牡丹皮質(zhì)量標(biāo)準(zhǔn)中英文版

1、MOUTAN CORTEX(牡丹皮 ,Mudanpi)Tree Peony Bark本品為毛茛科植物牡丹 Paeonia suffruticosa Andr.的枯燥根皮。秋季采挖 根部，除去細(xì)根和泥沙，剝?nèi)「?，曬干或刮去粗皮，除去木心，曬干。前者?xí) 稱(chēng)連丹皮，后者習(xí)稱(chēng)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.【性狀】 連丹皮 本品呈筒狀或半筒狀， 有縱剖開(kāi)的裂縫， 略向內(nèi)卷曲或 張開(kāi)，長(zhǎng)5-0.4cm。外外表灰褐色或黃褐色，有多數(shù)橫長(zhǎng)皮孔樣突起和細(xì)根痕， 栓皮脫落處粉紅色； 內(nèi)外表淡灰黃色或淺棕色， 有明顯的細(xì)縱紋， 常見(jiàn)發(fā)亮的結(jié) 晶。質(zhì)硬而脆，易折斷，斷面較平坦，淡粉紅色，粉性。氣芳香，味微

3、苦而澀。 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，外外表紅棕色或淡灰黃色，有時(shí)可見(jiàn)灰褐色 斑點(diǎn)狀殘存外皮。Guadanpi Outer surface bark shaver scars and reddish-brown or pale grayish-brown, sometimes grayish-brown stippled remained outer surface visible.【鑒別】 (1) 本品粉末淡紅棕色。淀粉粒甚多，單粒類(lèi)圓形或多角形，直 徑3-16ym,臍點(diǎn)點(diǎn)狀、裂縫狀或飛鳥(niǎo)狀；復(fù)粒由 2-6分粒組成。草酸鈣簇晶直 徑9-45m,有時(shí)含晶細(xì)胞連接，簇晶排列成行，或一個(gè)細(xì)胞含數(shù)個(gè)簇晶

6、。連丹 皮可見(jiàn)木栓細(xì)胞長(zhǎng)方形，壁稍厚，淺紅色。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，振搖10分鐘，濾過(guò)，濾液揮干， 殘?jiān)颖~ 2ml 使溶解，作為供試品溶液。另取丹皮酚對(duì)照品，加丙酮制成每 1ml含2mg的溶液，作為對(duì)照品溶液。照薄層色譜法附錄 W B丨試驗(yàn)，吸取 上述兩種溶液各10門(mén) 分別點(diǎn)于同一硅膠G薄層板上，以環(huán)己烷-乙酸乙酯-冰醋 酸

8、(4:1)為展開(kāi)劑，展開(kāi)，取出，晾干，噴以2%香草醛硫酸乙醇溶液1-10，在105C加熱至斑點(diǎn)顯色清晰。供試品色譜中，在與對(duì)照品色譜相應(yīng)的位置上， 顯相同的顏色斑點(diǎn)。(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.【檢查】水分 不得過(guò)13.0%：附錄IX H第二法測(cè)定，?？偦曳?不得過(guò)5.0%附錄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】照醇溶性浸出物測(cè)定法附錄 X A項(xiàng)下的熱浸法測(cè)定，用乙醇作溶劑，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.【含量測(cè)定】照高效液相色譜法附錄 VI D測(cè)定。Assay Carry out the method for high performance liquid chromatography(Appendix VI D).色譜條件與系統(tǒng)適用性試驗(yàn) 以十八烷基硅烷鍵合硅膠為填充劑； 以甲醇- 水45: 55為流動(dòng)相；檢測(cè)波

13、長(zhǎng)為274nm。理論板數(shù)按丹皮酚峰計(jì)算應(yīng)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.對(duì)照品溶液的制備 取丹皮酚對(duì)照品適量，精密稱(chēng)定，加甲醇制成每 1ml 含20測(cè)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.供試品溶液的制備取本品粗粉約0.5g,精密稱(chēng)定，置具塞錐形瓶中，精密 參加甲醇50ml，密塞，稱(chēng)定重量，

15、超聲處理功率 300W，頻率50kHz30分 鐘，放冷，再稱(chēng)定重量，用甲醇補(bǔ)足減失的重量，搖勻，濾過(guò)。精密量取續(xù)濾液 1ml，量10ml量瓶中，加甲醇稀釋至刻度，搖勻，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.測(cè)定法分別精密吸取對(duì)照品溶液與供試品溶液各10,1注入液相色譜儀，測(cè)定，即得。本品按枯燥品計(jì)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.飲片【炮制 】 迅速洗凈，潤(rùn)后切薄片，曬干。本品呈圓形或卷曲形的薄片。 連丹皮外表皮灰褐色或黃褐色， 栓皮脫落處粉 紅色；刮丹皮外表皮紅褐色或淡灰黃色。 內(nèi)表皮有時(shí)可見(jiàn)發(fā)亮的結(jié)晶。 切面淡粉 紅色，粉性。氣芳香，味微苦而

18、澀。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.【鑒別】 【檢查】 【浸出物】 【含量測(cè)定 】