牡丹皮质量标准中英文版

1、MOUTAN CORTEX(牡丹皮 ,Mudanpi)Tree Peony Bark本品为毛茛科植物牡丹 Paeonia suffruticosa Andr.的枯燥根皮。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 ro

2、ot bark is stripped off, and dried in the sun, or scrape off tertia, removed from duramen, dried in the sun. The former isLiandanpi, the later is Guadanpi.【性状】 连丹皮 本品呈筒状或半筒状， 有纵剖开的裂缝， 略向内卷曲或 张开，长5-0.4cm。外外表灰褐色或黄褐色，有多数横长皮孔样突起和细根痕， 栓皮脱落处粉红色； 内外表淡灰黄色或浅棕色， 有明显的细纵纹， 常见发亮的结 晶。质硬而脆，易折断，断面较平坦，淡粉红色，粉性。气芳香，味微

3、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 surfa

4、ce 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 astring

5、ent.刮丹皮 外外表有刮刀削痕，外外表红棕色或淡灰黄色，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3-16ym,脐点点状、裂缝状或飞鸟状；复粒由 2-6分粒组成。草酸钙簇晶直 径9-45m,有时含晶细胞连接，簇晶排列成行，或一个细胞含数个簇晶

6、。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 卩 m in diameter, hilum pointed, cleft or V-shaped, compound granules of 2-6 components. Clusters of calcium oxalate 9-45 卩 m in diameter, sometimes cr

7、ystal cells jointed, arranged in rows, or several clusters crystal in one cell. Cork cells rectangular in Liandanpi, slightly thick-walled, pale red. 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的溶液，作为对照品溶液。照薄层色谱法附录 W B丨试验，吸取 上述两种溶液各10门 分别点于同一硅胶G薄层板上，以环己烷-乙酸乙酯-冰醋 酸

8、(4:1)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105C加热至斑点显色清晰。供试品色谱中，在与对照品色谱相应的位置上， 显相同的颜色斑点。(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

9、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

10、 卩 l of each of the above two solutions. After developing and removal of the plate, dry in air. Spray with 2% soluti on of ferric chloride in etha nol 1 10and heat to the spots clear at 105°C. The spot in the chromatogram obtained with the test solution correspond in position and colour to the

11、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X 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项下的热浸法测定，用乙醇作溶剂，不得少于 15.0%。Extract Carry out the method for deter

12、mination 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).色谱条件与系统适用性试验 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

13、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 no

14、t less than 5000, calculated with the reference to the peak of paeonol.对照品溶液的制备 取丹皮酚对照品适量，精密称定，加甲醇制成每 1ml 含20测的溶液，即得。Reference solution Dissolve a quantity of paeonol CRS, weigh accurately, in methanol to prepare a solution containing 20卩 g per ml.供试品溶液的制备取本品粗粉约0.5g,精密称定，置具塞锥形瓶中，精密 参加甲醇50ml，密塞，称定重量，

15、超声处理功率 300W，频率50kHz30分 钟，放冷，再称定重量，用甲醇补足减失的重量，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

16、 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10,1注入液相色谱仪，测定，即得。本品按枯燥品计算，含丹皮酚C9H10O3不得少于1.2%。Procedure Inject accurately 10 卩 lo

17、f each of the referenee 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的薄片。 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的结晶。 切面淡粉 红色，粉性。气芳香，味微苦而

18、涩。Decoction piecesProcessing 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 】