2010版中国药典英文

一、药材来源一、药材来源 1.1.植植((动动))物来源的药材的来源部分的一般译法为物来源的药材的来源部分的一般译法为: : 药材英文名称药材英文名称is the is the 药用部位药用部位((名词单数名词单数) of ) of 植植((动动))物拉丁学名物拉丁学名 [[属名和种属名和种((变种变种))加词为斜体字加词为斜体字](](科名科名).). 例：例：Pummelo Peel is the dried unripe or almost ripe exocarp of Pummelo Peel is the dried unripe or almost ripe exocarp of Citrus grandisCitrus grandis ““TomentosaTomentosa”” or or Citrus grandisCitrus grandis (L.) Osbeck (L.) Osbeck (Fam. Rutaceae). (Fam. Rutaceae). 本品为芸香科植物化州柚本品为芸香科植物化州柚Citrus grandiCitrus grandi““TomentosaTomentosa””或柚或柚 Citrus grandis(L.)OsbeckCitrus grandis(L.)Osbeck的未成熟或近成熟的干燥外层果皮。的未成熟或近成熟的干燥外层果皮。 中国药典2010年版对应高效液相色谱方法图谱库 http://www.yaojia.org/forum-viewthread-tid-18761-fromuid-1023.html 2.2.药材的采收与产地加工部分的一般译法为药材的采收与产地加工部分的一般译法为:: 用用The drugThe drug作主语，单数。用被动语态，不用主动语态。作主语，单数。用被动语态，不用主动语态。““采采 收收””用用““to be collectedto be collected””((不用不用““to be pickedto be picked””，，““to be dug upto be dug up”” 等等 ))。。 ““除去杂质除去杂质 ””等等 ((名词单数名词单数 ))用用 ““ removed from foreign removed from foreign mattermatter””,,““洗净洗净””用用““washed cleanwashed clean””,,““干燥干燥””用用““drieddried””，， ““晒干晒干””为为 ““dried in the sundried in the sun””，，““阴干阴干””为为““dried in the shadedried in the shade””,,““低温干燥低温干燥”” 为为““dried at a lower temperaturedried at a lower temperature””。。““栽培变种栽培变种””为为““cultivarcultivar””。。 ““泥砂泥砂””为为““soilsoil””。。““须根须根 ..细根细根””：：““ fibrous rootfibrous root””用于单子叶植用于单子叶植 物、根茎上的不定根，物、根茎上的不定根，““rootletrootlet””用于双子叶植物主根上的细小用于双子叶植物主根上的细小 侧根、支根。侧根、支根。 „„ 例例1 The drug is collected in autumn, removed from foreign 1 The drug is collected in autumn, removed from foreign matter, washed clean, and dried in the sun.matter, washed clean, and dried in the sun. „„ 例例 2 The drug is collected at flowering to fruiting stage, 2 The drug is collected at flowering to fruiting stage, removed from thick stem, cut into section, and dried.removed from thick stem, cut into section, and dried. „„ ((注注 ::中国药典中国药典20052005年版一部英文版药用部位采用名词单数年版一部英文版药用部位采用名词单数 ,,如如 stem, leaf, fibrous root, rootletstem, leaf, fibrous root, rootlet等等).).中国药典2010年版对应高效液相色谱方法图谱库http://www.yaojia.org/forum-viewthread-tid-18761-fromuid-1023.html 二、理化鉴别二、理化鉴别 1.1.化学鉴别化学鉴别 „„ Shake 0. 5 g of the powder with 5 ml of ethanol for 5 Shake 0. 5 g of the powder with 5 ml of ethanol for 5 minutes and filter. Evaporate the filtrate to dryness, minutes and filter. Evaporate the filtrate to dryness, add dropwise antimony trichloride saturation solution add dropwise antimony trichloride saturation solution inin chloroform and evaporate again to dryness. A chloroform and evaporate again to dryness. A violetviolet--red colour is produced. red colour is produced. „„ 取本品粉末取本品粉末0.5g0.5g，加乙醇，加乙醇5ml5ml，振摇，振摇55分钟，滤过，滤分钟，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。干，即显紫红色。中国药典2010年版对应高效液相色谱方法图谱库 http://www.yaojia.org/forum-viewthread-tid-18761-fromuid-1023.html 2.2.薄层鉴别薄层鉴别 （（11）经常用到需统一的词汇和短语：）经常用到需统一的词汇和短语： a.a.超声处理超声处理用用ultrasonicateultrasonicate b.b.提取提取用用extractextract c.c.温浸温浸用用 warm maceratewarm macerate d.d.水浴加热水浴加热用用heat on a water bathheat on a water bath e.e.对照品（对照品溶液）对照品（对照品溶液）用用 ““对照品名对照品名””加加““CRSCRS”” 表 关于同志近三年现实表现材料材料类招标技术评分表图表与交易pdf视力表打印pdf用图表说话 pdf 示表示 （（reference solutionreference solution））;; 对照药材（对照药材溶液）对照药材（对照药材溶液） 用用reference drugreference drug（（reference drug solutionreference drug solution））; ; 供试供试 品溶液品溶液用用test solution test solution 中国药典2010年版对应高效液相色谱方法图谱库 http://www.yaojia.org/forum-viewthread-tid-18761-fromuid-1023.html f.f.薄层板薄层板 :: 硅胶硅胶GG薄层板薄层板... ... using silica gel G as the coating substanceusing silica gel G as the coating substance 用用1%1%氢氧化钠溶液制备的硅胶氢氧化钠溶液制备的硅胶GG薄层板薄层板... ... using silica gel G mixed with 1% solution of sodium using silica gel G mixed with 1% solution of sodium hydroxide as the coating substance hydroxide as the coating substance 含含4%4%醋酸钠的羧甲基纤维素钠溶液为黏合剂的硅胶醋酸钠的羧甲基纤维素钠溶液为黏合剂的硅胶GG 薄层板上薄层板上... ... using silica gel G mixed with sodium using silica gel G mixed with sodium carboxymethylcellulosecarboxymethylcellulose containing 4% solution of containing 4% solution of sodium acetate as the coating substance.sodium acetate as the coating substance. 中国药典2010年版对应高效液相色谱方法图谱库 http://www.yaojia.org/forum-viewthread-tid-18761-fromuid-1023.html g. g. 斑点斑点用用spot(sspot(s))，，条斑条斑用用 band(sband(s)) h. h. 分别置日光及紫外光灯分别置日光及紫外光灯(365nm)(365nm)下检视，日下检视，日 光下显光下显……色的斑点；紫外光灯下显色的斑点；紫外光灯下显……色的色的 斑点斑点用用…… spot in daylight and spot in daylight and …… spot spot under ultraviolet light at 365 nm respectively.under ultraviolet light at 365 nm respectively. 中国药典2010年版对应高效液相色谱方法图谱库 http://www.yaojia.org/forum-viewthread-tid-18761-fromuid-1023.html a. a. 供试品溶液制备供试品溶液制备常见以下几种情况：常见以下几种情况： „„ 超声处理提取超声处理提取 To 9g, cut into pieces, add 20ml of ether, To 9g, cut into pieces, add 20ml of ether, ultrasonicateultrasonicate for 20 minutes, and filter. for 20 minutes, and filter. Evaporate the filtrate to dryness, and dissolve Evaporate the filtrate to dryness, and dissolve the residue in 0.5ml ofthe residue in 0.5ml of nn--hexane as the test hexane as the test solution. solution. 取本品取本品9g9g，切碎，加乙醚，切碎，加乙醚20ml20ml，超声，超声 处理处理2020分钟，滤过，滤液挥干，残渣加分钟，滤过，滤液挥干，残渣加0.5ml 0.5ml 正己烷溶解，作为供试品溶液。（艾附暖宫正己烷溶解，作为供试品溶液。（艾附暖宫 丸）丸） 中国药典2010年版对应高效液相色谱方法图谱库 http://www.yaojia.org/forum-viewthread-tid-18761-fromuid-1023.html „„ 加热回流提取加热回流提取 Heat under reflux 2g, cut into piecesHeat under reflux 2g, cut into pieces,, with with 20ml of ethanol for 1 hour, cool and filter, 20ml of ethanol for 1 hour, cool and filter, use the filtrate as the test solution. use the filtrate as the test solution. 取本品取本品 2g2g，剪碎，加乙醇，剪碎，加乙醇20ml20ml，加热回流，加热回流1 1 小时，小时， 放冷，滤过，滤液作为供试品溶液。放冷，滤过，滤液作为供试品溶液。 中国药典2010年版对应高效液相色谱方法图谱库 http://www.yaojia.org/forum-viewthread-tid-18761-fromuid-1023.html „„ 萃取、过柱纯化萃取、过柱纯化 Extract the filtrate with two 15Extract the filtrate with two 15--ml quantities of ml quantities of nn-- butanolbutanol saturated with water, combine the saturated with water, combine the nn--butanolbutanol extracts, and evaporate to dryness. Dissolve the extracts, and evaporate to dryness. Dissolve the residue in 1 ml of dehydrated ethanol, add a quantity residue in 1 ml of dehydrated ethanol, add a quantity of alumina, stir well on a water bath, dry, and apply to of alumina, stir well on a water bath, dry, and apply to a small a small (10(10--15mm in diameter) 15mm in diameter) 或或 SepackSepack C18 column C18 column packed with neutral alumina (200 mesh, 1g, 10~15mm packed with neutral alumina (200 mesh, 1g, 10~15mm in diameter ), prein diameter ), pre--elute with 30ml of a mixture of elute with 30ml of a mixture of ethyl acetate and methanol (3:1). Elute with 30 ml of a ethyl acetate and methanol (3:1). Elute with 30 ml of a mixture of ethyl acetate and methanol (1:1), and mixture of ethyl acetate and methanol (1:1), and collect the collect the eluateeluate. Evaporate to dryness and dissolve . Evaporate to dryness and dissolve the residue in 0.5 ml of ethanol as the test solution. the residue in 0.5 ml of ethanol as the test solution. 中国药典2010年版对应高效液相色谱方法图谱库 http://www.yaojia.org/forum-viewthread-tid-18761-fromuid-1023.html 滤液用水饱和的正丁醇提取二次，合并正丁醇滤液用水饱和的正丁醇提取二次，合并正丁醇 提取液，蒸干，残渣加无水乙醇提取液，蒸干，残渣加无水乙醇1ml1ml使溶解，使溶解， 加适量氧化铝在水浴上拌匀，干燥，装入一预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（先装填好的中性氧化铝小柱（200200目，目，1g1g，内，内 径径1010--15mm15mm）或）或C18C18小柱上，用乙酸乙酯小柱上，用乙酸乙酯--甲醇甲醇 （（33：：11））30ml30ml预洗，再用乙酸乙酯预洗，再用乙酸乙酯--甲醇（甲醇（11：： 11））30ml30ml洗脱，收集洗脱液，残渣加乙醇洗脱，收集洗脱液，残渣加乙醇0.5ml0.5ml 使溶解，作为供试品溶液。使溶解，作为供试品溶液。 中国药典2010年版对应高效液相色谱方法图谱库 http://www.yaojia.org/forum-viewthread-tid-18761-fromuid-1023.html „„ 浸渍、水解浸渍、水解 Macerate 0.5 g of the pills in 20 ml of methanol for 1 Macerate 0.5 g of the pills in 20 ml of methanol for 1 hour, and filter. Evaporate 5 ml of the filtrate to hour, and filter. Evaporate 5 ml of the filtrate to dryness, dissolve the residue in 10 ml of water, add 1 dryness, dissolve the residue in 10 ml of water, add 1 ml of hydrochloric acid, heat on a water bath for 30 ml of hydrochloric acid, heat on a water bath for 30 minutes, and cool immediately. minutes, and cool immediately. 取本品取本品0.5 g0.5 g，加甲醇，加甲醇20ml20ml浸泡浸泡1 1 小时，滤过。取小时，滤过。取5ml5ml 滤液蒸干，残渣加滤液蒸干，残渣加10ml10ml水溶解，加水溶解，加1ml1ml盐酸，水浴加盐酸，水浴加 热热3030分钟，立即冷却。分钟，立即冷却。 中国药典2010年版对应高效液相色谱方法图谱库 http://www.yaojia.org/forum-viewthread-tid-18761-fromuid-1023.html b.b.对照品（对照药材）溶液的制备对照品（对照药材）溶液的制备 „„ 化学对照品作对照化学对照品作对照 Dissolve Dissolve chlorogenicchlorogenic acid CRS in methanol to produce acid CRS in methanol to produce a solution containing 1 mg per ml as the reference a solution containing 1 mg per ml as the reference solution. solution. 取绿原酸对照品，加甲醇溶解制成每取绿原酸对照品，加甲醇溶解制成每1ml 1ml 含含 1mg 1mg 的溶液，作为对照品溶液。的溶液，作为对照品溶液。 „„ 多个化学对照品混合对照多个化学对照品混合对照 Dissolve Dissolve ginsenosidesginsenosides Rb1, Re and Rg1 CRS in Rb1, Re and Rg1 CRS in methanol to produce a mixture containing 2 mg of each methanol to produce a mixture containing 2 mg of each per ml as the reference solution. per ml as the reference solution. „„ 对照药材作对照对照药材作对照 Prepare a solution of 0.5 g of Prepare a solution of 0.5 g of RheiRhei Radix et Radix et RhizomaRhizoma reference drug and 20 ml of methanol in the same reference drug and 20 ml of methanol in the same manner as the reference drug solution. manner as the reference drug solution. 另取大黄对照药另取大黄对照药 材材 0.5g0.5g，加甲醇，加甲醇20ml20ml，同法制成对照药材溶液。，同法制成对照药材溶液。中国药典2010年版对应高效液相色谱方法图谱库http://www.yaojia.org/forum-viewthread-tid-18761-fromuid-1023.html c.c.点样、展开、显色、检视点样、展开、显色、检视 „„ 点样、展开点样、展开 Carry out the method for thin layer chromatography Carry out the method for thin layer chromatography （（Appendix VI BAppendix VI B），）， using silica gel G as the coating using silica gel G as the coating substance and the upper layer of a mixture of butyl substance and the upper layer of a mixture of butyl acetate, formic acid and water ( 7:2.5:2.5) as the mobile acetate, formic acid and water ( 7:2.5:2.5) as the mobile phase. Apply separately 10 phase. Apply separately 10 μμll of the test solution and of the test solution and 2 2 μμll of the reference solution to the plate. of the reference solution to the plate. 照薄层色谱照薄层色谱 法（附录法（附录ⅥⅥ BB）试验，吸取供试品溶液）试验，吸取供试品溶液1010μμll，对照品，对照品 溶液溶液22μμll，分别点于同一硅胶，分别点于同一硅胶GG薄层板上，薄层板上， 以醋酸丁以醋酸丁 酯酯--甲酸甲酸--水水( 7:2.5:2.5) ( 7:2.5:2.5) 为展开剂，展开，为展开剂，展开，..............。。 „„ 显色、检视显色、检视 Spray with 5% sulfuric acid in ethanol and heat to the Spray with 5% sulfuric acid in ethanol and heat to the spot clear. Examine under ultraviolet light at 365 nm. spot clear. Examine under ultraviolet light at 365 nm. 以以5%5%硫酸乙醇溶液显色，热风加热至斑点显色清硫酸乙醇溶液显色，热风加热至斑点显色清 晰。置紫外光灯晰。置紫外光灯(365nm)(365nm)下检视。下检视。 中国药典2010年版对应高效液相色谱方法图谱库 http://www.yaojia.org/forum-viewthread-tid-18761-fromuid-1023.html d. d. 结果判断结果判断 The fluorescent spots in the chromatogram obtained with The fluorescent spots in the chromatogram obtained with the the test solution correspond in position and test solution correspond in position and colourcolour to the spots to the spots obtained with the reference drug solution; and an orange obtained with the reference drug solution; and an orange fluorescent spot in the chromatogram obtained with the test fluorescent spot in the chromatogram obtained with the test solution corresponds in position and solution corresponds in position and colourcolour to the spot in the to the spot in the chromatogram obtained with the reference solution. chromatogram obtained with the reference solution. 供试品供试品 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。色荧光斑点。 中国药典2010年版对应高效液相色谱方法图谱库 http://www.yaojia.org/forum-viewthread-tid-18761-fromuid-1023.html 三、三、Assay (Assay (含量测定含量测定)) （（11）分光光度法）分光光度法 „„ a. Ea. E值法值法 Weigh accurately 0.2 g of the coarse powder, distill with steam,Weigh accurately 0.2 g of the coarse powder, distill with steam, collect about 450 ml of the distillate, dilute to 500 ml with wacollect about 450 ml of the distillate, dilute to 500 ml with water ter and shake well. Carry out the method for and shake well. Carry out the method for ultraviolet ultraviolet spectrophotometryspectrophotometry and and colourimetrycolourimetry (Appendix V A), measure (Appendix V A), measure the absorbance at 274 nm and calculate the content of the absorbance at 274 nm and calculate the content of paeonolpaeonol, , taking 862 as the value of A(1%,1cm).taking 862 as the value of A(1%,1cm).取本品粗粉约取本品粗粉约0.2g0.2g，精密，精密 称定，用水蒸气蒸馏，收集馏出液约称定，用水蒸气蒸馏，收集馏出液约450ml450ml，加水至，加水至500ml500ml，， 摇匀。照紫外－可见分光光度法摇匀。照紫外－可见分光光度法((附录附录ⅤⅤ A)A)，在，在274nm274nm的波长的波长 处测定吸光度，按丹皮酚处测定吸光度，按丹皮酚(C9H10O3)(C9H10O3)的吸收系数的吸收系数( E1% 1cm)( E1% 1cm)为为 862862计算，即得。（注：计算，即得。（注：《《中国药典中国药典》》20052005年版一部牡丹皮的年版一部牡丹皮的 含量测定已改为含量测定已改为HPLCHPLC法，此处仅是译法的示例）法，此处仅是译法的示例） 中国药典2010年版对应高效液相色谱方法图谱库 http://www.yaojia.org/forum-viewthread-tid-18761-fromuid-1023.html „„ b.b. 标准 excel标准偏差excel标准偏差函数exl标准差函数国标检验抽样标准表免费下载红头文件格式标准下载 曲线法标准曲线法 „„ Reference solution Reference solution SulfonateSulfonate 20 mg of indigo CRS, accurately 20 mg of indigo CRS, accurately weighed, in a flask by adding 15 ml of sulfuric acid slowly and weighed, in a flask by adding 15 ml of sulfuric acid slowly and with constant stirring gently on a water bath at 80with constant stirring gently on a water bath at 80℃℃ for 1 hour. for 1 hour. Allow to cool, transfer the solution slowly to a 200 ml volumetrAllow to cool, transfer the solution slowly to a 200 ml volumetric ic flask containing a quality of water. Wash the flask and the flask containing a quality of water. Wash the flask and the residue with water. Combine the washing to the volumetric flask,residue with water. Combine the washing to the volumetric flask, add water to volume and mix well. Filter and discard the initialadd water to volume and mix well. Filter and discard the initial filtrate. Measure accurately 5 ml of the successive filtrate to filtrate. Measure accurately 5 ml of the successive filtrate to a 50 a 50 ml volumetric flask, add water to volume and mix well ml volumetric flask, add water to volume and mix well (containing 10 (containing 10 μμgg of indigo per ml). of indigo per ml). „„ ((青黛青黛))对照品溶液的制备对照品溶液的制备 取靛蓝对照品取靛蓝对照品20mg20mg，精密称定，置锥，精密称定，置锥 形瓶中，缓缓加入硫酸形瓶中，缓缓加入硫酸15ml15ml，用玻棒轻轻搅匀，置，用玻棒轻轻搅匀，置8080℃℃水浴中水浴中 磺化磺化11小时，随时搅拌，取出，冷却。将溶液缓缓移入盛有适量小时，随时搅拌，取出，冷却。将溶液缓缓移入盛有适量 水的水的200ml200ml量瓶中，用水洗涤容器及残渣，洗液并入量瓶中，加量瓶中，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，精密量取续滤液水至刻度，摇匀，滤过，精密量取续滤液5ml5ml，置，置50ml50ml量瓶中，量瓶中， 加水至刻度，摇匀，即得加水至刻度，摇匀，即得((每每1 ml1 ml中含靛蓝中含靛蓝10 10 μμgg))。。中国药典2010年版对应高效液相色谱方法图谱库 http://www.yaojia.org/forum-viewthread-tid-18761-fromuid-1023.html „„ Calibration standardCalibration standard Measure accurately 1.0, 2.0, 3.0, Measure accurately 1.0, 2.0, 3.0, 4.0 and 5.0 ml of the reference solution respectively into 4.0 and 5.0 ml of the reference solution respectively into 10 ml volumetric flask, add water to volume and mix 10 ml volumetric flask, add water to volume and mix well. Carry out the method for ultraviolet well. Carry out the method for ultraviolet spectrophotometryspectrophotometry and and colourimetrycolourimetry (Appendix V A), (Appendix V A), measure the absorbance at 610 nm and plot the measure the absorbance at 610 nm and plot the standard curve, using absorbance as ordinate and standard curve, using absorbance as ordinate and concentration as abscissa.concentration as abscissa. „„ 标准曲线的制备标准曲线的制备 精密量取对照品溶液精密量取对照品溶液1.0 ml1.0 ml、、2.0 ml2.0 ml、、 3.0 ml3.0 ml、、4.0 ml4.0 ml和和5.0 ml5.0 ml，分别置，分别置10 ml10 ml量瓶中，加水至量瓶中，加水至 刻度，摇匀。照紫外－可见分光光度法刻度，摇匀。照紫外－可见分光光度法((附录附录ⅤⅤ A )A )，， 在在610 nm610 nm的波长处测定吸光度，以吸光度为纵坐标，的波长处测定吸光度，以吸光度为纵坐标， 浓度为横坐标，绘制标准曲线。浓度为横坐标，绘制标准曲线。 中国药典2010年版对应高效液相色谱方法图谱库 http://www.yaojia.org/forum-viewthread-tid-18761-fromuid-1023.html „„ ProcedureProcedure Weigh accurately 0.4 g of the fine powder, carry out Weigh accurately 0.4 g of the fine powder, carry out the procedure as described under the reference the procedure as described under the reference solusionsolusion, , beginning at the words beginning at the words ““in a flaskin a flask…”…” to to ““Measure accurately 5 Measure accurately 5 ml of the successive filtrateml of the successive filtrate””. Transfer the filtrate to a 50 ml or . Transfer the filtrate to a 50 ml or 100 ml volumetric flask (adjust the absorbance to be within 0.20100 ml volumetric flask (adjust the absorbance to be within 0.20-- 0.45), dilute with water to volume and mix well. Measure the 0.45), dilute with water to volume and mix well. Measure the absorbance at 610 nm and read out the weight of indigo (absorbance at 610 nm and read out the weight of indigo (μμgg) in ) in the test solution from the standard curve, and calculate the the test solution from the standard curve, and calculate the content of C16H10N2O2.content of C16H10N2O2. „„ 测定法测定法 取本品细粉约取本品细粉约0.4 g0.4 g，精密称定，照对照品溶液的制备，精密称定，照对照品溶液的制备 项下的方法，自项下的方法，自““置锥形瓶中置锥形瓶中””起，至起，至““精密吸取续滤液精密吸取续滤液5 ml5 ml””，， 置置50 ml50 ml或或100 ml100 ml量瓶量瓶 ((使吸光度在使吸光度在0.200.20--0.450.45之间之间))中，加水至刻中，加水至刻 度，摇匀，在度，摇匀，在610 nm610 nm的波长处测定吸光度，从标准曲线上读出的波长处测定吸光度，从标准曲线上读出 供试品溶液中靛蓝的重量供试品溶液中靛蓝的重量((μμgg))，计算，即得。，计算，即得。 中国药典2010年版对应高效液相色谱方法图谱库 http://www.yaojia.org/forum-viewthread-tid-18761-fromuid-1023.html 一、药材来源 二、理化鉴别 a. 供试品溶液制备 常见以下几种情况： b.对照品（对照药材）溶液的制备 c.点样、展开、显色、检视 d. 结果判断 三、Assay (含量测定)� （1）分光光度法