附子

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

概述 Overview

本品为毛茛科植物乌头Aconitum carmichaelii Debx.的子根的加工品。6月下旬至8月上旬采挖，除去母根、须根及泥沙，习称“泥附子”，加工成下列规格。
Processed Aconite Lateral Root is the processed lateral root of Aconitum carmichaelii Debx. (Fam. Ranunculaceae). It is collected from late June to early August, removed from the mother root, fibrous roots, and soil, and processed into the following specifications.

（1）选择个大、均匀的泥附子，洗净，浸入胆巴的水溶液中过夜，再加食盐，继续浸泡，每日取出晒晾，并逐渐延长晒晾时间，直至附子表面出现大量结晶盐粒（盐霜）、体质变硬为止，习称“盐附子”。
(1) Select a large, uniform mud epiphyllum, wash, immersed in aqueous solution of cholecalciferol overnight, then add salt, continue to soak, and take out every day to dry in the sun and gradually extend the drying time until the epiphyllum surface appears to be a large number of crystalline salt particles (salt frost), the body hardened until the habitually known as "salt epiphyllum".

（2）取泥附子，按大小分别洗净，浸入胆巴的水溶液中数日，连同浸液煮至透心，捞出，水漂，纵切成厚约0.5 cm的片，再用水浸漂，用调色液使附片染成浓茶色，取出，蒸至出现油面、光泽后，烘至半干，再晒干或继续烘干，习称“黑顺片”。
(2) take mud epiphyllum, according to the size of the respective wash, immersed in the water solution of cholecalciferol for a few days, together with the immersion solution boiled to the heart, fish out, water bleaching, longitudinally cut into a thickness of about 0.5 cm of the slice, and then bleaching with water immersion, with the use of colouring solution so that the epiphyllum dyed into a strong tea colour, take out, steamed to the emergence of the oil surface, luster, baked to half-dry, and then dry in the sun or continue to dry, habitually referred to as the "Black Shun slice". It was then dried in the sun or continued to be dried, and was customarily called "Black Shun Piece".

（3）选择大小均匀的泥附子，洗净，浸入胆巴的水溶液中数日，连同浸液煮至透心，捞岀，剥去外皮，纵切成厚约0.3 cm的片，用水浸漂，取出，蒸透，晒干，习称“白附片”。
(3) Select mud epiphyllums of uniform size, wash them, immerse them in an aqueous solution of cholecalciferol for a few days, boil them together with the imbibing liquid until they are thoroughly boiled, pull them out, peel off the outer skin, cut them longitudinally into slices of about 0.3 cm in thickness, rinse them in water, take them out, steam them through, and dry them in the sun, which is customarily known as "white epiphyllum slices".

性状 Description

盐附子 Salt-processed Aconite Lateral Root

呈圆锥形，长4～7 cm，直径3～5 cm。表面灰黑色，被盐霜，顶端有凹陷的芽痕，周围有瘤状突起的支根或支根痕。体重，横切面灰褐色，可见充满盐霜的小空隙和多角形形成层环纹，环纹内侧导管束排列不整齐。气微，味咸而麻，刺舌。
It is conical, measuring 4-7 cm in length and 3-5 cm in diameter. The surface is grayish-black and covered with salt crystals. The top has a depressed bud mark, and there are nodular protrusions of lateral roots or root scars around it. The cross-section is grayish-brown, with small cavities filled with salt crystals and polygonal concentric rings. The vascular bundles on the inner side of the rings are arranged irregularly. It has a slight odor, a salty and numbing taste, and tingles the tongue.

黑顺片 Processed Aconite Lateral Root Slices

为纵切片，上宽下窄，长1.7～5 cm，宽0.9～3cm，厚0.2～0.5 cm。外皮黑褐色，切面暗黄色，油润具光泽，半透明状，并有纵向导管束。质硬而脆，断面角质样。气微，味淡。
Longitudinal slices, wider at the top and narrower at the bottom, measuring 1.7-5 cm in length, 0.9-3 cm in width, and 0.2-0.5 cm in thickness. The outer skin is dark brown, and the cut surface is dark yellow, oily, glossy, and semi-transparent, with longitudinal vascular bundles. It is hard and brittle in texture, with a horny appearance when broken. It has a slight odor and a mild taste.

白附片 Processed Aconite Lateral Root Slices

无外皮，黄白色，半透明，厚约0.3 cm。
Without skin are yellowish-white, semi-transparent, and approximately 0.3 cm thick.

鉴别 Identification

取本品粉末2 g，加氨试液3 ml润湿，加乙醚25 ml，超声处理30分钟，滤过，滤液挥干，残渣加二氯甲烷0.5 ml使溶解，作为供试品溶液。另取苯甲酰新乌头原碱对照品、苯甲酰乌头原碱对照品、苯甲酰次乌头原碱对照品，加异丙醇-二氯甲烷（1:1）混合溶液制成每1 ml各含1 mg的混合溶液，作为对照品溶液（单酯型生物碱）。再取新乌头碱对照品、次乌头碱对照品、乌头碱对照品，加异丙醇-二氯甲烷（1:1）混合溶液制成每1 ml各含1 mg的混合溶液，作为对照品溶液（双酯型生物碱）。照薄层色谱法（通则0502）试验，吸取供试品溶液和对照品溶液各5～10 μl，分别点于同一硅胶G薄层板上，以正己烷-乙酸乙酯-甲醇（6.4:3.6:1）为展开剂，置氨蒸气饱和20分钟的展开缸内，展开，取出，晾干，喷以稀碘化铋钾试液。供试品色谱中，盐附子在与新乌头碱对照品、次乌头碱对照品和乌头碱对照品色谱相应的位置上，显相同颜色的斑点；黑顺片或白附片在与苯甲酰新乌头原碱对照品、苯甲酰乌头原碱对照品、苯甲酰次乌头原碱对照品色谱相应的位置上，显相同颜色的斑点。
To 2 g of the powder, add 3ml of ammonia test solution to moisten, and then add 25 ml of ether. Ultrasonicate for 30 minutes, filter, evaporate the filtrate to dryness, dissolve the residue in 0.5 ml of dichloromethane as the test solution. Take benzoylaconine CRS, benzoylhypaconine CRS, and benzoylmesaconine CRS, and prepare a mixed solution containing 1 mg of each in 1 ml of isopropanol-dichloromethane (1:1) mixture as the reference solution (single-ester alkaloids). Take aconitine CRS, hypaconitine CRS, and mesaconitine CRS, and prepare a mixed solution containing 1 mg of each in 1 ml of isopropanol-dichloromethane (1:1) mixture as the reference solution (diester alkaloids). Perform the thin-layer chromatography test<0502> using silica gel G as the coating substance and a mixture of n-hexane, glacial acetic acid, and methanol (6.4:3.6:1) as the mobile phase. Place the plate in a developing tank saturated with ammonia vapor for 20 minutes, develop, remove, dry, and spray with a solution of iodine bismuth potassium iodide. In the chromatogram obtained with the test solution, the spots corresponding to benzoylaconine CRS, benzoylhypaconine CRS, and benzoylmesaconine CRS in the chromatogram obtained with the reference solution appear in the same color; the spots corresponding to benzoylaconine CRS, benzoylhypaconine CRS, and benzoylmesaconine CRS in the chromatogram obtained with the reference solution appear in the same color for processed Aconite Lateral Root Slices or Processed Aconite Lateral Root Slices.

检查 Examination

水分 Water

不得过15.0%（通则0832第二法）。
Not more than 15.0 per cent <0832,method 2>.

双酯型生物碱 Bisbenzylisoquinoline alkaloids

照〔含量测定〕项下色谱条件、供试品溶液的制备方法试验。
Carry out the test for preparation of the test solution and the determination of content under the conditions of chromatography <0512>.

对照品溶液的制备 Preparation of reference solution

取新乌头碱对照品、次乌头碱对照品、乌头碱对照品适量，精密称定，加异丙醇-二氯甲烷（1:1）混合溶液制成每1 ml各含5 μg的混合溶液，即得。
Take an appropriate amount of reference substances of neowutong alkaloid, isoneowutong alkaloid, and wutong alkaloid, accurately weigh, add a mixed solution of isopropanol and dichloromethane (1:1) to make a mixed solution containing 5 μg of each per ml.

测定法 Determination method

分别精密吸取上述对照品溶液与〔含量测定〕项下供试品溶液各10 μl，注入液相色谱仪，测定，即得。
Accurately aspirate 10 μl of the above reference solution and the test solution under the item of "content determination", inject into the liquid chromatograph, and determine.

本品含双酯型生物碱以新乌头碱（C33H45NO11）、次乌头碱（C33H45NO10）和乌头碱（C34H47NO11）的总量计，不得过0.020%。
The total amount of bisbenzylisoquinoline alkaloids, calculated as neowutong alkaloid (C33H45NO11), isoneowutong alkaloid (C33H45NO10), and wutong alkaloid (C34H47NO11), shall not exceed 0.020%.

含量测定 Content determination

照高效液相色谱法（通则0512）测定。
Determine according to the high-performance liquid chromatography method <0512>.

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-四氢呋喃（25:15）为流动相A，以0.1 mol/L醋酸铵溶液（每1000 ml加冰醋酸0.5 ml）为流动相B，按下表中的规定进行梯度洗脱，检测波长为235 nm。理论板数按苯甲酰新乌头原碱峰计算应不低于3000。
Use octadecylsilane-bonded silica gel as the filler; use acetonitrile-tetrahydrofuran (25:15) as mobile phase A, and use 0.1 mol/L ammonium acetate solution (add 0.5 ml of glacial acetic acid per 1000 ml) as mobile phase B. Perform gradient elution according to the specified conditions in the table, and detect at a wavelength of 235 nm. The theoretical plate number calculated based on the peak of benzoylneowutong alkaloid should not be less than 3000.

对照品溶液的制备 Preparation of reference solution

取苯甲酰新乌头原碱对照品、苯甲酰乌头原碱对照品、苯甲酰次乌头原碱对照品适量，精密称定，加异丙醇-二氯甲烷（1:1）混合溶液制成每1 ml各含10 μg的混合溶液，即得。
Take an appropriate amount of reference substances of benzoylneowutong alkaloid, benzoylwutong alkaloid, and benzoylisoneowutong alkaloid, accurately weigh, add a mixed solution of isopropanol and dichloromethane (1:1) to make a mixed solution containing 10 μg of each per 1 ml.

供试品溶液的制备 Preparation of test solution

取本品粉末（过三号筛）约2 g，精密称定，置具塞锥形瓶中，加氨试液3 ml，精密加入异丙醇-乙酸乙酯（1:1）混合溶液50 ml，称定重量，超声处理（功率300 W，频率40 kHz，水温在25℃以下）30分钟，放冷，再称定重量，用异丙醇-乙酸乙酯（1:1）混合溶液补足减失的重量，摇匀，滤过。精密量取续滤液25 ml，40℃以下减压回收溶剂至干，残渣精密加入异丙醇-二氯甲烷（1:1）混合溶液3 ml溶解，滤过，取续滤液，即得。
Take about 2 g of the powder of this product (passed through a No. 3 sieve), accurately weigh, place it in a stoppered conical flask, add 3 ml of ammonia test solution, accurately add 50 ml of a mixed solution of isopropanol and ethyl acetate (1:1), weigh, treat with ultrasound (power 300 W, frequency 40 kHz, water temperature below 25°C) for 30 minutes, cool, weigh again, make up for the lost weight with a mixed solution of isopropanol and ethyl acetate (1:1), shake well, and filter. Accurately take 25 ml of the filtrate, reduce the pressure below 40°C to recover the solvent to dryness, accurately add 3 ml of a mixed solution of isopropanol and dichloromethane (1:1) to dissolve the residue, filter, 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10 μl，注入液相色谱仪，测定，即得。
Accurately aspirate 10 μl of the reference solution and the test solution, inject into the liquid chromatograph, and determine.

本品按干燥品计算，含苯甲酰新乌头原碱（C31H43NO10）、苯甲酰乌头原碱（C32H45NO10）和苯甲酰次乌头原碱（C31H43NO9）的总量，不得少于0.010%。
The total amount of benzoylneowutong alkaloid (C31H43NO10), benzoylwutong alkaloid (C32H45NO10), and benzoylisoneowutong alkaloid (C31H43NO9), calculated as dry product, shall not be less than 0.010%.

饮片 Prepared slices

附片（黑顺片、白附片） Prepared Aconite Slices (Heishunpian, Baifupian)

炮制 Processing

直接入药。
Used directly in medicine.

性状 Property

同药材。
Same as the crude drug.

鉴别 Identification

同药材。
Same as the crude drug.

检查 Examination

总灰分 Total ash

不得过6.0%（通则2302）。
Not more than 6.0 per cent <2302>.

酸不溶性灰分 Acid-insoluble ash

不得过1.0%（通则2302）。
Not more than 1.0 per cent <2302>.

水分 Water

同药材。
Same as the crude drug.

双酯型生物碱 Bisbenzylisoquinoline alkaloids

同药材。
Same as the crude drug.

含量测定 Content determination

同药材。
Same as the crude drug.

淡附片 Light Aconite Slices

炮制 Processing

取盐附子，用清水浸漂，每日换水2～3次，至盐分漂尽，与甘草、黑豆加水共煮透心，至切开后口尝无麻舌感时，取出，除去甘草，黑豆，切薄片，晒干。
Take salted aconite, soak and rinse with clean water, change the water 2-3 times a day until the salt is completely removed, cook with licorice and black beans in water until thoroughly cooked, take out when there is no tingling sensation on the tongue after cutting, remove licorice and black beans, cut into thin slices, and dry.

每100 kg盐附子，用甘草5 kg、黑豆10 kg。
For every 100 kg of salted aconite, use 5 kg of licorice and 10 kg of black beans.

性状 Property

本品呈纵切片，上宽下窄，长1.7～5 cm，宽0.9～3 cm，厚0.2～0.5 cm。外皮褐色。切面褐色，半透明，有纵向导管束。质硬，断面角质样。气微，味淡，口尝无麻舌感。
This product is longitudinally sliced, wider at the top and narrower at the bottom, with a length of 1.7-5 cm, a width of 0.9-3 cm, and a thickness of 0.2-0.5 cm. The outer skin is brown. The cut surface is brown, translucent, and has longitudinal vascular bundles. The texture is hard, and the cross-section is horny. It has a slight odor, a mild taste, and no tingling sensation on the tongue.

检查 Examination

双酯型生物碱 Bisbenzylisoquinoline alkaloids

同药材，含双酯型生物碱以新乌头碱（C33H45NO11）、次乌头碱（C33H45NO10）和乌头碱（C34H47NO11）的总量计，不得过0.010%。
The total amount of bisbenzylisoquinoline alkaloids, calculated as neowutong alkaloid (C33H45NO11), isoneowutong alkaloid (C33H45NO10), and wutong alkaloid (C34H47NO11), shall not exceed 0.010%.

总灰分 Total ash

不得过7.0%（通则2302）。
Not more than 7.0 per cent <2302>.

酸不溶性灰分 Acid-insoluble ash

不得过1.0%（通则2302）。
Not more than 1.0 per cent <2302>.

水分 Water

同药材。
Same as the crude drug.

鉴别 Identification

同药材。
Same as the crude drug.

含量测定 Content determination

同药材。
Same as the crude drug.

炮附片 Processed Aconite Slices

炮制 Processing

取附片，照炒法（通则0213）用砂烫至鼓起并微变色。
Take prepared aconite slices, process them according to the method of stir-frying with sand (method 0213) until they swell and slightly change color.

性状 Property

本品形如黑顺片或白附片，表面鼓起黄棕色，质松脆。气微，味淡。
This product is similar to Heishunpian or Baifupian, with a swollen surface and a yellow-brown color. The texture is soft and brittle. It has a slight odor and a mild taste.

鉴别 Identification

同附片。
Same as the prepared aconite slices.

检查 Examination

同附片。
Same as the prepared aconite slices.

性 Property

大热；有毒。
Strongly hot; toxic.

味 Flavor

辛、甘。
Pungent and sweet.

归经 Meridian tropism

归心、肾、脾经。
Meridians tropism: Heart, Kidney, Spleen.

功能 Actions

回阳救逆，补火助阳，散寒止痛。
To restore yang and rescue collapse, tonify fire and assist yang, dispel cold and relieve pain.

主治 Indications

用于亡阳虚脱，肢冷脉微，心阳不足，胸痹心痛，虚寒吐泻，脘腹冷痛，肾阳虚衰，阳痿宫冷，阴寒水肿，阳虚外感，寒湿痹痛。
Used for collapse due to loss of yang, cold limbs and weak pulse, insufficient heart yang, chest obstruction and heart pain, vomiting and diarrhea due to deficiency-cold, cold pain in the epigastrium, kidney yang deficiency and decline, impotence and cold uterus, edema due to yin-cold, external attack of yang deficiency, and cold-damp arthralgia.

用量 Dosage

3～15 g。
3-15 g.

用法 Administration

先煎，久煎。
Decoct first, decoct for a long time.

注意 Precautions

孕妇慎用；不宜与半夏、瓜蒌、瓜蒌子、瓜蒌皮、天花粉、川贝母、浙贝母、平贝母、伊贝母、湖北贝母、白蔹、白及同用。
Caution should be exercised in pregnant women; it should not be used together with Banxia, Gualou, Gualouzi, Gualoupi, Tianhuafen, Chuanbeimu, Zhebeimu, Pingbeimu, Yibeimu, Hubeibeimu, Bailian, and Baiji.

贮藏 Storage

盐附子 Salted aconite

密闭，置阴凉干燥处。
Sealed, stored in a cool and dry place。

黑顺片及白附片 Heishunpian and Baifupian

置干燥处，防潮。
Stored in a dry place, protected from moisture.

注：盐附子仅做〔性状〕检测。
Note: Salted aconite is only used for the test of "Property".

Overview

Prepared Common Monkshood Daughter Root is the processed daughter root of Aconitum carmichaeli Debx. (Fam. Ranunculaceae). The drug is collected in late June to early August, removed from the parent root, rootlet and soil. It is known as “Nifuzi”, which can be processed into the following commercial varieties:

1. Yanfuzi (salted aconite daughter root)
2. Heishunpian (black slice)
3. Baifupian (white slice)

Description

Yanfuzi (salted aconite daughter root)

Conical, 4-7 cm long, 3-5 cm in diameter. Externally greyish-black, covered with fine powder of salt, topped with depressed bud scars and encircled with tubercled short rootlets or rootlet scars. Texture heavy. Transversely cut surface greyish-brown, showing small clefts filled with fine powder of salt and a polyangular cambium ring, and vascular bundles arranged irregularly inside the ring. Odour, slight; taste, salty, numb and pungent.

Heishunpian (black slice)

Longitudinal slices, the upper portion wide and the lower portion narrow, 1.7-5 cm long, 0.9-3 cm wide, 0.2-0.5 cm thick. The outer bark blackish-brown, cut surface dark yellow, oily and lustrous, translucent and showing longitudinal vascular bundles. Texture hard and fragile. Fracture horny. Odour, slight; taste, weak.

Baifupian (white slice)

Without outer bark, yellowish-white, translucent, about 3 mm thick.

Identification

Macerate 2 g of the powder with 3 ml of ammonia TS, add 25 ml of ether, ultrasonicate for 30 minutes and filter, evaporate the filtrate to dryness and dissolve in 0.5 ml of dichloromethane as the test solution. Dissolve benzoylmesaconine CRS, benzoylaconitine CRS and benzoylhypaconitine CRS and in a mixture of isopropanol and dichloromethane (1:1) to produce a mixture containing 1 mg of each per ml as the reference solution (monoester-alkaloids). Dissolve a quantity of mesaconine CRS, hypaconitine CRS and aconitine CRS in a mixture of isopropanol and dichloromethane (1:1) to produce a mixture containing 1 mg of each per ml as the reference solution (diester-alkaloids). Carry out the method for thin layer chromatography <0502>, using silica gel G as the coating substance and a mixture of n-hexane, ethyl acetate and methanol (6.4:3.6:1) as the mobile phase. Apply separately to the plate 5-10 μl of each of the test solution and the reference solutions. After developing in a chamber pre-equilibrated with ammonia vapor for 20 minutes and removal of the plate, dry in air, spray with dilute potassium iodobismuthate TS. The spots in the chromatogram obtained with the test solution of Yanfuzi correspond in position and colour to the spots of mesaconine CRS, hypaconitine CRS and aconitine CRS obtained with the reference solution. The spots in the chromatogram obtained with the test solution of Heishunpian or Baifupian correspond in position and colour to the spots of benzoylaconitine CRS, benzoylhypaconitine CRS and benzoylmesaconine CRS obtained with the reference solution.

Examination

Water

Not more than 15.0 per cent <0832, method 2>.

Diester-alkaloids

Chromatographic system and system suitability and Test solution As described under Assay.
Reference solution Weigh accurately mesaconine CRS, hypaconitine CRS and aconitine CRS respectively, dissolve in a mixture of isopropanol and dichloromethane (1:1) to produce a mixture containing 5 μg of each per ml.
Procedure Inject accurately 10 μl of each of the reference solution and the test solution obtained under Assay, respectively, into the column, and calculate the content.
It contains not more than 0.020 per cent of the total amount of mesaconine (C33H45NO11), hypaconitine (C33H45NO10) and aconitine (C34H47NO11), calculated with reference to the dried drug.

Prepared slices

Processing

Fupian “Heishunpain” and “Baifupian” are used directly.

Description and Identification

As required for the crude drug.

Water and Diester-alkaloids

As required for the crude drug.

Assay

As required for the crude drug.

Dan fupian

Blanch “Yanfuzi” with water, 2-3 times a day until all salt is rinsed out. Boil together with Glycyrrhizae Radix, black beans and water until the centre of the cut surface is devoid of white core and the cut slice is numbless to the tongue. Remove Glycyrrhizae Radix and black beans, cut the drug into slices, and dry.

To each 100 kg of “Yanfuzi”, add 5 kg of Glycyrrhizae Radix and 10 kg of black beans.

In longitudinal cut slices, the upper end wider than the lower end, 1.7-5 cm long, 0.9-3 cm wide, 0.2-0.5 cm thick. Externally brown. Cut surface brown, translucent and showing longitudinal vascular bundles. Texture hard, fracture horny. Odour slight; taste weak, no numbing sensation to tongue.

Identification

As required for the crude drug.

Water

As required for the crude drug.

Diester-alkaloids

It contains not more than 0.010 per cent of the total amount of mesaconine (C31H43NO10), hypaconitine (C32H45NO10) and aconitine (C31H43NO9), calculated with reference to the dried drug.

Assay

As required for the crude drug.

“Fupian” (processed)

Scald “Fupian” with sand as described under the method for scalding <0213> until it is inflated and slightly discoloured.

The shape similar to Heishunpian or Baifupian, externally inflated, yellowish-brown, texture fragile. Odour slight; taste weak.

Property and Flavor

Highly hot; pungent and sweet; toxic.

Meridian tropism

Heart, kidney and spleen meridians.

Actions

To restore yang, induce resuscitation tonify fire assist yang, dissipate cold and relieve pain.

Indications

Yang collapse, coldness of limbs and faint pulse, deficiency of heart yang with chest bi disorder and heart pain, deficiency cold vomiting and diarrhea, cold pain in the epigastrium and abdomen, debilitation of kidney yang, impotence and uterine coldness, yin-cold edema, external contraction with yang deficiency, and cold-dampness arthralgia.

Administration and dosage

3-15 g. It should be decocted first and for a long time.

Precautions and Warnings

Used cautiously for pregnant woman. Incompatible with Pinelliae Rhizoma, Trichosanthis Fructus, Trichosanthis Semen, Trichosanthis Pericarpium, Trichosanthis Radix, Fritillariae Cirrhosae Bulbus, Fritillariae Thunbergii Bulbus, Fritillariae Ussuriensis Bulbus, Frifillariae PallidiFlorae Bulbus, Fritillariae Hupehensis Bulbus, Ampelopsis Radix, and Bletillae Rhizoma.

Storage

Preserve “Yanfuzi” in well closed container, and store in a cool and dry place. Preserve “Heishunpian” and “Baifupian” in a dry place, protected from moisture.