水飞蓟

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

概述 Overview

本品为菊科植物水飞蓟Silybum marianum（L.）Gaertn.的干燥成熟果实。秋季果实成熟时采收果序，晒干，打下果实，除去杂质，晒干。
Silybum Marianum Fruit is the dried ripe fruit of Silybum marianum (L.) Gaertn. (Fam. Compositae). The drug is collected when the fruit is ripe in autumn, the fruit cluster is dried, the fruit is removed, impurities are eliminated, and then dried.

性状 Description

本品呈长倒卵形或椭圆形，长5～7 mm，宽2～3 mm。表面淡灰棕色至黑褐色，光滑，有细纵花纹。顶端钝圆，稍宽，有一圆环，中间具点状花柱残迹，基部略窄。质坚硬。破开后可见子叶2片，浅黄白色，富油性。气微，味淡。
Fruits are long obovate or elliptical, measuring 5-7 mm long and 2-3 mm wide. The surface is pale grayish-brown to blackish-brown, smooth, with fine longitudinal striations. The apex is blunt and slightly wider, with a circular ring and residual stigma in the center, and the base is slightly narrower. The texture is hard. When broken, two cotyledons can be seen, which are pale yellowish-white and oily. It has a slight odor and a mild taste.

鉴别 Identification

（1）本品粉末灰褐色。外果皮细胞表面观类长多角形，有的细胞含有色素。中果皮细胞圆柱形或椭圆形，壁具网状纹理。草酸钙柱晶散在。内果皮石细胞表面观宽梭形，层纹不明显。子叶细胞含有细小簇晶和脂肪油滴。
(1) The powder of this drug is grayish-brown. The surface of the outer pericarp cells appears to be elongated and polygonal, and some cells contain pigments. The cells of the middle pericarp are cylindrical or elliptical, with a reticulate texture on the wall. Calcium oxalate prisms are scattered. The surface of the inner pericarp stone cells appears to be wide and spindle-shaped, and the layering is not obvious. The cells of the cotyledon contain small cluster crystals and fat droplets.

（2）取本品粉末0.5 g，加乙醚20 ml，加热回流30分钟，滤过，弃去乙醚液，药渣挥尽乙醚，加甲醇20 ml，加热回流30分钟，滤过，滤液蒸干，残渣加甲醇1 ml使溶解，作为供试品溶液。另取水飞蓟宾对照品，加甲醇制成每1 ml含2 mg的溶液，作为对照品溶液。照薄层色谱法（通则0502）试验，吸取上述供试品溶液2 μl、对照品溶液5 μl，分别点于同一硅胶G薄层板上，以甲苯-甲酸乙酯-甲酸（10:6:1）为展开剂，展开二次，展距8 cm，取出，晾干，喷以5%三氯化铝乙醇溶液，置紫外光灯（365 nm）下检视。供试品色谱中，在与对照品色谱相应的位置上，显相同颜色的荧光斑点。
(2) Take 0.5 g of the powder, add 20 ml of ether, heat under reflux for 30 minutes, filter, discard the ether solution, evaporate the residue to dryness, evaporate the ether from the residue, add 20 ml of methanol, heat under reflux for 30 minutes, filter, evaporate the filtrate to dryness, dissolve the residue in 1 ml of methanol as the test solution. Take silybin CRS, add methanol to make a solution containing 2 mg per ml 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 toluene, ethyl acetate, and formic acid (10:6:1) as the mobile phase. Apply separately to the plate 2 μl of the test solution and 5 μl of the reference solution. After developing and removal of the plate, dry in air. Spray with a 5% solution of ferric chloride in ethanol, examine under ultraviolet light at 365 nm. The fluorescent spot in the chromatogram obtained with the test solution corresponds in position and colour to the spot in the chromatogram obtained with the reference solution.

检查 Examination

水分 Water

不得过10.0%（通则0832第二法）。
Not more than 10.0 per cent <0832,method 2>.

总灰分 Total ash

不得过9.0%（通则2302）。
Not more than 9.0 per cent <2302>.

浸出物 Extractives

照醇溶性浸岀物测定法（通则2201）项下的热浸法测定，用乙醇作溶剂，不得少于18.0%。
Carry out the method for determination of ethanol-soluble Extractives <2201,the hot maceration method>, using ethanol as the solvent,not less than 18.0 per cent.

含量测定 Content determination

照高效液相色谱法（通则0512）测定。
Carry out the method for determination of content 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；以甲醇-水-冰醋酸（48:52:1）为流动相；检测波长为287 nm。理论板数按水飞蓟宾峰计算应不低于5000。
Use octadecylsilane bonded silica gel as the filler; use methanol-water-acetic acid (48:52:1) as the mobile phase; detect at a wavelength of 287 nm. The theoretical plate number calculated based on the peak of silybin should not be less than 5000.

对照品溶液的制备 Preparation of reference solution

取水飞蓟宾对照品适量，精密称定，加甲醇制成每1 ml含0.12 mg的溶液，即得。
Take an appropriate amount of silybin reference substance, accurately weigh, add methanol to make a solution containing 0.12 mg per 1 ml.

供试品溶液的制备 Preparation of test solution

取本品粉末（过三号筛）0.5 g，精密称定，置具塞锥形瓶中，精密加入75%甲醇50 ml，称定重量，加热回流30分钟，放冷，再称定重量，用75%甲醇补足减失的重量，摇匀，静置，取上清液，即得。
Take 0.5 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 75% methanol, weigh, heat reflux for 30 minutes, cool, weigh again, make up for the lost weight with 75% methanol, shake well, let it stand, and take the supernatant.

测定法 Determination method

分别精密吸取对照品溶液与供试品溶液各5 μl，注入液相色谱仪，测定，以水飞蓟宾两个峰面积之和计算，即得。
Accurately draw 5 μl of the reference solution and the test solution respectively, inject into the liquid chromatograph, determine, and calculate the sum of the peak areas of silybin.

本品按干燥品计算，含水飞蓟宾（C25H22O10）不得少于0.60%。
Calculated on the dried product, the content of silybin (C25H22O10) should not be less than 0.60%.

饮片 Prepared slices

水飞蓟 Silybum Marianum

炮制 Processing

取原药材，除去杂质，筛去灰屑。
Take the original medicinal material, remove impurities, and sift out the ash.

性状 Characteristics

同药材。
Same as the medicinal material.

鉴别 Identification

同药材。
Same as the medicinal material.

检查 Examination

同药材。
Same as the medicinal material.

浸出物 Extractives

同药材。
Same as the medicinal material.

含量测定 Content determination

同药材。
Same as the medicinal material.

性 Property

凉。
Cold.

毒性 Toxicity

无。
None.

味 Flavor

苦。
Bitter.

归经 Meridian tropism

归肝、胆经。
Attributed to the liver and gall bladder meridians.

功能 Actions

清热解毒，疏肝利胆。
Clear heat and detoxify, soothe the liver and promote bile flow.

主治 Indications

用于肝胆湿热，胁痛，黄疸。
Used for damp-heat in the liver and gallbladder, hypochondriac pain, and jaundice.

用量 Dosage

无。
None.

用法 Administration

供配制成药用。
Used for preparation of medicinal products.

贮藏 Storage

置阴凉干燥处，防蛀。
Store in a cool and dry place, and protect against moth.

水飞蓟

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

概述 Overview

本品为菊科植物水飞蓟Silybum marianum（L.）Gaertn.的干燥成熟果实。秋季果实成熟时采收果序，晒干，打下果实，除去杂质，晒干。
Fruit of Silybum Marianum is the dried ripe fruit of Silybum marianu (L.) Gaertn. (Fam. Compositae). The drug is collected in autumn when the fruit is ripe, dried in the sun, the fruit is tapped out, removed from foreign matter, and dried again in the sun.

性状 Description

本品呈长倒卵形或椭圆形，长5～7mm，宽2～3mm。表面淡灰棕色至黑褐色，光滑，有细纵花纹，顶端钝圆，稍宽，有一圆环，中间具点状花柱残迹，基部略窄。质坚硬。破开后可见子叶2片，浅黄白色，富油性。气微，味淡。
Long-obovate or elliptical, 5-7 mm long, 2-3 mm wide. Externally pale greyish-brown or dark brown, smooth, with fine longitudinal veins. Summit obtuse-rounded, slightly broad, with a circular ring at the top, and a pointed remain of style in the centre; base slightly narrowed. Texture hard, cotyledons 2, pale yellowish-white, oily. Odour, slightly; taste, weak.

鉴别 Identification

（1）本品粉末灰褐色。外果皮细胞表面观类长多角形，有的细胞含有色素。中果皮细胞圆柱形或椭圆形，壁具网状纹理。草酸钙柱晶散在。内果皮石细胞表面观宽梭形，层纹不明显。子叶细胞含有细小簇晶和脂肪油滴。
（2）取本品粉末0.5g，加乙醚20ml，加热回流30分钟，滤过，弃去乙醚液，药渣挥尽乙醚，加甲醇20ml，加热回流30分钟，滤过，滤液蒸干，残渣加甲醇1ml使溶解，作为供试品溶液。另取水飞蓟宾对照品，加甲醇制成每1ml含2mg的溶液，作为对照品溶液。照薄层色谱法（通则0502）试验，吸取上述供试品溶液2μl、对照品溶液5μl，分别点于同一硅胶G薄层板上，以甲苯-甲酸乙酯-甲酸（10：6：1）为展开剂，展开二次，展距8cm，取出，晾干，喷以5%三氯化铝乙醇溶液，置紫外光灯（365nm）下检视。供试品色谱中，在与对照品色谱相应的位置上，显相同颜色的荧光斑点。

检查 Examination

水分 Water

不得过10.0%（通则0832第二法）。
Not more than 10.0 per cent <0832, method 2>.

总灰分 Total ash

不得过9.0%（通则2302）。
Not more than 9.0 per cent <2302>.

浸出物 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18.0%。
Carry out the hot extraction method for determination of ethanol-soluble extractives <2201>, using ethanol as the solvent, not less than 18.0 per cent.

含量测定 Assay

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-冰醋酸（48：52：1）为流动相；检测波长为287nm。理论板数按水飞蓟宾峰计算应不低于5000，
Use octadecylsilane bonded silica gel as the stationary phase, a mixture of methanol, water and glacial acetic acid (48 : 52 : 1) as the mobile phase. As detector a spectrophotometer set at 287 nm. The number of theoretical plates of column is not less than 5000, calculated with the reference to the peak of silybin.

对照品溶液的制备 Reference solution

取水飞蓟宾对照品适量，精密称定，加甲醇制成每1ml含0.12mg的溶液，即得。
Weigh accurately a quality of silybin CRS, dissolved in methanol to produce a solution of 0.12 mg per ml as the reference solution.

供试品溶液的制备 Test solution

取本品粉末（过三号筛）0.5g，精密称定，置具塞锥形瓶中，精密加入75%甲醇50ml，称定重量，加热回流30分钟，放冷，再称定重量，用75%甲醇补足减失的重量，摇匀，静置，取上清液，即得。
Weigh accurately 0.5 g of the powder (through No. 3 sieve) to a stoppered conical flask, add accurately 50 ml of 75% methanol, weigh and heat reflux on a water bath for 30 minutes, cool, weigh again, replenish the loss of weight with 75% methanol, mix well, and allow to stand, collect the supernatant 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5μl，注入液相色谱仪，测定，以水飞蓟宾两个峰面积之和计算，即得。
Inject accurately 5 μl of each of the reference solution and the test solution into the column and calculate the content with the sum of the two peak areas of silibin.

本品按干燥品计算，含水飞蓟宾（C25H22O10）不得少于0.60%。
It contains not less than 0.60 per cent of silibin (C25H22O10), calculated with reference to the dried drug.

饮片 Prepared slices

水飞蓟 Fruit of Silybum Marianum

炮制 Processing

取原药材，除去杂质，筛去灰屑。
Eliminate foreign matter and ash.

性 Property

凉。
Cool.

味 Flavor

苦。
Bitter.

归经 Meridian tropism

归肝、胆经。
Liver and gallbladder meridians.

功能 Actions

清热解毒，疏肝利胆。
To clear heat, remove toxin, soothe the liver and disinhibit gallbladder.

主治 Indications

用于肝胆湿热，胁痛，黄疸。
Liver-gallbladder dampness-heat, hypochondriac pain, and jaundice.

用法与用量 Administration and dosage

供配制成药用。
Used for preparation of Chinese patent medicine.

贮藏 Storage

置阴凉干燥处，防蛀。
Preserve in a cool and dry place, and protect from moth.