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(lèi)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(guò)75％，其它辣椒素類(lèi)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(lèi)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(kāi)劑中展開(kāi)，待展開(kāi)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(guò)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(guò)1.0%。

灼燒殘?jiān)骸?.0％。

辣椒素，二氫辣椒素及其它辣椒二萜類(lèi)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(guò)，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(chēng)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(chēng)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(lèi)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(lèi)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(lèi)化合物總百分含量不超過(guò)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(guò)摻加低活力的木瓜蛋白酶，乳糖或者其他合適的填充物來(lái)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