美國(guó)藥典-中英文對(duì)照(翻譯資料)

美國(guó)藥典－中英文對(duì)照

譯文

美國(guó)藥典中記載的辣椒堿資料

辣椒堿（辣椒素）

分子結(jié)構(gòu)式：C18H27NO3，分子量：305.41，化學(xué)名：（反）－N－[（4－N－羥基－3－甲氧基苯基）－甲基]－8－甲基－6－壬烯基酰胺

以干燥提取物計(jì)算，辣椒堿含辣椒二萜類化合物總量為標(biāo)示量的90％－100%,其中辣椒素的含量達(dá)到50％以上，辣椒素和二氫辣椒素總量超過75％，其它辣椒素類化合物總量不足15％。

注意事項(xiàng)：小心處置辣椒堿，謹(jǐn)防吸入辣椒堿微粒，勿使身體接觸辣椒堿。

包裝貯藏：密封包裝，置避光，陰涼處保存。

標(biāo)示量：以辣椒二萜類化合物總百分含量表示。

美國(guó)藥典參考標(biāo)準(zhǔn)：美國(guó)藥典辣椒素標(biāo)準(zhǔn)規(guī)范，美國(guó)藥典二氫辣椒素標(biāo)準(zhǔn)規(guī)范。

鑒別：配制1.0mg/ml辣椒堿甲醇溶液，配制符合美國(guó)藥典標(biāo)準(zhǔn)的辣椒堿1.0mg/ml甲醇溶液作為對(duì)照液，分別點(diǎn)樣于0.25mm厚硅膠、凝膠混合薄層板上，點(diǎn)樣量為10礚，將薄層板放于乙醚－甲醇（19:1）展開劑中展開，待展開劑前沿至薄層板3/4處時(shí)將薄層板取出，晾干，用0.5%2,6-二溴苯醌-氯化亞胺甲醇溶液噴霧顯色，放于氨氣中片刻，取出，鑒別色譜圖：供試液主要斑點(diǎn)顏色（蘭色）及R值與對(duì)照液主要斑點(diǎn)顏色（蘭色）及R值一致。

熔點(diǎn)〈741〉:57°－66°,一般熔融起始溫度至結(jié)束溫度溫差不超過5°。

干燥失重〈731〉:置40°P2O5真空干燥器中干燥5小時(shí)，失重不超過1.0%。

灼燒殘?jiān)骸?.0％。

辣椒素，二氫辣椒素及其它辣椒二萜類化合物含量測(cè)定：

流動(dòng)相：磷酸水溶液（l：1000，V/V）：乙腈(600:400)混勻，0.5祄微孔濾膜濾過，脫氣。流動(dòng)相視色譜行為可作適當(dāng)調(diào)整。

辣椒素對(duì)照液：精密稱取美國(guó)藥典標(biāo)準(zhǔn)的辣椒堿適量溶于甲醇中，配制約0.1mg/mL的辣椒甲醇溶液。

二氫辣椒素對(duì)照液：精密稱取美國(guó)藥典標(biāo)準(zhǔn)的辣椒堿適量溶于甲醇中，配制約0.025mg/mL的辣椒甲醇溶液。

供試液：精密量取辣椒堿約25mg于250mL容量瓶中，甲醇稀釋至刻度，搖勻。

色譜條件：檢測(cè)波長(zhǎng)281nm，色譜柱（4.6mmx250cm，5祄），柱溫：30°，調(diào)流速使辣椒堿主要色譜峰保留時(shí)間約為20min。記錄辣椒堿對(duì)照液色譜圖及峰面積，重復(fù)進(jìn)樣，RSD≤2%。

樣品處理：辣椒素對(duì)照液，二氫辣椒素對(duì)照液，供試液分別進(jìn)樣20礚，記錄色譜圖至兩倍主要色譜峰保留時(shí)間，記錄所有色譜峰面積，按公式25,000(C/W)(ru/rs)計(jì)算辣椒素百分含量,公式中C為辣椒素對(duì)照液濃度，單位mg/mL,W為供試液中辣椒堿含量，單位mg，ru和rs分別代表供試液中和對(duì)照液中辣椒素峰面積。辣椒素含量不低于55％。按公式25,000(C/W)(ru/rs)計(jì)算二氫辣椒素含量，公式中C為二氫辣椒素對(duì)照液濃度，單位mg/mL,W為供試液中辣椒素含量，單位為mg,ru和rs分別代表供試液和對(duì)照液中二氫辣椒素峰面積。測(cè)得辣椒素和二氫辣椒素總百分含量不低于75%.根據(jù)記錄供試液和對(duì)照液色譜圖峰面積，按公式25,000(C/W)(ru/rs)計(jì)算其它辣椒二萜類化合物百分含量，公式中C為對(duì)照液中辣椒素濃度，單位mg/mL，W為供試液中辣椒素含量，單位為mg，ru為供試液中其它辣椒二萜類化合物而非辣椒素、二氫辣椒素峰面積之和，rs為對(duì)照液中辣椒素峰面積。其它辣椒二萜類化合物總百分含量不超過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編輯[/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.

翻譯僅供參考：

木瓜蛋白酶

木瓜蛋白酶[9001-73-4]

木瓜蛋白酶是一種源自番木瓜乳汁（Fam.caricaceae）的純化的水解蛋白物。木瓜蛋白酶在這里定向檢測(cè)時(shí)其含量不得少于6000單位每毫克。具有較高的消化能力的木瓜蛋白酶也許可以通過摻加低活力的木瓜蛋白酶，乳糖或者其他合適的填充物來降低消化能力以達(dá)到官方的標(biāo)準(zhǔn)。

定義木瓜蛋白酶一個(gè)USP活力單位為在測(cè)定條件下指定的酪蛋白物質(zhì)釋放1μg酪氨酸所需要的量，所用的酶試液的濃度相當(dāng)與每毫升釋放40μg酪氨酸。

包裝與保藏—包裝要包緊，保存在避光，陰涼的地方

USP參考標(biāo)準(zhǔn)（11）—USP木瓜蛋白酶R.S

pH<791>在溶液中介于4.8與6.2之間（1in50？）

干燥失重<731>—60℃時(shí)在真空干燥箱中干燥4