牛黄

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

概述 Overview

本品为牛科动物牛Bos taurus domesticus Gmelin的干燥胆结石。宰牛时，如发现有牛黄，即滤去胆汁，将牛黄取出，除去外部薄膜，阴干。
Calculus Bovis is the dried gallstone of Bos taurus domesticus Gmelin (Fam. Bovidae). The gallstone is collected when slaughtering the cattle, remove the bile, take out the calculus, remove the external membrane, and dry in the shade.

性状 Description

本品多呈卵形、类球形、三角形或四方形，大小不一，直径0.6～3（4.5）cm，少数呈管状或碎片。表面黄红色至棕黄色，有的表面挂有一层黑色光亮的薄膜，习称“乌金衣”，有的粗糙，具疣状突起，有的具龟裂纹。体轻，质酥脆，易分层剥落，断面金黄色，可见细密的同心层纹，有的夹有白心。气清香，味苦而后甘，有清凉感，嚼之易碎，不粘牙。
Calculus Bovis is mostly ovoid, spheroidal, triangular or quadrangular in shape, of different sizes, measuring 0.6-3 (4.5) cm in diameter; a few are tubular or in fragments. Surface yellowish-red to brownish-yellow, some with a layer of black and shiny membrane, known as "black-gold coat"; some are rough, with wart-like projections, and some have fissures. Light in weight, brittle in texture, easily delaminated, fracture golden yellow, with fine concentric layers visible, some with white core. Odour, fragrant; taste, bitter and then sweet, with a cooling sensation; chewable and easily broken, non-adhesive to the teeth.

鉴别 Identification

（1） 取本品少量，加清水调和，涂于指甲上，能将指甲染成黄色，习称“挂甲"。
(1) Take a small amount of the drug, mix with water, and apply it to the nails. It can stain the nails yellow, known as "nail staining".

（2） 取本品少许，用水合氯醛试液装片，不加热，置显微镜下观察：不规则团块由多数黄棕色或棕红色小颗粒集成，稍放置，色素迅速溶解，并显鲜明金黄色，久置后变绿色。
(2) Take a small amount of the drug, prepare a slide with chloral hydrate solution, without heating, observe under a microscope: irregular masses composed of numerous yellow-brown or brownish-red small particles, after a short period of time, the pigment dissolves rapidly and appears bright golden yellow, and after a long period of time, it turns green.

（3） 取本品粉末10mg，加三氯甲烷20ml，超声处理30分钟，滤过，滤液蒸干，残渣加乙醇1ml使溶解，作为供试品溶液。另取胆酸对照品、去氧胆酸对照品，加乙醇制成每1ml各含2mg的混合溶液，作为对照品溶液。照薄层色谱法（通则0502）试验，吸取上述两种溶液各2μl，分别点于同一硅胶G薄层板上，以异辛烷-乙酸乙酯-冰醋酸（15∶7∶5）为展开剂，展开，取出，晾干，喷以10%硫酸乙醇溶液，在105℃加热至斑点显色清晰，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。
(3) Take 10mg of the powder, add 20ml of chloroform, treat with ultrasound for 30 minutes, filter, evaporate the filtrate to dryness, dissolve the residue in 1ml of ethanol as the test solution. Take cholic acid CRS and deoxycholic acid CRS, add ethanol to produce a mixed solution containing 2mg 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 isooctane, ethyl acetate, and glacial acetic acid (15:7:5) as the mobile phase. Apply separately to the plate 2 μl of each of the above two solutions. After developing and removal of the plate, dry in air. Spray with a 10% solution of sulfuric acid in ethanol, heat at 105°C to the spots clear. 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.

（4） 取本品粉末10mg，加三氯甲烷-冰醋酸（4∶1）混合溶液5ml，超声处理5分钟，滤过，取滤液作为供试品溶液。另取胆红素对照品，加三氯甲烷-冰醋酸（4∶1）混合溶液制成每1ml含0.5mg的溶液，作为对照品溶液。照薄层色谱法（通则0502）试验，吸取上述两种溶液各5μl，分别点于同一硅胶G薄层板上，以环己烷-乙酸乙酯-甲醇-冰醋酸（10∶3∶0.1∶0.1）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，显相同颜色的斑点。
(4) Take 10mg of the powder, add 5ml of chloroform-glacial acetic acid (4:1) mixed solution, treat with ultrasound for 5 minutes, filter, and take the filtrate as the test solution. Take bilirubin CRS, add chloroform-glacial acetic acid (4:1) mixed solution to produce a solution containing 0.5mg 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 hexane, ethyl acetate, methanol, and glacial acetic acid (10:3:0.1:0.1) as the mobile phase. Apply separately to the plate 5 μl of each of the above two solutions. After developing and removal of the plate, dry in air. The 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9.0%（通则0832第二法）。
Not more than 9.0 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>.

游离胆红素 Free bilirubin

照高效液相色谱法（通则0512）测定（避光操作）。
Determine by high-performance liquid chromatography <0512> (protected from light).

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

同〔含量测定〕胆红素项下。
Same as Bilirubin.

对照品溶液的制备 Preparation of reference solution

取胆红素对照品适量，精密称定，加二氯甲烷制成每1ml含6.87μg的溶液，即得。
Take an appropriate amount of bilirubin reference standard, accurately weigh, add dichloromethane to make a solution containing 6.87μg per 1ml.

供试品溶液的制备 Preparation of test solution

取本品粉末（过六号筛）约10mg，精密称定，置具塞锥形瓶中，精密加入二氯甲烷50ml，密塞，称定重量，振摇混匀，冰浴中超声处理（功率500W，频率53kHz）40分钟，再称定重量，用二氯甲烷补足减失的重量，摇匀，离心（转速为每分钟4000转），分取二氯甲烷液，滤过，取续滤液，即得。
Take about 10mg of the powder of this product (passed through a No. 6 sieve), accurately weigh, place it in a stoppered conical flask, accurately add 50ml of dichloromethane, seal the flask, weigh it, shake it well, treat it with ultrasound in an ice bath (power 500W, frequency 53kHz) for 40 minutes, weigh it again, make up for the lost weight with dichloromethane, shake it well, centrifuge it (at a speed of 4000 rpm per minute), take the dichloromethane liquid, filter it, and take the filtrate.

测定法 Determination method

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，即得。
Accurately take 5μl of the reference solution and the test solution, respectively, inject them into the liquid chromatograph, and determine the results.

含量测定 Content determination

胆酸 Cholic acid

取本品细粉约0.2g，精密称定，置具塞锥形瓶中，精密加入甲醇50ml，密塞，称定重量，超声处理30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25ml，蒸干，残渣加20%氢氧化钠溶液10ml，加热回流2小时，冷却，加稀盐酸19ml，调节pH值至酸性，用乙酸乙酯提取4次（25ml，25ml，20ml，20ml），乙酸乙酯液均用同一铺有少量无水硫酸钠的脱脂棉滤过，滤液合并，回收溶剂至干，残渣加甲醇溶解，转移至10ml量瓶中，加甲醇至刻度，摇匀，作为供试品溶液。另取胆酸对照品适量，精密称定，加甲醇制成每1ml含0. 48mg的溶液，作为对照品溶液。照薄层色谱法（通则0502）试验，精密吸取供试品溶液 2μl、对照品溶液1μl与3μl，分别交叉点于同一硅胶G薄层板上，以异辛烷-乙酸丁酯-冰醋酸-甲酸（8∶4∶2∶1）为展开剂， 展至14～17cm，取出，晾干，喷以30%硫酸乙醇溶液，在 105℃加热至斑点显色清晰，取出，在薄层板上覆盖同样大小的玻璃板，周围用胶布固定，照薄层色谱法（通则0502）进行扫描，波长：λS = 380nm，λR = 650nm，测量供试品吸光度积分值与对照品吸光度积分值，计算，即得。
Take about 0.2g of the fine powder of this product, accurately weigh, place it in a stoppered conical flask, accurately add 50ml of methanol, seal the flask, weigh it, treat it with ultrasound for 30 minutes, let it cool, weigh it again, make up for the lost weight with methanol, shake it well, and filter it. Accurately take 25ml of the filtrate, evaporate it to dryness, add 10ml of 20% sodium hydroxide solution to the residue, heat it under reflux for 2 hours, cool it, add 19ml of dilute hydrochloric acid, adjust the pH to acidic, extract it with ethyl acetate 4 times (25ml, 25ml, 20ml, 20ml), and filter the ethyl acetate solution with the same amount of anhydrous sodium sulfate. Combine the filtrate, recover the solvent to dryness, dissolve the residue in methanol, transfer it to a 10ml volumetric flask, add methanol to the mark, shake it well, and use it as the test solution. Take an appropriate amount of cholic acid reference standard, accurately weigh, add methanol to make a solution containing 0.48mg per 1ml, and use it as the reference solution. Perform the test according to the thin-layer chromatography method <0502>. Accurately take 2μl, 1μl, and 3μl of the test solution and the reference solution, respectively, at the intersection on the same silica gel G thin-layer plate, use n-hexane-ethyl acetate-glacial acetic acid-formic acid (8:4:2:1) as the developing agent, develop it to 14-17cm, take it out, dry it, spray it with a 30% sulfuric acid-ethanol solution, heat it at 105°C until the spots are clearly visible, take it out, cover the thin-layer plate with a glass plate of the same size, fix it with adhesive tape, and scan it according to the thin-layer chromatography method <0502>. Wavelength: λS = 380nm, λR = 650nm, measure the integrated absorbance of the test solution and the reference solution, and calculate the results.

本品按干燥品计算，含胆酸（C24 H40O5）不得少于4.0%。
Calculated on the dried product, the content of cholic acid (C24 H40O5) should not be less than 4.0%.

胆红素 Bilirubin

照高效液相色谱法（通则0512）测定（避光操作）。
Determine by high-performance liquid chromatography <0512> (protected from light).

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-1%冰醋酸溶液（95∶5）为流动相；检测波长为450nm。理论板数按胆红素峰计算应不低于3000。
Using octadecylsilane-bonded silica gel as the filler; using acetonitrile-1% glacial acetic acid solution (95:5) as the mobile phase; the detection wavelength is 450nm. The theoretical number of plates calculated based on the bilirubin peak should not be less than 3000.

对照品溶液的制备 Preparation of reference solution

取胆红素对照品适量，精密称定，加二氯甲烷制成每1ml含40μg的溶液，即得。
Take an appropriate amount of bilirubin reference standard, accurately weigh, add dichloromethane to make a solution containing 40μg per 1ml.

供试品溶液的制备 Preparation of test solution

取本品粉末（过六号筛）约10mg，精密称定，置具塞锥形瓶中，加入10%草酸溶液10ml，密塞，涡旋混匀，精密加入水饱和二氯甲烷100ml，密塞，称定重量，充分振摇，涡旋混匀，超声处理（功率500W，频率53kHz，水温25～35℃）40分钟，放冷，再称定重量，用水饱和二氯甲烷补足减失的重量，摇匀，离心（转速为每分钟4000转），分取二氯甲烷液，滤过，取续滤液，即得。
Take about 10mg of the powder of this product (passed through a No. 6 sieve), accurately weigh, place it in a stoppered conical flask, add 10% oxalic acid solution 10ml, seal the flask, vortex and mix well, accurately add water-saturated dichloromethane 100ml, seal the flask, weigh it, shake it well, vortex and mix well, treat it with ultrasound (power 500W, frequency 53kHz, water temperature 25-35°C) for 40 minutes, let it cool, weigh it again, make up for the lost weight with water-saturated dichloromethane, shake it well, centrifuge it (at a speed of 4000 rpm per minute), take the dichloromethane liquid, filter it, and take the filtrate.

测定法 Determination method

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，即得。
Accurately take 5μl of the reference solution and the test solution, respectively, inject them into the liquid chromatograph, and determine the results.

本品按干燥品计算，含胆红素（C33 H36 N4O6）不得少于25.0%。
Calculated on the dried product, the content of bilirubin (C33 H36 N4O6) should not be less than 25.0%.

性 Property

凉。
Cold.

味 Flavor

甘。
Sweet.

归经 Meridian tropism

归心、肝经。
Heart and liver meridians.

功能 Actions

清心，豁痰，开窍，凉肝，息风，解毒。
Clear the heart, resolve phlegm, open the orifices, cool the liver, relieve wind, and detoxify.

主治 Indications

用于热病神昏，中风痰迷，惊痫抽搐，癫痫发狂，咽喉肿痛，口舌生疮，痈肿疔疮。
Used for coma due to febrile diseases, stroke with phlegm obstruction, convulsions of epilepsy, mania of epilepsy, sore throat, oral ulcers, carbuncles, and furuncles.

用量 Dosage

0.15～0.35g。
0.15-0.35g.

用法 Administration

多入丸散用。外用适量，研末敷患处。
Taken orally in pill or powder form. For external use, apply an appropriate amount of powdered product to the affected area.

注意 Precautions

孕妇慎用。
Caution for pregnant women.

贮藏 Storage

遮光，密闭，置阴凉干燥处，防潮，防压。
Store in a light-resistant, airtight container in a cool and dry place, protected from moisture and pressure.

牛黄

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

概述 Overview

本品为牛科动物牛Bos taurus domesticus Gmelin的干燥胆结石。宰牛时，如发现有牛黄，即滤去胆汁，将牛黄取出，除去外部薄膜，阴干。
Cow-bezoar is the dried gallstone of Bos taurus domesticus Gmelin (Fam. Bovidae). If the bezoar is found during slaughter, the bile is filtered. The drug is collected, removed from surrounding thin membrane, and dried in the shade.

性状 Description

本品多呈卵形、类球形、三角形或四方形，大小不一，直径0.6～3（4.5）cm，少数呈管状或碎片。表面黄红色至棕黄色，有的表面挂有一层黑色光亮的薄膜，习称"乌金衣"，有的粗糙，具疣状突起，有的具龟裂纹。体轻，质酥脆，易分层剥落，断面金黄色，可见细密的同心层纹，有的夹有白心。气清香，味苦而后甘，有清凉感，嚼之易碎，不粘牙。
Mostly ovoid, subspheroidal, triangular or cubic, varying in size, 0.6-3 (4.5) cm in diameter, occasionally tubular or in broken pieces. Externally yellowish-red to brownish-yellow, some with a layer of black lustrous thin membrane, commonly known as "Wujinyi” (black-gold clothing) , some rough, with wart-like protuberances, some with crackes. Texture light and fragile, easily peeled, fracture golden yellow, with fine and dense concentric circular lines, some with white core. Odour, aromatic； taste, bitter then sweet, with cool sense； easily broken on chewing but not sticky to the teeth.

鉴别 Identification

（1）取本品少量，加清水调和，涂于指甲上，能将指甲染成黄色，习称"挂甲"。
(1) Mix some amount of the drug with water, and paint on nails； the colour of the nails turns to yellow, commonly known as “Guajia".

（2） 取本品少许，用水合氯醛试液装片，不加热，置显微镜下观察：不规则团块由多数黄棕色或棕红色小颗粒集成，稍放置，色素迅速溶解，并显鲜明金黄色，久置后变绿色。
(2)Mount a small quantity of the drug with chloral hydrate TS without heating. Examine under microscope： irregular masses consisting of a number of yellowish-brown or brownish- red small granules. Standing for a moment, the pigments dissolved rapidly, and a bright golden-yellow colour is produced, turning to green after standing for a long time.

（3） 取本品粉末10mg，加三氯甲烷20ml，超声处理30分钟，滤过，滤液蒸干，残渣加乙醇1ml使溶解，作为供试品溶液。另取胆酸对照品、去氧胆酸对照品，加乙醇制成每1ml各含2mg的混合溶液，作为对照品溶液。照薄层色谱法（通则0502）试验，吸取上述两种溶液各2μl，分别点于同一硅胶G薄层板上，以异辛烷-乙酸乙酯-冰醋酸（15：7：5）为展开剂，展开，取出，晾干，喷以10%硫酸乙醇溶液，在105℃加热至斑点显色清晰，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。
(3)To 10 mg of the powder add 20 ml of chloroform, ultrasonicate for 30 minutes, filter, evaporate the filtrate to dryness, dissolve the residue in 1 ml of ethanol as the test solution. Dissolve cholic acid CRS and deoxycholic acid CRS in ethanol to produce a mixture containing 2 mg of each 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 isooctane, ethyl acetate and glacial acetic acid (15：7：5) as the mobile phase. Apply separately to the plate 2 μl of each of the above two solutions. After developing and removal of the plate, dry in air. Spray with 10% sulfuric acid in ethanol, heat at 105℃ to the spots clear, examine under ultraviolet light at 365 nm. The two fluorescent spots in the chromatogram obtained with the test solution correspond in position and colour to the spots in the chromatogram obtained with the reference solution.

（4） 取本品粉末10mg，加三氯甲烷-冰醋酸（4：1）混合溶液5ml，超声处理5分钟，滤过，取滤液作为供试品溶液。另取胆红素对照品，加三氯甲烷-冰醋酸（4：1）混合溶液制成每1ml含0.5mg的溶液，作为对照品溶液。照薄层色谱法（通则0502）试验，吸取上述两种溶液各5μl，分别点于同一硅胶G薄层板上，以环己烷-乙酸乙酯-甲醇-冰醋酸（10：3：0.1：0.1）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，显相同颜色的斑点。
(4)To 10 mg of the power add 5 ml of a mixture of chloroform and glacial acetic acid (4 ：1), ultrasonicate for 5 minutes, filter, use the filtrate as the test solution. Dissolve bilirubin CRS in the mixture of chloroform and glacial acetic acid (4 ：1) produce a solution containing 0. 5 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 cyclohexane, acetyl acetate, methanol and glacial acetic acid (10 ：3 ： 0.1 ： 0.1) as the mobile phase. Apply separately to the plate 5 μl of each of the above two solutions. After developing and removal of the plate, dry in air. The 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9.0%（通则0832第二法）。
Not more than 9.0 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>.

游离胆红素 Free bilirubin

照高效液相色谱法（通则0512）测定（避光操作）
色谱条件与系统适用性试验

性味与归经 Property and Flavor

甘，凉。归心、肝经。
Cool； sweet. Heart and liver meridians.

功能与主治 Actions and Indications

清心，豁痰，开窍，凉肝，息风，解毒。用于热病神昏，中风痰迷，惊痫抽搐，癫痫发狂，咽喉肿痛，口舌生疮，痈肿疔疮。
To clear the heart, sweep phlegm, open the orifices, cool the liver, extinguish wind, and remove toxin. Used for loss of consciousness in febrile disease, wind-stroke and phlegm clouding the heart, seizures, convulsions, epilepsy, manic psychosis, swelling and sore throat, mouth and tongue sores, swelling abscess, deep-rooted boil and sore.

用法与用量 Administration and dosage

0.15～0.35g，多入丸散用。外用适量，研末敷患处。
0.15-0.35g, usually used in pills or powder. Appropriate amount for topical application after grinding it into powder.

注意 Precautions and Warnings

孕妇慎用。
Use with caution during pregnancy.

贮藏 Storage

遮光，密闭，置阴凉干燥处，防潮，防压。
Preserve in a well closed container, store in a cool and dry place, and protect from light, moisture and pressure.