2010版中国药典英文ppt课件

2010版中国药典英文版,1,一、药材来源,1.植(动)物来源的药材的来源部分的一般译法为:药材英文名称isthe药用部位(名词单数)of植(动)物拉丁学名属名和种(变种)加词为斜体字(科名).例：PummeloPeelisthedriedunripeoralmostripeexocarpofCitrusgrandis“Tomentosa”orCitrusgrandis(L.)Osbeck(Fam.Rutaceae).本品为芸香科植物化州柚Citrusgrandi“Tomentosa”或柚Citrusgrandis(L.)Osbeck的未成熟或近成熟的干燥外层果皮。,2,2.药材的采收与产地加工部分的一般译法为:用Thedrug作主语，单数。用被动语态，不用主动语态。“采收”用“tobecollected”(不用“tobepicked”，“tobedugup”等)。“除去杂质”等(名词单数)用“removedfromforeignmatter”,“洗净”用“washedclean”,“干燥”用“dried”，“晒干”为“driedinthesun”，“阴干”为“driedintheshade”,“低温干燥”为“driedatalowertemperature”。“栽培变种”为“cultivar”。“泥砂”为“soil”。“须根.细根”：“fibrousroot”用于单子叶植物、根茎上的不定根，“rootlet”用于双子叶植物主根上的细小侧根、支根。例1Thedrugiscollectedinautumn,removedfromforeignmatter,washedclean,anddriedinthesun.例2Thedrugiscollectedatfloweringtofruitingstage,removedfromthickstem,cutintosection,anddried.(注:中国药典2005年版一部英文版药用部位采用名词单数,如stem,leaf,fibrousroot,rootlet等).,3,二、理化鉴别,1.化学鉴别Shake0.5gofthepowderwith5mlofethanolfor5minutesandfilter.Evaporatethefiltratetodryness,adddropwiseantimonytrichloridesaturationsolutioninchloroformandevaporateagaintodryness.Aviolet-redcolourisproduced.取本品粉末0.5g，加乙醇5ml，振摇5分钟，滤过，滤液蒸干，滴加三氯化锑饱和的三氯甲烷溶液，再蒸干，即显紫红色。,4,2.薄层鉴别（1）经常用到需统一的词汇和短语：a.超声处理用ultrasonicateb.提取用extractc.温浸用warmmacerated.水浴加热用heatonawaterbathe.对照品（对照品溶液）用“对照品名”加“CRS”表示（referencesolution）;对照药材（对照药材溶液）用referencedrug（referencedrugsolution）;供试品溶液用testsolution,5,f.薄层板:硅胶G薄层板.usingsilicagelGasthecoatingsubstance用1%氢氧化钠溶液制备的硅胶G薄层板.usingsilicagelGmixedwith1%solutionofsodiumhydroxideasthecoatingsubstance含4%醋酸钠的羧甲基纤维素钠溶液为黏合剂的硅胶G薄层板上.usingsilicagelGmixedwithsodiumcarboxymethylcellulosecontaining4%solutionofsodiumacetateasthecoatingsubstance.,6,g.斑点用spot(s)，条斑用band(s)h.分别置日光及紫外光灯(365nm)下检视，日光下显色的斑点；紫外光灯下显色的斑点用spotindaylightandspotunderultravioletlightat365nmrespectively.(2)薄层鉴别基本的四个步骤，即供试品溶液制备；对照品溶液制备；点样、展开、显色；结果判断。,7,a.供试品溶液制备常见以下几种情况：,超声处理提取To9g,cutintopieces,add20mlofether,ultrasonicatefor20minutes,andfilter.Evaporatethefiltratetodryness,anddissolvetheresiduein0.5mlofn-hexaneasthetestsolution.取本品9g，切碎，加乙醚20ml，超声处理20分钟，滤过，滤液挥干，残渣加0.5ml正己烷溶解，作为供试品溶液。（艾附暖宫丸）,8,加热回流提取Heatunderreflux2g,cutintopieces,with20mlofethanolfor1hour,coolandfilter,usethefiltrateasthetestsolution.取本品2g，剪碎，加乙醇20ml，加热回流1小时，放冷，滤过，滤液作为供试品溶液。,9,萃取、过柱纯化Extractthefiltratewithtwo15-mlquantitiesofn-butanolsaturatedwithwater,combinethen-butanolextracts,andevaporatetodryness.Dissolvetheresiduein1mlofdehydratedethanol,addaquantityofalumina,stirwellonawaterbath,dry,andapplytoasmall(10-15mmindiameter)或SepackC18columnpackedwithneutralalumina(200mesh,1g,1015mmindiameter),pre-elutewith30mlofamixtureofethylacetateandmethanol(3:1).Elutewith30mlofamixtureofethylacetateandmethanol(1:1),andcollecttheeluate.Evaporatetodrynessanddissolvetheresiduein0.5mlofethanolasthetestsolution.,10,滤液用水饱和的正丁醇提取二次，合并正丁醇提取液，蒸干，残渣加无水乙醇1ml使溶解，加适量氧化铝在水浴上拌匀，干燥，装入一预先装填好的中性氧化铝小柱（200目，1g，内径10-15mm）或C18小柱上，用乙酸乙酯-甲醇（3：1）30ml预洗，再用乙酸乙酯-甲醇（1：1）30ml洗脱，收集洗脱液，残渣加乙醇0.5ml使溶解，作为供试品溶液。,11,浸渍、水解Macerate0.5gofthepillsin20mlofmethanolfor1hour,andfilter.Evaporate5mlofthefiltratetodryness,dissolvetheresiduein10mlofwater,add1mlofhydrochloricacid,heatonawaterbathfor30minutes,andcoolimmediately.取本品0.5g，加甲醇20ml浸泡1小时，滤过。取5ml滤液蒸干，残渣加10ml水溶解，加1ml盐酸，水浴加热30分钟，立即冷却。,12,b.对照品（对照药材）溶液的制备,化学对照品作对照DissolvechlorogenicacidCRSinmethanoltoproduceasolutioncontaining1mgpermlasthereferencesolution.取绿原酸对照品，加甲醇溶解制成每1ml含1mg的溶液，作为对照品溶液。多个化学对照品混合对照DissolveginsenosidesRb1,ReandRg1CRSinmethanoltoproduceamixturecontaining2mgofeachpermlasthereferencesolution.对照药材作对照Prepareasolutionof0.5gofRheiRadixetRhizomareferencedrugand20mlofmethanolinthesamemannerasthereferencedrugsolution.另取大黄对照药材0.5g，加甲醇20ml，同法制成对照药材溶液。,13,c.点样、展开、显色、检视,点样、展开Carryoutthemethodforthinlayerchromatography（AppendixVIB），usingsilicagelGasthecoatingsubstanceandtheupperlayerofamixtureofbutylacetate,formicacidandwater(7:2.5:2.5)asthemobilephase.Applyseparately10lofthetestsolutionand2lofthereferencesolutiontotheplate.照薄层色谱法（附录B）试验，吸取供试品溶液10l，对照品溶液2l，分别点于同一硅胶G薄层板上，以醋酸丁酯-甲酸-水(7:2.5:2.5)为展开剂，展开，.。显色、检视Spraywith5%sulfuricacidinethanolandheattothespotclear.Examineunderultravioletlightat365nm.以5%硫酸乙醇溶液显色，热风加热至斑点显色清晰。置紫外光灯(365nm)下检视。,14,d.结果判断,Thefluorescentspotsinthechromatogramobtainedwiththetestsolutioncorrespondinpositionandcolourtothespotsobtainedwiththereferencedrugsolution;andanorangefluorescentspotinthechromatogramobtainedwiththetestsolutioncorrespondsinpositionandcolourtothespotinthechromatogramobtainedwiththereferencesolution.供试品色谱中，在与对照药材色谱相应的位置上，显相同颜色的荧光斑点；在与对照品色谱相应的位置上，显相同的橙黄色荧光斑点。,15,三、Assay(含量测定)（1）分光光度法,a.E值法Weighaccurately0.2gofthecoarsepowder,distillwithsteam,collectabout450mlofthedistillate,diluteto500mlwithwaterandshakewell.Carryoutthemethodforultravioletspectrophotometryandcolourimetry(AppendixVA),measuretheabsorbanceat274nmandcalculatethecontentofpaeonol,taking862asthevalueofA(1%,1cm).取本品粗粉约0.2g，精密称定，用水蒸气蒸馏，收集馏出液约450ml，加水至500ml，摇匀。照紫外可见分光光度法(附录A)，在274nm的波长处测定吸光度，按丹皮酚(C9H10O3)的吸收系数(E1%1cm)为862计算，即得。（注：中国药典2005年版一部牡丹皮的含量测定已改为HPLC法，此处仅是译法的示例）,16,b.标准曲线法ReferencesolutionSulfonate20mgofindigoCRS,accuratelyweighed,inaflaskbyadding15mlofsulfuricacidslowlyandwithconstantstirringgentlyonawaterbathat80for1hour.Allowtocool,transferthesolutionslowlytoa200mlvolumetricflaskcontainingaqualityofwater.Washtheflaskandtheresiduewithwater.Combinethewashingtothevolumetricflask,addwatertovolumeandmixwell.Filteranddiscardtheinitialfiltrate.Measureaccurately5mlofthesuccessivefiltratetoa50mlvolumetricflask,addwatertovolumeandmixwell(containing10gofindigoperml).(青黛)对照品溶液的制备取靛蓝对照品20mg，精密称定，置锥形瓶中，缓缓加入硫酸15ml，用玻棒轻轻搅匀，置80水浴中磺化1小时，随时搅拌，取出，冷却。将溶液缓缓移入盛有适量水的200ml量瓶中，用水洗涤容器及残渣，洗液并入量瓶中，加水至刻度，摇匀，滤过，精密量取续滤液5ml，置50ml量瓶中，加水至刻度，摇匀，即得(每1ml中含靛蓝10g)。,17,CalibrationstandardMeasureaccurately1.0,2.0,3.0,4.0and5.0mlofthereferencesolutionrespectivelyinto10mlvolumetricflask,addwatertovolumeandmixwell.Carryoutthemethodforultravioletspectrophotometryandcolourimetry(AppendixVA),measuretheabsorbanceat610nmandplotthestandardcurve,usingabsorbanceasordinateandconcentrationasabscissa.标准曲线的制备精密量取对照品溶液1.0ml、2.0ml、3.0ml、4.0ml