1、2010版中国药典英文版,编译细则,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is the 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：Pummelo Peel is the dried unripe or almost ripe exocarp of Citrus grandis “Tomentosa” or Citrus grandis (L.) Osbeck (Fam. Rutaceae). 本品为芸香科植物化州柚Citrus grandi“Tomentosa”或柚Citrus grandis(L.)Osbe
2、ck的未成熟或近成熟的干燥外层果皮。,2.药材的采收与产地加工部分的一般译法为: 用The drug作主语，单数。用被动语态，不用主动语态。“采收”用“to be collected”(不用“to be picked”，“to be dug up”等)。“除去杂质”等(名词单数)用“removed from foreign matter”,“洗净”用“washed clean”,“干燥”用“dried”， “晒干”为“dried in the sun”，“阴干”为“dried in the shade”,“低温干燥”为“dried at a lower temperature”。“栽培变种”为
3、“cultivar”。“泥砂”为“soil”。“须根，细根”：“fibrous root”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1 The drug is collected in autumn, removed from foreign matter, washed clean, and dried in the sun. 例2 The drug is collected at flowering to fruiting stage, removed from thick stem, cut into section, and dried
4、. (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, fibrous root, rootlet等).,二、理化鉴别,1.化学鉴别 Shake 0. 5 g of the powder with 5 ml of ethanol for 5 minutes and filter. Evaporate the filtrate to dryness, add dropwise antimony trichloride saturation solution in chloroform and evaporate again to dryness. A violet
5、-red colour is produced. 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。,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ultrasonicate b.提取 用extract c.温浸 用 warm macerate d.水浴加热 用heat on a water bath e.对照品（对照品溶液） 用 “对照品名”加“CRS”表示（reference solution）; 对照药材（对照药材溶液） 用reference drug（reference drug solution）;
6、供试品溶液 用test solution,f.薄层板 : 硅胶G薄层板. using silica gel G as the coating substance 用1%氢氧化钠溶液制备的硅胶G薄层板. using silica gel G mixed with 1% solution of sodium hydroxide as the coating substance 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. using silica gel G mixed with sodium carboxymethylcellulose containing 4% solution
7、 of sodium acetate as the coating substance.,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 spot in daylight and spot under ultraviolet light at 365 nm respectively.,(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。,a. 供试品溶液制备 常见以下几种情况：,超声处理提取 To 9g, cut into pieces, add 20m
8、l of ether, ultrasonicate for 20 minutes, and filter. Evaporate the filtrate to dryness, and dissolve the residue in 0.5ml of n-hexane as the test solution. 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）,加热回流提取 Heat under reflux 2g, cut into pieces, with 20ml of ethanol for 1 hour,
9、 cool and filter, use the filtrate as the test solution. 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。,萃取、过柱纯化 Extract the filtrate with two 15-ml quantities of n-butanol saturated with water, combine the n-butanol extracts, and evaporate to dryness. Dissolve the residue in 1 ml of dehydrated ethanol,
10、add a quantity of alumina, stir well on a water bath, dry, and apply to a small (10-15mm in diameter) 或 Sepack C18 column packed with neutral alumina (200 mesh, 1g, 1015mm in diameter ), pre-elute with 30ml of a mixture of ethyl acetate and methanol (3:1). Elute with 30 ml of a mixture of ethyl acet
11、ate and methanol (1:1), and collect the eluate. Evaporate to dryness and dissolve the residue in 0.5 ml of ethanol as the test solution.,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
12、供试品溶液。,浸渍、水解 Macerate 0.5 g of the pills in 20 ml of methanol for 1 hour, and filter. Evaporate 5 ml of the filtrate to dryness, dissolve the residue in 10 ml of water, add 1 ml of hydrochloric acid, heat on a water bath for 30 minutes, and cool immediately. 取本品0.5 g，加甲醇20ml浸泡1 小时，滤过。取5ml滤液蒸干，残渣加10m
13、l水溶解，加1ml盐酸，水浴加热30分钟，立即冷却。,b.对照品（对照药材）溶液的制备,化学对照品作对照 Dissolve chlorogenic acid CRS in methanol to produce a solution containing 1 mg per ml as the reference solution. 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 Dissolve ginsenosides Rb1, Re and Rg1 CRS in methanol to produce a mixture containi
14、ng 2 mg of each per ml as the reference solution. 对照药材作对照 Prepare a solution of 0.5 g of Rhei Radix et Rhizoma reference drug and 20 ml of methanol in the same manner as the reference drug solution. 另取大黄对照药材 0.5g，加甲醇20ml，同法制成对照药材溶液。,c.点样、展开、显色、检视,点样、展开 Carry out the method for thin layer chromatogra
15、phy （Appendix VI B）， using silica gel G as the coating substance and the upper layer of a mixture of butyl acetate, formic acid and water ( 7:2.5:2.5) as the mobile phase. Apply separately 10 l of the test solution and 2 l of the reference solution to the plate. 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
16、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 Spray with 5% sulfuric acid in ethanol and heat to the spot clear. Examine under ultraviolet light at 365 nm. 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。,d. 结果判断,The fluorescent spots in the chromatogram obtained with the test solution correspond in p
17、osition and colour to the spots obtained with the reference drug solution; and an orange fluorescent spot in the chromatogram obtained with the test solution corresponds in position and colour to the spot in the chromatogram obtained with the reference solution. 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
18、品色谱相应的位置上，显相同的橙黄色荧光斑点。,三、Assay (含量测定) （1）分光光度法,a. E值法 Weigh accurately 0.2 g of the coarse powder, distill with steam, collect about 450 ml of the distillate, dilute to 500 ml with water and shake well. Carry out the method for ultr-violet spectrophotometry and colourimetry (Appendix V A), measure t
19、he absorbance at 274 nm and calculate the content of paeonol, taking 862 as the value of A(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）,b.标准曲线法 Reference solution Sulfonate 20
20、 mg of indigo CRS, accurately weighed, in a flask by adding 15 ml of sulfuric acid slowly and with constant stirring gently on a water bath at 80 for 1 hour. Allow to cool, transfer the solution slowly to a 200 ml volumetric flask containing a quality of water. Wash the flask and the residue with wa
21、ter. Combine the washing to the volumetric flask, add water to volume and mix well. Filter and discard the initial filtrate. Measure accurately 5 ml of the successive filtrate to a 50 ml volumetric flask, add water to volume and mix well (containing 10 g of indigo per ml). (青黛)对照品溶液的制备 取靛蓝对照品20mg，精密
22、称定，置锥形瓶中，缓缓加入硫酸15ml，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1 ml中含靛蓝10 g)。,Calibration standard Measure accurately 1.0, 2.0, 3.0, 4.0 and 5.0 ml of the reference solution respectively into 10 ml volumetric flask, add water to vol
23、ume and mix well. Carry out the method for ultraviolet spectrophotometry and colourimetry (Appendix V A), measure the absorbance at 610 nm and plot the standard curve, using absorbance as ordinate and concentration as abscissa. 标准曲线的制备 精密量取对照品溶液1.0 ml、2.0 ml、3.0 ml、4.0 ml和5.0 ml，分别置10 ml量瓶中，加水至刻度，摇匀
24、。照紫外可见分光光度法(附录 A )，在610 nm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。,Procedure Weigh accurately 0.4 g of the fine powder, carry out the procedure as described under the reference solusion, beginning at the words “in a flask” to “Measure accurately 5 ml of the successive filtrate”. Transfer the filtrate to a
25、50 ml or 100 ml volumetric flask (adjust the absorbance to be within 0.20-0.45), dilute with water to volume and mix well. Measure the absorbance at 610 nm and read out the weight of indigo (g) in the test solution from the standard curve, and calculate the content of C16H10N2O2. 测定法 取本品细粉约0.4 g，精密称
26、定，照对照品溶液的制备项下的方法，自“置锥形瓶中”起，至“精密吸取续滤液5 ml”，置50 ml或100 ml量瓶 (使吸光度在0.20-0.45之间)中，加水至刻度，摇匀，在610 nm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(g)，计算，即得。,检查,Total ash, Acid-insoluble ash (总灰分，酸不溶性灰分) Foreign matter (杂质) Acidity，Alkalinity (酸碱度) Chloride, Calcium, Sulfate, Mericutic, Phosphate (氯化物，钙盐，硫酸盐，汞盐，磷酸盐) Loss o
27、n drying (干燥失重) Water（水分测定） Residue on ignition (炽灼残渣) Heavy metal（重金属） Ansorbance (吸光度) Insoluble matter in ethanol (乙醇不溶物),Absorbance Dry the drug in vacuum desiccator over silica gel for 24 hours and grind into fine powder. Weigh accurately 30 mg into a Soxhlets extractor, extract with 70 ml of m
28、ethanol under reflux until the extract colourless, and cool. Transfer the extract to a 100 ml volumetric flask, and filter, if necessary. Wash the extractor with methanol, combine the washings into the same volumetric flask, dilutes with methanol to volume and mix well. Measure accurately 5 ml to a
29、50 ml volumetric flask, dilute with methanol to volume and mix well. Carry out the method for ultraviolet spectrophotometry and colourimetry (Appendix V A), measure the absorbance at 432 nm, not less than 0.50.取本品，置硅胶干燥器中，减压干燥24小时，研成细粉，精密称取30mg，置索氏提取器中，加甲醇70ml，加热回流至提取液无色，放冷，提取液移置100ml量瓶中(必要时滤过)，用甲醇分次洗涤提取器，洗液并入同一量瓶中，加甲醇至刻度，摇匀。精密量取5ml，置50ml量瓶中，加甲醇至刻度，摇匀，照紫外-可见分光光度法(附录 A)，在432nm的波长处测定吸光度，不得低于0.50。（西红花）,
