药典凡例-日本药典(中英文对照)

本文件由AI本文件由AI进行翻译，仅供行业交流使用，译文准确性不做最终负责，仅供参考GENERALNOTICES凡例JPXVIIITheofficialnameofthispharmacopoeiais第十八改正日本薬局方andmaybeabbreviatedas日局十八,日局18JPXVIIIorJP18.本药典的官方名称为第十八改正日本药典，可缩写为日局十八、日局18、JPXVIII或JP18。TheEnglishnameofthispharmacopoeiaisTheJapanesePharmacopoeia,EighteenthEdition.本药典的英文名称为《日本药典第十八版》（TheJapanesePharmacopoeia,EighteenthEdition）。Amongdrugs,theJapanesePharmacopoeiaDrugs(theJPDrugs)arethosespecifiedinthemonographs.Thetitlenamesandthecommonlyusednamesadoptedinthemonographshouldbeusedasofficialnames.Inthedrugmonograph,inadditiontoEnglishname,chemicalnameorLatinnamecanbementionedinthetitle,asappropriate.药品中，日本药典药品（简称JP药品）指各论中规定的药品。各论采用的标题名及常用名作为法定名称。药品各论的标题中，除英文名称外，可根据需要标注化学名称或拉丁名称。CrudeDrugsandtheirrelatedproductsareplacedtogetherin``CrudeDrugsandRelatedDrugs''intheposteriorpartoftheOfficialMonographs.Theseinclude:Extracts,Powders,Tinctures,Syrups,Spirits,FluidextractsorSuppositoriescontainingCrudeDrugsastheactiveingredient,andcombinationpreparationscontainingCrudeDrugsastheprincipalactiveingredient.药材及其相关制品集中列于法定各论后部的“药材及相关药品”酊剂、糖浆剂、醑剂、流浸膏剂或栓剂，以及以药材为主要活性成分的复方制剂。TheJPDrugsaretobetestedaccordingtotheprovisionsgiveninthepertinentmonographs,GeneralNotices,GeneralRulesforCrudeDrugs,GeneralRulesforPreparations,andGeneralTestsfortheirconformitytotheJapanesePharmacopoeia.However,theheadingsofDescription''andinadditionContainersandstorage''andShelflife''inthemonographsonpreparationsaregivenforinformation,andshouldnotbetakenasindicatingstandardsforconformity.Nevertheless,ContainersunderContainersandstorage''inthemonographonpreparationscontainingcrudedrugsasmainactiveingredientsarethestandardsforconformity.日本药典药品应依据相关各论、通用注意事项、药材通则、制剂通则及一般试验法的规定进行检验，以符合日本药典要求。但制剂各论中的“性状”项下，以及“容器与贮藏”和“有效期”项下的内容仅为参考信息，不“容器与贮藏”项下的容器要求为符合性标准。Inprinciple,unlessotherwisespecified,animalsusedforpreparingtheJPDrugsortheirsourcematerialsmustbehealthy.原则上，除非另有规定，用于制备日本药典药品或其原料的动物必须健康。InthisEnglishversion,theJPDrugsdescribedinthemonographsbeginwithacapitalletter.本英文版本中，各论所述的日本药典药品名称首字母大写。Themolecularformulasorconstitutionformulasinparentheses()afterthenameofdrugsorchemicalsdesignatechemicallypuresubstances.AtomicmassesadoptedintheJapanesePharmacopoeiaconformtothetableofAtomicWeightsoftheElements2015''(IUPAC)-StandardAtomicWeights2017(AtomicWeightsSubcommitteeoftheChemicalSocietyofJapan).However,theatomicmassesoftheelementswhoseatomicweightisindicatedwithanintervalinthe2015tableconformtothetableofAtomicWeightsoftheElements2007''(IUPAC)-StandardAtomicWeights2010(AtomicWeightsSubcommitteeoftheChemicalSocietyofJapan).Molecularmassesareindicatedtotwodecimalplacesroundedfromthreedecimals.药品或化学品名称后括号内的分子式或结构式表示化学纯物质。日本药典采用的原子量符合《2015年元素原子量表》（IUPAC）-《2017年标准原子量》（日本化学会原子量委员会）的规定。但2015年量表中原子量标注为区间值的元素，其原子量遵循《2007年元素原子量表》（IUPAC）-《2010年标准原子量》（日本化学会原子量委员会）的规定。分子量按三位小数四舍五入后保留两位小数表示。Thefollowingabbreviationsareusedfortheprincipalunits.主要单位用以下缩写表示meter米mcentimeter厘米cmmillimeter毫米mmmicrometer微米μmnanometer纳米nmkilogram千克kggram克gmilligram毫克mgmicrogram微克μgnanogram纳克ngpicogram皮克pgCelsiusdegree摄氏度°Cmole摩尔molmillimole毫摩尔mmolsquarecentimeter平方厘米cm²liter升Lmilliliter毫升mLmicroliter微升μLmegahertz兆赫兹MHzpercentimeter每厘米cm⁻¹newton牛顿Nkilopascal千帕斯卡kPapascal帕斯卡Papascalsecond帕斯卡·秒Pa·smillipascalsecond毫帕斯卡·秒mPa·ssquaremillimeterpersecond平方毫米每秒mm²/slux勒克斯lxmoleperliter摩尔每升mol/L本文件由AI本文件由AI进行翻译，仅供行业交流使用，译文准确性不做最终负责，仅供参考millimoleperliter毫摩尔每升mmol/Lmasspercent质量分数%(质量分数)masspartspermillion百万分之质量分数ppm质量分数)masspartsperbillion十亿分之质量分数ppb质量分数)volumepercent体积分数vol体积分数)volumepartspermillion百万分之体积分数volppm体积分数)masspervolumepercent质量体积分数w/v质量体积分数)microsiemenspercentimeter微西门子每厘米μS·cm⁻¹endotoxinunit内毒素单位EUcolonyformingunit菌落形成单位CFUNote:ppm''usedintheNuclearMagneticResonanceSpectroscopyindicatesthechemicalshift,andw/v%''isusedintheformulaorcompositionofpreparations.注：核磁共振光谱中使用的“ppm”表示化学位移，“w/v%”本文件由AI本文件由AI进行翻译，仅供行业交流使用，译文准确性不做最终负责，仅供参考TheunitusedforexpressingthepotencyoftheJPDrugsisrecognizedasthequantityofdrug.TheJPDrugsaretobetestedaccordingtotheprovisionsgiveninthepertinentmonographs,GeneralNotices,GeneralRulesforCrudeDrugs,GeneralRulesforPreparations,andGeneralTestsfortheirconformitytotheJapanesePharmacopoeia.(SeetheGeneralNotices5.)Usuallyitisexpressedbyadefinitequantityofadefinitestandardsubstancewhichshowsadefinitebiologicalactivity,anddiffersaccordingtoeachdrug.Theunitsaredetermined,inprinciple,bycomparisonwitheachreferencestandardbymeansofbiologicalmethods.Theterm``Unit''usedfortheJParticlesindicatestheunitdefinedintheJapanesePharmacopoeia.表示日本药典药品效价的单位为药品的法定计量单位。日本药典药品应依据相关各论、通用注意事项、药材通则、制剂通则及一般试验法的规定进行检验，以符合日本药典要求（见通用注意事项第5条）。效价单位通常以具有特定生物活性的标准物质的一定数量表示，且因药品而异。原则上，效价单位通过生物测定法与相应对照品比对确定。日本药典药品中使用的“单位（Unit）”指日本药典中定义的单位。Thestatement``Beingspecifiedseparately.''inthemonographsmeansthatthetestsaretobespecifiedwhenthedrugsaregrantedapprovalbasedontheLawonSecuringQuality,EfficacyandSafetyofProductsincludingPharmaceuticalsandMedicalDevices.各论中“另行规定”的表述，指该药品依据《药事法》（含药品及医疗器械等产品质量、有效性和安全性保障相关法律）获得批准时，将明确相关检验要求。Fromthepointofviewofqualityassurance,requirementsthatshouldbenotedonmanufacturingprocesses,ifappropriateinadditiontothespecifications,areshownintheheadingManufacture''inmonograph.Itmaycontainrequirementsregardingcontrolofmaterials,manufacturingprocessesandintermediates,andrequirementsregardingtestsinprocessandomissionoftestsfortherelease.Thefulfilmentofrequirementsmentionedinthisheadingareconfirmedbasedontheinformationobtainedduringtheestablishmentofmanufacturingmethodatthedevelopmentstage,thecontrolofmanufacturingprocesses,orthetestsfortherelease.AlsoeveninthecaseofabsenceoftheheadingManufacture''inmonograph,itisimportanttonoteappropriatecontrolsofmaterials,manufacturingprocessesandintermediatesinindividualdrugs.从质量保证角度出发，除质量标准外，各论中“生产”项下将酌情列出生产过程中应注意的要求。该部分可能包括原料、生产工艺及中间体的控制要求，以及过程检验和放行检验豁免的相关规定。该项下要求的符合性，通过研发阶段工艺建立过程中获取的信息、生产过程控制情况或放行检验结果予以确认。即使各论中未设“生产”项下，各药品也应重视对原料、生产工艺及中间体的适当控制。WhenanassurancethataproductisoftheJPDrugqualityisobtainedconsistentlyfromdataderivedfromthemanufacturingprocessvalidationstudies,andfromtherecordsofappropriatemanufacturingprocesscontrolandofthetestresultsofthequalitycontrol,theperformanceofsometestitemsinthemonographatreleaseonaproductmaybeomittedasoccasiondemands.Moreover,thequalityevaluationoffinalproducts(drugsubstancesanddrugproducts)basedonin-processdataincludingin-processtestingresultsandmonitoringdataonprocessparameterscanreplacespecificspecificationsandtestmethodsinthemonographorperformingthetestmethods,ifappropriate.若通过生产工艺验证研究数据、适当的生产过程控制记录及质量控制检验结果，能够持续确认产品符合日本药典药品质量要求，可根据需要豁免部分各论中规定的放行检验项目。此外，若合适，基于过程检验结果、工艺参数监测数据等过程数据对成品（原料药及制剂）进行的质量评价，可替代各论中的特定质量标准、检验方法或免除该检验方法的执行。ThetestmethodsspecifiedintheJapanesePharmacopoeiacanbereplacedbyalternativemethodswhichgivebetteraccuracyandprecision.However,whereadifferenceintestresultsissuspected,onlytheresultobtainedbytheproceduregiveninthePharmacopoeiaiseffectiveforthefinaljudgment.日本药典规定的检验方法可采用准确度和精密度更优的替代方法。但当怀疑检验结果存在差异时，仅药典规定方法得出的结果可作为最终判定依据。Thedetailsofthebiologicaltestmethodsmaybechangedinsofarastheydonotaffecttheessentialqualitiesofthetest.生物检验方法的细节可在不影响检验核心质量的前提下进行修改。Thetemperatureforthetestsorstorageisdescribed,inprinciple,inspecificfigures.However,thefollowingexpressionsmaybeusedinstead.Standardtemperature,ordinarytemperature,roomtemperature,andlukewarmaredefinedas20°C,15–25°C,1–30°C,and30–40°C,respectively.Acoldplace,unlessotherwisespecified,shallbeaplacehavingatemperatureof1–15°C.Thetemperatureofcoldwater,lukewarmwater,warmwater,andhotwateraredefinedasnotexceeding10°C,30–40°C,60–70°C,andabout100°C,respectively.Thetermheatedsolvent''orhotsolvent''meansasolventheatedalmosttotheboilingpointofthesolvent,andthetermwarmedsolvent''orwarmsolvent''usuallymeansasolventheatedtoatemperaturebetween60°Cand70°C.Theterm``heatonorinawaterbath''indicates,unlessotherwisespecified,heatingwithaboilingwaterbathorasteambathatabout100°C.Coldextractionandwarmextractionareusuallyperformedattemperaturesof15–25°Cand35–45°C,respectively.检验或贮藏温度原则上以具体数值表示，也可采用下列表述。标准温度、常温、室温、微温分别定义为20℃、15–25℃、1–30℃、30–40℃。冷处，除非另有规定，指温度为1–15℃的场所。冷水、微温水、温水、热水的温度分别定义为不超过10℃、30–40℃、60–70℃、约100℃。“加热溶剂”或“热溶剂”指加热至接近沸点的“水浴加热”，除非另有规定，指采用沸水浴或约100℃的蒸汽浴加热。冷浸提取和温浸提取通常分别在15–25℃和35–45℃下进行。Tomeasurethenumberofdrops,adroppingdevicewhichdelivers20dropsofwaterweighing0.90–1.10gat20°Cshallbeused.滴数测定应使用特定滴液装置，该装置在20℃时滴出20滴水的质量为0.90–1.10g。Theterm``invacuum''indicates,unlessotherwisespecified,apressurenotexceeding2.0kPa.“真空下”，除非另有规定，指压力不超过2.0kPa。Theacidityoralkalinityofasolution,unlessotherwisespecified,isdeterminedbyblueorredlitmuspapers.Toindicatethesepropertiesmoreprecisely,pHvaluesareused.溶液的酸碱性，除非另有规定，采用蓝色或红色石蕊试纸测定。如需更精确表示，可使用pH值。ThetermsinTable1areusedtoexpressthedegreeofcuttingofCrudeDrugsorfinenessofpowderDrugs.表1中的术语用于表示药材的切段程度或粉末状药品的细度。Table1No.筛号46.58.61850100200Nominal4750μm2800μm2000μm850μm300μm150μm75μmionofsieve筛孔公称尺寸Namesofthedrugswhichpassthroughtherespectivesieves通过相应筛网的药品名称CoarsecuttingModeratelyfinecutting中切段FinecuttingCoarsepowder粗粉Moderatelyfinepowder中粉Finepowder细粉VeryfinepowderThewatertobeusedinthetestsofdrugsshallbethewatersuitableforperformingtherelevanttest,suchasthewaternotcontaininganysubstancethatwouldinterferewiththetest.药品检验所用的水应为适合相关检验的水，如不含干扰检验的物质。Asforwordingsolutionofasolute'',wherethenameofthesolventisnotstated,thetermsolution''indicatesasolutioninwater.对于“某溶质的溶液”表述，若未注明溶剂名称，“溶液”指水溶液。Forsolutionanexpressionsuchas(1in3)'',(1in10)'',or(1in100)''meansthat1gofasolidisdissolvedin,or1mLofaliquidisdilutedwiththesolventtomakethetotalvolumeof3mL,10mLor100mL,respectively.Fortheliquidmixtureanexpressionsuchas(10:1)''or``(5:3:1)''meansthattherespectivenumbersofparts,byvolume,ofthedesignatedliquidsaretobemixed.溶液中“（1→3）”“（1→10）”或“（1→100）”等表述，指1g固体溶解于溶剂中，或1mL液体用溶剂稀释，使总体积分别达到3mL、10mL或100mL。液体混合物中“（10:1）”或“（5:3:1）”等表述，指按指定液体的体积份数进行混合。Thetermweighaccurately''meanstoweighdowntothedegreeof0.1mg,10mg,1mgor0.1mgbytakingintoaccountthepurposeofthetestandusingarelevantweighingdevice.Thetermweighexactly''meanstoweightothegivendecimalplaces.“精密称定”指根据检验目的，使用相应称量仪器，称量至0.1mg、10mg、1mg或0.1mg精度。“准确称量”指称量至规定的小数位数。Avalueofn''figuresinatestoftheJPDrugsshallbeobtainedbyroundingoffavalueofn+1''figures.日本药典药品检验中，n位有效数字的数值通过对n+1位有效数字的数值四舍五入获得。Unlessotherwisespecified,alltestsoftheJPDrugsshallbeperformedattheordinarytemperatureandobservationsoftheresultsshallfollowimmediatelyaftertheoperations.However,thejudgmentforatestwhichisaffectedbytemperatureshouldbebasedontheconditionsatthestandardtemperature.除非另有规定，日本药典药品的所有检验均在常温下进行，操作后立即观察结果。但受温度影响的检验，其判定应基于标准温度条件下的结果。Thetermsimmediately''/atonce''usedinthetestoftheJPDrugsmeanthattheprocedureistobeperformedwithin30secondsaftertheprecedingprocedure.日本药典药品检验中使用的“立即”表述，指该操作应在前一操作完成后30秒内进行。InthesectionundertheheadingDescription,thetermwhite''isusedtoindicatewhiteorpracticallywhite,andcolorless''iscolorlessorpracticallycolorless.Unlessotherwisespecified,thetestofcoloriscarriedoutbyplacing1gofasoliddrugonasheetofwhitepaperorinawatchglassplacedonwhitepaper.Aliquiddrugisputintoacolorlesstesttubeof15-mminternaldiameterandisobservedinfrontofawhitebackgroundthroughalayerof30mm.Forthetestofclarityofliquiddrugsthesameprocedureisappliedwitheitherablackorwhitebackground.Fortheobservationoffluorescenceofaliquiddrug,onlyablackbackgroundshallbeused.“性状”项下，“白色”指白色或类白色，“无色”指无色或几乎无色。除非另有规定，颜色检验方法为：取1g固体药品置于白纸上或白纸上的表面皿中观察；取液体药品置于内径15mm的无色试管中，在白色背景前通过30mm液层观察。液体药品的澄清度检验采用相同操作，可在黑色或白色背景下进行；液体药品的荧光观察仅在黑色背景下进行。InthesectionundertheheadingDescription,theterm``odorless''isusedtoindicateodorlessorpracticallyodorless.Unlessotherwisespecified,thetestofodorshallbecarriedoutbyplacing1gofasoliddrugor1mLofaliquiddruginabeaker.“性状”项下，“无臭”指无臭或几乎无臭。除非另有规定，气味检验方法为：取1g固体药品或1mL液体药品置于烧杯中观察。InthesectionundertheheadingDescription,solubilitiesareexpressedbythetermsinTable2.Unlessotherwisespecified,solubilitymeansthedegreeofdissolutionoftheJPDrugs,previouslypowderedinthecaseofasoliddrug,within30minutesinasolventat20±5°C,byvigorousshakingfor30secondseachtimeat5-minuteintervals.“性状”项下，溶解度采用表2中的术语表示。除非另有规定，溶解度指日本药典药品在20±5℃条件下，于溶剂中溶解的程度（固体药品需预先粉碎）。溶解过程为每间隔5分钟剧烈振摇30秒，持续30分钟。Table2Descriptiveterm描述术语Volumeofsolventrequiredfordissolving1gor1mLofsolute溶解1g或1mL溶质所需溶剂体积Verysoluble极易溶解Lessthan1mL小于1mLFreelysoluble易溶From1mLtolessthan10mL1mL至小于10mLSoluble溶解From10mLtolessthan30mL10mL至小于30mLSparinglysoluble略溶From30mLtolessthan100mL30mL至小于100mLSlightlysoluble微溶From100mLtolessthan1000mL100mL至小于1000mLVeryslightlysoluble极微溶解From1000mLtolessthan10000mL1000mL至小于10000mLPracticallyinsoluble,orinsoluble几乎不溶或不溶10000mLandover10000mL及以上Inthetestofadrug,thetermdissolve''ormiscible''indicatesthatitdissolvesin,ormixesinarbitraryproportionwiththesolventtoformaclearsolutionormixture.Insolublematerialsotherthanthedrugincludingfibersshouldnotbedetectedorpracticallyinvisible,ifany.药品检验中，“溶解”或“混溶”指药品溶解于溶剂中，或与溶剂按任意比例混合，形成澄清溶液或混合物。除药品外，不得检出纤维等不溶性杂质；若有，应几乎不可见。Identificationisthetesttoidentifytheactiveingredient(s)ofthedrugbaseduponitsspecificproperty.鉴别是依据药品的特有性质，确认其活性成分的检验项目。Purityisthetesttodetectimpurities/contaminantsindrugs,andit,aswellasotherrequirementsineachmonograph,specifiesthepurityofthedrugusuallybylimitingthekind/natureandquantityoftheimpurities/contaminants.Theimpurities/contaminantssubjecttothepuritytestarethosesupposedtogenerate/contaminateduringthemanufacturingprocessorstorage,includinghazardousagentssuchasheavymetals,arsenic,etc.Ifanyforeignsubstancesareusedorsupposedtobeadded,itisnecessarytoperformteststodetectorlimitthepresenceofsuchsubstances.纯度检验是检测药品中杂质/污染物的项目，与各论中的其他要求一致，通常通过限定杂质/污染物的种类、性质及含量来明确药品纯度。纯度检验的杂质/污染物包括生产或贮藏过程中可能产生或引入的物质，如重金属、砷等有害物质。若使用或可能引入外来物质，需进行相应检验以检测或限制其存在。Inprinciple,theJPDrugProductsarecontrolledappropriatelyaccordingtothedirectionunderElementalImpuritiesoftheGeneralTests.Whenelementalimpuritiesinthedrugproductsareappropriatelycontrolledinaccordancewiththedirection,itisnotnecessarytoperformthetestsonelementalimpuritiessuchasheavymetalsandarsenicspecifiedinthemonographsincluding,butnotlimitedto,thoseofdrugproducts,drugsubstancesandexcipients.原则上，日本药典制剂应按照一般试验法中“元素杂质”据该要求得到适当控制，则无需进行各论（包括但不限于制剂、原料药及辅料各论）中规定的重金属、砷等元素杂质检验。Inprinciple,unlessspecifiedinthemonograph,theJPDrugsarecontrolledappropriatelyaccordingtothedirectionunderResidualSolventsofthegeneraltests.原则上，除非各论另有规定，日本药典药品应按照一般试验法中“残留溶剂”项下的要求进行适当控制。Concerningharmfulsubstancesreportedasintentionallycontaminatedtodrugs,thecontrolrequirementforthepresenceorabsenceofcontaminationisdescribedintheheading``Potentialadulteration''inthemonograph,asnecessary.Thesesubstancesarecontrolledbytestsonmaterials,manufacturingprocesses,intermediates,orfinalproducts.Thenecessityandfrequencyofthetestsarespecifiedseparatelyonindividualdrugsdependingonthecontrolstrategyestablishedaspartofqualityriskmanagement.对于有报告称可能被故意掺入药品的有害物质，各论中“潜在掺杂物”项下将根据需要明确其污染控制要求。此类物质通过原料、生产工艺、中间体或成品检验进行控制。检验的必要性及频次，根据质量风险管理制定的控制策略，针对各药品另行规定。Theterm``constantmass''indryingorignition,unlessotherwisespecified,meansthatthemassdifferenceafteranadditional1hourofdryingorignitionisnotmorethan0.10%oftheprecedingmassofthedriedsubstanceorignitedresidue.ForCrudeDrugs,thedifferenceisnotmorethan0.25%.However,whenthedifferencedoesnotexceed0.5mginachemicalbalance,50mginasemi-microbalance,or5mginamicrobalance,theconstantmasshasbeenattained.干燥或炽灼中的“恒重”，除非另有规定，指连续干燥或炽灼1小时后，两次质量差异不超过前一次干燥物质或炽灼残渣质量的0.10%。药材的恒重差异不超过0.25%。但使用化学天平称量时，差异不超过0.5mg；使用半微量天平称量时，差异不超过50mg；使用微量天平称量时，差异不超过5mg，即视为达到恒重。Assayisthetesttodeterminethecomposition,thecontentoftheactiveingredients,andthepotencyunitofmedicinebyphysical,chemicalorbiologicalprocedures.含量测定是通过物理、化学或生物方法，测定药品的组成、活性成分含量及效价单位的检验项目。Instatingtheappropriatequantitiestobetakenforassay,theuseofthewordabout''indicatesaquantitywithin10%ofthespecifiedmass.Theworddry''inrespectofthesampleindicatesdryingunderthesameconditions,asdescribedinLossondryinginthemonograph.含量测定中“约取”的表述，指取用量为规定质量的±10%范围内。样品相关的“干燥”表述，指按照各论中“干燥失重”项下规定的条件进行干燥。ForthecontentofaningredientdeterminedbyAssayinthemonographs,ifitisexpressedsimplyas``notlessthanacertainpercentage''withoutindicatingitsupperlimit,101.0%isunderstoodastheupperlimit.各论中含量测定项下的成分含量，若仅表述为“不得低于某一百分比”而未注明上限，其上限默认为101.0%。Sterilitymeansaconditionwhennotargetmicroorganismisdetectedbythespecifiedmethod.Sterilizationmeansaprocesswherebykillingorremovalofalllivingmicroorganismsinanobjecttobesterilizedisaccomplished.Aseptictechniqueiscontrolledtechniquetomaintaintheasepticcondition.无菌指通过规定方法未检出目标微生物的状态。灭菌指杀灭或去除待灭菌物品中所有活微生物的过程。无菌操作法是维持无菌状态的受控操作技术。ThecontaineristhedevicewhichholdstheJPDrugs.Thestopperorcap,etc.,isconsideredaspartofthecontainer.Thecontainershavenophysicalandchemicalreactivityaffectingthespecifieddescriptionandqualityofthecontents.容器指盛装日本药典药品的器具，瓶塞、瓶盖等视为容器的组成部分。容器不得与内容物发生影响其规定性状及质量的物理或化学反应。Awell-closedcontainerprotectsthecontentsfromextraneoussolidsandfromlossofthedrugunderordinaryorcustomaryco