水蛭

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

Overview 概述

Leech is the dried whole body of Whitmania pigra Whitman, Hirudo nipponica Whitman, or Whitmania acranulata Whitman (Fam. Hirudinidae). It is collected in summer and autumn, killed by boiling water, and dried in the sun or at low temperature.
本品为水蛭科动物蚂蟥Whitmania pigra Whitman、水蛭Hirudo nipponica Whitman或柳叶蚂蟥Whitmania acranulata Whitman的干燥全体。夏、秋二季捕捉，用沸水烫死，晒干或低温干燥。

Description 性状

蚂蟥Whitmania pigra Whitman

It is flat and spindle-shaped, with numerous segments, 4-10 cm long and 0.5-2 cm wide. The dorsal surface is dark brown or blackish-brown, slightly raised, and when soaked in water, black spots arranged in 5 longitudinal stripes can be seen. The ventral surface is flat and brownish-yellow. The sides are brownish-yellow, the anterior end is slightly pointed, and the posterior end is blunt and round. There is a sucker at each end, with the anterior sucker being inconspicuous and the posterior sucker being larger. The texture is brittle, easily broken, and the fracture surface is gelatinous. It has a slight fishy odor.
呈扁平纺锤形，有多数环节，长4～10 cm，宽0.5～2 cm。背部黑褐色或黑棕色，稍隆起，用水浸后，可见黑色斑点排成5条纵纹；腹面平坦，棕黄色。两侧棕黄色，前端略尖，后端钝圆，两端各具1吸盘，前吸盘不显著，后吸盘较大。质脆，易折断，断面胶质状。气微腥。

水蛭Hirudo nipponica Whitman

It is flat and elongated, with a twisted and curved body, 2-5 cm long and 0.2-0.3 cm wide.
扁长圆柱形，体多弯曲扭转，长2～5 cm，宽0.2～0.3 cm。

柳叶蚂蟥Whitmania acranulata Whitman

It is narrow and flat, 5-12 cm long and 0.1-0.5 cm wide.
狭长而扁，长5～12 cm，宽0.1-0.5 cm。

Identification 鉴别

To 1 g of the powder add 5 ml of ethanol, treat with ultrasound for 15 minutes, filter, and take the filtrate as the test solution. Take 1 g of the reference drug Hirudo nipponica and prepare the reference drug solution in the same manner. Carry out the method for thin layer chromatography<0502>, using silica gel G as the coating substance and a mixture of cyclohexane and ethyl acetate (4:1) as the mobile phase. Apply separately to the plate 5 μl 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. The purple-red spot in the chromatogram obtained with the test solution corresponds in position to the spot in the chromatogram obtained with the reference drug solution; under ultraviolet light at 365 nm, the same orange-red fluorescent spot is observed.
取本品粉末1 g，加乙醇5 ml，超声处理15分钟，滤过，取滤液作为供试品溶液。另取水蛭对照药材1 g，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5 μl，分别点于同一硅胶G薄层板上，以环己烷-乙酸乙酯（4:1）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。供试品色谱中，在与对照药材色谱相应的位置上，显相同的紫红色斑点；紫外光灯（365 nm）下显相同的橙红色荧光斑点。

Examination 检查

Water 水分

Not more than 18.0 per cent <0832,method 2>.
不得过18.0%（通则0832第二法）。

Total ash 总灰分

Not more than 8.0 per cent <2302>.
不得过8.0%（通则2302）。

Acid-insoluble ash 酸不溶性灰分

Not more than 2.0 per cent <2302>.
不得过2.0%（通则2302）。

pH value 酸碱度

Take about 1 g of the powder (passed through a No. 3 sieve) of the sample, add 10 ml of 0.9% sodium chloride solution, stir well, macerate for 30 minutes with occasional shaking, centrifuge, take the supernatant, and determine the pH value according to the method for pH determination <0631>. It should be 5.0-7.5.
取本品粉末（过三号筛）约1 g，加入0.9%氯化钠溶液10 ml，充分搅拌，浸提30分钟，并时时振摇，离心，取上清液，照pH值测定法（通则0631）测定，应为5.0～7.5。

Heavy metals and harmful elements 重金属及有害元素

Determine according to the method for determination of lead, cadmium, arsenic, mercury, and copper <2321> by atomic absorption spectrophotometry or inductively coupled plasma mass spectrometry. The lead content should not exceed 10 mg/kg, the cadmium content should not exceed 1 mg/kg, the arsenic content should not exceed 5 mg/kg, and the mercury content should not exceed 1 mg/kg.
照铅、镉、砷、汞、铜测定法（通则2321原子吸收分光光度法或电感耦合等离子体质谱法）测定，铅不得过10 mg/kg、镉不得过1 mg/kg、砷不得过5 mg/kg、汞不得过1 mg/kg。

Aflatoxins 黄曲霉毒素

Determine according to the method for determination of mycotoxins <2351>.
照真菌毒素测定法（通则2351）测定。

The content of aflatoxin B1 in the sample should not exceed 5 μg per 1000g , and the total content of aflatoxin G2, aflatoxin G1, aflatoxin B2, and aflatoxin B1 should not exceed 10 μg.
本品每1000 g含黄曲霉毒素B1不得过5 μg，黄曲霉毒素G2、黄曲霉毒素G1、黄曲霉毒素B2和黄曲霉毒素B1的总量不得过10 μg。

Assay 含量测定

Take about 1 g of the powder (passed through a No. 3 sieve) of the sample, accurately weigh, accurately add 5 ml of 0.9% sodium chloride solution, stir well, macerate for 30 minutes with occasional shaking, centrifuge, accurately take 100 μl of the supernatant, place it in a test tube (8 mm×38 mm), add 200 μl of tris(hydroxymethyl)aminomethane hydrochloride buffer solution containing 0.5% (bovine) fibrinogen (calculated as solid) <Note 1> (prepared for immediate use), shake well, place it in a water bath at (37℃±0.5℃) for 5 minutes, and add 1 ml of thrombin solution containing 40 units per ml <Note 2> (add 5 μl every 1 minute, gently shake while adding) until coagulation (leech) or add 1ml of thrombin solution containing 10 units per ml <Note 2> (add 2 μl every 4 minutes, gently shake while adding) until coagulation (leech or medicinal leech). Record the volume of consumed thrombin solution and calculate according to the following formula:
取本品粉末（过三号筛）约1 g，精密称定，精密加入0.9%氯化钠溶液5 ml，充分搅拌，浸提30分钟，并时时振摇，离心，精密量取上清液100μl，置试管（8 mm×38 mm）中，加入含0.5%（牛）纤维蛋白原（以凝固物计）的三羟甲基氨基甲烷盐酸缓冲液［注1]（临用配制）200 μl，摇匀，置水浴中（37℃±0.5℃）温浸5分钟，滴加每1 ml中含40单位的凝血酶溶液［注2]（每1分钟滴加1次，每次5 μl，边滴加边轻轻摇匀）至凝固（水蛭）或滴加每1 ml中含10单位的凝血酶溶液［注2]（每4分钟滴加1次，每次2 μl，边滴加边轻轻摇匀）至凝固（蚂蟥、柳叶蚂蟥），记录消耗凝血酶溶液的体积，按下式计算：

U is the content of thrombin activity units per 1 g, U/g;
U为每1 g含凝血酶活性单位，U/g；

C1 is the concentration of thrombin solution, μ/ml;
C1为凝血酶溶液的浓度，μ/ml；

C2 is the concentration of the sample solution, g/ml;
C2为供试品溶液的浓度，g/ml；

V1 is the volume of consumed thrombin solution, μl;
V1为消耗凝血酶溶液的体积，μl；

V2 is the volume of the sample solution added, μl.
V2为供试品溶液的加入量，μl。

The amount of thrombin that neutralizes one unit is one unit of antithrombin activity.
中和一个单位的凝血酶的量，为一个抗凝血酶活性单位。

The content of antithrombin activity in the sample should not be less than 16.0 U per 1 g for leeches and not less than 3.0U for medicinal leeches.
本品每1 g含抗凝血酶活性水蛭应不低于16.0U；蚂蟥、柳叶蚂蟥应不低于3.0 U。

Prepared slices 饮片

Leech 水蛭

Processing 炮制

Clean the leeches, cut into sections, and dry.
洗净，切段，干燥。

Appearance 性状

The sample is irregular in shape, flat or flat cylindrical. The dorsal surface is blackish-brown and slightly raised, and the ventral surface is brownish-brown with fine transverse annular lines. The cut surface is grayish-white to brownish-yellow and gelatinous. The texture is brittle and the odor is slightly fishy.
本品呈不规则的段状、扁块状或扁圆柱状。背部表面黑褐色，稍隆起，腹面棕褐色，均可见细密横环纹。切面灰白色至棕黄色，胶质状。质脆，气微腥。

Blanched leech 烫水蛭

Processing 炮制

Take clean leech sections, blanch them with talcum powder according to the method for blanching <0213> until slightly swollen.
取净水蛭段，照炒法（通则0213）用滑石粉烫至微鼓起。

Appearance 性状

The sample is irregular in shape, flat or flat cylindrical, slightly swollen, with blackish-brown on the dorsal surface and brownish-yellow to brownish-brown on the ventral surface, with a small amount of white talcum powder attached. The cut surface is spongy, grayish-white to dark yellow. The odor is slightly fishy.
本品呈不规则段状、扁块状或扁圆柱状，略鼓起，背部黑褐色，腹面棕黄色至棕褐色，附有少量白色滑石粉。断面松泡，灰白色至焦黄色。气微腥。

Examination 检查

Water 水分

Not more than 14.0 per cent, same as the crude drug.
同药材，不得过14.0%。

Total ash 总灰分

Not more than 10.0 per cent, same as the crude drug.
同药材，不得过10.0%。

Acid-insoluble ash 酸不溶性灰分

Not more than 3.0 per cent, same as the crude drug.
同药材，不得过3.0%。

pH value 酸碱度

Same as the crude drug.
同药材。

Heavy metals and harmful elements 重金属及有害元素

Same as the crude drug.
同药材。

Aflatoxins 黄曲霉毒素

Same as the crude drug.
同药材。

Identification 鉴别

Same as the crude drug.
同药材。

Property 性

Neutral.
平。

Toxicity 毒性

Slightly toxic.
有小毒。

Flavor 味

Salty，bitter.
咸、苦。

Meridian tropism 归经

Meridian tropism: Liver meridian.
归肝经。

Actions 功能

To promote blood circulation and remove blood stasis, resolve masses and dissipate nodules.
破血通经，逐瘀消癥。

Indications 主治

Used for blood stasis causing amenorrhea, masses and lumps, stroke with hemiplegia, and traumatic injuries.
用于血瘀经闭，癥瘕痞块，中风偏瘫，跌扑损伤。

Dosage 用量

1-3 g.
1～3 g。

Administration 用法

None.
无。

Precautions 注意

Not to be used during pregnancy.
孕妇禁用。

Storage 贮藏

Store in a dry place, protected from moth.
置干燥处，防蛀。

Note 1: Preparation of tris(hydroxymethyl)aminomethane hydrochloride buffer solution: Take 25ml of 0.2 mol/L tris(hydroxymethyl)aminomethane solution and about 40 ml of 0.1 mol/L hydrochloric acid solution, add water to 100ml, and adjust the pH value to 7.4.
注：［1］三羟甲基氨基甲烷盐酸缓冲液的配制 取0.2 mol/L三羟甲基氨基甲烷溶液25ml与0.1 mol/L盐酸溶液约40 ml，加水至100 ml，调节pH值至7.4。

Note 2: Preparation of thrombin solution: Take an appropriate amount of thrombin reagent and prepare a solution containing 40 units or 10 units of thrombin per 1 ml with physiological saline (prepared for immediate use).
［2］凝血酶溶液的配制 取凝血酶试剂适量，加生理盐水配制成每1 ml含凝血酶40个单位或10个单位的溶液（临用配制）。

水蛭

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

Overview 概述

Leech is the dried body of Whitmania pigra Whitman, Hirudo nipponica Whitman or Whitmania acranulata Whitman (Fam. Hirudinidae). The drug is collected in summer or autumn, scalded to death with boiling water, dried in the sun or at a low temperature.
本品为水蛭科动物蚂蟥Whitmania pigra Whitman、水蛭Hirudo nipponica Whitman或柳叶蚂蟥Whitmania acranulata Whitman的干燥全体。夏、秋二季捕捉，用沸水烫死，晒干或低温干燥。

Description 性状

呈扁平纺锤形，有多数环节，长4～10cm，宽0.5～2cm。背部黑褐色或黑棕色，稍隆起，用水浸后，可见黑色斑点排成5条纵纹；腹面平坦，棕黄色。两侧棕黄色，前端略尖，后端钝圆，两端各具1吸盘，前吸盘不显著，后吸盘较大。质脆，易折断，断面胶质状。气微腥。
蚂蟥

扁长圆柱形，体多弯曲扭转，长2～5cm，宽0.2～0.3cm。
水蛭

狭长而扁，长5～12cm，宽0.1～0.5cm。
柳叶蚂蟥

Identification 鉴别

To 1 g of the powder add 5 ml of ethanol, ultrasonicate for 15 minutes, filter and use the filtrate as the test solution. Prepare a solution of 1 g of Hirudo reference drug in the same manner as the reference drug solution. Carry out the method for thin layer chromatography<0502>, using silica gel G as the coating substance and a mixture of cyclohexane and acetyl acetate (4:1) as the mobile phase. Apply separately 5 μl of the above two solutions to the plate. After developing and removal of the plate, dry in air. Spray with a 10% solution of sulfuric acid in ethanol and heat at 105℃ to spots clear. The purplish-red spots in the chromatogram obtained with the test solution correspond in position and colour to the spots in the chromatogram obtained with the reference drug solution. Examine under ultraviolet light at 365 nm. The orange-red 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 drug solution.
取本品粉末1g，加乙醇5ml，超声处理15分钟，滤过，取滤液作为供试品溶液。另取水蛭对照药材1g，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5μl，分别点于同一硅胶G薄层板上，以环己烷-乙酸乙酯（4：1）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。供试品色谱中，在与对照药材色谱相应的位置上，显相同的紫红色斑点；紫外光灯（365nm）下显相同的橙红色荧光斑点。

Examination 检查

Water 水分

Not more than 18.0 per cent <0832, method 2>.
不得过18.0%（通则0832第二法）。

Total ash 总灰分

Not more than 8.0 per cent <2302>.
不得过8.0%（通则2302）。

Acid-insoluble ash 酸不溶性灰分

Not more than 2.0 per cent <2302>.
不得过2.0%（通则2302）。

Acidity 酸碱度

To about 1 g of powder (through No.3 sieve) add 10 ml of a 0.9% solution of sodium chloride, mix well and macerate for 30 minutes by shaking frequently, centrifuge, use the supernatant as the test solution. Carry out the method for determination of pH value<0631>, it should be 5.0 to 7.5.
取本品粉末（过三号筛）约1g，加入0.9%氯化钠溶液10ml，充分搅拌，浸提30分钟，并时时振摇，离心，取上清液，照pH值测定法（通则0631）测定，应为5.0～7.5。

Heavy metals and harmful elements 重金属及有害元素

Carry out the method for determination of lead, cadmium, arsenic, mercury, and copper<2321, atomic absorption spectrophotometry or inductively coupled plasma mass spectrometry>, not more than 10 mg/kg of lead, 1 mg/kg of cadmium, 5 mg/kg of arsenic, 1 mg/kg of mercury.
照铅、镉、砷、汞、铜测定法（通则2321原子吸收分光光度法或电感耦合等离子体质谱法）测定，铅不得过10mg/kg、镉不得过1mg/kg、砷不得过5mg/kg、汞不得过1mg/kg。

Aflatoxins 黄曲霉毒素

本品每1000g含黄曲霉毒素B1不得过5μg，黄曲霉毒素G2、黄曲霉毒素G1、黄曲霉毒素B2和黄曲霉毒素B1的总量不得过10μg。
照黄曲霉毒素测定法（通则2351）测定。

Assay 含量测定

U=（C1V1/C2V2）
取本品粉末（过三号筛）约1g，精密称定，精密加入0.9%氯化钠溶液5ml，充分搅拌，浸提30分钟，并时时振摇，离心，精密量取上清液100μl，置试管（8mm×38mm）中，加入含0.5%（牛）纤维蛋白原（以凝固物计）的三羟甲基氨基甲烷盐酸缓冲液[注1]（临用配制）200μl，摇匀，置水浴中（37℃±0.5℃）温浸5分钟，滴加每1ml中含40单位的凝血酶溶液[注2]（每1分钟滴加1次，每次5μl，边滴加边轻轻摇匀）至凝固（水蛭）或滴加每1ml中含10单位的凝血酶溶液[注2]（每4分钟滴加1次，每次2μl，边滴加边轻轻摇匀）至凝固（蚂蟥、柳叶蚂蟥），记录消耗凝血酶溶液的体积，按下式计算：

Prepared slices 饮片

Leech 水蛭

Processing 炮制

Wash clean, cut into sections, and dry.
洗净，切段，干燥。

Leech (scalded) 烫水蛭

Scald sections of the clean Leech with talc powder as described under the method for scalding<0213> until it becomes slightly expanded.
取净水蛭段，照烫法（通则0213）用滑石粉烫至微鼓起。

In irregular flattened pieces or cylinder, slightly expanded, externally brownish-yellow to blackish-brown, with a few white talc. Fracture loose, greyish-white to burned yellow. Odour, slightly stinking.
本品呈不规则扁块状或扁圆柱形，略鼓起，表面棕黄色至黑褐色，附有少量白色滑石粉。断面松泡，灰白色至焦黄色。气微腥。

Examination 检查

Water 水分

Not more than 14.0 per cent, following the method for the crude drug.
同药材，不得过14.0%。

Total ash 总灰分

Not more than 10.0 per cent, following the method for the crude drug.
同药材，不得过10.0%。

Acid-insoluble ash 酸不溶性灰分

Not more than 3.0 per cent, following the method for the crude drug.
同药材，不得过3.0%。

Acidity, Heavy metals and harmful elements, Aflatoxins 酸碱度、重金属及有害元素、黄曲霉毒素

As required for the crude drug.
同药材。

Property and Flavor 性味与归经

Neutral; salty and bitter; slightly toxic. Liver meridian.
咸、苦，平；有小毒。归肝经。

Actions and Indications 功能与主治

To break blood, and unblock the meridian, expel stasis, and eliminate mass. Blood stasis amenorrhea, aggregation accumulation masses, glomus, hemiplegia caused by wind-stroke, and traumatic injuries.
破血通经，逐瘀消癥。用于血瘀经闭，癥瘕痞块，中风偏瘫，跌扑损伤。

Administration and dosage 用法与用量

1-3 g.
l～3g。

Precautions and Warnings 注意

Contraindicated during pregnancy.
孕妇禁用。

Storage 贮藏

Preserve in a dry place, and protect from moth.
置干燥处，防蛀。

[1] 三羟甲基氨基甲烷盐酸缓冲液的配制 0.2mol/L三羟甲基氨基甲烷溶液25ml与0.1mol/L盐酸溶液约40ml，加水至100ml，调节pH值至7.4。
注：