青黛

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

概述 Overview

本品为爵床科植物马蓝Baphicacanthus cusia（Nees）Bremek.、蓼科植物蓼蓝Polygonum tinctorium Ait. 或十字花科植物菘蓝Isatis indigotica Fort. 的叶或茎叶经加工制得的干燥粉末、团块或颗粒。
Indigo Naturalis is the dried powder, mass or granule of the leaves or stems and leaves of Baphicacanthus cusia (Nees) Bremek. of the family Acanthaceae, Polygonum tinctorium Ait. of the family Polygonaceae, or Isatis indigotica Fort. of the family Cruciferae, processed.

性状 Description

本品为深蓝色的粉末，体轻，易飞扬；或呈不规则多孔性的团块、颗粒，用手搓捻即成细末。微有草腥气，味淡。
Indigo Naturalis is a deep blue powder, light in weight and easily dispersible; or irregular porous masses or granules, which can be easily crushed into fine powder by hand. It has a slight fishy odor and a mild taste.

鉴别 Identification

（1）取本品少量，用微火灼烧，有紫红色的烟雾产生。
(1) Take a small amount of the drug, burn it with a small flame, and produce purple-red smoke.

（2）取本品少量，滴加硝酸，产生气泡并显棕红色或黄棕色。
(2) Take a small amount of the drug, add nitric acid dropwise, produce bubbles and show brownish-red or yellowish-brown color.

（3）取本品50mg，加三氯甲烷5ml，充分搅拌，滤过，滤液作为供试品溶液。另取靛蓝对照品、靛玉红对照品，加三氯甲烷分别制成每1ml含1mg和0.5mg的溶液，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，以甲苯-三氯甲烷-丙酮（5:4:1）为展开剂，展开，取出，晾干。供试品色谱中，在与对照品色谱相应的位置上，显相同的蓝色和浅紫红色的斑点。
(3) Take 50mg of the drug, add 5ml of chloroform, stir well, filter, and use the filtrate as the test solution. Take indigo blue reference substance and indigo carmine reference substance, add chloroform to make solutions containing 1mg and 0.5mg per 1ml, respectively, as the reference solutions. Perform thin-layer chromatography test<0502> on the above three solutions, take 5μl of each solution, spot them separately on the same silica gel G thin-layer plate, use toluene-chloroform-acetone (5:4:1) as the mobile phase, develop, take out, and dry. In the chromatogram of the test solution, there are spots of the same blue and light purple-red color at the corresponding positions as those in the chromatogram of the reference solutions.

检查 Examination

水分 Water

不得过7.0%（通则0832第二法）。
Not more than 7.0 per cent <0832,method 2>.

水溶性色素 Water-soluble pigments

取本品0.5g，加水10ml，振摇后放置片刻，水层不得显深蓝色。
Take 0.5 g of the sample, add 10 ml of water, shake and let stand for a moment, the water layer should not appear deep blue.

含量测定 Content determination

靛蓝照高效液相色谱法（通则0512）测定。
Determine by high performance liquid chromatography with indigo carmine <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；以甲醇-水（75:25）为流动相；检测波长为606nm。理论板数按靛蓝峰计算应不低于1800。
Use octadecylsilane bonded silica gel as the filler; use methanol-water (75:25) as the mobile phase; detect at a wavelength of 606 nm. The theoretical plate number calculated based on the peak of indigo carmine should not be less than 1800.

对照品溶液的制备 Preparation of reference solution

取靛蓝对照品2.5mg，精密称定，置250ml量瓶中，加2%水合氯醛的三氯甲烷溶液（取水合氯醛，置硅胶干燥器中放置24小时，称取2.0g，加三氯甲烷至100ml，放置，出现浑浊，以无水硫酸钠脱水，滤过，即得）约220ml，超声处理（功率250W，频率33kHz）1.5小时，放冷，加2%水合氯醛的三氯甲烷溶液至刻度，摇匀，即得（每1ml中含靛蓝10μg）。
Take 2.5 mg of indigo carmine reference substance, accurately weigh, place it in a 250 ml volumetric flask, add a solution of 2% chloral hydrate in chloroform (take chloral hydrate, place it in a silica gel desiccator for 24 hours, weigh 2.0 g, add chloroform to 100 ml, let it stand, when turbidity appears, dehydrate with anhydrous sodium sulfate, filter, and obtain) about 220 ml, ultrasonicate (power 250 W, frequency 33 kHz) for 1.5 hours, let it cool, add a solution of 2% chloral hydrate in chloroform to the mark, shake well, and obtain (each 1 ml contains 10 μg of indigo carmine).

供试品溶液的制备 Preparation of test solution

取本品细粉约50mg，精密称定，置250ml量瓶中，加2%水合氯醛的三氯甲烷溶液约220ml，超声处理（功率250W，频率33kHz）30分钟，放冷，加2%水合氯醛的三氯甲烷溶液至刻度，摇匀，滤过，取续滤液，即得。
Take about 50 mg of the sample powder, accurately weigh, place it in a 250 ml volumetric flask, add a solution of 2% chloral hydrate in chloroform about 220 ml, ultrasonicate (power 250 W, frequency 33 kHz) for 30 minutes, let it cool, add a solution of 2% chloral hydrate in chloroform to the mark, shake well, filter, and take the filtrate to obtain.

测定法 Determination method

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。
Precisely aspirate 10 μl of the reference solution and the test solution respectively, inject into the liquid chromatograph, determine, and obtain.

本品按干燥品计算，含靛蓝（C16H10N2O2）不得少于2.0%
Calculate based on the dried product, the content of indigo carmine (C16H10N2O2) should not be less than 2.0%.

靛玉红 照高效液相色谱法（通则0512）测定。
Indigo jade red Determine by high performance liquid chromatography with indigo carmine <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；以甲醇-水（70:30）为流动相；检测波长为292nm。理论板数按靛玉红峰计算应不低于3000。
Use octadecylsilane bonded silica gel as the filler; use methanol-water (70:30) as the mobile phase; detect at a wavelength of 292 nm. The theoretical plate number calculated based on the peak of indigo carmine should not be less than 3000.

对照品溶液的制备 Preparation of reference solution

取靛玉红对照品2.5mg，精密称定，置50ml量瓶中，加N，N-二甲基甲酰胺约45ml，超声处理（功率250W，频率33kHz）使溶解，放冷，加N，N-二甲基甲酰胺至刻度，摇匀；精密量取10ml，置100ml量瓶中，加N，N-二甲基甲酰胺至刻度，摇匀，即得（每1ml中含靛玉红5μg）。
Take 2.5 mg of indigo carmine reference substance, accurately weigh, place it in a 50 ml volumetric flask, add about 45 ml of N,N-dimethylformamide, ultrasonicate (power 250 W, frequency 33 kHz) to dissolve, let it cool, add N,N-dimethylformamide to the mark, shake well; accurately take 10 ml, place it in a 100 ml volumetric flask, add N,N-dimethylformamide to the mark, shake well, and obtain (each 1 ml contains 5 μg of indigo carmine).

供试品溶液的制备 Preparation of test solution

取本品细粉约50mg，精密称定，置25ml量瓶中，加N，N-二甲基甲酰胺约20ml，超声处理（功率250W，频率33kHz）30分钟，放冷，加N，N-二甲基甲酰胺至刻度，摇匀，滤过，取续滤液，即得。
Take about 50 mg of the sample powder, accurately weigh, place it in a 25 ml volumetric flask, add about 20 ml of N,N-dimethylformamide, ultrasonicate (power 250 W, frequency 33 kHz) for 30 minutes, let it cool, add N,N-dimethylformamide to the mark, shake well, filter, and take the filtrate to obtain.

测定法 Determination method

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。
Precisely aspirate 10 μl of the reference solution and the test solution respectively, inject into the liquid chromatograph, determine, and obtain.

本品按干燥品计算，含靛玉红（C16H10N2O2）不得少于0.13%。
Calculate based on the dried product, the content of indigo carmine (C16H10N2O2) should not be less than 0.13%.

性 Property

寒。
Cold.

味 Flavor

咸。
Salty.

归经 Meridian tropism

归肝经。
Meridian tropism: Liver meridian.

功能 Actions

清热解毒, 凉血消斑，泻火定惊。
Clear heat and detoxify, cool blood and eliminate spots, purge fire and calm convulsions.

主治 Indications

用于温毒发斑，血热吐衄，胸痛咳血，口疮，痄腮，喉痹，小儿惊痫。
Used for fever, epistaxis, chest pain and coughing up blood, mouth sores, mumps, paralysis of throat, paediatric eclampsia.

用量 Dosage

1～3g。
1-3 g

用法 Administration

宜入丸散用。外用适量。
Suitable for pill or powder. External use appropriate amount.

贮藏 Storage

置干燥处。
Store in a dry place.

青黛

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

概述 Overview

本品为爵床科植物马蓝Baphicacanthus cusia（Nees） Bremek.、蓼科植物蓼蓝Polygonum tinctorium Ait.或十字花科植物菘蓝Isatis indigotica Fort.的叶或茎叶经加工制得的干燥粉末、团块或颗粒。
Natural Indigo is the dried powder, mass or granules prepared from the leaf or the stem and leaf of Baphicacanthus cusia (Nees) Bremek. (Fam. Acanthaceae), Polygonum tinctorium Ait. (Fam. Polygonaceae) or Isatis indigotica Fort. (Fam. Cruciferae).

性状 Description

本品为深蓝色的粉末，体轻，易飞扬；或呈不规则多孔性的团块、颗粒，用手搓捻即成细末。微有草腥气，味淡。
A deep blue powder, light and puffy or irregular and porous masses or granules, finely powdered on twisting. Odour, slightly grassy; taste, weak.

鉴别 Identification

（1）取本品少量，用微火灼烧，有紫红色的烟雾产生。
(1) Burn gently a small quantity of the powder, a purplish-red smoke is produced.

（2）取本品少量，滴加硝酸，产生气泡并显棕红色或黄棕色。
(2) To a small quantity of the powder, add nitric acid dropwise, a brownish-red or yellowish brown colour is produced with effervescence.

（3）取本品50mg，加三氯甲烷5ml，充分搅拌，滤过，滤液作为供试品溶液。另取靛蓝对照品、靛玉红对照品，加三氯甲烷分别制成每1ml含1mg和0.5mg的溶液，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，以甲苯-三氯甲烷-丙酮（5：4：1）为展开剂，展开，取出，晾干。供试品色谱中，在与对照品色谱相应的位置上，显相同的蓝色和浅紫红色的斑点。
(3) To 50 mg of the drug add 5 ml of chloroform, stir well and filter, the filtrate used as the test solution. Dissolve indigo CRS and indirubin CRS in chloroform to prepare two solutions containing 1 mg and 0.5 mg per ml, respectively, as the reference solutions. Carry out the method for thin layer chromatography<0502>, using silica gel G as the coating substance and a mixture of toluene-chloroform-acetone (5:4:1) as the mobile phase. Apply separately to the plate 5 μl of each of the above three solutions. After developing and removal of the plate, dry in air. The blue spot and pale purplish-red spot in the chromatogram obtained with the test solution correspond in position and colour to the spots in the chromatograms obtained with the reference solutions.

检查 Examination

水分 Water

不得过7.0%（通则0832第二法）。
Not more than 7.0 per cent <0832, method 2>.

水溶性色素 Water-soluble pigment

取本品0.5g，加水10ml，振摇后放置片刻，水层不得显深蓝色。
Shake 0.5 g of the powder with 10 ml of water and allow to stand for a moment; the water layer shows no deep blue colour.

含量测定 Assay

靛蓝 Indigo

照高效液相色谱法（通则0512）测定。
Carry out the method for high performance liquid chromatography<0512>.

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

以十八烷基硅烷键合硅胶为填充剂；以甲醇-水（75：25）为流动相；检测波长为606nm。理论板数按靛蓝峰计算应不低于1800。
Use octadecylsilane bonded silica gel as the stationary phase and a mixture of methanol and water (75 : 25) as the mobile phase. As detector a spectrophotometer set at 606 nm. The number of theoretical plates of the column is not less than 1800, calculated with reference to the peak of indigo.

对照品溶液的制备 Reference solution

取靛蓝对照品2.5mg，精密称定，置250ml量瓶中，加2%水合氯醛的三氯甲烷溶液（取水合氯醛，置硅胶干燥器中放置24小时，称取2.0g，加三氯甲烷至100ml，放置，出现浑浊，以无水硫酸钠脱水，滤过，即得）约220ml，超声处理（功率250W，频率33kHz） 1.5小时，放冷，加2%水合氯醛的三氯甲烷溶液至刻度，摇匀，即得（每1ml中含靛蓝10μg）。
Weigh accurately 2.5 mg of indigo CRS in a 250 ml volumetric flask, add about 220 ml of 2% solution of chloral hydrate in chloroform (to 2.0 g of chloral hydrate previously dried over silica gel for 24 hours, add chloroform to 100 ml, allow to stand until the solution turbid, dehydrate with anhydrous sodium sulfate, and filter), ultrasonicate (power 250 W, frequency 33 kHz) for 1.5 hours, cool, dilute with a 2% solution of chloral hydrate in chloroform to volume, and mix well as the reference solution (containing 10 μg per ml).

供试品溶液的制备 Test solution

取本品细粉约50mg，精密称定，置250ml量瓶中，加2%水合氯醛的三氯甲烷溶液约220ml，超声处理（功率250W，频率33kHz）30分钟，放冷，加2%水合氯醛的三氯甲烷溶液至刻度，摇匀，滤过，取续滤液，即得。
Weigh accurately 50 mg of the fine powder to a 250 ml volumetric flask, add about 220 ml of 2% solution of chloral hydrate in chloroform, ultrasonicate (power 250 W, frequency 33 kHz) for 30 minutes, cool, dilute with 2% solution of chloral hydrate in chloroform to volume. shake well and filter, use the successive filtrate as the test solution.

测定法 Procedure

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。
Inject accurately 10 μl of each of the reference solution and the test solution, respectively, into the column, and calculate the content.

本品按干燥品计算，含靛蓝（C16H10N2O2）不得少于2.0%。
It contains not less than 2.0 per cent of indigo (C16H10N2O2), calculated with reference to the dried drug.

靛玉红 Indirubin

照高效液相色谱法（通则0512）测定。
Carry out the method for high performance liquid chromatography<0512>.

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

以十八烷基硅烷键合硅胶为填充剂；以甲醇-水（70：30）为流动相；检测波长为292nm。 理论板数按靛玉红峰计算应不低于3000。
Use octadecylsilane bonded silica gel as the stationary phase and a mixture of methanol and water (70:30) as the mobile phase. As detector a spectrophotometer set at 292 nm. The number of theoretical plates of the column is not less than 3000, calculated with reference to the peak of indirubin.

对照品溶液的制备 Reference solution

取靛玉红对照品2.5mg，精密称定，置50ml量瓶中，加N，N-二甲基甲酰胺约45ml，超声处理 （功率250W，频率33kHz）使溶解，放冷，加N，N-二甲基甲酰胺至刻度，摇匀；精密量取10ml，置100ml量瓶中，加N，N-二甲基甲酰胺至刻度，摇匀，即得（每1ml中含靛玉红5μg）。
Weigh accurately 2.5 mg of indirubin CRS in a 50 ml volumetric flask, dissolve in about 45 ml of N, N-dimethylformamide by ultrasonicating (power 250 W, frequency 33 kHz), cool, dilute with N, N-dimethyl-formamide to volume and mix well (containing 5 μg per ml).

供试品溶液的制备 Test solution

取本品细粉约50mg，精密称定，置25ml量瓶中，加N，N-二甲基甲酰胺约20ml，超声处理（功率 250W，频率33kHz）30分钟，放冷，加N， N-二甲基甲酰胺至刻度，摇匀，滤过，取续滤液，即得。
Weigh accurately 50 mg of the fine powder in a 25 ml volumetric flask, add about 20 ml of N, N-dimethylformamide, ultrasonicate (power 250 W, frequency 33 kHz) for 30 minutes, cool, dilute with N, N-dimethylformamide to volume, mix well and filter, use the successive filtrate as the test solution.

测定法 Procedure

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。
Inject accurately 10 μl of each of the reference solution and the test solution, respectively, into the column, and calculate the content.

本品按干燥品计算，含靛玉红（C16H10N2O2）不得少于0.13%。
It contains not less than 0.13 per cent of indirubin (C16H10N2O2), calculated with reference to the dried drug.

性味与归经 Property and Flavor

咸，寒。归肝经。
Cold; salty. Liver meridian.

功能与主治 Actions and Indications

清热解毒，凉血消斑，泻火定惊。用于温毒发斑，血热吐衄，胸痛咳血，口疮，痄腮，喉痹，小儿惊痫。
To clear heat, remove toxin, cool the blood, resolve macule, purge fire, and settle convulsion. Used for macula and papule caused by warm toxin, blood heat with hematemesis, chest pain with hemoptysis, mouth sore, mumps, sore throat, and infantile fright epilepsy.

用法与用量 Administration and Dosage

1～3g，宜入丸散用。外用适量。
1-3 g, used in pills or powder. Appropriate amount for topical application.

贮藏 Storage

置干燥处。
Preserve in a dry place.