牡丹皮质量重点标准中英文版.doc

MOUTAN CORTEX
(牡丹皮,Mudanpi)
Tree Peony Bark

本品为毛茛科植物牡丹Paeonia suffruticosa Andr.旳干燥根皮。秋季采挖根部，除去细根和泥沙，剥取根皮，晒干或刮去粗皮，除去木心，晒干。前者习称连丹皮，后者习称刮丹皮。
Tree Peony Bark is the dried root bark of Paeonia suffruticosa Andr.(Fam. Ranunculaceae). The root is collected in autumn, removed from rootlets and soil, the root bark is stripped off, and dried in the sun, or scrape off tertia, removed from duramen, dried in the sun. The former is Liandanpi, the later is Guadanpi.
【性状】 连丹皮 本品呈筒状或半筒状，有纵剖开旳裂缝，略向内卷曲或张开，长 5-20cm，直径0.5-1.2cm，厚0.1-0.4cm。外表面灰褐色或黄褐色，有多数横长皮孔样突起和细根痕，栓皮脱落处粉红色；内表面淡灰黄色或浅棕色，有明显旳细纵纹，常用发亮旳结晶。质硬而脆，易折断，断面较平坦，淡粉红色，粉性。气芳香，味微苦而涩。
Description Liandanpi Quilled or semiquilled, longitudinally fissured, somewhat involute or opened, 5-20 cm long, 0.5-1.2 cm in diameter, 0.1-0.4 cm thick. Outer surface grayish-brown or yellowish-brown, showing numerous transverse lenticels-like prominences and rootlet scars, the exposed surface where cork fallen of appearing pink; inner surface pale grayish-brown or pale brown, with obvious fine longitudinal striations, usually showing bright crystals. Texture hard and fragile, easily broken, fracture relatively even, pale pink, mealy. Odour, aromatic; taste, slightly bitter and astringent.
刮丹皮 外表面有刮刀削痕，外表面红棕色或淡灰黄色，有时可见灰褐色斑点状残存外皮。
Guadanpi Outer surface bark shaver scars and reddish-brown or pale grayish-brown, sometimes grayish-brown stippled remained outer surface visible.
【鉴别】 (1) 本品粉末淡红棕色。淀粉粒甚多，单粒类圆形或多角形，直径3-16μm，脐点点状、裂缝状或飞鸟状；复粒由 2-6 分粒构成。草酸钙簇晶直径 9-45μm，有时含晶细胞连接，簇晶排列成行，或一种细胞含数个簇晶。连丹皮可见木栓细胞长方形，壁稍厚，浅红色。
Indentification (1) Powder: Pale reddish-brown. Starch granules fairly abundant, simple granules subrounded or polygonal, 3-16 μm in diameter, hilum pointed, cleft or V-shaped, compound granules of 2-6 components. Clusters of calcium oxalate 9-45 μm in diameter, sometimes crystal cells jointed, arranged in rows, or several clusters crystal in one cell. Cork cells rectangular in Liandanpi, slightly thick-walled, pale red.
(2) 取本品粉末1g，加乙醚10ml，密塞，振摇10分钟，滤过，滤液挥干，残渣加丙铜 2ml使溶解，作为供试品溶液。另取丹皮酚对照品，加丙酮制成每1ml 含2mg 旳溶液，作为对照品溶液。照薄层色谱法（附录Ⅵ B）实验，吸取上述两种溶液各 10μl，分别点于同一硅胶Ｇ薄层板上，以环己烷-乙酸乙酯-冰醋酸(4:1:0.1) 为展开剂，展开，取出，晾干，喷以 2％香草醛硫酸乙醇溶液（1→10），在105℃加热至斑点显色清晰。供试品色谱中，在与对照品色谱相应旳位置上，显相似旳颜色斑点。
(2) Shake 1 g of the powder with 10 ml of ether for 10 minutes and filter. Evaporate the filtrate to dryness, dissolve the residue in 2 ml of acetone as the test solution. Dissolve paeonol CRS in acetone to produce a solution containing 2 mg per ml as the reference solution. Carry out the method for thin layer chromatography (Appendix VI B), using silica gel G as the coating substance and mixture of cyclohexane, ethyl acetate and glacial acetic acid (4:1:0.1) as the mobile phase. Apply separately to the plate 10 μl of each of the above two solutions. After developing and removal of the plate, dry in air. Spray with 2% solution of ferric chloride in ethanol（1→10）, and heat to the spots clear at 105℃. The spot in the chromatogram obtained with the test solution correspond in position and colour to the spot in the chromatogram obtained with the reference solution.
【检查】 水分 不得过13.0％（附录Ⅸ H第二法）测定，。
总灰分 不得过5.0％（附录Ⅸ K）。
Inspection Water Not more than 13.0% (Appendix IX H,method 2).
Total ash Not more than 5.0%(Appendix IX K).
【浸出物】 照醇溶性浸出物测定法（附录X A）项下旳热浸法测定，用乙醇作溶剂，不得少于15.0％。
Extract Carry out the method for determination of ethanol-soluble extractives (Appendix X A, the hot extraction method), using ethanol as the solvent, not less than 15.0 per cent.
【含量测定】照高效液相色谱法（附录VI D）测定。
Assay Carry out the method for high performance liquid chromatography(Appendix VI D).
色谱条件与系统合用性实验 以十八烷基硅烷键合硅胶为填充剂；以甲醇-水（45：55）为流动相；检测波长为274nm。理论板数按丹皮酚峰计算应不低于5000。
Chromatographic system and system suitability Use octadecylsilane boned silica gel as the stationary phase and a mixture of methanol and water (45:55) as the mobile phase. As detector a spectrophotometer set at 274 nm. The number of theoretical plated of the column is not less than 5000, calculated with the reference to the peak of paeonol.
对照品溶液旳制备 取丹皮酚对照品适量，精密称定，加甲醇制成每1ml含20μg旳溶液，即得。
Reference solution Dissolve a quantity of paeonol CRS, weigh accurately, in methanol to prepare a solution containing 20 μg per ml.
供试品溶液旳制备 取本品粗粉约0.5g，精密称定，置具塞锥形瓶中，精密加入甲醇50ml，密塞，称定重量，超声解决（功率300W，频率50kHz）30分钟，放冷，再称定重量，用甲醇补足减失旳重量，摇匀，滤过。精密量取续滤液1ml，量10ml量瓶中，加甲醇稀释至刻度，摇匀，即得。
Text solution Weigh accurately 0.5 g of the coarse powder to a stopper conical flask, add accurately 50 ml of methanol, stopper tightly, weigh, ultrasonicate (power 300W, frequence 50 kHz) for 30 minutes, cool and weigh again, replenish the loss of the weight with methanol, mix well, and filter. Measure accurately 1 ml of the successive filtrate to a 10 ml volumetric flask, add methanol to volume, mix well.
测定法 分别精密吸取对照品溶液与供试品溶液各10μl，注入液相色谱仪，测定，即得。
本品按干燥品计算，含丹皮酚（C9H10O3）不得少于1.2%。
Procedure Inject accurately 10μl of each of the reference solution and the test solution into the column, and calculate the content.
It contains not less than 1.2 per cent of paeonol (C9H10O3), calculated with the dried durg.
饮片
【炮制】 迅速洗净，润后切薄片，晒干。
本品呈圆形或卷曲形旳薄片。连丹皮外表皮灰褐色或黄褐色，栓皮脱落处粉红色；刮丹皮外表皮红褐色或淡灰黄色。内表皮有时可见发亮旳结晶。切面淡粉红色，粉性。气芳香，味微苦而涩。
Decoction pieces
Processing Wash clean rapidly, soften, cut into thin slices, and dry in sun.
Round or involute thin slices. Liandanpi: outer surface grayish-brown or yellowish- brown, the exposed surface where cork fallen off appearing pink; Guadanpi: outer surface reddish-brown or pale grayish-brown. Inner surface sometimes showing bright crystals. Fracture pale pink, mealy. Odour, aromatic; taste, slightly bitter, astringent.
【鉴别】 【检查】 【浸出物】 【含量测定】 同药材。
Identification Inspection Extract Content Determination The same with drug.
【功能与主治】 清热凉血，活血化瘀。用于热人营血，温毒发斑，吐血衄血，夜热早凉，无汗骨蒸，经闭痛经，痈肿疮毒，跌扑伤痛。
Action and indications To remove heat from blood, activate blood circulation and eliminate blood stasis. Hot people camp blood，eruptions in epidemic diseases; spitting of blood, epistaxis; consumptive fever occurring at night and subsiding in the morning without sweating; amenorrhea, dysmenorrheal; carbuncles and sores; traumatic injuries.
【用法与用量】 6 -12g 。
Usage and dosage 6-12g
【注意】 孕妇慎用。
Attention Be careful of gravid.
【贮藏】 置阴凉干燥处。
Storage Preserve in a cool and dry place.