美国药典-中英文对照(翻译资料)

美国药典－中英文对照

译文

美国药典中记载的辣椒碱资料

辣椒碱（辣椒素）

分子结构式：C18H27NO3，分子量：305.41，化学名：（反）－N－[（4－N－羟基－3－甲氧基苯基）－甲基]－8－甲基－6－壬烯基酰胺

以干燥提取物计算，辣椒碱含辣椒二萜类化合物总量为标示量的90％－100%,其中辣椒素的含量达到50％以上，辣椒素和二氢辣椒素总量超过75％，其它辣椒素类化合物总量不足15％。

注意事项：小心处置辣椒碱，谨防吸入辣椒碱微粒，勿使身体接触辣椒碱。

包装贮藏：密封包装，置避光，阴凉处保存。

标示量：以辣椒二萜类化合物总百分含量表示。

美国药典参考标准：美国药典辣椒素标准规范，美国药典二氢辣椒素标准规范。

鉴别：配制1.0mg/ml辣椒碱甲醇溶液，配制符合美国药典标准的辣椒碱1.0mg/ml甲醇溶液作为对照液，分别点样于0.25mm厚硅胶、凝胶混合薄层板上，点样量为10礚，将薄层板放于乙醚－甲醇（19:1）展开剂中展开，待展开剂前沿至薄层板3/4处时将薄层板取出，晾干，用0.5%2,6-二溴苯醌-氯化亚胺甲醇溶液喷雾显色，放于氨气中片刻，取出，鉴别色谱图：供试液主要斑点颜色（兰色）及R值与对照液主要斑点颜色（兰色）及R值一致。

熔点〈741〉:57°－66°,一般熔融起始温度至结束温度温差不超过5°。

干燥失重〈731〉:置40°P2O5真空干燥器中干燥5小时，失重不超过1.0%。

灼烧残渣：≤1.0％。

辣椒素，二氢辣椒素及其它辣椒二萜类化合物含量测定：

流动相：磷酸水溶液（l：1000，V/V）：乙腈(600:400)混匀，0.5祄微孔滤膜滤过，脱气。流动相视色谱行为可作适当调整。

辣椒素对照液：精密称取美国药典标准的辣椒碱适量溶于甲醇中，配制约0.1mg/mL的辣椒甲醇溶液。

二氢辣椒素对照液：精密称取美国药典标准的辣椒碱适量溶于甲醇中，配制约0.025mg/mL的辣椒甲醇溶液。

供试液：精密量取辣椒碱约25mg于250mL容量瓶中，甲醇稀释至刻度，摇匀。

色谱条件：检测波长281nm，色谱柱（4.6mmx250cm，5祄），柱温：30°，调流速使辣椒碱主要色谱峰保留时间约为20min。记录辣椒碱对照液色谱图及峰面积，重复进样，RSD≤2%。

样品处理：辣椒素对照液，二氢辣椒素对照液，供试液分别进样20礚，记录色谱图至两倍主要色谱峰保留时间，记录所有色谱峰面积，按公式25,000(C/W)(ru/rs)计算辣椒素百分含量,公式中C为辣椒素对照液浓度，单位mg/mL,W为供试液中辣椒碱含量，单位mg，ru和rs分别代表供试液中和对照液中辣椒素峰面积。辣椒素含量不低于55％。按公式25,000(C/W)(ru/rs)计算二氢辣椒素含量，公式中C为二氢辣椒素对照液浓度，单位mg/mL,W为供试液中辣椒素含量，单位为mg,ru和rs分别代表供试液和对照液中二氢辣椒素峰面积。测得辣椒素和二氢辣椒素总百分含量不低于75%.根据记录供试液和对照液色谱图峰面积，按公式25,000(C/W)(ru/rs)计算其它辣椒二萜类化合物百分含量，公式中C为对照液中辣椒素浓度，单位mg/mL，W为供试液中辣椒素含量，单位为mg，ru为供试液中其它辣椒二萜类化合物而非辣椒素、二氢辣椒素峰面积之和，rs为对照液中辣椒素峰面积。其它辣椒二萜类化合物总百分含量不超过15％。

C18H27NO3305.41

6-Nonenamide,(E)-N-[(4-Hydroxy-3-methoxy-phenyl)methyl]-8-methyl.

(E)-8-Methyl-N-vanillyl-6-nonenamide

[404-86-4].

Capsaicincontainsnotlessthan90.0percentandnotmorethan110.0percentofthelabeledpercentageoftotalcapsaicinoids.Thecontentofcapsaicin(C18H27NO3)isnotlessthan55percent,andthesumofthecontentsofcapsaicinanddihydrocapsaicin(C18H29NO3)isnotlessthan75percent,andthecontentofothercapsaicinoidsisnotmorethan15percent,allcalculatedonthedriedbasis.

Caution——HandleCapsaicinwithcare.Preventinhalationofparticlesofitandpreventitscontactwithanypartofthebody.

Packagingandstorage——Preserveintightcontainers,protectedfromlight,andstoreinacoolplace.

Labeling——Labelittostatethepercentagecontentoftotalcapsaicinoids.

USPReferencestandards〈11〉——USPCapsaicinRS.USPDihydrocapsaicinRS.

Identification——PrepareatestsolutionofCapsaicininmethanolcontaininglmgpermL.PrepareaStandardsolutionofUSPCapsaicinRSinmethanolcontaininglmgpermL.Separatelyapply10-礚portionsofthetestsolutionandtheStandardsolutiontoathin-layerchromatographicplate(seeChromatography〈21〉)coatedwitha0.25-mmlayerofchromatographicsilicagelmixture.Developthechromatogramsinasolventsystemconsistingofamixtureofetherandmethanol(19:1)untilthesolventfronthasmovedaboutthreefourthsofthelengthoftheplate.Removetheplatefromthechamber,andallowittoair-dry.Spraytheplatewitha0.5%solutionof2,6-dibromoquinone-chlorimideinmethanol,allowtostandinachambercontainingammoniafumes,andexaminethechromatograms:thebluecolorandtheRvalueoftheprincipalspotobtainedfromthetestsolutioncorrespondtothosepropertiesoftheprincipalspotobtainedfromtheStandardsolution.

Meltingrange〈741〉:between57°and66°,buttherangebetweenbeginningandendofmeltingdoesnotexceed5°.

Lossondrying〈731〉:Dryitinvacuumoverphosphoruspentoxideat40°for5hours:itlosesnotmorethan1.0%ofitsweight.

Residueonignition〈281〉:notmorethan1.0%.

Contentofcapsaicin,dihydrocapsaicin,andothercapsaicinoids—Mobilephase—Prepareamixtureofdilutedphosphoricacid(lin1000)andacetonitrile(600:400).Filterthroughafilterhavingaporosityof0.5祄orfiner,anddegas.Makeadjustmentsifnecessary(seeSystemSuitabilityunderChromatography〈621〉).

Standarddihydrocapsaicinsolution—DissolveanaccuratelyweighedquantityofUSPCapsaicinRSquantitativelyinmethanoltoobtainasolutionhavingaknownconcentrationofabout0.1mgpermL.

Standarddihydrocapsaicinsolution—DissolveanaccuratelyweighedquantityofUSPDihydrocapsaicinRSquantitativelyinmethanoltoobtainasolutionhavingaknownconcentrationofabout0.025mgpermL.

Testsolution—Transferabout25mgofCapsaicin,accuratelyweighed,toa250-mLvolumetricflask,dilutewithmethanoltovolume,andmix.

Chromatographicsystem(seeChromatography〈621〉)—Theliquidchromatographisequippedwitha281-nmdetectoranda4.6-mmx25-cmcolumnthatcontains5-μmpackingL11andismaintainedataconstanttemperatureofabout30°.Adjusttheflowratetoobtainaretentiontimeofabout20minutesforthemaincapsaicinpeak.ChromatographtheStandardcapsaicinsolution,andrecordthepeakresponsesasdirectedforprocedure:therelativestandarddeviationforreplicateinjectionsisnotmorethan2%.

Procedure—Separatelyinjectequalvolunes(about20μL)oftheStandardcapsaicinsolution,theStandarddihydrocapsaicinsolution,andtheTestsolutionintothechromatograph,recordthechromatogramforaperiodoftimethatistwicethatoftheretentiontimeofcapsaicin,andmeasuretheareasoftheresponsesforallofthepeaks.Calculatethepercentageofcapsaicin(C18H27NO3)intheportionofCapsaicintakenbytheformula:

25,000(C/W)(gu/gs),

inwhichCistheconcentration,inmgpermL,ofUSPCapsaicinRSintheStandardcapsaicinsolution,Wistheweight,inmg,ofCapsaicintakentopreparetheTestsolution,andruandrsarethecapsaicinpeakresponsesobtainedfromtheTestsolution,andtheStandardatethepercentageofdihydrocapsaicin(C18H29NO3)intheportionofCapsaicintakenbytheformula:

25,000(C/W)(gu/gs),

inwhichCistheconcentration,inmgpermL,ofUSPDihydrocapsaicinRSintheStandardcapsaicinsolution,Wistheweight,inmg,ofCapsaicintakentopreparetheTestsolution,andruandrsarethedihydrocapsaicinpeakresponsesobtainedfromtheTestsolutionandtheStandarddihydrocapsaicinsolution,respectively.Thesumofthepercentageofcapsaicinfoundandofthepercentageofdihydrocapsaicinfoundisnotlessthan75%.UsingthechromatogramsobtainedfromtheStandardcapsaicinsolutionandtheTestsolution,calculatethepercentageofothercapsaicinoidsintheportionofCapsaicintakenbytheformula:

25,000(C/W)(gu/gs),

inwhichCistheconcentration,inmgpermL,ofUSPCapsaicinRSinthe,Wistheweight,inmg,ofCapsaicintakentopreparetheTestsolution,rTisthesumofthepeakresponsesofthecapsaicinoidsotherthancapsaicinanddihydrocapsaicininthechromatogramobtainedfromtheTestsolution,andrsisthecapsaicinpeakresponseobtainedfromtheStandardcapsaicinsolution.Notmorethan15%ofothercapsaicinoidsisfound.

[[i]本帖最后由tinalongding于2008-12-817:24编辑[/i]]2008-12-817:23tinalongdingPapain

Papain[9001-73-4]

PapainisapurifiedproteolyticsubstancederivedfromCaricapapayaLinné(Fam.caricaceae).papain,whenassayeddirectedherein,containsnotlessthan6000unitspermg.Papainofahigherdigestivepowermaybereducedtotheofficialstandardbyadmixturewithpapainofloweractivity,lactose,orothersuitablediluents.

OneUSPUnitofpapainistheactivitythatreleasestheof1μgoftyrosinefromaspecifiedcaseinsubstanceundertheconditionsoftheAssay，usingtheenzymeconcentrationthatliberates40μgoftyrosinepermLoftestsolution.

Packagingandstorage－Preserveintight,light-resistantcontainersinacoolplace.

USPreferencestandards(11)—USPpapainRS.

pH<791>:between4.8and6.2inasolution(1in50).

Lossondrying<731>—Dryitinavacuumovenat60℃for4hours:itlossesnotmorethan7.0%ofitsweight.

Assay(caseindigestivepower)—

Dibasicsodiumphosphate.,0.05M—dissolve7.1gofanhydrousdibasicsodiumphosphateinwatertomake1000mL.add1dropoftolueneasapreservative.

Citricacid,0.05M—dissolve10.5gofcitricacidmonohydrateinwatertomake1000mL.Add1dropontolueneasapreservative.

Caseinsubstrate—Disperse1gofHammersten-typecaseinin50mLon0.05MDibasicsodiumphosphate.Placeinaboilingwaterbathfor30minuteswithoccasionalstirring.Cooltoroomtemperature,andadd0.05MCitricacidtoadjusttoapHof

6.0±0.1.stirthesolutionrapidlyandcontinuouslyduringtheadditionofthe0.05MCitricacidtopreventprecipitationofthecasein.Dilutewithwaterto100mL.preparefreshdaily.

Buffersolution(Phosphate-CysteineDisodiumethylenediaminetetraacetateBuffer)—dissolve3.55gofanhydrousdibasicphosphatein400mLofwaterina500-mLvolumetricflask.Add7.0gofdisodiumEDTAand3.05gofcysteinehydrochloridemonohydrate.Adjustwith1Nhydrochloricacidor1NsodiumhydroxidetoapHof6.0±0.1.dilutewithwatertovolume,andmix.Preparefreshdaily.

Trichloroaceticacidsolution—Dissolve30gofreagentgradetrichloroaceticacidinwater.anddilutewithwaterto100mL.Thissolutionmaybestoredatroomtemperature.

Standardpreparation—Weighaccurately100mgofUSPPapainRSina100-mLvolumetricflask.AndaddBuffersolutiontodissolve.DilutewithBuffersolutiontovolume,andmix.Transfer2.0mLofthissolutiontoa50-mLvolumetricflask,dilutewithBuffersolutiontovolume,andmix.Usewithin30minutesafterpreparation.

Assaypreparation—Transferanaccuratelyweighedamountofpapain.,equivalenttoabout100mgofUSPPapainRS,toa10-mLvolumetricflask,dilutewithBuffersolutiontovolume,andmix.Transfer2.0mLofthissolutiontoa50-mLvolumetricflsk,dilutewithBuffersolutiontovolume,andmix.

Procedure—Intoeachof12testtubes(18-×150-mm)pipet5.0mLofcaseinsubstrate.Placeinawaterbathat40°,andallow10minutestoreachbathtemperature.Intoeachoftwoofthetubes(thetestsareruninduplicateexceptfortheblanks)

labeledS1,pipet1.0mLoftheStandardpreparationand1.0mLoftheBuffersolution,Mixbyswirling,notezerotime,insertthestopper,andreplaceinthebath.Intoeachof2othertubes,labeled

S2pipet1.5mLofstandard.preparationand0.5mLofBuffersolution,andproceedasbefore.Repeatthisprocedurefor2tubes,labeledS3towhich2.0mLofstandardpreparationisadded,andfor2tube,labledU2,towhich1.5mLofAssaypreparationand0.5mL

Buffersolutionareadded.After60minutes,accurarytimed,addtoall12tubes3.0mLoftrichloroaceticacidsolution,andshakevigorously.Withthe4tubestowhichnostandardpreparationorAssaypreparationwereadded,prepareblanksbypipeting,respectively,1.0mLofstandardpreparationand1.0mLofBuffersolution1.5mLofstandardpreparationand0.5mLofBuffersolution;2.0mLofstandardpreparation;and1.5mLAssaypreparationand0.5mLofBuffersolution.Replacealltubesinthe40°waterbathfor30to40minutes,toallowtocoagulatefullytheprecipitatedprotein.Filterthroughmedium-porosityfilterpaper,discarding

thefirst3mLofthefiltrate(filtratesusedareclear).Readtheabsorbancesat280nm,ofthefiltratesifallsolutionsagainsttheirrespectiveblanks.PlottheabsorbancereadingsforS1,S2¬andS3againsttheenzymeconcentrationofeachcorrespondinglevel.Byinterpolationfromthiscurve,takingintoconsiderationdilutionfactors,calculatethepotencyinUnits,intheweightofpapaintakenbytheformula.:

(50,000/3)CA,

Inwhich50,000/3isafactorderivedbytheexpression100(50/2)(10/1.5),Cistheconcentration,inmgpermL,obtainedfromthestandardcurve,andAistheactivityoftheReferenceStandardinUnitspermg.

翻译仅供参考：

木瓜蛋白酶

木瓜蛋白酶[9001-73-4]

木瓜蛋白酶是一种源自番木瓜乳汁（Fam.caricaceae）的纯化的水解蛋白物。木瓜蛋白酶在这里定向检测时其含量不得少于6000单位每毫克。具有较高的消化能力的木瓜蛋白酶也许可以通过掺加低活力的木瓜蛋白酶，乳糖或者其他合适的填充物来降低消化能力以达到官方的标准。

定义木瓜蛋白酶一个USP活力单位为在测定条件下指定的酪蛋白物质释放1μg酪氨酸所需要的量，所用的酶试液的浓度相当与每毫升释放40μg酪氨酸。

包装与保藏—包装要包紧，保存在避光，阴凉的地方

USP参考标准（11）—USP木瓜蛋白酶R.S

pH<791>在溶液中介于4.8与6.2之间（1in50？）

干燥失重<731>—60℃时在真空干燥箱中干燥4