猪胆粉

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

Overview 概述

Pig Bile Powder is the dried bile of Sus scrofa domestica Brisson (Fam. Suidae).
本品为猪科动物猪Sus scrofa domestica Brisson.胆汁的干燥品。

Processing 制法

The bile is collected from pigs, filtered, dried, and powdered.
取猪胆汁，滤过，干燥，粉碎，即得。

Description 性状

Pig Bile Powder is yellow or grayish-yellow powder. It has a slight fishy odor, a bitter taste, and is hygroscopic.
本品为黄色或灰黄色粉末。气微腥，味苦，易吸潮。

Identification 鉴别

Take 0.1g of the fine powder, add 5ml of 10% sodium hydroxide solution, heat at 120°C for 4 hours, cool, adjust the pH value to 2-3 by adding hydrochloric acid, shake well. Extract with four 10ml portions of ethyl acetate, combine the extracts, evaporate to dryness. Dissolve the residue in 10ml of ethanol as the test solution. Take an appropriate amount of deoxycholic acid CRS, dissolve in ethanol to produce a solution containing 1mg per ml as the Reference solution. Carry out the method for thin layer chromatography<0502>, using the upper layer solution of a newly prepared mixture of isooctane, ether, glacial acetic acid, n-butanol, and water (10:5:5:3:1) as the coating substance and a mixture of petroleum ether(60-90°C)and ether(4:5)as the mobile phase. Apply separately to the plate 2μl 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 daylight and ultraviolet light at 365nm. The spots or 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.
取本品细粉0.1g，加10%氢氧化钠溶液5ml，120℃加热4小时，放冷，滴加盐酸调节pH值至2～3，摇匀。用乙酸乙酯振摇提取4次，每次10ml，合并提取液，蒸干，残渣加乙醇10ml使溶解，作为供试品溶液。另取猪去氧胆酸对照品适量，加乙醇制成每1ml含1mg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，以新配制的异辛烷-乙醚-冰醋酸-正丁醇-水（10︰5︰5︰3︰1）的上层溶液为展开剂，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，分别置日光和紫外光灯（365nm）下检视。供试品色谱中，在与对照品色谱相应的位置上，显相同颜色的斑点或荧光斑点。

Examination 检查

Ox Bile, Sheep Bile 牛胆、羊胆

Take 0.1g each of Ox Bile and Sheep Bile, prepare the test solutions according to the method described under "Identification" from the step of "add 5ml of 10% sodium hydroxide solution", and prepare the reference solutions of the corresponding medicinal materials in the same way. Carry out the method for thin layer chromatography<0502>, using the same procedure as described under "Identification". The spots in the chromatogram obtained with the test solution should not correspond in position and colour to the spots in the chromatogram obtained with the reference solutions of Ox Bile and Sheep Bile.
取牛胆、羊胆对照药材各0.1g，按〔鉴别〕项下的供试品溶液制备方法，自“加10%氢氧化钠溶液5ml”起，同法分别制成对照药材溶液。照薄层色谱法（通则0502）试验，吸取〔鉴别〕项下的供试品溶液和上述对照药材溶液各2μl，分别点于同一硅胶G薄层板上，同上述〔鉴别〕项下方法展开，显色。供试品色谱中，不得显与牛胆、羊胆对照药材相同的斑点。

Reducing sugars 还原糖

Take 10mg of the powder, dissolve in 2ml of water, add a few drops of α-naphthol ethanol solution (1→50), shake well, add about 0.5ml of sulfuric acid slowly along the tube wall, the interface of the two liquids should not show a purple-red ring.
取本品10mg，加水2ml使溶解，滴加α-萘酚乙醇溶液（1→50）数滴，摇匀，沿管壁缓缓加入硫酸约0.5ml，两液接界面不得显紫红色环。

Foreign organic matter 异性有机物

Take 10mg of the powder, dissolve in 2ml of water, centrifuge or filter, take the insoluble matter, observe under a microscope, there should be no plant tissue, animal tissue, or starch.
取本品10mg，加水2ml使溶解，离心或滤过，取不溶物，置显微镜下观察，不得有植物组织、动物组织或淀粉等。

Water 水分

Take about 0.3g of the powder, accurately weigh, carry out the determination of water content according to the method for water determination<0832, method 3>, the water content should not be more than 10.0%.
取本品约0.3g，精密称定，照水分测定法（通则0832第三法）测定，不得过10.0%。

Assay 含量测定

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

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

Use octadecylsilane bonded silica gel as the filler (column length 250mm; inner diameter 4.6mm); use a mixture of methanol and 0.03mol/L sodium dihydrogen phosphate solution (70:30) as the mobile phase (adjust the pH value to 4.4 with phosphoric acid); detect at a wavelength of 200nm. The theoretical plate number calculated from the peak of tauroursodeoxycholic acid should not be less than 3000.
以十八烷基硅烷键合硅胶为填充剂（色谱柱长为250mm；内径为4.6mm）；以甲醇-0.03mol/L磷酸二氢钠溶液（70︰30）为流动相（用磷酸调节pH值为4.4）；检测波长为200nm。理论板数按牛磺猪去氧胆酸峰计算应不低于3000。

Preparation of reference solution 对照品溶液的制备

Take an appropriate amount of tauroursodeoxycholic acid CRS, accurately weigh, dissolve in methanol to produce a solution containing 0.5mg per ml, and set aside.
取牛磺猪去氧胆酸对照品适量，精密称定，加甲醇制成每1ml含0.5mg的溶液，即得。

Preparation of test solution 供试品溶液的制备

Take about 0.5g of the powder, accurately weigh, place it in a 50ml volumetric flask, add 20ml of methanol, ultrasonicate (power 500W, frequency 40kHz) for 20 minutes, cool, add methanol to the mark, shake well, filter, and take the filtrate.
取本品粉末约0.5g，精密称定，置50ml量瓶中，加入甲醇20ml，超声处理（功率500W，频率40kHz）20分钟，放冷，加甲醇至刻度，摇匀，滤过，取续滤液，即得。

Assay method 测定法

Accurately aspirate 20μl each of the reference solution and the test solution, inject into the liquid chromatograph, and determine the content.
分别精密吸取对照品溶液与供试品溶液各20μl，注入液相色谱仪，测定，即得。

Calculate the content of tauroursodeoxycholic acid (C26H45O6NS) in the dried powder, which should not be less than 2.0%.
本品按干燥品计算，含牛磺猪去氧胆酸（C26H45O6NS）不得少于2.0%。

Property 性

Cold.
寒。

Flavor 味

Bitter.
苦。

Meridian tropism 归经

Liver, gallbladder, lung, and large intestine meridians.
归肝、胆、肺、大肠经。

Actions 功能

It clears heat and moistens dryness, stops coughing and relieves asthma, and detoxifies.
清热润燥，止咳平喘，解毒。

Indications 主治

It is used for cough, asthma, fever with thirst, red eyes, sore throat, jaundice, diarrhea, dysentery, constipation, and boils and swelling.
用于顿咳，哮喘，热病燥渴，目赤，喉痹，黄疸，泄泻，痢疾，便秘，痈疮肿毒。

Dosage 用量

0.3-0.6g. For external use, use an appropriate amount.
0.3～0.6g。外用适量。

Administration 用法

Taken orally or made into pills or powder. Grind into powder or mix with water and apply to the affected area.
冲服或入丸散。研末或水调涂敷患处。

Storage 贮藏

Store in a sealed container, protected from light, in a cool and dry place.
密封，避光，置阴凉干燥处。

猪胆粉

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

Overview 概述

Pig Gall Powder is the dried bile of Sus scrofa domestica Brisson (Fam. Suidae).
本品为猪科动物猪Sus scrofa domestica Brisson.胆汁的干燥品。

Processing 制法

Take pig bile, filter, dry and pulverize.
取猪胆汁，滤过，干燥，粉碎，即得。

Description 性状

Yellow, greyish-yellow powder. Odour, slightly stinking. Taste, bitter, easily moistened.
本品为黄色或灰黄色粉末。气微腥，味苦，易吸潮。

Identification 鉴别

To 0.1 g of the fine powder, add 5 ml of 10% sodium hydroxide solution, heat at 120℃ for 4 hours, and cool. Adjust to pH 2-3 with hydrochloride acid, mix well. Extract by shaking with four 10-ml quantities of ethyl acetate, evaporate the combined extracts to dryness. Dissolve the residue in 10-ml of ethanol as the test solution. Dissolve a quantity of hyodeoxycholic acid CRS in ethanol to produce a solution containing 1 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 the upper layer of a freshly prepared mixture of isooctane, ether, glacial acetic acid, n-butanol and water (10 : 5 : 5 : 3 : 1) as the mobile phase. Apply separately 2 μl of each of the test solution and the reference solution to the plate. After developing and removal of the plate, dry in air, spray with a 10% solution of sulfuric acid in ethanol, heat at 105℃ to visualize clearly. Examine in daylight and under ultraviolet light at 365 nm. The 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.
取本品细粉0.1g，加10%氢氧化钠溶液5ml，120℃加热4小时，放冷，滴加盐酸调节pH值至2～3，摇匀。用乙酸乙酯振摇提取4次，每次10ml，合并提取液，蒸干，残渣加乙醇10ml使溶解，作为供试品溶液。另取猪去氧胆酸对照品适量，加乙醇制成每1ml含1mg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，以新配制的异辛烷-乙醚-冰醋酸-正丁醇-水（10：5：5：3：1）的上层溶液为展开剂，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，分别置日光和紫外光灯（365nm）下检视。供试品色谱中，在与对照品色谱相应的位置上，显相同颜色的斑点或荧光斑点。

Examination 检查

Fellis Bovis, Fellis Caprae seu Ovis 牛、羊胆

Take 0.1 g each of Fellis Bovis reference drug and Fellis Caprae seu Ovis reference drug, produce two reference drug solutions in the same manner as preparation of the test solution under Identification, beginning at the words "add 5 ml of 10% sodium hydroxide...". Carry out the method for thin layer chromatography <0502>, using silica gel G as the coating substance. apply separately to the plate 2 μl each of the test solution obtained under Identification and the above two reference drug solutions. Developing and visualizing in the same manner as described under the test of Identification. The spots in the chromatogram obtained with the test solution should not be corresponding in position and colour to the spots in the chromatogram obtained with the reference drug solutions.
取牛、羊胆对照药材各0.1g，按〔鉴别〕项下的供试品溶液制备方法，自“加10%氢氧化钠溶液5ml”起，同法制成对照药材溶液。照薄层色谱法（通则0502）试验，吸取〔鉴别〕项下的供试品溶液和上述对照药材溶液各2μl，分别点于同一硅胶G薄层板上，同上述〔鉴别〕项下方法展开，显色。供试品色谱中，不得显与牛、羊胆对照药材相同的斑点。

Reducing sugars 还原糖

Dissolve 10 mg of the powder in 2 ml of water, add several drops of α-naphthol in ethanol (1→50), mix well, add dropwise 0.5 mil of sulfuric acid along the tube wall, a purplish-red ring is not visible at the junction of the two layers.
取本品10mg，加水2ml使溶解，滴加α-萘酚乙醇溶液（1→50）数滴，摇匀，沿管壁缓缓加入硫酸约0.5ml，两液接界面不得显紫红色环。

Foreign organic matter 异性有机物

Dissolve 10 mg of the powder in 2 ml of water, centrifuge or filter. Examine the residue under the microscope. No plant. animal tissues or starch is visible.
取本品10mg，加水2ml使溶解，离心或滤过，取不溶物，置显微镜下观察，不得有植物组织、动物组织或淀粉等。

Water 水分

Weigh accurately 0.3 g of the powder, carry out the method for determination of water <0832, method 3>, not more than 10.0 per cent.
取本品约0.3g，精密称定，照水分测定法（通则0832第三法）测定，不得过10.0%。

Assay 含量测定

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

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

Use octadecylsilane bonded silica gel as the stationary phase (250 mm × 4.6 mm and a mixture of methanol and 0.03 mol/L sodium dihydrogenphosphate adjust to pH 4.4 with phosphoric acid) (70 : 30) as the mobile phase. As detector a spectrophotometer set at 200 nm. The number of theoretical plates of the column is not less than 3000, calculated with reference to the peak of taurohyodeoxycholic acid.
以十八烷基硅烷键合硅胶为填充剂（色谱柱长为250mm；内径为4.6mm）；以甲醇-0.03mol/L磷酸二氢钠溶液（70：30）为流动相（用磷酸调节pH值为4.4）；检测波长为200nm。理论板数按牛磺猪去氧胆酸峰计算应不低于3000。

Reference solution 对照品溶液的制备

Dissolve a quantity of taurohy-odeoxycholic acid CRS, accurately weighed, in methanol to prepare a solution containing 0.5 mg per ml.
取牛磺猪去氧胆酸对照品适量，精密称定，加甲醇制成每1ml含0.5mg的溶液，即得。

Test solution 供试品溶液的制备

Weigh accurately 0.5 g of the powder to a 50 ml volumetric flask, add 20 ml of methanol. Ultrasonicate (power 500 W, frequency 40 kHz) for 20 minutes, cool and dilute with methanol to volume, mix well and filter, use the successive filtrate as the test solution.
取本品粉末约0.5g，精密称定，置50ml量瓶中，加入甲醇20ml，超声处理（功率500W，频率40kHz）20分钟，放冷，加甲醇至刻度，摇匀，滤过，取续滤液，即得。

Procedure 测定法

Inject accurately 20 μl of each of the reference solution and the test solution, respectively, into the column, determine and calculate the content.
分别精密吸取对照品溶液与供试品溶液各20μl，注入液相色谱仪，测定，即得。

It contains not less than 2.0 per cent of taurohyodeoxycholic acid (C26H45O6NS), calculated with reference to the dried drug.
本品按干燥品计算，含牛磺猪去氧胆酸（C26H45O6NS）不得少于2.0%。

Property and Flavor 性味与归经

Cold; bitter. Liver, gallbladder, lung, large intestine meridians.
苦，寒。归肝、胆、肺、大肠经。

Actions 功能与主治

To clear heat, moisten dryness, suppress cough, relieve panting, and remove toxin. Used for whooping cough, asthma, febrile disease with dryness thirst, red eyes, throat bi disorder, jaundice, diarrhea, dysentery, constipation, abscess, sore, swelling skin infections.
清热润燥，止咳平喘，解毒。用于顿咳，哮喘，热病燥渴，目赤，喉痹，黄疸，泄泻，痢疾，便秘，痈疮肿毒。

Administration and dosage 用法与用量

0.3-0.6 g, taken with water or used in pills and powder; Appropriate amount for topical application, ground into powder, or mixed with water for applying to the affected area.
0.3～0.6g，冲服或入丸散。外用适量，研末或水调涂敷患处。

Storage 贮藏

Preserve in tightly closed container, and protect from light and stored in a cool and dry place.
密封，避光，置阴凉干燥处。