熟地黄

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

Overview 概述

Prepared Rehmannia Root is the processed product of Rehmannia glutinosa Libosch. (Fam. Scrophulariaceae).
本品为生地黄的炮制加工品。

Processing 炮制

(1) Take raw dihuang, according to the wine stewing method (general rule 0213) stewed until the wine sucked out, take out, drying until the mucus of the outer skin is slightly dry, cut thick slices or blocks, drying, that is, obtained. For every 100 kg of raw dihuang, use 30-50 kg of yellow wine.
（1）取生地黄，照酒炖法（通则0213）炖至酒吸尽，取出，晾晒至外皮黏液稍干时，切厚片或块，干燥，即得。每100 kg生地黄，用黄酒30～50 kg。

(2) Take raw dihuang, according to the method of steaming (Tongzhi 0213) steamed to black moist, take out, sunshine to about eighty percent dry, cut thick slices or blocks, dry, that is, get.
（2）取生地黄，照蒸法（通则0213）蒸至黑润，取出，晒至约八成干时，切厚片或块，干燥，即得。

Description 性状

Pieces or fragments of irregular shape, of variable size and thickness. Surface black and glossy, with a large amount of sticky substance. Texture soft and slightly tough, not easily broken; fracture black and glossy. Odour, slight; taste, sweet.
本品为不规则的块片、碎块，大小、厚薄不一。表面乌黑色，有光泽，黏性大。质柔软而带韧性，不易折断，断面乌黑色，有光泽。气微，味甜。

Identification 鉴别

To 1 g of the powder add 50 ml of 80% methanol, treat with ultrasound for 30 minutes, filter, evaporate the filtrate to dryness, dissolve the residue in 5 ml of water. Extract with four 10 ml portions of water-saturated n-butanol, combine the n-butanol extracts, evaporate to dryness. Dissolve the residue in 2 ml of methanol as the test solution. Dissolve catalpol CRS in methanol 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 a mixture of ethyl acetate-methanol-formic acid(16:0.5:2)as the mobile phase. Apply separately to the plate 5 μl of the test solution and 2 μl of the Reference solution. After developing and removal of the plate, dry in air. Spray with a 0.1% solution of 2,2-diphenyl-1-picrylhydrazyl in anhydrous ethanol. Dry. 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.
取本品粉末1 g，加80%甲醇50 ml，超声处理30分钟，滤过，滤液蒸干，残渣加水5 ml使溶解，用水饱和正丁醇振摇提取4次，每次10 ml，合并正丁醇液，蒸干，残渣加甲醇2 ml使溶解，作为供试品溶液。另取毛蕊花糖苷对照品，加甲醇制成每1 ml含1 mg的溶液，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5 μl、对照品溶液2 μl，分别点于同一硅胶G薄层板上，以乙酸乙酯-甲醇-甲酸（16∶0.5∶2）为展开剂，展开，取出，晾干，用0.1%的2,2-二苯基-1-苦肼基无水乙醇溶液浸渍，晾干。供试品色谱中，在与对照品色谱相应的位置上，显相同的颜色斑点。

Examination 检查

Same as Rehmannia.
同地黄。

Extractives 浸出物

Same as Rehmannia.
同地黄。

Assay 含量测定

Determine 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; use methanol-0.1% phosphoric acid solution (5:95) as the mobile phase, and detect at a wavelength of 203 nm. The theoretical plate number calculated based on the peak of Rehmannioside D should not be less than 5000.
以十八烷基硅烷键合硅胶为填充剂；以甲醇-0.1%磷酸溶液（5∶95）为流动相，检测波长为203 nm。理论板数按地黄苷D峰计算应不低于5000。

Preparation of reference solution 对照品溶液的制备

Take an appropriate amount of Rehmannioside D reference substance, accurately weigh it, add 25% methanol to make a solution containing 70 μg per 1 ml.
取地黄苷D对照品适量，精密称定，加25%甲醇制成每1 ml含70 μg的溶液，即得。

Preparation of test solution 供试品溶液的制备

Take this product and cut it into small pieces of about 5 mm. After drying under reduced pressure at 80°C for 24 hours, grind it into coarse powder. Take about 1 g, accurately weigh it, place it in a stoppered conical flask, accurately add 25% methanol 25 ml, weigh it, perform ultrasonic treatment (power 400 W, frequency 50 kHz) for 1 hour, let it cool, weigh it again, make up for the weight loss with 25% methanol, shake well, centrifuge at high speed for 10 minutes, take the supernatant and filter it, and take the filtrate.
取本品切成约5 mm的小块，经80℃减压干燥24小时后，研成粗粉，取约1 g，精密称定，置具塞锥形瓶中，精密加入25%甲醇25 ml，称定重量，超声处理（功率400 W，频率50 kHz）1小时，放冷，再称定重量，用25%甲醇补足减失的重量，摇匀，高速离心10分钟，取上清液滤过，取续滤液，即得。

Assay method 测定法

Accurately take 10 μl of the reference solution and the test solution, inject them 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10 μl，注入液相色谱仪，测定，即得。

The content of Rehmannioside D (C27H42O20) in this product should not be less than 0.050%.
本品含地黄苷D（C27H42O20）不得少于0.050%。

Property 性

Slightly warm.
微温。

Toxicity 毒性

None.
无。

Flavor 味

Sweet.
甘。

Meridian tropism 归经

Liver and kidney meridians.
归肝、肾经。

Actions 功能

Nourish blood and nourish yin, tonify essence and fill the marrow.
补血滋阴，益精填髓。

Indications 主治

Used for blood deficiency and withered yellow, palpitations and flustered, irregular menstruation, excessive menstrual flow, liver and kidney yin deficiency, soreness and weakness of the waist and knees, steaming bone and tidal heat, night sweats and spermatorrhea, internal heat and thirst, dizziness, tinnitus, premature graying of hair.
用于血虚萎黄，心悸怔忡，月经不调，崩漏下血，肝肾阴虚，腰膝酸软，骨蒸潮热，盗汗遗精，内热消渴，眩晕，耳鸣，须发早白。

Dosage 用量

9-15 g.
9～15 g。

Administration 用法

None.
无。

Storage 贮藏

Store in a well-ventilated and dry place.
置通风干燥处。

熟地黄

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

Overview 概述

The drug is the processed Rehmanniae Radix.
本品为生地黄的炮制加工品。

Procedure 制法

To stew the Rehmanniae Radix as described under the method for stewing with wine <0213>, until the wine is absorbed entirely, take out, dry in the sun until the mucilage in bark is slightly dried, cut into thick slices or pieces, and dry thoroughly.
（1）取生地黄，照酒炖法（通则0213）炖至酒吸尽，取出，晾晒至外皮黏液稍干时，切厚片或块，干燥，即得。

To each 100 kg of Rehmanniae Radix add 30-50 kg of yellow rice wine.
每100kg生地黄，用黄酒30～50kg。

To steam the Rehmannise Radix as described under the method for steaming <0213> until it becomes blackish and shiny, take out, dry in the sun to be eighty percent dried, cut into thick slices or pieces, and dry thoroughly.
（2）取生地黄，照蒸法（通则0213）蒸至黑润，取出，晒至约八成干时，切厚片或块，干燥，即得。

Description 性状

Occurring in irregular slices and pieces, broken lumps, varying in size and thickness. Externally black, lustrous, more sticky. Texture soft and flexible, not easy to break, fracture black, lustrous. Odour, slight; taste, sweet.
本品为不规则的块片、碎块，大小、厚薄不一。表面乌黑色，有光泽，黏性大。质柔软而带韧性，不易折断，断面乌黑色，有光泽。气微，味甜。

Identification 鉴别

To 1 g of the powder add 50 ml of 80% methanol, ultrasonicate for 30 minutes, filter. Evaporate the filtrate to dryness, dissolve the residue in 5 ml of water. Extract with four 10-ml quantities of n-butanol saturated with water by shaking, combine the n-butanal solutions, evaporate to dryness. Dissolve the residue in 2 ml of methanol as the test solution. Dissolve a quantity of verbascoside CRS in methanol 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 a mixture of ethyl acetate, methanol and formic acid (16 : 0.5 : 2) as the mobile phase. Apply separately 5 μl of the test solution and 2 μl of the reference solution to the plate. After developing and removal of the plate. dry in air. Soak the plate briefly in a 0.1% solution of 2, 2-diphenyl-1-picrylhydrazyl in dehydrated ethanol, take out and 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.
取本品粉末1g，加80%甲醇50ml，超声处理30分钟，滤过，滤液蒸干，残渣加水5ml使溶解，用水饱和正丁醇振摇提取4次，每次10ml，合并正丁醇液，蒸干，残渣加甲醇2ml使溶解，作为供试品溶液。另取毛蕊花糖苷对照品，加甲醇制成每1ml含1mg的溶液，作为对照品溶液。照薄层色谱法（通则0502）试验，吸取供试品溶液5µl、对照品溶液2µl，分别点于同一硅胶G薄层板上，以乙酸乙酯-甲醇-甲酸（16：0.5：2）为展开剂，展开，取出，晾干，用0.1%的2，2-二苯基-1-苦肼基无水乙醇溶液浸渍，晾干。供试品色谱中，在与对照品色谱相应的位置上，显相同的颜色斑点。

Examination 检查

Water 水分

As required for Rehmanniae Radix.
同地黄。

Total ash 总灰分

As required for Rehmanniae Radix.
同地黄。

Acid-insoluble ash 酸不溶性灰分

As required for Rehmanniae Radix.
同地黄。

Extractives 浸出物

As required for Rehmanniae Radix.
同地黄。

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 and a mixture of acetonitrile and 0.1% solution of acetic acid (16 : 84) as the mobile phase. As detector spectrophotometer set at 334 nm. The number of theoretical plates of the column is not less than 5000, calculated with reference to the peak of verbascoside.
以十八烷基硅烷键合硅胶为填充剂；以乙腈-0.1%醋酸溶液（16：84）为流动相；检测波长为334nm。理论板数按毛蕊花糖苷峰计算应不低于5000。

Reference solution 对照品溶液制备

Dissolve a quantity of verbascoside CRS, accurately weighed, in mobile phase to prepare a solution containing 10 μg per ml as the reference solution.
取毛蕊花糖苷对照品适量，精密称定，加流动相制成每1ml含10µg的溶液，即得。

Test solution 供试品溶液制备

Weigh accurately 2 g of the very coarse powder to a round-bottomed flask, add accurately 100 ml of methanol and weigh. Heat under reflux for 30 minutes, cool and weigh again, replenish the loss of solvent with methanol, mix well and filter. Measure accurately 50 ml of the successive filtrate and recover the solvent in vacuum to nearly dryness. Dissolve the residue with the mobile phase and transfer to a 10 ml volumetric flask and dilute with the mobile phase to the volume, mix well, filter and use the successive filtrate as the test solution.
取本品最粗粉约2g，精密称定，置圆底烧瓶中，精密加入甲醇100ml，称定重量，加热回流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50ml，减压回收溶剂近干，残渣用流动相溶解，转移至10ml量瓶中，加流动相至刻度，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, 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 0.020 per cent of verbascoside (C29H36O15), calculated with reference to the dried drug.
本品按干燥品计算，含毛蕊花糖苷（C29H36O15）不得少于0.020%。

Property and Flavor 性味与归经

Mild warm; sweet. Liver and kidney meridians.
甘，微温。归肝、肾经。

Actions 功能与主治

To nourish blood, replenish yin, replenish the essence and the marrow. Blood deficiency, sallow complexion, palpitations, fearful throbbing, menstrual irregularities, flooding and spotting, liver-kidney yin deficiency, soreness and weakness in the lower back and knees, bone-steaming and tidal fever, night sweating seminal emission, interior heat, wasting-thirst, dizziness. tinnitus, and premature greying.
补血滋阴，益精填髓。用于血虚萎黄，心悸怔忡，月经不调，崩漏下血，肝肾阴虚，腰膝酸软，骨蒸潮热，盗汗遗精，内热消渴，眩晕，耳鸣，须发早白。

Administration and dosage 用法与用量

9-15 g.
9～15g。

Storage 贮藏

Preserve in a ventilated and dry place.
置通风干燥处。