美国药典中英文对照翻译资料.docx

美国药典中英文对照翻译资料.docx

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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:

23tinalongding

Papain

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-mLvolum