美国药典中英文对照(翻译资料).doc

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）一N—[（4—N—羟基一3—甲氧基苯基）一甲基]一8—甲基一6—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％一100%,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,将薄层板放于乙醚一甲醇（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°一66°,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^o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（I: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，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/⑸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%C18H27NO3305.416-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-mpackiigL11andismaintainedataconstanttemperatureofabout30°.Adjusttheflowratetoobtainaretentiontimeofabout20minutesforthemaincapsaicinpeak.ChromatographtheStandardcapsaicinsolution,andrecordthepeakresponsesasdirectedforprocedure:therelativestandarddeviationforreplicateinjectionsisnotmorethan2%.ProcedureSeparatelyinjectequalvolunes(about20L)oftheStandardcapsaicinsolution,theStandarddihydrocapsaicinsolution,andtheTestsolutionintothechromatograph,recordthechromatogramforaperiodoftimethatistwicethatoftheretentiontimeofcapsaicin,andmeasuretheareasoftheresponsesforallofthepeaks.Calculatethepercentageofcapsaicin(C18H27NO3)intheportionofCapsaicintakenbytheformula:25,000(C/W)(gu/gs),inwhichCistheconcentration,inmgpermL,ofUSPCapsaicinRSintheStandardcapsaicinsolution,Wistheweight,inmg,ofCapsaicintakentopreparetheTestsolution,andruandrsarethe。