阿胶

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

概述 Overview

本品为马科动物驴Equus asinus L.的干燥皮或鲜皮经煎煮、浓缩制成的固体胶。
Donkey-hide Gelatin is the solid gelatin prepared by decocting and concentrating the dried skin or fresh skin of the donkey, an animal of the Equidae family.

制法 Preparation

将驴皮浸泡去毛，切块洗净，分次水煎，滤过，合并滤液，浓缩（可分别加入适量的黄酒、冰糖及豆油）至稠膏状，冷凝，切块，晾干，即得。
The donkey skin is soaked to remove the hair, cut into pieces and washed. It is decocted in water in several portions, filtered, and the filtrate is combined. The combined filtrate is concentrated (with the addition of appropriate amounts of yellow rice wine, rock sugar, and soybean oil) to obtain a thick paste. The paste is cooled, cut into pieces, and dried to obtain the final product.

性状 Description

本品呈长方形块、方形块或丁状。棕色至黑褐色，有光泽。质硬而脆，断面光亮，碎片对光照视呈棕色半透明状。气微，味微甘。
Donkey-hide Gelatin is in the form of rectangular blocks, square blocks, or pieces. It is brown to dark brown in color and has a glossy appearance. The texture is hard and brittle, and the fractured surface is shiny. When the fragments are held up to the light, they appear brown and translucent. It has a slight odor and a slightly sweet taste.

鉴别 Identification

取本品粉末0.1g，加1%碳酸氢铵溶液50ml，超声处理30分钟，用微孔滤膜滤过，取续滤液100μl，置微量进样瓶中，加胰蛋白酶溶液10μl（取序列分析用胰蛋白酶，加1%碳酸氢铵溶液制成每1ml中含1mg的溶液，临用时配制），摇匀，37℃恒温酶解12小时，作为供试品溶液。另取阿胶对照药材0.1g，同法制成对照药材溶液。照〔含量测定〕特征多肽项下色谱、质谱条件试验，选择质荷比（m/z）539.8（双电荷）→612.4和m/z539.8（双电荷）→923.8作为检测离子对。取阿胶对照药材溶液，进样5μl，按上述检测离子对测定的MRM色谱峰的信噪比均应大于3:1。
吸取供试品溶液5μl，注入高效液相色谱-质谱联用仪，测定。以质荷比（m/z）539.8（双电荷）→612.4和m/z539.8（双电荷）→923.8离子对提取的供试品离子流色谱中，应同时呈现与对照药材色谱保留时间一致的色谱峰。

检查 Examination

水分 Water

取本品1g，精密称定，加水2ml，加热溶解后，置水浴上蒸干，使厚度不超过2mm，照水分测定法（通则0832第二法）测定，不得过15.0%。
Take 1g of the sample, accurately weigh, add 2ml of water, dissolve by heating, evaporate on a water bath until the thickness does not exceed 2mm, and determine according to the method for water determination <0832, method 2>, not more than 15.0 per cent.

总灰分 Total ash

不得过8.0%（通则2302）。
Not more than 8.0 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。
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 0.3mg/kg; the arsenic content should not exceed 2mg/kg; the mercury content should not exceed 0.2mg/kg; and the copper content should not exceed 20mg/kg.

水不溶物 Insoluble matter

取本品1.0g，精密称定，加水5ml，加热使溶解，转移至已恒重10ml具塞离心管中，用温水5ml分3次洗涤，洗液并入离心管中，摇匀。置40℃水浴保温15分钟，离心（转速为每分钟2000转）10分钟，去除管壁浮油，倾去上清液，沿管壁加入温水至刻度，离心，如法清洗3次，倾去上清液，离心管在105℃加热2小时，取出，置干燥器中冷却30分钟，精密称定，计算，即得。
Take 1.0g of the sample, accurately weigh, add 5ml of water, heat to dissolve, transfer to a centrifuge tube with a constant weight of 10ml, wash with 5ml of warm water in 3 portions, combine the washings into the centrifuge tube, shake well. Keep warm in a 40°C water bath for 15 minutes, centrifuge (at a speed of 2000 rpm) for 10 minutes, remove the floating oil on the tube wall, pour off the supernatant along the tube wall, add warm water to the mark along the tube wall, centrifuge, repeat the washing process 3 times, pour off the supernatant, heat the centrifuge tube at 105°C for 2 hours, take out, cool in a desiccator for 30 minutes, accurately weigh, calculate, and obtain the result.

饮片 Prepared slices

阿胶 Donkey-hide gelatin

炮制 Processing

捣成碎块。
Crush into small pieces.

性状 Appearance

本品呈不规则块状，大小不一。其余同药材。
The product is irregular in shape and varies in size. The rest is the same as the medicinal material.

检查 Examination

水分 Water

同药材，不得过10.0%。
Same as the medicinal material, not more than 10.0 per cent.

总灰分 Total ash

不得过4.0%（通则2302）。
Not more than 4.0 per cent <2302>.

阿胶珠 Donkey-hide gelatin pill

炮制 Processing

取阿胶，烘软，切成1cm左右的丁，照炒法（通则0213）用蛤粉烫至成珠，内无溏心时，取出，筛去蛤粉，放凉。
Take donkey-hide gelatin, heat and soften it, cut it into pieces about 1cm in size, use the frying method <0213> to cook with clam powder until it forms a pill, remove it when there is no uncooked part inside, sieve off the clam powder, and let it cool.

性状 Appearance

本品呈类球形。表面棕黄色或灰白色，附有白色粉末。体轻，质酥，易碎。断面中空或多孔状，淡黄色至棕色。气微，味微甜。
The product is spherical. The surface is brownish-yellow or grayish-white with white powder attached. It is light in weight, crisp in texture, and fragile. The cross-section is hollow or porous, pale yellow to brown. It has a slight odor and a slightly sweet taste.

检查 Examination

水分 Water

同药材，不得过10.0%。
Same as the medicinal material, not more than 10.0 per cent.

总灰分 Total ash

同药材。
Same as the medicinal material.

鉴别 Identification

同药材。
Same as the medicinal material.

含量测定 Content determination

氨基酸 Amino acids

同药材。
Same as the medicinal material.

性 Property

平。
Neutral.

味 Flavor

甘。
Sweet.

归经 Meridian tropism

归肺、肝、肾经。

功能 Actions

补血滋阴，润燥，止血。
Nourishes blood and nourishes yin, moisturizes dryness, and stops bleeding.

主治 Indications

用于血虚萎黄，眩晕心悸，肌痿无力，心烦不眠，虚风内动，肺燥咳嗽，劳嗽咯血，吐血尿血，便血崩漏，妊娠胎漏。
Used for blood deficiency and withered yellow, dizziness and palpitations, muscular atrophy and weakness, restlessness and insomnia, deficiency wind stirring internally, lung dryness cough, cough with blood due to exertion, vomiting blood and hematuria, bleeding and collapse, and threatened abortion during pregnancy.

用量 Dosage

3～9g。
3-9g.

用法 Administration

烊化兑服。
Closed and blended.

贮藏 Storage

密闭。
Store in a sealed container.

阿胶

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

概述 Overview

本品为马科动物驴Equus asinm L.的干燥皮或鲜皮经煎煮、浓缩制成的固体胶。
Donkey-hide Glue is the solid glue prepared from the dried or fresh skin of Equus asinus Linnaeus (Fam. Equidae) by decoction and concentration.

制法 Procedure

将驴皮浸泡去毛，切块洗净，分次水煎，滤过，合并滤液，浓缩（可分别加入适量的黄酒、冰糖及豆油）至稠膏状，冷凝，切块，晾干，即得。
Soak the donkey-hide, remove the hairs, cut into small pieces, rinse again, decoct with water several times, filter and combine the filtrates. Concentrate the glutinous filtrate ( or add a quantity of yellow rice wine, crystal sugar, soya-bean oil, respectively) to thick glue, allow to cool and congeal, cut into pieces, and dry in the air.

性状 Description

本品呈长方形块、方形块或丁状。棕色至黑褐色，有光泽。质硬而脆，断面光亮，碎片对光照视呈棕色半透明状。气微，味微甘。
Rectangular, square piece or small piece, brown to dark-brown, lustrous. Texture hard and fragile, fracture lustrous, fragment brown and translucent when looking against the light. Odour, slight； taste, slightly sweet.

鉴别 Identification

取本品粉末0.1g，加1%碳酸氢铵溶液50ml，超声处理30分钟，用微孔滤膜滤过，取续滤液l00μl，置微量进样瓶中，加胰蛋白酶溶液10μl（取序列分析用胰蛋白酶，加1%碳酸氢铵溶液制成每1ml中含1mg的溶液，临用时配制），摇匀，37℃恒温酶解12小时，作为供试品溶液。另取阿胶对照药材0.1g，同法制成对照药材溶液。照高效液相色谱-质谱法（通则0512和通则0431）试验，以十八烷基硅烷键合硅胶为填充剂（色谱柱内径为2.1mm）；以乙腈为流动相A，以0.1%甲酸溶液为流动相B，按下表中的规定进行梯度洗脱；流速为每分钟0.3ml。采用质谱检测器，电喷雾正离子模式（ESI+），进行多反应监测（MRM），选择质荷比（m/z） 539.8（双电荷）→612.4和m/z 539.8（双电荷）→923.8作为检测离子对。取阿胶对照药材溶液，进样5μl，按上述检测离子对测定的MRM色谱峰的信噪比均应大于3：1。
To 0.1 g of the powder, add 50 ml of 1% solution of ammonium bicarbonate, ultrasonicate for 30 minutes, filter with millipore filter. Transfer 100 μl of the successive filtrate into a trace sample bottle, add 10 μl of trypsin solution ( dissolve trypsin for sequence analysis in 1% solution of ammonium bicarbonate to produce a solution containing 1 mg per ml, prepare when use) , mix well, hydrolyze by enzyme at 37℃ for 12 hours, use the hydrolysate as the test solution. Prepare a solution of 0.1 g of Asini Corii Colla reference drug in the same manner as the reference drug solution. Carry out the method for high performance liquid chromatography-mass spectrometry 〈 0512 and 0431〉, use octadecylsilane bonded silica gel as the stationary phase (2.1 mm in inner diameter) , and use acetonitrile as the mobile phase A, 0.1% solution of formic acid as mobile phase B, elute in gradient at 0.3 ml per minute as the following:

As detector a mass spectrometer set in positive electrospray ionization ( ESI＋ ) interface, using multiple reactions monitoring (MRM) mode. Monitor the ion pairs at m/z 539.8 (double charged) →612.4 and m/z 539. 8 (double charged) →923.8. Inject 5 μl of each of the reference drug solution and the test solution respectively to the column and determine. The signal to noise ratio (SNR) of the peaks in the chromatogram obtained with the reference solution should be greater than 3 : 1. The peaks in the chromatogram obtained with the test solution correspond in retention time to the peaks in the chromatogram obtained with the reference drug solution.

检查 Examination

水分 Water

取本品1g，精密称定，加水2ml，加热溶解后，置水浴上蒸干，使厚度不超过2mm，照水分测定法（通则0832第二法）测定，不得过15.0%。
Heat to dissolve 1 g, accurately weighed, in 2 ml of water, and evaporate to dryness on a water bath. Keep the thickness not over than 2 mm. Carry out the method for the determination of water 〈 0832 , method 2 〉, not more than 15.0 per cent.

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 method for determination of lead (Pb), cadmium (Cd), arsenic (As), mercury (Hg) and copper (Cu)〈2321, atomic absorption spectrophotometry or inductively-coupled plasma mass spectrometry), not more than 5 mg/kg of Pb; not more than 0.3 mg/kg of Cd； not more than 2 mg/kg of As； not more than 0.2 mg/kg of Hg； not more than 20 mg/ kg of Cu.

水不溶物 Insoluble matter in water

取本品1.0g，精密称定，加水5ml，加热使溶解，转移至巳恒重10ml具塞离心管中，用温水5ml分3次冼涤，洗液并入离心管中，摇匀。置40℃水浴保温15分钟，离心（转速为每分钟2000转）10分钟，去除管壁浮油，倾去上清液，沿管壁加入温水至刻度，离心，如法清洗3次，倾去上清液，离心管在105℃加热2小时，取出，置干燥器中冷却30分钟，精密称定，计算，即得。
Weigh accurately 1.0 g of the powder in a flask, add 5 ml of water and heat to dissolve. Transfer to a 10 ml stoppered centrifuge tube previously dried to constant weight. Wash the flask 3 times with 5 ml of warm water, combine the washings to the centrifuge tube and mix well. Keep warm on a water bath at 40℃ for 15 minutes, centrifuge ( 2000 rotations per minute) for 10 minutes, discard the oil slick on tube wall and supernatant. Add warm water to volume along the tube wall, centrifuge, wash 3 times in the same manner and discard the supernatant. Heat the centrifuge tube at 105℃ for 2 hours, take out, cool in a desiccator for 30 minutes, weigh accurately and calculate, not more than 2.0 per cent.

其他 Other requirements

应符合胶剂项下有关的各项规定（通则0184）。
Complies with the general requirements for glues 〈 0184 〉.

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).

饮片 Prepared slices

阿胶 Asini Corii Colla

炮制 Processing

捣成碎块。
Pound into pieces.

阿胶珠 Asini Corii Colla (beaded)

取阿胶，烘软，切成1cm左右的丁，照烫法 （通则0213）用蛤粉烫至成珠，内无溏心时，取出，筛去蛤粉，放凉。
Soften by heating, cut into small squares (about 1 cm long), then stir-bake to beads as described under the method for stir-baking with powdered clam-shell〈 0213〉until the inner not runny, take out, remove the powdered clam-shell by sifting, and allow to cool.

检查 Examination

水分 Water

同药材，不得过10.0%，
Same as the crude drug, not more than 10.0%.

总灰分 Total ash

同药材，不得过4.0%。
Same as the crude drug, not more than 4.0%.

鉴别 Identification

同药材。
Same as the crude drug.

含量测定 Assay

同药材。
Same as the crude drug.

性味与归经 Property and Flavor

甘，平。归肺、肝、肾经。
Neutral ； sweet. Meridian tropism Lung, liver and kidney meridians.

功能与主治 Actions

补血滋阴，润燥，止血。用于血虚萎黄，眩晕心悸，肌痿无力，心烦不眠，虚风内动，肺燥咳嗽，劳嗽咯血，吐血尿血，便血崩漏，妊娠胎漏。
To nourish blood, replenish yin, moisten dryness, and stanch bleeding. Indicated for blood deficiency with sallow complexion, dizziness, palpitations, weak muscle, lack of strength, insomnia caused by vexation, internal stirring of defiency wind, cough caused by lung dryness, cough in consumptive disease, hemoptysis, hematemesis and hematuria, bloody stool, memstrnal flooding and spotting, and vaginal bleeding during pregnancy.

用法与用量 Administration and dosage

3～9g。烊化兑服。
3-9 g, taken after dissolving in boiling decoction.

贮藏 Storage

密闭。
Preserve in tightly closed container.