根据《中国药典·2020年版·一部》记载：本天然药材由牛胆粉、胆酸、猪去氧胆酸、牛磺酸、胆红素、胆固醇、微量元素等加工制成。
According to the Chinese Pharmacopoeia: 2020 edition: Volume I, this natural medicinal material is processed from ox gall powder, cholic acid, deoxycholic acid, taurine, bilirubin, cholesterol, trace elements, etc.
NMM ID | nmm-002c |
系统名 | Artificial Calculus Bovis |
系统中文名 | 人工牛黄（rén gōng niú huáng） |
通用名 | Ren-gong-niu-huang |
通用中文名 | 人工牛黄（rén gōng niú huáng） |
类型 | artificial |
物种基源 | |
药用部位 | |
特殊描述 | |
炮制方法 | |
系统名命名解释 | 根据《中国药典·2020年版·一部》记载：本天然药材由牛胆粉、胆酸、猪去氧胆酸、牛磺酸、胆红素、胆固醇、微量元素等加工制成。 According to the Chinese Pharmacopoeia: 2020 edition: Volume I, this natural medicinal material is processed from ox gall powder, cholic acid, deoxycholic acid, taurine, bilirubin, cholesterol, trace elements, etc. |
通用名命名解释 | NMMGN衍生自《中国药典·2020年版·一部》相关中药材中文名。 |
上级药材 | |
下级药材 | |
创建人 | |
审核专家 |
人工牛黄
中文文本参考：《中国药典（2020年版）》
English text reference: Chinese Pharmacopoeia (2020 Edition)
概述 Overview
本品由牛胆粉、胆酸、猪去氧胆酸、牛磺酸、胆红素、胆固醇、微量元素等加工制成。
Artificial Calculus Bovis is prepared from the processed mixture of Ox Gallstone Powder, Cholic Acid, Deoxycholic Acid, Taurine, Bilirubin, Cholesterol, and trace elements.
性状 Description
本品为黄色疏松粉末。味苦，微甘。
It is a yellow, loose powder with a bitter and slightly sweet taste.
鉴别 Identification
（1）取〔含量测定〕胆红素项下的续滤液，照紫外-可见分光光度法（通则0401）测定，在453nm波长处有最大吸收。
(1) Take the filtrate from the determination of bilirubin content, and measure it by ultraviolet-visible spectrophotometry (General Rule 0401). The maximum absorption is at a wavelength of 453nm.
（2）取本品0.1g，置10ml量瓶中，加甲醇适量，超声处理5分钟，加甲醇稀释至刻度，摇匀，静置，取上清液作为供试品溶液。另取胆酸对照品、猪去氧胆酸对照品，加甲醇制成每1ml各含1mg的混合溶液，作为对照品溶液。照薄层色谱法（通则0502）试验，吸取供试品溶液4μl、对照品溶液2μl，分别点于同一硅胶G薄层板上，以正己烷-乙酸乙酯-醋酸-甲醇（20∶25∶2∶3）上层溶液为展开剂，展开，取出，晾干，喷以10%磷钼酸乙醇溶液，在105℃加热至斑点显色清晰。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。
(2) Take 0.1g of the product, place it in a 10ml volumetric flask, add an appropriate amount of methanol, treat it with ultrasound for 5 minutes, dilute it with methanol to the mark, shake it well, let it stand, and take the supernatant as the test solution. Take Cholic Acid reference substance and Deoxycholic Acid reference substance, add methanol to make a mixed solution containing 1mg per 1ml, as the reference solution. Perform thin-layer chromatography (General Rule 0502) test, take 4μl of the test solution and 2μl of the reference solution, spot them separately on the same silica gel G thin-layer plate, use the upper layer solution of n-hexane-acetic ether-acetic acid-methanol (20:25:2:3) as the developing agent, develop, take out, dry, spray with a 10% solution of phosphomolybdic acid in ethanol, heat at 105°C until the spots are clearly visible. In the chromatogram of the test solution, spots of the same color appear at the corresponding positions as in the chromatogram of the reference solution.
（3）取牛胆粉对照药材10mg，加甲醇适量，超声处理使充分溶解，再加甲醇至10ml，摇匀，静置，取上清液作为对照药材溶液。照薄层色谱法（通则0502）试验，吸取〔鉴别〕（2）项下的供试品溶液和上述对照药材溶液各8μl，分别点于同一硅胶G薄层板上，以甲苯-冰醋酸-水（7.5∶10∶0.3）为展开剂，展开，取出，晾干，喷以10%磷钼酸乙醇溶液，在105℃加热至斑点显色清晰。供试品色谱中，在与对照药材色谱相应的位置上，显相同颜色的斑点。
(3) Take 10mg of Ox Gallstone Powder reference material, add an appropriate amount of methanol, treat it with ultrasound to dissolve it sufficiently, then add methanol to 10ml, shake it well, let it stand, and take the supernatant as the reference material solution. Perform thin-layer chromatography (General Rule 0502) test, take 8μl of the test solution under [Identification] (2) and 8μl of the above reference material solution, spot them separately on the same silica gel G thin-layer plate, use toluene-acetic acid-water (7.5:10:0.3) as the developing agent, develop, take out, dry, spray with a 10% solution of phosphomolybdic acid in ethanol, heat at 105°C until the spots are clearly visible. In the chromatogram of the test solution, spots of the same color appear at the corresponding positions as in the chromatogram of the reference material.
（4）取本品50mg，加水5ml，超声处理5分钟，加甲醇至10ml，静置，取上清液作为供试品溶液。另取牛磺酸对照品，加甲醇制成每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2μl，分别点于同一硅胶G薄层板上，以正丁醇-乙醇-冰醋酸-水（4∶1∶2∶1）为展开剂，展开，取出，晾干，在105℃加热10分钟，喷以1%茚三酮乙醇溶液，在105℃加热至斑点显色清晰。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 50mg of the product, add 5ml of water, treat it with ultrasound for 5 minutes, add methanol to 10ml, let it stand, and take the supernatant as the test solution. Take Taurine reference substance, add methanol to make a solution containing 0.5mg per 1ml, as the reference solution. Perform thin-layer chromatography (General Rule 0502) test, take 2μl of each of the above two solutions, spot them separately on the same silica gel G thin-layer plate, use n-butanol-ethanol-acetic acid-water (4:1:2:1) as the developing agent, develop, take out, dry, heat at 105°C for 10 minutes, spray with a 1% solution of ninhydrin in ethanol, heat at 105°C until the spots are clearly visible. In the chromatogram of the test solution, spots of the same color appear at the corresponding positions as in the chromatogram of the reference solution.
检查 Examination
水分 Water
不得过5.0%（通则0832第二法）。
Not more than 5.0 per cent <0832,method 2>.
含量测定 Content determination
胆酸 Cholic acid
对照品溶液的制备 Preparation of reference solution
取胆酸对照品12.5mg，精密称定，置25ml量瓶中，加60%冰醋酸溶液使溶解，并稀释至刻度，摇匀，即得（每1ml中含胆酸0.5mg）。
Take 12.5mg of cholic acid control product, weigh it precisely, put it in 25ml measuring flask, add 60% glacial acetic acid solution to make it dissolve, and dilute it to the scale, shake it well, that is to say, it is obtained (0.5mg of cholic acid in every 1ml).
标准曲线的制备 Preparation of standard curve
精密量取对照品溶液0.2ml、0.4ml、0.6ml、0.8ml、lml，分别置具塞试管中，各管加入60%冰醋酸溶液稀释成1.0ml，再分别加新制的糠醛溶液（1→100）1.0ml，摇匀，在冰浴中放置5分钟，精密加入硫酸溶液（取硫酸50ml与水65ml混合）13ml，混匀，在70℃水浴中加热10分钟，迅速移至冰浴中，放置2分钟，以相应的试剂为空白，照紫外-可见分光光度法（通则0401），在605nm波长处测定吸光度，以吸光度为纵坐标，浓度为横坐标，绘制标准曲线。
Precision measurement of the control solution 0.2ml, 0.4ml, 0.6ml, 0.8ml, lml, respectively, placed in a stoppered test tube, each tube add 60% glacial acetic acid solution diluted to 1.0ml, and then add a new furfural solution (1 → 100) 1.0ml, shaking well, placed in an ice bath for 5 minutes, precision add sulfuric acid solution (take 50ml of sulfuric acid mixed with 65ml of water) 13ml, mix well, heat in 70℃ water bath for 10 minutes, quickly move to the ice bath, placed in 2 minutes, with the corresponding reagent as a blank, according to the UV-visible spectrophotometric method (General rule 0401), the absorbance at 605nm wavelength, absorbance as the vertical coordinate, the concentration as the horizontal coordinate, plotting the standard curve.
测定法 Determination method
取本品约0.1g，精密称定，置50ml量瓶中，加 60%冰醋酸溶液适量，超声处理5分钟，用60%冰醋酸溶液稀释至刻度，摇匀，滤过，弃去初滤液，精密量取续滤液各1ml，分别置甲、乙两个具塞试管中，于甲管中加新制的糠醛溶液1ml，乙管中加水1ml作空白，照标准曲线制备项下的方法，自“在冰浴中放置5分钟”起，依法测定吸光度，从标准曲线上读出供试品溶液中含胆酸的重量，计算，即得。
Take about 0.1g of this product, weigh it precisely, put it in a 50ml measuring flask, add 60% glacial acetic acid solution, ultrasonic treatment for 5 minutes, dilute it with 60% glacial acetic acid solution to the scale, shake it well, filtrate, discard the initial filtrate, measure 1ml of each of the filtrate, put it into two stoppered tubes of A and B, add 1ml of newly-made furfural solution into the tube of A, add 1ml of water in the tube of B as a blank, and then analyse it according to the method under preparation, from "placing in ice bath for 5 minutes" onwards, determine the absorbance according to law, read out the weight of the test solution containing cholic acid from the standard curve, and calculate it, it is obtained. According to the method under the standard curve, from "placed in an ice bath for 5 minutes", according to the law to determine the absorbance, from the standard curve read out the weight of cholic acid in the test solution, calculation, that is obtained.
本品按干燥品计算，含胆酸（C24H40O5）不得少于13.0%。
This product contains not less than 13.0% of bile acid (C24H40O5) calculated as dried product.
胆红素 Bilirubin
对照品溶液的制备 Preparation of reference solution
取胆红素对照品10mg，精密称定，置100ml棕色量瓶中，加三氯甲烷80ml，超声处理使充分溶解，加三氯甲烷稀释至刻度，摇匀。精密量取10ml，置 50ml棕色量瓶中，用三氯甲烷稀释至刻度，摇匀，即得（每 1ml中含胆红素20μg）。
Take 10mg of bilirubin control, weigh it precisely, put it into 100ml brown measuring flask, add 80ml of trichloromethane, sonicate to make it fully dissolved, dilute it with trichloromethane to the scale, shake well. Precision measurement of 10ml, placed in 50ml brown measuring flask, diluted with trichloromethane to the scale, shaking well, that is to obtain (each 1ml contains bilirubin 20μg).
标准曲线的制备 Preparation of standard curve
精密量取对照品溶液4ml、5ml、 6ml、7ml、8ml，分别置25ml棕色量瓶中，用三氯甲烷稀释至刻度，摇匀，照紫外-可见分光光度法（通则0401），在 453nm处测定吸光度，以吸光度为纵坐标，浓度为横坐标，绘制标准曲线。
Measure 4 ml, 5 ml, 6 ml, 7 ml, 8 ml of the control solution in a 25 ml brown measuring flask, dilute with trichloromethane to the scale, shake well, and then measure the absorbance at 453 nm according to the UV-visible spectrophotometric method (General rule 0401), take the absorbance as the vertical coordinate and the concentration as the horizontal coordinate, and then draw the standard curve.
测定法 Determination method
取本品约80mg，精密称定，置100ml棕色量瓶中，加三氯甲烷80ml超声处理使充分溶解，用三氯甲烷稀释至刻度，摇匀，滤过，弃去初滤液，取续滤液，在453nm波长处测定吸光度，从标准曲线上读出供试品溶液中含胆红素的重 量，计算，即得。
Take about 80mg of this product, weigh it precisely, put it in a 100ml brown measuring flask, add 80ml of trichloromethane and ultrasonic treatment to make it fully dissolved, dilute it to the scale with trichloromethane, shake it well, filter it, discard the initial filtrate, take the filtrate, determine the absorbance at 453nm, and then read out the weight of the bilirubin in the test solution from the standard curve, and then calculate it, that is, it is obtained.
本品按干燥品计算，含胆红素（C33H36N4O6）不得少于 0.63%。
This product contains not less than 0.63% of bilirubin (C33H36N4O6) calculated as dry product.
性 Property
凉。
Cold.
味 Flavor
甘。
Sweet.
归经 Meridian tropism
归心、肝经。
Heart and liver meridians.
功能 Actions
清热解毒，化痰定惊。
To clear heat and detoxify, resolve phlegm, and calm convulsions.
主治 Indications
用于痰热谵狂，神昏不语，小儿急惊风，咽喉肿痛，口舌生疮，痈肿疔疮。
Used for phlegm-heat mania, coma with incoherent speech, infantile convulsions, sore throat, mouth and tongue sores, carbuncles and furuncles.
用量 Dosage
一次0.15～0.35g。
0.15-0.35g per dose.
用法 Administration
多作配方用。外用适量敷患处。
Often used in formulas. For external use, apply an appropriate amount to the affected area.
注意 Precautions
孕妇慎用。
Caution for pregnant women.
贮藏 Storage
密封，防潮，避光，置阴凉处。
Seal, moisture-proof, avoid light, store in a cool place.
附：1 .胆红素质量标准 | Bilirubin quality standard
胆红素 Bilirubin
本品由猪（或牛）胆汁经提取、加工制成。
This product is made from pig ( or cow ) bile by extraction and processing.
性状 Description
本品为橙色至红棕色结晶性粉末。
This product is an orange to reddish-brown crystalline powder.
鉴别 Identification
（1）取〔含量测定〕项下溶液，照紫外-可见分光光度法（通则0401），在400～500nm 波长处，测定吸收曲线，并与胆红素对照品图谱比较，应一致。其最大吸收为453nm。
(1) Take the solution under [Content Determination], according to the UV-visible spectrophotometric method (General rule 0401), in the wavelength of 400-500nm, determine the absorption curve, and compare with the spectrum of bilirubin control product, it should be consistent. The maximum absorption is 453nm.
（2）取本品，加三氯甲烷制成每1ml含0.1mg的溶液，作为供试品溶液。另取胆红素对照品，同法制成对照品溶液。 照薄层色谱法（通则0502）试验，吸取上述两种溶液各10μl， 分别点于同一硅胶G薄层板上，以甲苯-乙酸乙酯-冰醋酸 （10∶1∶0.5）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。
(2) Take this product, add trichloromethane to make a solution containing 0.1mg per 1ml, as the test solution. Take bilirubin control product, the same method into the control solution. According to the thin layer chromatography (General rule 0502) test, absorb the above two solutions of 10μl, respectively, point in the same silica gel G thin layer plate, with toluene - ethyl acetate - glacial acetic acid (10:1:0.5) as the unfolding agent, unfolding, take out, and dry. In the chromatogram of the test article, spots of the same colour are shown on the corresponding positions of the chromatogram of the control article.
检查 Examination
干燥失重 Loss on drying
取本品约0.5g，在五氧化二磷60℃ 减压干燥4小时，减失重量不得过2.0%（通则0831）。
About 0.5g of this product was taken and dried at 60 °C for 4 hours under reduced pressure with phosphorus pentoxide, and the weight loss should not exceed 2.0 % ( General rule 0831 ).
含量测定 Content determination
取本品约10mg，精密称定，用少量三氯甲烷研磨后转移至100ml棕色量瓶中，超声处理使溶解，取出，迅速放冷，再加三氯甲烷稀释至刻度，摇匀。精密量取5ml， 置100ml棕色量瓶中，加三氯甲烷稀释至刻度，摇匀。照紫外-可见分光光度法（通则0401），在453nm的波长处测定吸光度，按胆红素的吸收系数（）1038计算，即得。
Take about 10mg of this product, precision weighing, with a small amount of trichloromethane grinding transferred to 100ml brown measuring flask, ultrasonic treatment to dissolve, remove, quickly cooled, then add trichloromethane diluted to the scale, shaking. Measure 5ml precisely, put it in 100ml brown measuring flask, add trichloromethane and dilute to the scale, shake well. According to the UV-visible spectrophotometric method (General rule 0401), determine the absorbance at 453nm, according to the absorption coefficient of bilirubin () 1038 calculation, that is obtained.
本品按干燥品计算，含胆红素（C33H36N4O6）不得少于 90.0%。
This product contains not less than 90.0% of bilirubin (C33H36N4O6) calculated as dry product.
用途 Uses
人工牛黄的原料。
Raw material for artificial bezoar.
贮藏 Storage
密闭，防潮，避光。
Seal, moisture-proof, avoid light.
2.猪去氧胆酸质量标准 | Deoxycholic acid quality standard
猪去氧胆酸 Deoxycholic acid
本品由猪胆汁经提取、加工制成。
This product is made from pig bile by extraction and processing.
本品为3α,6α－二羟基-5β -胆烷酸。
This product is 3α, 6α-dihydroxy-5β-cholanic acid.
性状 Description
本品为白色或类白色的粉末。气微，味微苦。
This product is a white or off-white powder. Slightly odorous, slightly bitter taste.
本品在乙醇中易溶，在丙酮中微溶，在乙酸乙酯、三氯甲烷或乙醚中极微溶解，在水中几乎不溶。
This product is easily soluble in ethanol, slightly soluble in acetone, extremely slightly soluble in ethyl acetate, chloroform or ether, and almost insoluble in water.
熔点 Melting point
本品的熔点不得低于l170°C (通则0612），熔融时同时分解。
The melting point of this product should not be lower than l170 ° C ( general rule 0612 ), and it should be decomposed at the same time.
鉴别 Identification
取本品约5mg，加60%冰醋酸溶液2ml溶解，加新制的1%糠醛溶液2ml，混匀，将此溶液分成2份，分别置甲、乙两管中，甲管中加硫酸溶液（7→10）10ml，乙管中加硫酸溶液（4→10）10ml，将甲、乙两管置70℃水浴中保温数分钟，甲管应显红色渐变紫红色，乙管应不显色。
Take about 5mg of this product, add 2ml of 60 % glacial acetic acid solution to dissolve, add 2ml of newly prepared 1 % furfural solution, mix well, divide this solution into 2 parts, and place it in tubes A and B respectively. Add 10ml of sulfuric acid solution ( 7 → 10 ) to tube A, add 10ml of sulfuric acid solution ( 4 → 10 ) to tube B, and place tubes A and B in a 70 ° C water bath for several minutes.
检查 Examination
醇溶度 Solubility in alcohol
取本品0.5g，加乙醇50ml，置60℃水浴上温热使溶解，于20～25℃静置1小时，溶液应澄清并不得有明显沉淀。
Take 0.5g of this product, add 50ml of ethanol, place it in a 60 °C water bath to dissolve it, and stand at 20-25 °C for 1 hour. The solution should be clarified and there should be no obvious precipitation.
干燥失重 Loss on drying
取本品，在105℃干燥至恒重，减失重量不得过 1.0%（通则 0831）。
The product was dried to constant weight at 105 °C, and the weight loss should not exceed 1.0 % ( General rule 0831 ).
炽灼残渣 Residue on ignition
不得过0.2%（通则0841）。
Not more than 0.2 % ( general rule 0841 ).
用途 Uses
人工牛黄的原料。
Raw material for artificial bezoar.
贮藏 Storage
密闭保存。
Store in a sealed container.
3.牛胆粉质量标准 | Ox gall powder quality standard
牛胆粉 Ox gall powder
本品由牛胆汁加工制成。
This product is made from bovine bile.
性状 Description
本品为黄棕色至黄褐色的粉末。味苦，有吸湿性。
This product is a yellow-brown to yellowish-brown powder. Bitter taste, hygroscopic.
鉴别 Identification
取本品50mg，加甲醇10ml，超声处理使充分溶解，静置使澄清，取上清液作为供试品溶液。另取牛胆粉对照药材50mg，同法制成对照药材溶液。照薄层色谱法（通则 0502）试验，吸取上述两种溶液各4μl，分别点于同一硅胶G薄层板上，以甲苯-冰醋酸-水（7.5∶10∶0.3）为展开剂，展开，取出，晾干，喷以10%磷钼酸乙醇溶液，在105℃加热约 5分钟。供试品色谱中，在与对照药材色谱相应的位置上，显相同颜色的斑点。
Take 50 mg of this product, add 10 ml of methanol, ultrasonic treatment to fully dissolve, stand still to clarify, and take the supernatant as the test solution. In addition, 50 mg of bovine bile powder was taken as the control medicinal material, and the control medicinal material solution was prepared by the same method. According to the test of thin layer chromatography ( general rule 0502 ), 4 μl of the above two solutions were taken and point on the same silica gel G thin layer plate, respectively. Toluene-glacial acetic acid-water ( 7.5 ∶ 10 ∶ 0.3 ) was used as the developing agent, unfolded, removed, dried, sprayed with 10 % phosphomolybdic acid ethanol solution, and heated at 105 °C for about 5 minutes. In the chromatogram of the test sample, the spots of the same color appeared at the corresponding position of the chromatogram of the control medicinal material.
检查 Examination
水分 Water
不得过5.0%（通则0832第二法）。
Not more than 5.0 per cent <0832,method 2>.
猪胆粉 Pig gall powder
取本品0.1g，加甲醇10ml，超声处理使溶解，滤过，滤液置水浴上蒸至近干，用2. 5mol/L氢氧化钠溶液5ml 分次溶解，并转入具塞试管中，置水浴上水解5小时后，取出，放冷，滴加盐酸调节pH值至2～3，用乙酸乙酯提取3次，每次10ml，合并乙酸乙酯液浓缩至干，残渣加甲醇1ml使溶解， 作为供试品溶液。另取猪去氧胆酸对照品，加甲醇制成每 1ml含lmg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2μl，分别点于同一硅胶G 薄层板上，以异辛烷-正丁醚-冰醋酸（8∶5∶5）为展开剂，展开，取出，晾干，喷以10%磷钼酸乙醇溶液，在105℃加热至斑点显色清晰。供试品色谱中，在与对照品色谱相应的位置上，不得显相同颜色的斑点。
Take 0.1g of this product, add methanol 10ml, ultrasonic treatment to dissolve, filtration, filtrate in a water bath to steam until nearly dry, with 2.5mol / L sodium hydroxide solution 5ml dissolved in batches, and transferred to a stoppered test tube, placed in a water bath hydrolysis for 5 hours, take out, let it cool, add hydrochloric acid dropwise to adjust the pH value to 2 ~ 3, extracted with ethyl acetate for 3 times, each time 10 ml, and combined with the ethyl acetate solution concentrated to dryness, as a test solution. Add 1ml of methanol to the residue to dissolve, as the test solution. Take porcine deoxycholic acid control product, add methanol to make a solution containing lmg per 1ml, as a control solution. According to thin-layer chromatography (General rule 0502) test, absorb the above two solutions of 2μl, were spotted on the same silica gel G thin-layer plate, iso-octane - n-butyl ether - glacial acetic acid (8:5:5) as an unfolding agent, unfolding, remove, drying, sprayed with 10% phosphomolybdic acid ethanol solution, heated to 105 ℃ until the spots show clear colour. In the chromatogram of the test article, in the corresponding position with the chromatogram of the control article, the spots of the same colour shall not be shown.
含量测定 Content determination
对照品溶液的制备 Preparation of reference solution
取胆酸对照品 12.5mg，精密称定，置25ml量瓶中，加60%冰醋酸溶液使溶解，并稀释至刻度，摇匀，即得（每lml中含胆酸0.5mg）。
Take 12.5mg of cholic acid reference substance, precise weighing, place it in a 25ml volumetric flask, add 60 % glacial acetic acid solution to dissolve it, and dilute it to the scale, shake well, and obtain ( 0.5mg of cholic acid per ml ).
标准曲线的制备 Preparation of standard curve
精密量取对照品溶液0.2ml、0.4ml、 0.6ml、0.8ml、lml，分别置具塞试管中，各管加入60%冰醋酸溶液稀释成1.0ml，再分别加入新制的糠醛溶液（1→100）1.0ml，摇匀，在冰浴中放置5分钟，精密加入硫酸溶液（取硫酸50ml与水65ml混合）13ml，混匀，在70℃水浴中加热 10分钟，迅速移至冰浴中，放置2分钟，以相应的试剂为空白。 照紫外-可见分光光度法（通则0401），在605nm的波长处测定吸光度，以吸光度为纵坐标，浓度为横坐标，绘制标准曲线。
Precisely measure the reference solution 0.2ml, 0.4ml, 0.6ml, 0.8ml, lml, respectively, in the test tube, each tube was added with 60 % glacial acetic acid solution diluted to 1.0ml, and then added to the new furfural solution ( 1 → 100 ) 1.0ml, shaken well, placed in an ice bath for 5 minutes, precisely added sulfuric acid solution ( 50ml of sulfuric acid mixed with 65ml of water ) 13ml, mixed well, heated in a 70 °C water bath for 10 minutes, quickly moved to the ice bath, placed for 2 minutes, with the corresponding reagent as a blank. The absorbance was measured at a wavelength of 605 nm by ultraviolet-visible spectrophotometry ( general rule 0401 ). The standard curve was drawn with absorbance as the ordinate and concentration as the abscissa.
测定法 Determination method
取本品约0.15g，精密称定，置50ml量瓶中，加 60%冰醋酸溶液适量，超声处理使溶解，取出，放冷，加60% 冰醋酸溶液稀释至刻度，摇匀，滤过，弃去初滤液，精密量取续 滤液5ml，置50ml量瓶中，并用60%冰醋酸溶液稀释至刻度，摇匀，精密量取各1ml，分别置甲、乙两个试管中。于甲管中加新制的糠醛溶液1ml，乙管中加水1ml作空白，照标准曲线 的制备项下的方法，自“在冰浴中放置5分钟”起，依法测定吸 光度。从标准曲线上读出供试品溶液中含胆酸的重量，计算，即得。
Take about 0.15g of this product, accurately weighed, placed in a 50ml volumetric flask, added with an appropriate amount of 60 % glacial acetic acid solution, dissolved by ultrasonic treatment, taken out, cooled, diluted with 60 % glacial acetic acid solution to the scale, shaken well, filtered, discarded the initial filtrate, accurately measured the subsequent filtrate 5ml, placed in a 50ml volumetric flask, diluted with 60 % glacial acetic acid solution to the scale, shaken well, accurately measured each 1ml, and placed in two test tubes A and B, respectively. The new furfural solution 1ml was added to the tube A, and 1ml water was added to the tube B as a blank. According to the method under the preparation of the standard curve, the absorbance was measured according to the law from ' placed in the ice bath for 5 minutes '. The weight of cholic acid in the test solution was read from the standard curve and calculated.
本品按干燥品计算，含胆酸（C24H40O5）不得少于42.0%。
The content of cholic acid ( C24H40O5 ) should not be less than 42.0 %.
用途 Uses
人工牛黄的原料。
Raw material for artificial bezoar.
贮藏 Storage
置阴凉干燥处，避光，密封保存，防潮。
Place in a cool and dry place, avoid light, sealed, moistureproof.
4.胆酸质量标准 | Cholic acid quality standard
胆酸 Cholic acid
本品由牛、羊胆汁或胆膏经提取、加工制成。
This product is made from cow or sheep bile or bile paste by extraction and processing.
性状 Description
本品为白色或类白色的粉末。气微，味苦。
This product is a white or off-white powder. Slightly odorous, slightly bitter taste.
鉴别 Identification
取本品0.1mg，加60%冰醋酸溶液2ml，超声处理10分钟使溶解，滤过，取滤液1ml，置试管中，加新制的糠醛溶液（1→100）lml与硫酸溶液（取硫酸50ml与水65ml混合）13ml，在70℃水浴中加热，溶液应呈蓝紫色。
Take 0.1mg of this product, add 2ml of 60 % glacial acetic acid solution, ultrasonic treatment for 10 minutes to dissolve, filter, take 1ml of the filtrate, place in the test tube, add new furfural solution ( 1 → 100 ) lml and sulfuric acid solution ( take sulfuric acid 50ml and water 65ml mixed ) 13ml, heated in a water bath at 70 °C, the solution should be blue-purple.
检查 Examination
醇溶度 Solubility in alcohol
取本品0.5g，加乙醇50ml，于60℃加热并超声处理使充分溶解，于20～25℃静置1小时，溶液应澄清并不得有明显沉淀。
Take 0.5g of this product, add 50ml of ethanol, heat at 60 °C and ultrasonic treatment to fully dissolve, and stand at 20 ~ 25 °C for 1 hour. The solution should be clarified and there should be no obvious precipitation.
干燥失重 Loss on drying
取本品，在105℃干燥2小时，减失重量不得过 1.0%（通则 0831）。
Take this product, dried at 105 °C for 2 hours, the weight loss should not be more than 1.0 % ( General rule 0831 ).
炽灼残渣 Residue on ignition
不得过0.3%（通则0841）。
Not more than 0.3 % ( general rule 0841 ).
含量测定 Content determination
对照品溶液的制备 Preparation of reference solution
取胆酸对照品 12.5mg，精密称定，置25ml量瓶中，加60%冰醋酸溶液使溶解，并稀释至刻度，摇匀，即得（每lml中含胆酸0.5mg）。
Take 12.5mg of cholic acid control product, weigh it precisely, put it in 25ml measuring flask, add 60% glacial acetic acid solution to make it dissolve, and dilute it to the scale, shake it well, that is to say, it is obtained (0.5mg of cholic acid in each lml).
标准曲线的制备 Preparation of standard curve
精密量取对照品溶液0.2ml、0.4ml、 0.6ml、0.8ml、lml，分别置具塞试管中，各管加入60%冰醋酸溶液稀释成1.0ml，再分别加入新制的糠醛溶液（1→100）1.0ml，摇匀，在冰浴中放置5分钟，精密加入硫酸溶液（取硫酸50ml与水65ml混合）13ml，混匀，在70℃水浴中加热10分钟，迅速移至冰浴中，放置2分钟，以相应的试剂为空白。 照紫外-可见分光光度法（通则0401），在605nm的波长处测定吸光度，以吸光度为纵坐标，浓度为横坐标，绘制标准曲线。
Precisely measure the control solution 0.2ml, 0.4ml, 0.6ml, 0.8ml, lml, respectively, placed in a stoppered test tube, each tube was added 60% glacial acetic acid solution diluted to 1.0ml, and then added freshly made furfural solution (1→100) 1.0ml, shaking well, and placed in an ice bath for 5 minutes, precise addition of sulphuric acid solution (take 50 ml of sulphuric acid mixed with 65 ml of water) 13ml, mix well, heat in 70 ℃ water bath for 10 minutes, quickly moved to the ice bath, placed in 2 minutes, with the corresponding reagent as a blank. According to the UV-visible spectrophotometric method (General rule 0401), the absorbance was measured at 605nm, and the standard curve was drawn with the absorbance as the vertical coordinate and the concentration as the horizontal coordinate.
测定法 Determination method
取本品约0.15g，精密称定，置50ml量瓶中，加 60%冰醋酸溶液适量，超声处理使溶解，取出，放冷，加60% 冰醋酸溶液稀释至刻度，摇匀，滤过，弃去初滤液，精密量取续 滤液5ml，置50ml量瓶中，并用60%冰醋酸溶液稀释至刻度，摇匀，精密量取各1ml，分别置甲、乙两个试管中。于甲管中加新制的糠醛溶液1ml，乙管中加水1ml作空白，照标准曲线 的制备项下的方法，自“在冰浴中放置5分钟”起，依法测定吸 光度。从标准曲线上读出供试品溶液中含胆酸的重量，计算，即得。
Take about 0.15g of this product, weighed precisely, placed in a 50ml measuring flask, add 60% glacial acetic acid solution, ultrasonic treatment to dissolve, remove, cool, add 60% glacial acetic acid solution diluted to the scale, shaking well, filtration, discarding the initial filtrate, precision measurement of 5ml of filtrate, placed in a 50ml measuring flask, and diluted to the scale with 60% glacial acetic acid solution, shaking well, precision measurement of 1ml each, respectively, in the first two test tubes, B two test tubes. Add 1ml of new furfural solution into tube A and 1ml of water into tube B as blank, and measure the absorbance according to the method under the preparation of standard curve from "5 minutes in ice bath". Read out the weight of cholic acid in the test solution from the standard curve, calculate and obtain.
本品按干燥品计算，含胆酸（C24H40O5）不得少于80.0%。
This product contains not less than 80.0% of bile acid (C24H40O5) calculated as dried product.
用途 Uses
人工牛黄的原料。
Raw material for artificial bezoar.
贮藏 Storage
密闭保存。
Store in a sealed container
- 胆固醇质量标准 | Cholesterol quality standard
胆固醇 Cholesterol
本品由牛、羊、猪脑经提取、加工制成。
This product is made from the brain of cattle, sheep and pig by extraction and processing.
性状 Description
本品为白色、类白色结晶或结晶性粉末。气微。
This product is white, white-like crystalline or crystalline powder. Gas micro.
熔点 Melting point
本品的熔点不得低于140°C (通则0612) 。
The melting point of the product shall not be less than 140 ° C ( general rule 0612 ).
鉴别 Identification
(1) 取本品10mg, 加三氯甲烧1ml 使溶解， 加硫酸1ml, 三氯甲烧层显血红色，硫酸层显绿色荧光。
( 1 ) Take 10mg of this product, add 1ml of trichloromethane to dissolve, add 1ml of sulfuric acid, the trichloromethane burning layer shows blood red, and the sulfuric acid layer shows green fluorescence.
(2) 取本品约5mg, 加三氯甲烷2ml 使溶解，加醋酐1ml与硫酸1滴， 即显粉红色， 立即成红色后变蓝色直至亮绿色。
( 2 ) Take about 5mg of this product, add 2ml of chloroform to dissolve, add 1ml of acetic anhydride and 1 drop of sulfuric acid, that is, pink, immediately turn red and turn blue until bright green.
检查 Examination
醇溶度 Solubility in alcohol
取本品0.4g, 加乙醇50 ml, 温热使充分溶解，静置2 小时，溶液应澄清并不得有沉淀产生。
Take 0.4 g of this product, add 50 ml of ethanol, warm to fully dissolve, stand for 2 hours, the solution should be clarified and no precipitation should be produced.
酸度 Acidity
取本品约lg, 精密称定，置锥形瓶中，加乙醚10ml使溶解，精密加0. lmol/L 氢氧化钠溶液10ml, 振摇1 分钟，缓缓加热，将乙酰除去，煮沸5 分钟，放冷，加水10ml 与酚酞指示液2 滴， 用硫酸滴定液(0. lmol/L) 滴定至终点，并进行空白试验校正。供试品消耗量与空白试验消耗量之差不得过0. 5ml 。
Take this product about lg, precise weighing, placed in a conical flask, add ether 10ml to dissolve, precise add 0.1mol / L sodium hydroxide solution 10ml, shake for 1 minute, slowly heat, remove acetyl, boil for 5 minutes, cool, add water 10ml and phenolphthalein indicator solution 2 drops, titrate with sulfuric acid titration solution ( 0.lmol / L ) to the end point, and carry out blank test correction. The difference between the consumption of the test sample and the consumption of the blank test should not be more than 0.5ml.
干燥失重 Loss on drying
取本品，在105°C 干燥3 小时，减失重量不得过1. 0% (通则0831) 。
Take this product, dried at 105 ° C for 3 hours, the weight loss should not be more than 1.0 % ( General rule 0831 ).
炽灼残渣 Residue on ignition
取本品1. Og, 依法检查（通则0841），残渣不得过0. 2% 。
Take 1.0g of this product, check according to the law ( general rule 0841 ), the residue shall not exceed 0.2 %.
用途 Uses
人工牛黄的原料。
Raw material for artificial bezoar.
贮藏 Storage
密闭，避光。
Closed, avoid light.
人工牛黄
中文文本参考：《中国药典（2015年版）》
English text reference: Chinese Pharmacopoeia (2015 Edition)
概述 Overview
本品由牛胆粉、胆酸、猪去氧胆酸、牛磺酸、胆红素、胆固醇、微量元素等加工制成。
Artificial Calculus Bovis is prepared from the processed mixture of Ox Gallstone Powder, Cholic Acid, Deoxycholic Acid, Taurine, Bilirubin, Cholesterol, and trace elements.
性状 Description
本品为黄色疏松粉末。味苦，微甘。
It is a yellow, loose powder with a bitter and slightly sweet taste.
鉴别 Identification
（1）取〔含量测定〕胆红素项下的续滤液，照紫外-可见分光光度法（通则0401）测定，在453nm波长处有最大吸收。
(1) Take the filtrate from the determination of bilirubin content, and measure it by ultraviolet-visible spectrophotometry (General Rule 0401). The maximum absorption is at a wavelength of 453nm.
（2）取本品0.1g，置10ml量瓶中，加甲醇适量，超声处理5分钟，加甲醇稀释至刻度，摇匀，静置，取上清液作为供试品溶液。另取胆酸对照品、猪去氧胆酸对照品，加甲醇制成每1ml各含1mg的混合溶液，作为对照品溶液。照薄层色谱法（通则0502）试验，吸取供试品溶液4μl、对照品溶液2μl，分别点于同一硅胶G薄层板上，以正己烷-乙酸乙酯-醋酸-甲醇（20∶25∶2∶3）上层溶液为展开剂，展开，取出，晾干，喷以10%磷钼酸乙醇溶液，在105℃加热至斑点显色清晰。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。
(2) Take 0.1g of the product, place it in a 10ml volumetric flask, add an appropriate amount of methanol, treat it with ultrasound for 5 minutes, dilute it with methanol to the mark, shake it well, let it stand, and take the supernatant as the test solution. Take Cholic Acid reference substance and Deoxycholic Acid reference substance, add methanol to make a mixed solution containing 1mg per 1ml, as the reference solution. Perform thin-layer chromatography (General Rule 0502) test, take 4μl of the test solution and 2μl of the reference solution, spot them separately on the same silica gel G thin-layer plate, use the upper layer solution of n-hexane-acetic ether-acetic acid-methanol (20:25:2:3) as the developing agent, develop, take out, dry, spray with a 10% solution of phosphomolybdic acid in ethanol, heat at 105°C until the spots are clearly visible. In the chromatogram of the test solution, spots of the same color appear at the corresponding positions as in the chromatogram of the reference solution.
（3）取牛胆粉对照药材10mg，加甲醇适量，超声处理使充分溶解，再加甲醇至10ml，摇匀，静置，取上清液作为对照药材溶液。照薄层色谱法（通则0502）试验，吸取〔鉴别〕（2）项下的供试品溶液和上述对照药材溶液各8μl，分别点于同一硅胶G薄层板上，以甲苯-冰醋酸-水（7.5∶10∶0.3）为展开剂，展开，取出，晾干，喷以10%磷钼酸乙醇溶液，在105℃加热至斑点显色清晰。供试品色谱中，在与对照药材色谱相应的位置上，显相同颜色的斑点。
(3) Take 10mg of Ox Gallstone Powder reference material, add an appropriate amount of methanol, treat it with ultrasound to dissolve it sufficiently, then add methanol to 10ml, shake it well, let it stand, and take the supernatant as the reference material solution. Perform thin-layer chromatography (General Rule 0502) test, take 8μl of the test solution under [Identification] (2) and 8μl of the above reference material solution, spot them separately on the same silica gel G thin-layer plate, use toluene-acetic acid-water (7.5:10:0.3) as the developing agent, develop, take out, dry, spray with a 10% solution of phosphomolybdic acid in ethanol, heat at 105°C until the spots are clearly visible. In the chromatogram of the test solution, spots of the same color appear at the corresponding positions as in the chromatogram of the reference material.
（4）取本品50mg，加水5ml，超声处理5分钟，加甲醇至10ml，静置，取上清液作为供试品溶液。另取牛磺酸对照品，加甲醇制成每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2μl，分别点于同一硅胶G薄层板上，以正丁醇-乙醇-冰醋酸-水（4∶1∶2∶1）为展开剂，展开，取出，晾干，在105℃加热10分钟，喷以1%茚三酮乙醇溶液，在105℃加热至斑点显色清晰。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 50mg of the product, add 5ml of water, treat it with ultrasound for 5 minutes, add methanol to 10ml, let it stand, and take the supernatant as the test solution. Take Taurine reference substance, add methanol to make a solution containing 0.5mg per 1ml, as the reference solution. Perform thin-layer chromatography (General Rule 0502) test, take 2μl of each of the above two solutions, spot them separately on the same silica gel G thin-layer plate, use n-butanol-ethanol-acetic acid-water (4:1:2:1) as the developing agent, develop, take out, dry, heat at 105°C for 10 minutes, spray with a 1% solution of ninhydrin in ethanol, heat at 105°C until the spots are clearly visible. In the chromatogram of the test solution, spots of the same color appear at the corresponding positions as in the chromatogram of the reference solution.
检查 Examination
水分 Water
不得过5.0%（通则0832第二法）。
Not more than 5.0 per cent <0832,method 2>.
含量测定 Content determination
胆酸 Cholic acid
对照品溶液的制备 Preparation of reference solution
取胆酸对照品12.5mg，精密称定，置25ml量瓶中，加60%冰醋酸溶液使溶解，并稀释至刻度，摇匀，即得（每1ml中含胆酸0.5mg）。
Take 12.5mg of cholic acid control product, weigh it precisely, put it in 25ml measuring flask, add 60% glacial acetic acid solution to make it dissolve, and dilute it to the scale, shake it well, that is to say, it is obtained (0.5mg of cholic acid in every 1ml).
标准曲线的制备 Preparation of standard curve
精密量取对照品溶液0.2ml、0.4ml、0.6ml、0.8ml、lml，分别置具塞试管中，各管加入60%冰醋酸溶液稀释成1.0ml，再分别加新制的糠醛溶液（1→100）1.0ml，摇匀，在冰浴中放置5分钟，精密加入硫酸溶液（取硫酸50ml与水65ml混合）13ml，混匀，在70℃水浴中加热10分钟，迅速移至冰浴中，放置2分钟，以相应的试剂为空白，照紫外-可见分光光度法（通则0401），在605nm波长处测定吸光度，以吸光度为纵坐标，浓度为横坐标，绘制标准曲线。
Precision measurement of the control solution 0.2ml, 0.4ml, 0.6ml, 0.8ml, lml, respectively, placed in a stoppered test tube, each tube add 60% glacial acetic acid solution diluted to 1.0ml, and then add a new furfural solution (1 → 100) 1.0ml, shaking well, placed in an ice bath for 5 minutes, precision add sulfuric acid solution (take 50ml of sulfuric acid mixed with 65ml of water) 13ml, mix well, heat in 70℃ water bath for 10 minutes, quickly move to the ice bath, placed in 2 minutes, with the corresponding reagent as a blank, according to the UV-visible spectrophotometric method (General rule 0401), the absorbance at 605nm wavelength, absorbance as the vertical coordinate, the concentration as the horizontal coordinate, plotting the standard curve.
测定法 Determination method
取本品约0.1g，精密称定，置50ml量瓶中，加 60%冰醋酸溶液适量，超声处理5分钟，用60%冰醋酸溶液稀释至刻度，摇匀，滤过，弃去初滤液，精密量取续滤液各1ml，分别置甲、乙两个具塞试管中，于甲管中加新制的糠醛溶液1ml，乙管中加水1ml作空白，照标准曲线制备项下的方法，自“在冰浴中放置5分钟”起，依法测定吸光度，从标准曲线上读出供试品溶液中含胆酸的重量，计算，即得。
Take about 0.1g of this product, weigh it precisely, put it in a 50ml measuring flask, add 60% glacial acetic acid solution, ultrasonic treatment for 5 minutes, dilute it with 60% glacial acetic acid solution to the scale, shake it well, filtrate, discard the initial filtrate, measure 1ml of each of the filtrate, put it into two stoppered tubes of A and B, add 1ml of newly-made furfural solution into the tube of A, add 1ml of water in the tube of B as a blank, and then analyse it according to the method under preparation, from "placing in ice bath for 5 minutes" onwards, determine the absorbance according to law, read out the weight of the test solution containing cholic acid from the standard curve, and calculate it, it is obtained. According to the method under the standard curve, from "placed in an ice bath for 5 minutes", according to the law to determine the absorbance, from the standard curve read out the weight of cholic acid in the test solution, calculation, that is obtained.
本品按干燥品计算，含胆酸（C24H40O5）不得少于13.0%。
This product contains not less than 13.0% of bile acid (C24H40O5) calculated as dried product.
胆红素 Bilirubin
对照品溶液的制备 Preparation of reference solution
取胆红素对照品10mg，精密称定，置100ml棕色量瓶中，加三氯甲烷80ml，超声处理使充分溶解，加三氯甲烷稀释至刻度，摇匀。精密量取10ml，置 50ml棕色量瓶中，用三氯甲烷稀释至刻度，摇匀，即得（每 1ml中含胆红素20μg）。
Take 10mg of bilirubin control, weigh it precisely, put it into 100ml brown measuring flask, add 80ml of trichloromethane, sonicate to make it fully dissolved, dilute it with trichloromethane to the scale, shake well. Precision measurement of 10ml, placed in 50ml brown measuring flask, diluted with trichloromethane to the scale, shaking well, that is to obtain (each 1ml contains bilirubin 20μg).
标准曲线的制备 Preparation of standard curve
精密量取对照品溶液4ml、5ml、 6ml、7ml、8ml，分别置25ml棕色量瓶中，用三氯甲烷稀释至刻度，摇匀，照紫外-可见分光光度法（通则0401），在 453nm处测定吸光度，以吸光度为纵坐标，浓度为横坐标，绘制标准曲线。
Measure 4 ml, 5 ml, 6 ml, 7 ml, 8 ml of the control solution in a 25 ml brown measuring flask, dilute with trichloromethane to the scale, shake well, and then measure the absorbance at 453 nm according to the UV-visible spectrophotometric method (General rule 0401), take the absorbance as the vertical coordinate and the concentration as the horizontal coordinate, and then draw the standard curve.
测定法 Determination method
取本品约80mg，精密称定，置100ml棕色量瓶中，加三氯甲烷80ml超声处理使充分溶解，用三氯甲烷稀释至刻度，摇匀，滤过，弃去初滤液，取续滤液，在453nm波长处测定吸光度，从标准曲线上读出供试品溶液中含胆红素的重 量，计算，即得。
Take about 80mg of this product, weigh it precisely, put it in a 100ml brown measuring flask, add 80ml of trichloromethane and ultrasonic treatment to make it fully dissolved, dilute it to the scale with trichloromethane, shake it well, filter it, discard the initial filtrate, take the filtrate, determine the absorbance at 453nm, and then read out the weight of the bilirubin in the test solution from the standard curve, and then calculate it, that is, it is obtained.
本品按干燥品计算，含胆红素（C33H36N4O6）不得少于 0.63%。
This product contains not less than 0.63% of bilirubin (C33H36N4O6) calculated as dry product.
性 Property
凉。
Cold.
味 Flavor
甘。
Sweet.
归经 Meridian tropism
归心、肝经。
Heart and liver meridians.
功能 Actions
清热解毒，化痰定惊。
To clear heat and detoxify, resolve phlegm, and calm convulsions.
主治 Indications
用于痰热谵狂，神昏不语，小儿急惊风，咽喉肿痛，口舌生疮，痈肿疔疮。
Used for phlegm-heat mania, coma with incoherent speech, infantile convulsions, sore throat, mouth and tongue sores, carbuncles and furuncles.
用量 Dosage
一次0.15～0.35g。
0.15-0.35g per dose.
用法 Administration
多作配方用。外用适量敷患处。
Often used in formulas. For external use, apply an appropriate amount to the affected area.
注意 Precautions
孕妇慎用。
Caution for pregnant women.
贮藏 Storage
密封，防潮，避光，置阴凉处。
Seal, moisture-proof, avoid light, store in a cool place.
附：1 .胆红素质量标准 | Bilirubin quality standard
胆红素 Bilirubin
本品由猪（或牛）胆汁经提取、加工制成。
This product is made from pig ( or cow ) bile by extraction and processing.
性状 Description
本品为橙色至红棕色结晶性粉末。
This product is an orange to reddish-brown crystalline powder.
鉴别 Identification
（1）取〔含量测定〕项下溶液，照紫外-可见分光光度法（通则0401），在400～500nm 波长处，测定吸收曲线，并与胆红素对照品图谱比较，应一致。其最大吸收为453nm。
(1) Take the solution under [Content Determination], according to the UV-visible spectrophotometric method (General rule 0401), in the wavelength of 400-500nm, determine the absorption curve, and compare with the spectrum of bilirubin control product, it should be consistent. The maximum absorption is 453nm.
（2）取本品，加三氯甲烷制成每1ml含0.1mg的溶液，作为供试品溶液。另取胆红素对照品，同法制成对照品溶液。 照薄层色谱法（通则0502）试验，吸取上述两种溶液各10μl， 分别点于同一硅胶G薄层板上，以甲苯-乙酸乙酯-冰醋酸 （10∶1∶0.5）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。
(2) Take this product, add trichloromethane to make a solution containing 0.1mg per 1ml, as the test solution. Take bilirubin control product, the same method into the control solution. According to the thin layer chromatography (General rule 0502) test, absorb the above two solutions of 10μl, respectively, point in the same silica gel G thin layer plate, with toluene - ethyl acetate - glacial acetic acid (10:1:0.5) as the unfolding agent, unfolding, take out, and dry. In the chromatogram of the test article, spots of the same colour are shown on the corresponding positions of the chromatogram of the control article.
检查 Examination
干燥失重 Loss on drying
取本品约0.5g，在五氧化二磷60℃ 减压干燥4小时，减失重量不得过2.0%（通则0831）。
About 0.5g of this product was taken and dried at 60 °C for 4 hours under reduced pressure with phosphorus pentoxide, and the weight loss should not exceed 2.0 % ( General rule 0831 ).
含量测定 Content determination
取本品约10mg，精密称定，用少量三氯甲烷研磨后转移至100ml棕色量瓶中，超声处理使溶解，取出，迅速放冷，再加三氯甲烷稀释至刻度，摇匀。精密量取5ml， 置100ml棕色量瓶中，加三氯甲烷稀释至刻度，摇匀。照紫外-可见分光光度法（通则0401），在453nm的波长处测定吸光度，按胆红素的吸收系数（）1038计算，即得。
Take about 10mg of this product, precision weighing, with a small amount of trichloromethane grinding transferred to 100ml brown measuring flask, ultrasonic treatment to dissolve, remove, quickly cooled, then add trichloromethane diluted to the scale, shaking. Measure 5ml precisely, put it in 100ml brown measuring flask, add trichloromethane and dilute to the scale, shake well. According to the UV-visible spectrophotometric method (General rule 0401), determine the absorbance at 453nm, according to the absorption coefficient of bilirubin () 1038 calculation, that is obtained.
本品按干燥品计算，含胆红素（C33H36N4O6）不得少于 90.0%。
This product contains not less than 90.0% of bilirubin (C33H36N4O6) calculated as dry product.
用途 Uses
人工牛黄的原料。
Raw material for artificial bezoar.
贮藏 Storage
密闭，防潮，避光。
Seal, moisture-proof, avoid light.
2.猪去氧胆酸质量标准 | Deoxycholic acid quality standard
猪去氧胆酸 Deoxycholic acid
本品由猪胆汁经提取、加工制成。
This product is made from pig bile by extraction and processing.
本品为3α,6α－二羟基-5β -胆烷酸。
This product is 3α, 6α-dihydroxy-5β-cholanic acid.
性状 Description
本品为白色或类白色的粉末。气微，味微苦。
This product is a white or off-white powder. Slightly odorous, slightly bitter taste.
本品在乙醇中易溶，在丙酮中微溶，在乙酸乙酯、三氯甲烷或乙醚中极微溶解，在水中几乎不溶。
This product is easily soluble in ethanol, slightly soluble in acetone, extremely slightly soluble in ethyl acetate, chloroform or ether, and almost insoluble in water.
熔点 Melting point
本品的熔点不得低于l170°C (通则0612），熔融时同时分解。
The melting point of this product should not be lower than l170 ° C ( general rule 0612 ), and it should be decomposed at the same time.
鉴别 Identification
取本品约5mg，加60%冰醋酸溶液2ml溶解，加新制的1%糠醛溶液2ml，混匀，将此溶液分成2份，分别置甲、乙两管中，甲管中加硫酸溶液（7→10）10ml，乙管中加硫酸溶液（4→10）10ml，将甲、乙两管置70℃水浴中保温数分钟，甲管应显红色渐变紫红色，乙管应不显色。
Take about 5mg of this product, add 2ml of 60 % glacial acetic acid solution to dissolve, add 2ml of newly prepared 1 % furfural solution, mix well, divide this solution into 2 parts, and place it in tubes A and B respectively. Add 10ml of sulfuric acid solution ( 7 → 10 ) to tube A, add 10ml of sulfuric acid solution ( 4 → 10 ) to tube B, and place tubes A and B in a 70 ° C water bath for several minutes.
检查 Examination
醇溶度 Solubility in alcohol
取本品0.5g，加乙醇50ml，置60℃水浴上温热使溶解，于20～25℃静置1小时，溶液应澄清并不得有明显沉淀。
Take 0.5g of this product, add 50ml of ethanol, place it in a 60 °C water bath to dissolve it, and stand at 20-25 °C for 1 hour. The solution should be clarified and there should be no obvious precipitation.
干燥失重 Loss on drying
取本品，在105℃干燥至恒重，减失重量不得过 1.0%（通则 0831）。
The product was dried to constant weight at 105 °C, and the weight loss should not exceed 1.0 % ( General rule 0831 ).
炽灼残渣 Residue on ignition
不得过0.2%（通则0841）。
Not more than 0.2 % ( general rule 0841 ).
用途 Uses
人工牛黄的原料。
Raw material for artificial bezoar.
贮藏 Storage
密闭保存。
Store in a sealed container.
3.牛胆粉质量标准 | Ox gall powder quality standard
牛胆粉 Ox gall powder
本品由牛胆汁加工制成。
This product is made from bovine bile.
性状 Description
本品为黄棕色至黄褐色的粉末。味苦，有吸湿性。
This product is a yellow-brown to yellowish-brown powder. Bitter taste, hygroscopic.
鉴别 Identification
取本品50mg，加甲醇10ml，超声处理使充分溶解，静置使澄清，取上清液作为供试品溶液。另取牛胆粉对照药材50mg，同法制成对照药材溶液。照薄层色谱法（通则 0502）试验，吸取上述两种溶液各4μl，分别点于同一硅胶G薄层板上，以甲苯-冰醋酸-水（7.5∶10∶0.3）为展开剂，展开，取出，晾干，喷以10%磷钼酸乙醇溶液，在105℃加热约 5分钟。供试品色谱中，在与对照药材色谱相应的位置上，显相同颜色的斑点。
Take 50 mg of this product, add 10 ml of methanol, ultrasonic treatment to fully dissolve, stand still to clarify, and take the supernatant as the test solution. In addition, 50 mg of bovine bile powder was taken as the control medicinal material, and the control medicinal material solution was prepared by the same method. According to the test of thin layer chromatography ( general rule 0502 ), 4 μl of the above two solutions were taken and point on the same silica gel G thin layer plate, respectively. Toluene-glacial acetic acid-water ( 7.5 ∶ 10 ∶ 0.3 ) was used as the developing agent, unfolded, removed, dried, sprayed with 10 % phosphomolybdic acid ethanol solution, and heated at 105 °C for about 5 minutes. In the chromatogram of the test sample, the spots of the same color appeared at the corresponding position of the chromatogram of the control medicinal material.
检查 Examination
水分 Water
不得过5.0%（通则0832第二法）。
Not more than 5.0 per cent <0832,method 2>.
猪胆粉 Pig gall powder
取本品0.1g，加甲醇10ml，超声处理使溶解，滤过，滤液置水浴上蒸至近干，用2. 5mol/L氢氧化钠溶液5ml 分次溶解，并转入具塞试管中，置水浴上水解5小时后，取出，放冷，滴加盐酸调节pH值至2～3，用乙酸乙酯提取3次，每次10ml，合并乙酸乙酯液浓缩至干，残渣加甲醇1ml使溶解， 作为供试品溶液。另取猪去氧胆酸对照品，加甲醇制成每 1ml含lmg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2μl，分别点于同一硅胶G 薄层板上，以异辛烷-正丁醚-冰醋酸（8∶5∶5）为展开剂，展开，取出，晾干，喷以10%磷钼酸乙醇溶液，在105℃加热至斑点显色清晰。供试品色谱中，在与对照品色谱相应的位置上，不得显相同颜色的斑点。
Take 0.1g of this product, add methanol 10ml, ultrasonic treatment to dissolve, filtration, filtrate in a water bath to steam until nearly dry, with 2.5mol / L sodium hydroxide solution 5ml dissolved in batches, and transferred to a stoppered test tube, placed in a water bath hydrolysis for 5 hours, take out, let it cool, add hydrochloric acid dropwise to adjust the pH value to 2 ~ 3, extracted with ethyl acetate for 3 times, each time 10 ml, and combined with the ethyl acetate solution concentrated to dryness, as a test solution. Add 1ml of methanol to the residue to dissolve, as the test solution. Take porcine deoxycholic acid control product, add methanol to make a solution containing lmg per 1ml, as a control solution. According to thin-layer chromatography (General rule 0502) test, absorb the above two solutions of 2μl, were spotted on the same silica gel G thin-layer plate, iso-octane - n-butyl ether - glacial acetic acid (8:5:5) as an unfolding agent, unfolding, remove, drying, sprayed with 10% phosphomolybdic acid ethanol solution, heated to 105 ℃ until the spots show clear colour. In the chromatogram of the test article, in the corresponding position with the chromatogram of the control article, the spots of the same colour shall not be shown.
含量测定 Content determination
对照品溶液的制备 Preparation of reference solution
取胆酸对照品 12.5mg，精密称定，置25ml量瓶中，加60%冰醋酸溶液使溶解，并稀释至刻度，摇匀，即得（每lml中含胆酸0.5mg）。
Take 12.5mg of cholic acid reference substance, precise weighing, place it in a 25ml volumetric flask, add 60 % glacial acetic acid solution to dissolve it, and dilute it to the scale, shake well, and obtain ( 0.5mg of cholic acid per ml ).
标准曲线的制备 Preparation of standard curve
精密量取对照品溶液0.2ml、0.4ml、 0.6ml、0.8ml、lml，分别置具塞试管中，各管加入60%冰醋酸溶液稀释成1.0ml，再分别加入新制的糠醛溶液（1→100）1.0ml，摇匀，在冰浴中放置5分钟，精密加入硫酸溶液（取硫酸50ml与水65ml混合）13ml，混匀，在70℃水浴中加热 10分钟，迅速移至冰浴中，放置2分钟，以相应的试剂为空白。 照紫外-可见分光光度法（通则0401），在605nm的波长处测定吸光度，以吸光度为纵坐标，浓度为横坐标，绘制标准曲线。
Precisely measure the reference solution 0.2ml, 0.4ml, 0.6ml, 0.8ml, lml, respectively, in the test tube, each tube was added with 60 % glacial acetic acid solution diluted to 1.0ml, and then added to the new furfural solution ( 1 → 100 ) 1.0ml, shaken well, placed in an ice bath for 5 minutes, precisely added sulfuric acid solution ( 50ml of sulfuric acid mixed with 65ml of water ) 13ml, mixed well, heated in a 70 °C water bath for 10 minutes, quickly moved to the ice bath, placed for 2 minutes, with the corresponding reagent as a blank. The absorbance was measured at a wavelength of 605 nm by ultraviolet-visible spectrophotometry ( general rule 0401 ). The standard curve was drawn with absorbance as the ordinate and concentration as the abscissa.
测定法 Determination method
取本品约0.15g，精密称定，置50ml量瓶中，加 60%冰醋酸溶液适量，超声处理使溶解，取出，放冷，加60% 冰醋酸溶液稀释至刻度，摇匀，滤过，弃去初滤液，精密量取续 滤液5ml，置50ml量瓶中，并用60%冰醋酸溶液稀释至刻度，摇匀，精密量取各1ml，分别置甲、乙两个试管中。于甲管中加新制的糠醛溶液1ml，乙管中加水1ml作空白，照标准曲线 的制备项下的方法，自“在冰浴中放置5分钟”起，依法测定吸 光度。从标准曲线上读出供试品溶液中含胆酸的重量，计算，即得。
Take about 0.15g of this product, accurately weighed, placed in a 50ml volumetric flask, added with an appropriate amount of 60 % glacial acetic acid solution, dissolved by ultrasonic treatment, taken out, cooled, diluted with 60 % glacial acetic acid solution to the scale, shaken well, filtered, discarded the initial filtrate, accurately measured the subsequent filtrate 5ml, placed in a 50ml volumetric flask, diluted with 60 % glacial acetic acid solution to the scale, shaken well, accurately measured each 1ml, and placed in two test tubes A and B, respectively. The new furfural solution 1ml was added to the tube A, and 1ml water was added to the tube B as a blank. According to the method under the preparation of the standard curve, the absorbance was measured according to the law from ' placed in the ice bath for 5 minutes '. The weight of cholic acid in the test solution was read from the standard curve and calculated.
本品按干燥品计算，含胆酸（C24H40O5）不得少于42.0%。
The content of cholic acid ( C24H40O5 ) should not be less than 42.0 %.
用途 Uses
人工牛黄的原料。
Raw material for artificial bezoar.
贮藏 Storage
置阴凉干燥处，避光，密封保存，防潮。
Place in a cool and dry place, avoid light, sealed, moistureproof.
4.胆酸质量标准 | Cholic acid quality standard
胆酸 Cholic acid
本品由牛、羊胆汁或胆膏经提取、加工制成。
This product is made from cow or sheep bile or bile paste by extraction and processing.
性状 Description
本品为白色或类白色的粉末。气微，味苦。
This product is a white or off-white powder. Slightly odorous, slightly bitter taste.
鉴别 Identification
取本品0.1mg，加60%冰醋酸溶液2ml，超声处理10分钟使溶解，滤过，取滤液1ml，置试管中，加新制的糠醛溶液（1→100）lml与硫酸溶液（取硫酸50ml与水65ml混合）13ml，在70℃水浴中加热，溶液应呈蓝紫色。
Take 0.1mg of this product, add 2ml of 60 % glacial acetic acid solution, ultrasonic treatment for 10 minutes to dissolve, filter, take 1ml of the filtrate, place in the test tube, add new furfural solution ( 1 → 100 ) lml and sulfuric acid solution ( take sulfuric acid 50ml and water 65ml mixed ) 13ml, heated in a water bath at 70 °C, the solution should be blue-purple.
检查 Examination
醇溶度 Solubility in alcohol
取本品0.5g，加乙醇50ml，于60℃加热并超声处理使充分溶解，于20～25℃静置1小时，溶液应澄清并不得有明显沉淀。
Take 0.5g of this product, add 50ml of ethanol, heat at 60 °C and ultrasonic treatment to fully dissolve, and stand at 20 ~ 25 °C for 1 hour. The solution should be clarified and there should be no obvious precipitation.
干燥失重 Loss on drying
取本品，在105℃干燥2小时，减失重量不得过 1.0%（通则 0831）。
Take this product, dried at 105 °C for 2 hours, the weight loss should not be more than 1.0 % ( General rule 0831 ).
炽灼残渣 Residue on ignition
不得过0.3%（通则0841）。
Not more than 0.3 % ( general rule 0841 ).
含量测定 Content determination
对照品溶液的制备 Preparation of reference solution
取胆酸对照品 12.5mg，精密称定，置25ml量瓶中，加60%冰醋酸溶液使溶解，并稀释至刻度，摇匀，即得（每lml中含胆酸0.5mg）。
Take 12.5mg of cholic acid control product, weigh it precisely, put it in 25ml measuring flask, add 60% glacial acetic acid solution to make it dissolve, and dilute it to the scale, shake it well, that is to say, it is obtained (0.5mg of cholic acid in each lml).
标准曲线的制备 Preparation of standard curve
精密量取对照品溶液0.2ml、0.4ml、 0.6ml、0.8ml、lml，分别置具塞试管中，各管加入60%冰醋酸溶液稀释成1.0ml，再分别加入新制的糠醛溶液（1→100）1.0ml，摇匀，在冰浴中放置5分钟，精密加入硫酸溶液（取硫酸50ml与水65ml混合）13ml，混匀，在70℃水浴中加热10分钟，迅速移至冰浴中，放置2分钟，以相应的试剂为空白。 照紫外-可见分光光度法（通则0401），在605nm的波长处测定吸光度，以吸光度为纵坐标，浓度为横坐标，绘制标准曲线。
Precisely measure the control solution 0.2ml, 0.4ml, 0.6ml, 0.8ml, lml, respectively, placed in a stoppered test tube, each tube was added 60% glacial acetic acid solution diluted to 1.0ml, and then added freshly made furfural solution (1→100) 1.0ml, shaking well, and placed in an ice bath for 5 minutes, precise addition of sulphuric acid solution (take 50 ml of sulphuric acid mixed with 65 ml of water) 13ml, mix well, heat in 70 ℃ water bath for 10 minutes, quickly moved to the ice bath, placed in 2 minutes, with the corresponding reagent as a blank. According to the UV-visible spectrophotometric method (General rule 0401), the absorbance was measured at 605nm, and the standard curve was drawn with the absorbance as the vertical coordinate and the concentration as the horizontal coordinate.
测定法 Determination method
取本品约0.15g，精密称定，置50ml量瓶中，加 60%冰醋酸溶液适量，超声处理使溶解，取出，放冷，加60% 冰醋酸溶液稀释至刻度，摇匀，滤过，弃去初滤液，精密量取续 滤液5ml，置50ml量瓶中，并用60%冰醋酸溶液稀释至刻度，摇匀，精密量取各1ml，分别置甲、乙两个试管中。于甲管中加新制的糠醛溶液1ml，乙管中加水1ml作空白，照标准曲线 的制备项下的方法，自“在冰浴中放置5分钟”起，依法测定吸 光度。从标准曲线上读出供试品溶液中含胆酸的重量，计算，即得。
Take about 0.15g of this product, weighed precisely, placed in a 50ml measuring flask, add 60% glacial acetic acid solution, ultrasonic treatment to dissolve, remove, cool, add 60% glacial acetic acid solution diluted to the scale, shaking well, filtration, discarding the initial filtrate, precision measurement of 5ml of filtrate, placed in a 50ml measuring flask, and diluted to the scale with 60% glacial acetic acid solution, shaking well, precision measurement of 1ml each, respectively, in the first two test tubes, B two test tubes. Add 1ml of new furfural solution into tube A and 1ml of water into tube B as blank, and measure the absorbance according to the method under the preparation of standard curve from "5 minutes in ice bath". Read out the weight of cholic acid in the test solution from the standard curve, calculate and obtain.
本品按干燥品计算，含胆酸（C24H40O5）不得少于80.0%。
This product contains not less than 80.0% of bile acid (C24H40O5) calculated as dried product.
用途 Uses
人工牛黄的原料。
Raw material for artificial bezoar.
贮藏 Storage
密闭保存。
Store in a sealed container
- 胆固醇质量标准 | Cholesterol quality standard
胆固醇 Cholesterol
本品由牛、羊、猪脑经提取、加工制成。
This product is made from the brain of cattle, sheep and pig by extraction and processing.
性状 Description
本品为白色、类白色结晶或结晶性粉末。气微。
This product is white, white-like crystalline or crystalline powder. Gas micro.
熔点 Melting point
本品的熔点不得低于140°C (通则0612) 。
The melting point of the product shall not be less than 140 ° C ( general rule 0612 ).
鉴别 Identification
(1) 取本品10mg, 加三氯甲烧1ml 使溶解， 加硫酸1ml, 三氯甲烧层显血红色，硫酸层显绿色荧光。
( 1 ) Take 10mg of this product, add 1ml of trichloromethane to dissolve, add 1ml of sulfuric acid, the trichloromethane burning layer shows blood red, and the sulfuric acid layer shows green fluorescence.
(2) 取本品约5mg, 加三氯甲烷2ml 使溶解，加醋酐1ml与硫酸1滴， 即显粉红色， 立即成红色后变蓝色直至亮绿色。
( 2 ) Take about 5mg of this product, add 2ml of chloroform to dissolve, add 1ml of acetic anhydride and 1 drop of sulfuric acid, that is, pink, immediately turn red and turn blue until bright green.
检查 Examination
醇溶度 Solubility in alcohol
取本品0.4g, 加乙醇50 ml, 温热使充分溶解，静置2 小时，溶液应澄清并不得有沉淀产生。
Take 0.4 g of this product, add 50 ml of ethanol, warm to fully dissolve, stand for 2 hours, the solution should be clarified and no precipitation should be produced.
酸度 Acidity
取本品约lg, 精密称定，置锥形瓶中，加乙醚10ml使溶解，精密加0. lmol/L 氢氧化钠溶液10ml, 振摇1 分钟，缓缓加热，将乙酰除去，煮沸5 分钟，放冷，加水10ml 与酚酞指示液2 滴， 用硫酸滴定液(0. lmol/L) 滴定至终点，并进行空白试验校正。供试品消耗量与空白试验消耗量之差不得过0. 5ml 。
Take this product about lg, precise weighing, placed in a conical flask, add ether 10ml to dissolve, precise add 0.1mol / L sodium hydroxide solution 10ml, shake for 1 minute, slowly heat, remove acetyl, boil for 5 minutes, cool, add water 10ml and phenolphthalein indicator solution 2 drops, titrate with sulfuric acid titration solution ( 0.lmol / L ) to the end point, and carry out blank test correction. The difference between the consumption of the test sample and the consumption of the blank test should not be more than 0.5ml.
干燥失重 Loss on drying
取本品，在105°C 干燥3 小时，减失重量不得过1. 0% (通则0831) 。
Take this product, dried at 105 ° C for 3 hours, the weight loss should not be more than 1.0 % ( General rule 0831 ).
炽灼残渣 Residue on ignition
取本品1. Og, 依法检查（通则0841），残渣不得过0. 2% 。
Take 1.0g of this product, check according to the law ( general rule 0841 ), the residue shall not exceed 0.2 %.
用途 Uses
人工牛黄的原料。
Raw material for artificial bezoar.
贮藏 Storage
密闭，避光。
Closed, avoid light.
本天然药材由牛胆粉、胆酸、猪去氧胆酸、牛磺酸、胆红素、胆固 醇、微量元素等加工制成。
This product is made from processed materials such as cow bile powder, bile acid, pig deoxycholic acid, taurine, bilirubin, cholesterol, and trace elements.