丹参

中文文本参考：《中国药典（2020年版）》
English text reference: Chinese Pharmacopoeia (2020 Edition)

概述 Overview

本品为唇形科植物丹参Salvia miltiorrhiza Bge.的干燥根和根茎。春、秋二季采挖，除去泥沙，干燥。
Salvia Root and Rhizome is the dried root and rhizome of Salvia miltiorrhiza Bge. (Fam. Labiatae). The drug is collected in spring and autumn, removed from soil and sand, and dried.

性状 Description

本品根茎短粗，顶端有时残留茎基。根数条，长圆柱形，略弯曲，有的分枝并具须状细根，长10～20 cm，直径0.3～1 cm。表面棕红色或暗棕红色，粗糙，具纵皱纹。老根外皮疏松，多显紫棕色，常呈鳞片状剥落。质硬而脆，断面疏松，有裂隙或略平整而致密，皮部棕红色，木部灰黄色或紫褐色，导管束黄白色，呈放射状排列。气微，味微苦涩。
Rhizomes short and thick, with sometimes remaining stem base at the top. Roots several, long cylindrical, slightly curved, some branched and with fibrous roots, 10-20 cm long, 0.3-1 cm in diameter. Surface brownish-red or dark brownish-red, rough, with longitudinal wrinkles. Outer bark of old roots loose, mostly purplish-brown, often exfoliating in scales. Texture hard and brittle, fracture loose with cracks or slightly even and dense. Cortex brownish-red, wood grayish-yellow or purplish-brown, vascular bundles yellowish-white, arranged radially. Odour, slight; taste, slightly bitter and astringent.

栽培品较粗壮，直径0.5～1.5cm。表面红棕色，具纵皱纹，外皮紧贴不易剥落。质坚实，断面较平整，略呈角质样。
Cultivated product is thicker and sturdier, with a diameter of 0.5-1.5 cm. Surface reddish-brown with longitudinal wrinkles, tightly attached and not easily peeled off. Texture solid, fracture relatively even, slightly horny in appearance.

鉴别 Identification

（1）本品粉末红棕色。石细胞类圆形、类三角形、类长方形或不规则形，也有延长呈纤维状，边缘不平整，直径14～70 μm，长可达257 μm，孔沟明显，有的胞腔内含黄棕色物。木纤维多为纤维管胞，长梭形，末端斜尖或钝圆，直径12～27 μm，具缘纹孔点状，纹孔斜裂缝状或十字形，孔沟稀疏。网纹导管和具缘纹孔导管直径11～60 μm。
(1) Powder of this drug is reddish-brown. Stone cells are circular, triangular, rectangular or irregular in shape, some elongated and fibrous, with uneven edges, 14-70 μm in diameter and up to 257 μm in length, with obvious pits and some containing yellowish-brown substances in the cell cavity. Wood fibers are mostly fiber vessel cells, elongated and spindle-shaped, with obliquely pointed or blunt rounded ends, 12-27 μm in diameter, with pitted points, oblique cracks or cross-shaped pits, and sparse pits. Diameter of reticulate vessels and pitted vessels is 11-60 μm.

（2）取本品粉末1 g，加乙醇5 ml，超声处理15分钟，离心，取上清液作为供试品溶液。另取丹参对照药材1 g，同法制成对照药材溶液。再取丹参酮ⅡA对照品、丹酚酸B对照品，加乙醇制成每1 ml分别含0.5 mg和1.5 mg的混合溶液，作为对照品溶液。照薄层色谱法（通则0502）试验，吸取上述三种溶液各5 μl，分别点于同一硅胶G薄层板上，使成条状，以三氯甲烷-甲苯-乙酸乙酯-甲醇-甲酸（6:4:8:1:4）为展开剂，展开，展至约4 cm，取出，晾干，再以石油醚（60～90℃）-乙酸乙酯（4:1）为展开剂，展开，展至约8 cm，取出，晾干，分别置日光及紫外光灯（365 nm）下检视。供试品色谱中，在与对照药材色谱和对照品色谱相应的位置上，显相同颜色的斑点或荧光斑点。
(2) Take 1 g of the powder, add 5 ml of ethanol, treat with ultrasound for 15 minutes, centrifuge, and take the supernatant as the test solution. Take 1 g of the reference drug Danshen, prepare the reference drug solution in the same way. Take Danshensu A and Salvianolic Acid B reference substances, add ethanol to prepare mixed solutions containing 0.5 mg and 1.5 mg per 1 ml, respectively, as the reference solution. Carry out the method for thin layer chromatography<0502>, using silica gel G as the coating substance and a mixture of chloroform, toluene, ethyl acetate, methanol, and formic acid (6:4:8:1:4) as the mobile phase. Apply separately to the plate 5 μl of each of the above three solutions. Develop until the solvent front has moved about 4 cm, remove the plate, dry in air. Develop again using a mixture of petroleum ether (60-90°C) and ethyl acetate (4:1) as the mobile phase, develop until the solvent front has moved about 8 cm, remove the plate, dry in air, and examine under daylight and ultraviolet light at 365 nm. The spots or fluorescent spots in the chromatogram obtained with the test solution correspond in position and colour to the spots in the chromatograms obtained with the reference drug and reference solution.

检查 Examination

水分 Water

不得过13.0%（通则0832第二法）。
Not more than 13.0 per cent <0832,method 2>.

总灰分 Total ash

不得过10.0%（通则2302）。
Not more than 10.0 per cent <2302>.

酸不溶性灰分 Acid-insoluble ash

不得过3.0%（通则2302）。
Not more than 3.0 per cent <2302>.

重金属及有害元素 Heavy metals and harmful elements

照铅、镉、砷、汞、铜测定法（通则2321原子吸收分光光度法或电感耦合等离子体质谱法）测定，铅不得过5 mg/kg；镉不得过1 mg/kg；砷不得过2 mg/kg；汞不得过0.2 mg/kg；铜不得过20 mg/kg。
Determine according to the method for determination of lead, cadmium, arsenic, mercury, and copper <2321, atomic absorption spectrophotometry or inductively coupled plasma mass spectrometry>. The lead content should not exceed 5mg/kg; the cadmium content should not exceed 1mg/kg; the arsenic content should not exceed 2mg/kg; the mercury content should not exceed 0.2mg/kg; the copper content should not exceed 20mg/kg.

浸出物 Extractives

水溶性浸出物 Water-soluble extractives

照水溶性浸出物测定法（通则2201）项下的冷浸法测定，不得少于35.0%。
Carry out the method for determination of water-soluble extractives <2201>, the cold maceration method, not less than 35.0 per cent.

醇溶性浸出物 Alcohol-soluble extractives

照醇溶性浸出物测定法（通则2201）项下的热浸法测定，用乙醇作溶剂，不得少于15.0%。
Carry out the method for determination of alcohol-soluble extractives <2201>, the hot maceration method, using ethanol as the solvent, not less than 15.0 per cent.

含量测定 Assay

丹参酮类 Tanshinones

照高效液相色谱法（通则0512）测定。
Determine by high-performance liquid chromatography <0512>.

色谱条件与系统适用性试验 Chromatographic conditions and system suitability test

以十八烷基硅烷键合硅胶为填充剂；以乙腈为流动相A，以0.02%磷酸溶液为流动相B，按下表中的规定进行梯度洗脱；柱温为20℃；检测波长为270 nm。理论板数按丹参酮ⅡA峰计算应不低于60000。
Use octadecylsilane-bonded silica gel as the stationary phase; use acetonitrile as mobile phase A and 0.02% phosphoric acid solution as mobile phase B, perform gradient elution according to the specified conditions in the table below; column temperature is 20℃; detection wavelength is 270 nm. The theoretical plate number calculated based on the peak of tanshinone IIA should not be less than 60000.

对照品溶液的制备 Preparation of reference solution

取丹参酮ⅡA对照品适量，精密称定，置棕色量瓶中，加甲醇制成每1 ml含20 μg的溶液，即得。
Take an appropriate amount of tanshinone IIA reference standard, accurately weigh, place it in a brown volumetric flask, add methanol to make a solution containing 20 μg per ml.

供试品溶液的制备 Preparation of test solution

取本品粉末（过三号筛）约0.3 g，精密称定，置具塞锥形瓶中，精密加入甲醇50 ml，密塞，称定重量，超声处理（功率140 W，频率42 kHz）30分钟，放冷，再称定重量，用甲醇补足减失的重量，摇匀，滤过，取续滤液，即得。
Take about 0.3 g of the powder of this product (passed through a No. 3 sieve), accurately weigh, place it in a stoppered conical flask, accurately add 50 ml of methanol, seal the flask, weigh, perform ultrasonic treatment (power 140 W, frequency 42 kHz) for 30 minutes, cool, weigh again, make up for the weight loss with methanol, shake well, filter, and take the filtrate.

测定法 Method of determination

分别精密吸取对照品溶液与供试品溶液各10 μl，注入液相色谱仪，测定。以丹参酮ⅡA对照品为参照，以其相应的峰为S峰，计算隐丹参酮、丹参酮Ⅰ的相对保留时间，其相对保留时间应在规定值的±5%范围之内。相对保留时间及校正因子见下表。
Accurately aspirate 10 μl of the reference solution and the test solution, respectively, inject into the liquid chromatograph, and determine. Take the peak of tanshinone IIA reference standard as the reference peak (S peak), calculate the relative retention time of cryptotanshinone and tanshinone I, and the relative retention time should be within the range of ±5% of the specified value. The relative retention time and correction factor are shown in the table below.

以丹参酮ⅡA的峰面积为对照，分别乘以校正因子，计算隐丹参酮、丹参酮Ⅰ、丹参酮ⅡA的含量。
Take the peak area of tanshinone IIA as the reference, multiply by the correction factor, and calculate the content of cryptotanshinone, tanshinone I, and tanshinone IIA.

本品按干燥品计算，含丹参酮ⅡA（C19H18O3）、隐丹参酮（C19H20O3）和丹参酮Ⅰ（C18H12O3）的总量不得少于0.25%。
Calculated on the dried product basis, the total content of tanshinone IIA (C19H18O3), cryptotanshinone (C19H20O3), and tanshinone I (C18H12O3) should not be less than 0.25%.

丹酚酸B Salvianolic acid B

照高效液相色谱法（通则0512）测定。
Determine by high-performance liquid chromatography <0512>.

色谱条件与系统适用性试验 Chromatographic conditions and system suitability test

以十八烷基硅烷键合硅胶为填充剂；以乙腈-0.1%磷酸溶液（22:78）为流动相；柱温为20℃；流速为每分钟1.2 ml；检测波长为286 nm。理论板数按丹酚酸B峰计算应不低于6000。
Use octadecylsilane-bonded silica gel as the stationary phase; use acetonitrile-0.1% phosphoric acid solution (22:78) as the mobile phase; column temperature is 20℃; flow rate is 1.2 ml per minute; detection wavelength is 286 nm. The theoretical plate number calculated based on the peak of salvianolic acid B should not be less than 6000.

对照品溶液的制备 Preparation of reference solution

取丹酚酸B对照品适量，精密称定，加甲醇-水（8:2）混合溶液制成每1 ml含0.10 mg的溶液，即得。
Take an appropriate amount of salvianolic acid B reference standard, accurately weigh, and add methanol-water (8:2) mixed solution to make a solution containing 0.10 mg per ml.

供试品溶液的制备 Preparation of test solution

取本品粉末（过三号筛）约0.15 g，精密称定，置具塞锥形瓶中，精密加入甲醇-水（8:2）混合溶液50 ml，密塞，称定重量，超声处理（功率140 W，频率42 kHz）30分钟，放冷，再称定重量，用甲醇-水（8:2）混合溶液补足减失的重量，摇匀，滤过，精密量取续滤液5 ml，移至10 ml量瓶中，加甲醇-水（8:2）混合溶液稀释至刻度，摇匀，滤过，取续滤液，即得。
Take about 0.15 g of the powder of this product (passed through a No. 3 sieve), accurately weigh, place it in a stoppered conical flask, accurately add 50ml of methanol-water (8:2) mixed solution, seal the flask, weigh, perform ultrasonic treatment (power 140 W, frequency 42 kHz) for 30 minutes, cool, weigh again, make up for the weight loss with methanol-water (8:2) mixed solution, shake well, filter, accurately take 5 ml of the filtrate, transfer to a 10 ml volumetric flask, dilute with methanol-water (8:2) mixed solution to the mark, shake well, filter, and take the filtrate.

测定法 Method of determination

分别精密吸取对照品溶液与供试品溶液各10 μl，注入液相色谱仪，测定，即得。
Accurately aspirate 10 μl of the reference solution and the test solution, respectively, inject into the liquid chromatograph, and determine.

本品按干燥品计算，含丹酚酸B（C36H30O16）不得少于3.0%。
Calculated on the dried product basis, the content of salvianolic acid B (C36H30O16) should not be less than 3.0%.

饮片 Prepared slices

丹参 Salvia miltiorrhiza

炮制 Processing

除去杂质和残茎，洗净，润透，切厚片，干燥。
Remove impurities and residual stems, wash, soften until thoroughly moistened, cut into thick slices, and dry in the sun.

性状 Appearance

本品呈类圆形或椭圆形的厚片。外表皮棕红色或暗棕红色，粗糙，具纵皱纹。切面有裂隙或略平整而致密，有的呈角质样，皮部棕红色，木部灰黄色或紫褐色，有黄白色放射状纹理。气微，味微苦涩。
This product is in the form of circular or elliptical thick slices. The outer surface is reddish-brown or dark reddish-brown, rough, with longitudinal wrinkles. The cut surface has cracks or is slightly flat and dense, some are horny, the bark is reddish-brown, the wood is grayish-yellow or purplish-brown, and there are yellowish-white radial lines. It has a slight odor and a slightly bitter and astringent taste.

检查 Examination

酸不溶性灰分 Acid-insoluble

同药材，不得过2.0%（通则2302）。
Same as the crude drug, not more than 2.0 per cent <2302>.

水分 Water

同药材。
Same as the crude drug.

总灰分 Total ash

同药材。
Same as the crude drug.

浸出物 Extractives

醇溶性浸出物 Alcohol-soluble extractives

同药材，不得少于11.0%。
Same as the crude drug, not less than 11.0 per cent.

水溶性浸出物 Water-soluble extractives

同药材。
Same as the crude drug.

鉴别 Identification

同药材。
Same as the crude drug.

酒丹参 Wine-processed Salvia miltiorrhiza

炮制 Processing

取丹参片，照酒炙法（通则0213）炒干。
Take Salvia miltiorrhiza slices, process according to the method of wine-frying <0213>, and dry.

性状 Appearance

本品形如丹参片，表面红褐色，略具酒香气。
This product is similar to Salvia miltiorrhiza slices, with a reddish-brown surface and a slight wine aroma.

检查 Examination

水分 Water

同药材，不得过10.0%（通则0832第二法）。
Same as the crude drug, not more than 10.0 per cent <0832,method 2>.

总灰分 Total ash

同药材。
Same as the crude drug.

浸出物 Extractives

醇溶性浸出物 Alcohol-soluble extractives

同药材，不得少于11.0%。
Same as the crude drug, not less than 11.0 per cent.

水溶性浸出物 Water-soluble extractives

同药材。
Same as the crude drug.

鉴别 Identification

同药材。
Same as the crude drug.

性 Property

微寒。
Slightly cold.

味 Flavor

苦。
Bitter.

归经 Meridian tropism

归心、肝经。
Heart and liver meridians.

功能 Actions

活血祛瘀，通经止痛，清心除烦，凉血消痈。
Activate blood circulation to remove blood stasis, promote menstruation and relieve pain, clear the heart and relieve restlessness, cool the blood and dissipate abscesses.

主治 Indications

用于胸痹心痛，脘腹胁痛，癥瘕积聚，热痹疼痛，心烦不眠，月经不调，痛经经闭，疮疡肿痛。
Used for chest pain, epigastric and abdominal pain, abdominal masses and accumulations, hot painful obstruction, restlessness and insomnia, irregular menstruation, dysmenorrhea and amenorrhea, and painful sores and swellings.

用量 Dosage

10～15 g。
10-15 g.

用法 Administration

无。
None.

注意 Precautions

不宜与藜芦同用。
Not suitable for use with Chenopodium ambrosioides.

贮藏 Storage

置干燥处。
Store in a dry place.

丹参

文本参考：《中国药典（2015年版）》
Text reference: Chinese Pharmacopoeia (2015 Edition)

概述 Overview

本品为唇形科植物丹参Salvia miltiorrhiza Bge.的干燥根和根茎。春、秋二季采挖，除去泥沙，干燥。
Danshen Root is the dried root and rhizome of Salvia miltiorrhiza Bge. (Fam. Labiatae). The drug is collected in spring or autumn, removed from soil, and dried.

性状 Description

本品根茎短粗，顶端有时残留茎基。根数条，长圆柱形，略弯曲，有的分枝并具须状细根，长10～20cm，直径0.3～1cm。表面棕红色或暗棕红色，粗糙，具纵皱纹。老根外皮疏松，多显紫棕色，常呈鳞片状剥落。质硬而脆，断面疏松，有裂隙或略平整而致密，皮部棕红色，木部灰黄色或紫褐色，导管束黄白色，呈放射状排列。气微，味微苦涩。
Rhizomes short and stout, sometimes with remains of a stem at the apex.Several roots, long cylindrical, slightly curved, some branched and with rootlets, 10-20 cm long, 0.3-1 cm in diameter.Externally brownish-red or dark brownish-red, rough, longitudinally wrinkled.The bark of old roots loose, mostly purplish brown, usually scaling off.Texture hard and fragile, fracture loose with clefts or slightly even and dense, bark brownish-red, wood greyish-yellow or purplish-brown, showing bundles of vessels, yellowish-white, arranged radially.

鉴别 Identification

（1）本品粉末红棕色。石细胞类圆形、类三角形、类长方形或不规则形，也有延长呈纤维状，边缘不平整，直径14～70μm，长可达257μm，孔沟明显，有的胞腔内含黄棕色物。木纤维多为纤维管胞，长梭形，末端斜尖或钝圆，直径12～27μm，具缘纹孔点状，纹孔斜裂缝状或十字形，孔沟稀疏。网纹导管和具缘纹孔导管直径11～60μm。
（2）取本品粉末1g，加乙醇5ml，超声处理15分钟，离心，取上清液作为供试品溶液。另取丹参对照药材1g，同法制成对照药材溶液。再取丹参酮ⅡA对照品、丹酚酸B对照品，加乙醇制成每1ml分别含0.5mg和1.5mg的混合溶液，作为对照品溶液。照薄层色谱法（通则0502）试验，吸取上述三种溶液各5μl，分别点于同一硅胶G薄层板上，使成条状，以三氯甲烷-甲苯-乙酸乙酯-甲醇-甲酸（6：4：8：1：4）为展开剂，展开，展至约4cm，取出，晾干，再以石油醚（60～90℃）-乙酸乙酯（4：1）为展开剂，展开，展至约8cm，取出，晾干，分别在日光及紫外光灯（365nm）下检视。供试品色谱中，在与对照药材色谱和对照品色谱相应的位置上，显相同颜色的斑点或荧光斑点。

检查 Examination

水分 Water

不得过13.0%（通则0832第二法）。
Not more than 13.0 per cent <0832, method 2>.

总灰分 Total ash

不得过10.0%（通则2302）。
Not more than 10.0 per cent <2302>.

酸不溶性灰分 Acid-insoluble ash

不得过3.0%（通则2302）。
Not more than 3.0 per cent <2302>.

重金属及有害元素 Heavy metals and harmful elements

照铅、镉、砷、汞、铜测定法（通则2321原子吸收分光光度法或电感耦合等离子体质谱法）测定，铅不得过5mg/kg；镉不得过0.3mg/kg；砷不得过2mg/kg；汞不得过0.2mg/kg；铜不得过20mg/kg。
Carry out the methods for determination of lead, cadmium, arsenic, mercury and copper <2321, atomic absorption spectro-photometry or inductively coupled plasma mass spectrometry>, not more than 5 mg/kg of lead, 0.3 mg/kg of cadmium, 2 mg/kg of arsenic, 0.2 mg/kg of mercury and 20 mg/kg of copper.

浸出物 Extractives

水溶性浸出物
照水溶性浸出物测定法（通则2201）项下的冷浸法测定，不得少于35.0%。

含量测定 Assay

丹参酮类
照高效液相色谱法（通则0512）测定。

饮片 Prepared slices

炮制 Processing

丹参除去杂质和残茎，洗净，润透，切厚片，干燥。
Processing Salviae Miltiorrhizae Radix et Rhizoma Remove foreign matter and remains of stems, wash clean, soften thoroughly, cut into thick slices, and dry.

性味与归经 Property and Flavor

苦，微寒。归心、肝经。
Mild cold; bitter.

功能与主治 Actions

活血祛瘀，通经止痛，清心除烦，凉血消痈。用于胸痹心痛，脘腹胁痛，癥瘕积聚，热痹疼痛，心烦不眠，月经不调，痛经经闭，疮疡肿痛。
To activate blood, eliminate stasis, unblock the meridians, relieve pain, clear the heart, relieve vexation, cool the blood and disperse abscesses. Used for chest bi disorder, heart pain, pain in the epigastrium and abdomen, hypochondriac pain, aggregation and accumulation, painful heat bi disorder, insomnia caused by vexation, menstrual irregularities, dysmenorrhea, amenorrhea, sore, ulcer, swelling and pain.

用法与用量 Administration and dosage

10～15g。
10-15 g.

注意 Precautions and Warnings

不宜与藜芦同用。
Incompatible with Veratri Nigri Radix et Rhizoma.

贮藏 Storage

置干燥处。
Preserve in a dry place.