersarevials,ampuls,andprefilledsyringes.USP38單劑量容器：單劑量容器是用于注射用無菌藥物（注射或輸液）的一種容器，不需要滿足抗菌效果的測試標準。[注意——只對于這個定義，容器是包裝系統(tǒng)和容器密封系統(tǒng)代名詞]。單劑量容器是為單個病人單次注射/輸液使用的。單劑量容器貼上標簽，當空間允許，應(yīng)在標簽包括適當?shù)膩G棄說明。典型的單劑量容器是西林瓶、安剖、預(yù)灌封注射器）。Unit-dosecontainer：USP38Asingle-unitpackagingsystemforanarticleintendedforadministrationbyotherthantheparenteralrouteasasingledose.單一劑量容器：除了非腸道給藥，藥品單劑量給藥的一次用包裝系統(tǒng)。Unit-of-usecontainer:USP38Apackagingsystemthatcontainsaspecificquantityofanarticlethatisintendedtobedispensedassuchwithoutfurthermodificationexceptfortheadditionofappropriatelabeling.Unit-of-usepackagingmaynotberepackagedforsale.單位使用容器：含有特定數(shù)量藥品的包裝系統(tǒng)，這些藥品打算分發(fā)不能進一步修改，除了增加適當?shù)臉撕灐挝皇褂冒b不能重新包裝銷售。Pharmacybulkpackage:ApackagingsystemUSP38ofasterilepreparationforparenteralusethatcontainsmanysingledoses.Thecontentsareintendedforuseinapharmacyadmixtureprogramandarerestrictedtothepreparationofadmixturesforinfusionor,throughasteriletransferdevice,forthefillingofemptysterilesyringes.藥房大包裝：含有多個單劑量注射用滅菌制劑的包裝系統(tǒng)。其內(nèi)容物用于藥房調(diào)配且僅限于混合輸液的配制或者通過滅菌傳輸裝置，填充空的無菌注射器。Theclosureshallbepenetratedonlyonetimeafterconstitution,ifnecessary,USP38withasuitablesteriletransferdeviceordispensingsetthatallowsmeasureddispensingofthecontents.ThePharmacybulkpackageistobeusedonlyinasuitableworkareasuchasalaminarflowhood(oranequivalentclean-aircompoundingarea).組成藥房大包裝后只能刺穿封塞一次，如果必要，用一個合適的無菌傳輸設(shè)備或能夠允許測量調(diào)配藥量的配藥裝置。藥房大包裝只在合適的工作區(qū)域使用，如層流凈化罩（或相同的空氣潔凈級別的區(qū)域）。DesignationasaPharmacybulkpackageislimitedtoInjection,forInjection,orInjectableEmulsiondosageformsasdefinedinNomenclature1121,GeneralNomenclatureForms.USP38藥房大包裝僅限于注射，注射或可注射乳劑劑型在1121通用術(shù)語形式中的術(shù)語里有定義。Pharmacybulkpackage,althoughcontainingmorethanonesingledose,isexemptfromthemultiple-dosecontainervolumelimitof30mLandtherequirementthatitcontainsasubstanceorsuitablemixtureofsubstancestopreventthegrowthofmicroorganisms.SeeLabeling7forlabelingrequirements.USP38藥房大包裝，雖然含有一個以上的單劑量，但不受多劑量包裝30mL的體積限制，并不得含防止微生物生長的種物質(zhì)或混合物。見7標簽，對標簽的要求。Small-volumeinjections:AninjectionthatUSP38ispackagedincontainerslabeledascontaining100mLorless.小容量注射劑：裝入標示量為100mL或100mL以下容器的注射液。Large-volumeinjections:AnUSP38injectionthatisintendedforintravenoususe,andispackagedincontainerslabeledascontainingmorethan100mL.大容量注射劑：用于靜脈注射使用，并裝在標示量大于100mL容器的注射液。Child-resistantpackaging:USP38ApackagingsystemdesignedorconstructedtomeetConsumerProductSafetyCommissionstandardspertainingtoopeningbychildren(16CFR§1700.20).兒童安全包裝：設(shè)計或構(gòu)建的包裝系統(tǒng)符合消費者產(chǎn)品安全委員會標準適合對兒童開放(16CFR§1700.20)。Senior-friendlypackaging:USP38ApackagingsystemdesignedorconstructedtomeetConsumerProductSafetyCommissionstandardspertainingtoopeningbysenioradults(16CFR§1700.20).老人適用型包裝：設(shè)計或構(gòu)建的包裝系統(tǒng)符合消費者產(chǎn)品安全委員會標準適合對老年人開放。Tamper-evidentpackaging:USP38Apackagingsystemthatmaynotbeaccessedwithoutobviousdestructionofthesealorsomeportionofthepackagingsystem.Tamper-evidentpackagingshallbeusedforasterilearticleintendedforophthalmicoroticuse,exceptwhereextemporaneouslycompoundedforimmediatedispensingonprescription.Articlesintendedforsalewithoutprescriptionarealsorequiredtocomplywiththetamper-evidentpackagingandlabelingrequirementsoftheFDAwhereapplicable.Preferably,theimmediatecontainerand/ortheoutercontainerorprotectivepackagingusedbyamanufacturerordistributorforalldosageformsthatarenotspecificallyexemptisdesignedsoastoshowevidenceofanytamperingwiththecontents.防篡改包裝：是指只有明顯的破壞密封性或包裝系統(tǒng)的部分才能取出內(nèi)部產(chǎn)品的一種包裝系統(tǒng)。防篡改包裝應(yīng)用于眼用或耳用無菌產(chǎn)品，除非為了立即調(diào)配處方的無準備混合。用于銷售的非處方藥也要求符合防篡改包裝和適用于FDA的標簽要求。對于所有劑型而言，最好應(yīng)設(shè)計生產(chǎn)者或經(jīng)銷商所用的不能免除的直接包裝和/或外包裝或保護性包裝，以作為內(nèi)容有任何篡改的證據(jù)。Hermeticcontainer:Apackagingsystemthatisimpervioustoairoranyothergasundertheordinaryorcustomaryconditionsofhandling,shipment,storage,anddistribution.USP38密封容器：在處理、運輸、存儲和分布的普通或習(xí)慣性條件下不受空氣或其他氣體影響的包裝系統(tǒng)。Tightcontainer:USP38ApackagingsystemthatprotectsthecontentsUSP38fromcontaminationbyextraneousliquids,solids,orvapors;fromlossofthearticle;andfromefflorescence,deliquescence,orevaporationundertheordinaryorcustomaryconditionsofhandling,shipment,storage,anddistributionandiscapableoftightreclosure.Whereatightcontainerisspecified,itmaybereplacedbyahermeticcontainerforasingledoseofanarticle.[Note—Wherepackagingandstorageinatightcontainerorwell-closedcontainerisspecifiedintheindividualmonograph,thecontainerusedforanarticlewhendispensedonprescriptionmeetstherequirementsinContainers—PerformanceTesting671.]USP38緊密容器：在處理、運輸、存儲和分布的普通或習(xí)慣性條件下避免藥品受外來液體、固體或蒸汽的污染；避免藥品損失和風(fēng)化、潮解或蒸發(fā)且能夠密封的包裝系統(tǒng)，且該包裝系統(tǒng)可以重新緊密包裝。密閉容器是指定的，用于單劑量藥物時可以被密封容器取代。[注意——藥品包裝和儲存的密閉容器或?qū)Ｕ撝兄付ǖ拿芊馊萜?，當分配處方時，藥物所使用的容器符合671容器-性能測試的要求。Well-closedcontainer:USP38ApackagingsystemthatprotectsthecontentsUSP38fromcontaminationbyextraneoussolidsUSP38andfromlossofthearticleundertheordinaryorcustomaryconditionsofhandling,shipment,storage,anddistribution.SeeContainers—PerformanceTesting671.密封容器：在處理、運輸、存儲和分布的普通或習(xí)慣性條件下避免藥品受到外來固體污染，避免藥品損失的包裝系統(tǒng)。見671容器-性能測試。Light-resistantcontainer:USP38ApackagingsystemthatprotectsthecontentsUSP38fromtheeffectsoflightbyvirtueofthespecificpropertiesofthematerialofwhichitiscomposed,includinganycoatingappliedtoit.Aclearandcolorlessoratranslucentcontainermaybemadelight-resistantbymeansofanopaquecoveringorbyuseofsecondarypackaging,inwhichcasethelabelofthecontainerbearsastatementthattheopaquecoveringorsecondarypackagingisneededuntilthearticlesaretobeusedoradministered.Whereitisdirectedto“protectfromlight”inanindividualmonograph,preservationinalight-resistantcontainerisintended.SeeContainers—PerformanceTesting671,LightTransmissionTest.耐光容器：由特定性能材料組成能保護藥物不受光的影響的包裝系統(tǒng)，包括所使用的任何涂層。清晰和無色或半透明容器可以通過一個不透明的覆蓋方法制成耐光的，或用于次級包裝。在這種情況下，容器的標簽必需要有不透明的覆蓋物或次級包裝的聲明，直到藥品被使用或給藥。專論中針對“閉光”，要求保存在耐光容器。見671容器-性能測試，光傳輸測試。Blackclosuresystemorblackbands:Theuseofablackclosuresystemonavial(e.g.,ablackcapoversealandablackferruletoholdtheelastomericclosure)ortheuseofablackbandorseriesofbandsabovetheconstrictiononanampulisprohibited,exceptforPotassiumChlorideforInjectionConcentrate.SeeLabeling7.USP38黑色密封系統(tǒng)或黑色封邊：除了氯化鉀濃縮注射液外，在小瓶上使用黑色密封系統(tǒng)（如：黑色頂封蓋和黑色金屬箍來維持橡膠塞）或安瓿上使用黑色封邊或一系列封邊均是被禁止的。見7標簽。Addthefollowing:以下是增加的內(nèi)容：INJECTIONPACKAGING注射液包裝Validationofcontainer–closureintegritymustdemonstratenopenetrationofmicrobialcontaminationorchemicalorphysicalimpurities.Inaddition,thesolutesandthevehiclemustmaintaintheirspecifiedtotalandrelativequantitiesorconcentrationswhenexposedtoanticipatedextremeconditionsofmanufacturingandprocessing,storage,shipment,anddistribution.Closuresformultiple-dosepackagingsystemspermitthewithdrawalofthecontentswithoutremovalordestructionoftheclosure.Theclosurepermitspenetrationbyaneedleand,uponwithdrawaloftheneedle,closesatonce,protectingthecontentsagainstcontamination.Validationofthemultiple-dosecontainer–closureintegritymustincludeverificationthatsuchapackagepreventsmicrobialcontaminationorlossofproductcontentsunderanticipatedconditionsofmultipleentryanduse.容器密封完整性驗證必須證明沒有微生物污染或化學(xué)或物理雜質(zhì)的進入。除此之外，當容器暴露于生產(chǎn)和加工、儲存、運輸和銷售的極端環(huán)境下時，溶質(zhì)和溶劑必須保持其標示總量和相對量或濃度。多劑量包裝系統(tǒng)的封塞應(yīng)能在不除去或毀壞封塞的情況下抽出內(nèi)容物。塞子可被針頭刺入，當抽出針頭時，應(yīng)立即封閉容器以防污染。多劑量容器密封完整性驗證必須包括確認此包裝在多次刺入和使用的預(yù)期條件下能夠防止微生物污染或者產(chǎn)品含量的損失。Piggybackpackagingsystemsareusuallyintravenousinfusioncontainer–closuresystemsusedtoadministerasecondinfusionthroughaconnectorofsometypeoraninjectionportontheadministrationsetofthefirstfluid,therebyavoidingtheneedforanotherinjectionsiteonthepatient'sbody.Piggybackpackagingsystemsalsoareknownassecondaryinfusioncontainers.便攜式包裝系統(tǒng)通常是靜脈輸液容器密封系統(tǒng)，該系統(tǒng)通過多種類型的連接器或第一次輸注給藥的裝置的注射孔進行第二次輸注給藥，因此避免了在病人身上在此尋找注射位置。便攜式包裝系統(tǒng)也被稱為第二次輸注容器。Thevolumeofinjectioninasingle-dosepackagingsystemprovidestheamountspecifiedforone-timeparenteraladministrationandinnocaseismorethansufficienttopermitthewithdrawalandadministrationof1L.單劑量包裝系統(tǒng)注射液的容量規(guī)定了一次性注射用指定的數(shù)量，并在任何情況下，足以允許1L的抽取和給藥量。Preparationsintendedforintraspinal,intracisternal,orperiduraladministrationarepackagedonlyinsingle-dosepackagingsystems.脊柱內(nèi)注射、腦池液注射或硬膜外注射給藥的制劑，只能灌裝在單劑量容器中。Unlessotherwisespecifiedintheindividualmonograph,amultiple-dosepackagingsystemcontainsavolumeofinjectionsufficienttopermitthewithdrawalofNMT30mL.除非專論另有規(guī)定，多劑量包裝系統(tǒng)含有的可抽出注射液體積不得超過30ml。Thefollowinginjectionsareexemptfromthe1-Lrestrictionoftheforegoingrequirementsrelatingtopackaging:以下的注射液不受上述關(guān)于包裝的1L要求的限制。Injectionspackagedforextravascularuseasirrigationsolutionsorperitonealdialysissolutions.灌洗用或腹膜透析用的血管外注射液包裝。Injectionspackagedforintravascularuseasparenteralnutritionorasreplacementorsubstitutionfluidtobeadministeredcontinuouslyduringhemofiltration.胃腸外營養(yǎng)用或血液過濾期間不斷給藥的置換液用的血管內(nèi)注射液包裝。Injectionspackagedforintravascularusethatmaybeusedforintermittent,continuous,orbolusreplacementfluidadministrationduringhemodialysisorotherprocedures,unlessexceptedabove,mustconformtothe1-Lrestriction.Injectionslabeledforveterinaryuseareexemptfrompackagingandstoragerequirementsconcerningthelimitationtosingle-dosepackagingsystemsandthelimitationonthevolumeofmultiple-dosecontainers.在血液透析或其他程序過程中可能用于間歇性、連續(xù)性或大劑量更換給藥的血管內(nèi)注射液的包裝必須符合1L限制，除非不屬于以上條件。獸用標記的注射器不受關(guān)于單劑量包裝系統(tǒng)和多劑量容器體積限制的包裝和儲存要求。Sterilesolidspackaging:Containers,includingtheclosures,fordrysolidsintendedforinjectiondonotinteractphysicallyorchemicallywiththepreparationinanymannertoalterthestrength,quality,orpuritybeyondtheofficialrequirementsundertheordinaryorcustomaryconditionsofhandling,shipment,storage,sale,anduse.Apackagingsystemforasterilesolidpermitstheadditionofasuitablesolventandwithdrawalofportionsoftheresultingsolutionorsuspensioninsuchmannerthatthesterilityoftheproductismaintained.WheretheAssayinamonographprovidesaprocedurefortheSamplesolution,inwhichthetotalwithdrawablecontentsaretobewithdrawnfromasingle-dosepackagingsystemwithahypodermicneedleandsyringe,thecontentsaretobewithdrawnascompletelyaspossibleintoadryhypodermicsyringeofaratedcapacitynotexceedingthreetimesthevolumetobewithdrawnandfittedwitha21-gaugeneedleNLT2.5cm(1inch)inlength,withcarebeingtakentoexpelanyairbubbles,anddischargedintoacontainerfordilutionandassay.USP38無菌固體包裝：用于注射給藥干燥固體的容器，包括封塞，不應(yīng)與制劑產(chǎn)生物理或化學(xué)的相互作用以致在規(guī)定或通常處理、運輸、存儲、銷售及使用中以任何方式對強度、質(zhì)量和純度超出法定要求。無菌固體包裝系統(tǒng)允許加入適宜的溶劑，抽出制成的溶液或懸浮液部分，這樣能保持產(chǎn)品的無菌度。在專論的“含量測定”中規(guī)定樣品溶液程序，規(guī)定用皮下注射針頭和注射器從單劑量容器中抽出全部內(nèi)容物，應(yīng)盡可能完全地抽出，抽到干燥的皮下注射器中，注射器的標示容量不得超過抽出量的3倍，并應(yīng)裝長度不少于2.5cm（1英寸）的21號針頭，小心排出氣泡，轉(zhuǎn)移入一個容器進行稀釋和測定。MEDICALGASPACKAGING藥用氣體包裝Gascylinder:Agascylinderisametallicpackagingsystemconstructedofsteeloraluminumdesignedtoholdmedicalgasesunderpressure.MedicalgasesincludeCarbonDioxideUSP,HeliumUSP,MedicalAirUSP,nitricoxide,NitrousOxideUSP,NitrogenNF,andOxygenUSP.Asasafetymeasure,forcarbondioxide,cyclopropane,helium,medicalair,nitrousoxide,andoxygen,thePin-IndexSafetySystemofmatchedfittingsisrecommendedforcylindersofSizeEorsmaller.氣瓶：氣瓶是一個金屬包裝系統(tǒng)，由鋼或鋁構(gòu)成，在壓力下用來保存醫(yī)療氣體。醫(yī)療氣體包括二氧化碳USP,醫(yī)用空氣USP,一氧化氮,一氧化二氮USP,氮氣NF和氧氣USP。Pin-Index安全系統(tǒng)作為一項安全措施，為二氧化碳、環(huán)丙烷、氦、醫(yī)療空氣、一氧化二氮和氧推薦的匹配配件是型號為E或更小的氣瓶。ASSOCIATEDCOMPONENTS相關(guān)組件Manyassociatedcomponentsaregraduatedfordoseadministration.Itistheresponsibilityofthemanufacturertoensurethattheappropriatedosingcomponentisprovidedorthatageneralpurposecomponent,suchasthosedescribedinthissection,isspecifiedfordeliveringtheappropriatedosewiththeintendedaccuracy.Thegraduationsshouldbelegibleandindelible.許多相關(guān)組件根據(jù)給藥劑量是有刻度的。廠家有責(zé)任確保提供符合劑量的組件或通用組件，如這個章節(jié)所描述的那些組件，用于發(fā)放適當?shù)膭┝浚陬A(yù)期的準確度里?？潭葢?yīng)該是清晰的，不可磨滅的。Graduatedassociatedcomponentsdescribedinthissectionareforgeneraluse.Graduatedmarkingsshouldbelegible,indelible,andonanextraoralnonproductcontactsurface.Underidealconditionsofuse,thevolumeerrorincurredinmeasuringliquidsforindividualdoseadministrationbymeansofsuchgraduatedcomponentsshouldbeNMT10%oftheindicatedamountoftheliquidpreparationwithwhichthegraduatedcomponentwillbeused.Fewliquidpreparationshavethesamesurfaceandflowcharacteristics.Therefore,thevolumedeliveredvariesmateriallyfromonepreparationtoanother.本章節(jié)所描述的有刻度的相關(guān)組件是普遍使用的?？潭葮擞洃?yīng)該是清晰，不可磨滅的，且在產(chǎn)品不能接觸的外表面。在理想的使用條件下，單劑量給藥時用這些刻度組件測量液體所招致的體積誤差小于等于10%，表示在有刻度元件內(nèi)的液體制劑的量是可用的。一些液體制劑具有相同的表面和流動特性。因此，從一個制劑到另一個制劑的輸液量實際上是不同的。PolymersandingredientsaddedtopolymersthatareusedinthefabricationofassociatedcomponentsmustconformtotherequirementsintheapplicablesectionsoftheCodeofFederalRegulations,Title21,IndirectFoodAdditives.用于制造相關(guān)組件的聚合物和添加到聚合物的材料必須符合美國聯(lián)邦法規(guī)，標題21，間接食品添加劑適用章節(jié)的要求。Dosingcup:Ameasuringdeviceconsistingofasmallcupthatispackagedwithoralliquidarticlesorthatmaybesoldandpurchasedseparately.加藥杯：由一個包裝口服液體藥物的小杯子組成的一個測量容器，也可以單獨出售和購買。Dosingspoon:Ameasuringdeviceconsistingofabowlandahandlethatispackagedwithoralliquidarticlesorthatmaybesoldandpurchasedseparately.Thehandlemaybeagraduatedtube.加藥匙：由一個包裝口服液體藥物的碗狀物和手柄組成的一個測量容器，也可以單獨出售和購買。柄可能是個刻度管。Medicinedropper:Ameasuringdeviceconsistingofatransparentortranslucentbarrelortubethatisgenerallyfittedwithacollapsiblebulb.Itispackagedwithoralliquidarticlesormaybesoldandpurchasedseparately.醫(yī)藥用滴管:由透明或半透明的槍管或管組成的測量容器，通常配有一個可折疊的球狀物。包裝口服液體藥物，可以單獨出售和購買。Dropperstypicallyvaryincapacity;however,thedeliveryendshouldbearoundopeninghavinganexternaldiameterofabout3mm.Thebarrelmaybegraduated.[Note—Fewmedicinalliquidshavethesamesurfaceandflowcharacteristicsaswater,andthereforethesizeofdropsvariesmateriallyfromonepreparationtoanother.]滴管通常在容量上是多變的，然而，出口端應(yīng)該是一個外直徑為3mm的圓孔。槍管要有刻度。[注意——一些藥用液體具有和水相同的表面和流量特性，因此，從一個制劑到另一個制劑的滴量實際上是變化的]。Oralsyringe:Ameasuringdeviceconsistingofaplungerandbarrelmadeofsuitablerigid,transparentortranslucentplasticmaterialandasealontheend.Itispackagedwithoralliquidarticlesormaybesoldandpurchasedseparately.Thesyringeshouldexpelameasuredamountofaliquidarticledirectlyintothepatient'smouth.Fingergripslocatedattheopenendofthebarrelshouldbetheappropriatesize,shape,andstrength,andshouldallowthesyringetobeheldsecurelyduringuse.Thebarrelmaybegraduated.口腔注射器：由一個活塞和剛性適合的透明或半透明塑料制成的管組成的測量容器，且在末端封口。用于包裝口服液體藥品或者可以單獨出售和購買。注射器可以將被測量液體直接進注入病人的嘴。位于筒開口端的指套應(yīng)有適當?shù)拇笮。螤?，和力量，且?yīng)該允許注射器在使用期間能夠保持安全牢固。管需要標刻度。Teaspoon:Ameasuringdeviceconsistingofashallowbowl,ovalorround,attheendofahandle.Ateaspoonhasbeenestablishedascontaining4.93±0.24mL.Forthepracticeofadministeringarticles,theteaspoonmayberegardedasrepresentingavolumeof5mL.茶匙：是由一個圓形或橢圓形的，末端有個柄的淺碗組成。既定的茶匙有4.93±0.24mL。根據(jù)藥物給藥的實踐，茶匙可以被視為是5mL的量。Articlesintendedforadministrationbyteaspoonshouldbeformulatedonthebasisofdosagein5-mLunits,suchthatanycomponentusedtoadministerliquidarticlesshoulddeliver5mLwhereverateaspooncalibrationisindicated.Ahouseholdspoonisnotanacceptablealternativetothegraduatedteaspoondescribedherein.用茶匙給藥的藥物應(yīng)該建立在用量是5-mL每單元的基礎(chǔ)上。這樣任何用于液體藥品給藥的元件應(yīng)該提供5mL，無論有沒有指明茶匙要校準。家里的勺子不能代替這里所描述的有標量的茶匙。POISONPREVENTIONPACKAGINGACT(PPPA)防毒包裝法案（PPPA）Thisactrequiresspecialpackagingofmosthumanoralprescriptiondrugs,oralcontrolleddrugs,certainnon-oralprescriptiondrugs,certaindietarysupplements,andmanyover-the-counter(OTC)drugpreparationsinordertoprotectthepublicfrompersonalinjuryorillnessfrommisuseofthesepreparations(16CFR§1700.14).該法案要求對大多數(shù)人用口服處方藥，口服控制藥物，某些非口服處方藥，某些膳食補充劑，以及很多非處方藥（OTC）的藥物制劑進行特殊包裝，其目的是為了保護公眾免受濫用這些制劑帶來的人身傷害或疾?。▍⒖?6CFR§1700.14）。TheimmediatepackagingofsubstancesregulatedunderthePPPAmustcomplywiththespecialpackagingstandards(16CFR§1700.15and16CFR§1700.16)andappliestoallpackagingtypesincludingreclosable,nonclosable,andunit-dosetypes.在防毒包裝法案（PPPA）監(jiān)管下，直接接觸藥物的包裝必須符合特殊包裝標準（參考16

CFR

§1700.15

和16

CFR

§1700.16），且適用于包括可重新密封、不可密封和單位劑量類型所有包裝類型。Specialpackagingisnotrequiredeitherfordrugsdispensedwithinahospitalsettingforinpatientadministrationorbymanufacturersandpackagersofbulk-packagedprescriptiondrugsrepackagedbythepharmacist.PPPA-regulatedprescriptiondrugsmaybedispensedinnonchild-resistantpackagingupontherequestofthepurchaserorwhendirectedinalegitimateprescription(15U.S.C.§1473).無論是為住院病人管理設(shè)置的醫(yī)院內(nèi)用藥量，還是藥師重新包裝由生產(chǎn)商和包裝商散裝包裝的處方藥都不需要特殊包裝。基于采購人的要求，或者當一個合法的處方指導(dǎo)時，PPPA監(jiān)管的處方藥可能分配到非兒童安全包裝。（參考15

U.S.C.

§1473）ManufacturersorpackagersofPPPA-regulatedOTCpreparationsareallowedtopackageonesizeinnonchild-resistantpackagingaslongaspopular-size,specialpackagesarealsosupplied.Thenonchild-resistantpackagingrequiresspeciallabeling(16CFR§1700.5).允許PPPA監(jiān)管的OTC制劑的生產(chǎn)商或包裝商包裝一個非兒童安全包裝尺寸，只要這個尺寸受歡迎，也可以提供特殊包裝。非兒童安全包裝需要特殊標簽。（參考16

CFR

§1700.5）Changetoread:STORAGECONDITIONS儲存條件Specificdirectionsarestatedinsomemonographswithrespecttostorageconditions,e.g.,thetemperatureorhumidityatwhichanarticlemustbestoredandshipped.Suchdirectionsapply,exceptwherethelabelonthearticlehasdifferentstorageconditionsthatarebasedonstabilitystudies.Wherenospecificstorageconditionsareprovidedintheindividualmonograph,butthelabelofanarticlestatesstorageconditionsbasedonstabilitystudies,suchlabeledstoragedirectionsapply.USP38在一些專論中對儲存條件有一些特定的規(guī)定，如藥物儲存和運輸必需的溫度和濕度。這些方向的應(yīng)用，除了在藥物的標簽上有不同的儲存條件，也建立在穩(wěn)定性研究的基礎(chǔ)上。在專論上沒有提供特定儲存條件，但是藥物標簽上的儲存條件，建在穩(wěn)定性的基礎(chǔ)上，這樣標為儲存方向適用。Freezer:Aplaceinwhichthetemperatureismaintainedbetween-25°and-10°(-13°and-14°F).冷凍箱：溫度維持在-25°到-10°之間的地方（-13°和-14°F）。Refrigerator:AcoldUSP38placeinwhichthetemperatureismaintainedbetween2°and8°(36°and46°F).冰箱：溫度維持在2°和8°之間的一個寒冷的地方（36°和46°F)Cold:Anytemperaturenotexceeding8°(46°F).冷凍：不超過8°的任意溫度(46°F)。Cool:Anytemperaturebetween8°and15°(46°and59°F).[Note—Anarticleforwhichstorageinacoolplaceisdirectedmay,alternatively,bestoredandshippedasrefrigerated,unlessotherwisespecifiedbytheindividualmonograph.]陰涼：8°和15°(46°和59°F)之間的任意溫度。[注意——儲存陰涼處的藥物直接或者用冰箱儲存或運輸。除非專論另有規(guī)定]。Roomtemperature:Thetemperatureprevailinginaworkarea.室溫：一般工作區(qū)域的溫度。Controlledroomtemperature:ThetemperaturemaintainedthermostaticallythatencompassesUSP38attheusualandcustomaryworkingenvironmentof20°–25°(68°–77°F).Thefollowingconditionsalsoapply.控制的室溫：溫度保持自動調(diào)溫，包括20°–25°(68°–77°F)的習(xí)慣性工作環(huán)境。下列的條件同樣適用。Meankinetictemperaturenottoexceed25°.USP38Excursionsbetween15°and30°(59°and86°F)thatareexperiencedinpharmacies,hospitals,andwarehouses,andduringshippingareallowed.ProvidedUSP38themeankinetictemperaturedoesnotexceed25°,transientU