蟾酥

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

Overview 概述

Venenum Bufonis is the dried secretion of the auricular and skin glands of Bufo bufo gargarizans Cantor or Bufo melanostictus Schneider (Fam. Bufonidae). The drug is collected in summer and autumn, when the toads are abundant, and is squeezed out, washed, processed, and dried.
本品为蟾蜍科动物中华大蟾蜍 Bufo bufo gargarizans Cantor 或黑眶蟾蜍 Bufo melanostictus Schneider 的干燥分泌物。多于夏、秋二季捕捉蟾蜍，洗净，挤取耳后腺和皮肤腺的白色浆液，加工，干燥。

Description 性状

Venenum Bufonis occurs as flattened roundish masses or pieces. The former is hard and not easily broken, with a brownish-brown fracture surface, horny and slightly lustrous; the latter is brittle and easily broken, with a reddish-brown fracture surface, semi-transparent. It has a slight fishy odor, initially sweet and then with a persistent spicy sensation. The powder causes sneezing when smelled.
本品呈扁圆形团块状或片状。棕褐色或红棕色。团块状者质坚，不易折断，断面棕褐色，角质状，微有光泽；片状者质脆，易碎，断面红棕色，半透明。气微腥，味初甜而后有持久的麻辣感，粉末嗅之作嚏。

Identification 鉴别

When the section of the drug is moistened with water, it becomes raised and milky white.
（1）本品断面沾水，即呈乳白色隆起。

Take 0.1g of the powder, add 5ml of methanol, soak for 1 hour, filter, add a small amount of solid p-dimethylaminobenzaldehyde to the filtrate, and then add a few drops of sulfuric acid. The solution turns blue-purple.
（2）取本品粉末0.1g，加甲醇5ml，浸泡1小时，滤过，滤液加对二甲氨基苯甲醛固体少量，滴加硫酸数滴，即显蓝紫色。

Take 0.1g of the powder, add 5ml of chloroform, soak for 1 hour, filter, evaporate the filtrate to dryness, dissolve the residue in a small amount of acetic anhydride, and then add sulfuric acid. The solution initially turns blue-purple and gradually changes to blue-green.
（3）取本品粉末0.1g，加三氯甲烷5ml，浸泡1小时，滤过，滤液蒸干，残渣加醋酐少量使溶解，滴加硫酸，初显蓝紫色，渐变为蓝绿色。

To prepare the test solution, take 10ml of the solution obtained in the Assay section, evaporate to dryness in a water bath, dissolve in 2ml of methanol. Prepare the reference solution by taking 0.2g of the reference drug, adding 10ml of methanol, heating under reflux for 30 minutes, filtering, and using the filtrate 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 n-hexane, chloroform, and acetone (4:3:3) as the mobile phase. Apply separately to the plate 10 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 until the spots are clearly visible, and examine under daylight and ultraviolet light at 365 nm. The chromatogram obtained with the test solution shows spots or fluorescent spots of the same color as those obtained with the reference drug in corresponding positions.
（4）取〔含量测定〕项下供试品溶液10ml，水浴蒸干，用甲醇2ml溶解，作为供试品溶液。另取蟾酥对照药材0.2g，加甲醇10ml，加热回流30分钟，滤过，滤液作为对照药材溶液。照薄层色谱法（通则0502）试验，吸取上述两种溶液各10μl，分别点于同一硅胶G薄层板上，以环己烷-三氯甲烷-丙酮（4∶3∶3）为展开剂，展开，取出，晾干，喷以10%硫酸乙醇溶液，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，在与对照药材色谱相应的位置上，显相同颜色的斑点或荧光斑点。

Chromatographic Fingerprint 特征图谱

The determination is performed by high-performance liquid chromatography according to the method described in Assay.
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

Same as the Assay section.
同〔含量测定〕项。

Preparation of reference solutions 参照物溶液的制备

Take 25mg of the reference drug, prepare the reference solution of the reference drug according to the method described in the Assay section; take the reference solution of the reference drug described in the Assay section as the reference solution of the reference drug.
取蟾酥对照药材25mg，按〔含量测定〕项下供试品溶液制备方法制成对照药材参照物溶液；另取〔含量测定〕项下的对照品溶液，作为对照品参照物溶液。

Preparation of test solution 供试品溶液的制备

Take the test solution described in the Assay section, and the test solution is obtained.
取〔含量测定〕项下的供试品溶液，即得。

Assay method 测定法

Precisely aspirate 5μl of the reference solution and the test solution, inject into the liquid chromatograph, and determine.
分别精密吸取参照物溶液与供试品溶液各5μl，注入液相色谱仪，测定，即得。

The test solution should exhibit 5 characteristic peaks, which should correspond to the 5 characteristic peaks in the chromatogram of the reference drug. Peak 4 should have the same retention time as the peak of venenum bufonis toxin in the reference drug.
供试品特征图谱中应呈现5个特征峰，并应与对照药材参照物色谱峰中的5个特征峰相对应，其中峰4应与华蟾酥毒基参照物峰的保留时间相一致。

Examination 检查

Water 水分

Not more than 13.0 per cent <0832,method 2>.
不得过13.0%（通则0832第二法）。

Total ash 总灰分

Not more than 5.0 per cent <2302>.
不得过5.0%（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）。

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; acetonitrile as mobile phase A, 0.3% acetic acid solution as mobile phase B, perform gradient elution according to the specified conditions in the table below; column temperature is 30°C; flow rate is 0.6 ml per minute; detection wavelength is 296 nm. The theoretical plate number calculated based on the peak of hucansu toxin should not be less than 10000.
以十八烷基硅烷键合硅胶为填充剂；以乙腈为流动相A，0.3%乙酸溶液为流动相B，按下表中的规定进行梯度洗脱；柱温为30℃；流速为每分钟0.6ml；检测波长为296nm。理论板数按华蟾酥毒基峰计算应不低于10000。

Preparation of reference solution 对照品溶液的制备

Take an appropriate amount of hucansu toxin reference substance, accurately weigh, dissolve in methanol to obtain a solution containing 100 μg per 1 ml.
取华蟾酥毒基对照品适量，精密称定，加甲醇制成每1ml含100μg的溶液，即得。

Preparation of test solution 供试品溶液的制备

Take about 25 mg of this product powder, accurately weigh, place it in a stoppered conical flask, accurately add 20 ml of methanol, weigh, heat under reflux for 1 hour, cool, weigh again, make up for the weight loss with methanol, shake well, filter, and take the filtrate.
取本品细粉约25mg，精密称定，置具塞锥形瓶中，精密加入甲醇20ml，称定重量，加热回流1小时，放冷，再称定重量，用甲醇补足减失的重量，摇匀，滤过，取续滤液，即得。

Assay method 测定法

Precisely aspirate 10 μl of the above-mentioned reference solution and 10-20 μl of the test solution, inject into the liquid chromatograph for determination. Take hucansu toxin reference substance as the reference, and calculate the relative retention time of chansudin and lipophilic chansudin based on its corresponding peak. The relative retention time should be within the range of ±5% of the specified value. The relative retention time and correction factor are shown in the table below.
分别精密吸取上述对照品溶液10μl与供试品溶液10～20μl，注入液相色谱仪，测定，以华蟾酥毒基对照品为参照，以其相应的峰为S峰，计算蟾毒灵和脂蟾毒配基的相对保留时间，其相对保留时间应在规定值的±5%范围之内。相对保留时间及校正因子见下表∶

Take hucansu toxin reference substance as the reference, multiply by the correction factor respectively, and calculate the content of hucansu toxin, chansudin, and lipophilic chansudin.
以华蟾酥毒基对照品为对照，分别乘以校正因子，计算华蟾酥毒基、蟾毒灵和脂蟾毒配基的含量。

Calculated on the dried product basis, the total content of chansudin (C24H34O4), hucansu toxin (C26H34O6), and lipophilic chansudin (C24H32O4) should not be less than 7.0%.
本品按干燥品计算，含蟾毒灵(C24H34O4)、华蟾酥毒基(C26H34O6)和脂蟾毒配基(C24H32O4)的总量不得少于7.0%。

Prepared slices 饮片

Toad Venom powder 蟾酥粉

Processing 炮制

Take toad venom, crush it, soak it in white wine, stir it frequently until it becomes a thick paste, dry it, and grind it into powder.
取蟾酥，捣碎，加白酒浸渍，时常搅动至呈稠膏状，干燥，粉碎。

For every 10kg of toad venom, use 20kg of white wine.
每10kg蟾酥，用白酒20kg。

Property 性状

This product is brownish-yellow to brown powder. It has a slight fishy odor and a sweet taste followed by a persistent spicy sensation. It can cause sneezing when smelled.
本品为棕黄色至棕褐色粉末。气微腥，味初甜而后有持久的麻辣感，嗅之作嚏。

Examination 检查

Water 水分

Not more than 8.0 per cent, same as the crude drug.
同药材，不得过8.0%。

Identification 鉴别

(2)(3)(4) are the same as the crude drug.
(2)(3)(4) 同药材。

Characterisation mapping 特征图谱

Same as the crude drug.
同药材。

Assay 含量测定

Same as the crude drug.
同药材。

Property 性

warm.
温。

Toxicity 毒性

Toxic.
有毒。

Flavor 味

Pungent.
辛。

Meridian tropism 归经

Meridian tropism: Heart meridian.
归心经。

Actions 功能

Detoxification, pain relief, opening the orifices and awakening the mind.
解毒，止痛，开窍醒神。

Indications 主治

Used for carbuncles, furuncles, sore throat, heatstroke with loss of consciousness, abdominal distension, abdominal pain, vomiting, and diarrhea.
用于痈疽疔疮，咽喉肿痛，中暑神昏，痧胀腹痛吐泻。

Dosage 用量

0.015-0.03 g.
0.015～0.03g。

Administration 用法

Often used in pill or powder form. For external use, use an appropriate amount.
多入丸散用。外用适量。

Precautions 注意

Caution for pregnant women.
孕妇慎用。

Storage 贮藏

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

蟾酥

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

Overview 概述

Toad Venom is the dried secretion of Bufo bufo gargarizans Cantor or Bufo melanostictus Schneider (Fam. Bufonidae). Usually the toad is collected in summer or autumn, washed clean. The white serous fluid of the parotid glands and skin glands is squeezed out, processed, and dried.
本品为蟾蜍科动物中华大蟾蜍Bufo bufo gargarizans Cantor 或黑框蟾蜍Bufo melanostictus Schneider 的干燥分泌物。多于夏、秋二季捕捉蟾蜍，洗净，挤取耳后腺和皮肤腺的白色浆液，加工，干燥。

Description 性状

In flattened and rounded masses or slices, brown or reddish-brown. Texture of the mass hard, uneasily broken, fracture brown, cuticuloid, slightly lustrous. Texture of the slice fragile, easily broken, fracture reddish-brown, translucent. Odour, slightly stinking taste sweet at first, persistently tingling and pungent latter. Sneeze on smelling the powder.
本品呈扁圆形团块状或片状。棕褐色或红棕色。团块状者质坚，不易折断，断面棕褐色，角质状，微有光痒；片状者质脆，易碎，断面红棕色，半透明。气微腥，味初甜而后有持久的麻辣感，粉末嗅之作嚏。

Identification 鉴别

(1) A creamy white bump is produced on the fracture when touching water.
（1）本品断面沾水，即呈乳白色隆起。

(2) Macerate 0.1 g of the powder in 5 ml of methanol for 1 hour, filter. To the filtrate add a small quantity of p-dimethylaminobenzaldehyde and several drops of sulfuric acid, a bluish-violet colour is produced.
（2）取本品粉末0.1g，加甲醇5ml，浸泡1小时，滤过，滤液加对二甲氨基苯甲醛固体少量，滴加硫酸数滴，即显蓝紫色。

(3) Macerate 0.1g of the powder in 5 ml of chloroform for 1 hour, filter,evaporate the filtrate to dryness. Dissolve the residue in a small quantity of acetic anhydride, add sulfuric acid dropwise, a bluish-violet colour is produced, which turns gradually to bluish-green.
（3）取本品粉末0.1g，加三氯甲烷5ml，浸泡1小时，滤过，滤液蒸干，残渣加醋酐少量使溶解，滴加硫酸，初显蓝紫色，渐变为蓝绿色。

(4) Heat 0.2 g of the powder with 10 ml of ethanol under reflux for 30 minutes, filter, transfer the filtrate to a 10 ml volumetric flask and add ethanol to volume as the test solution. Prepare a solution of 0.2 g of Bufonis Venenum reference drug in the same manner as the reference drug solution. Dissolve a quantity of resibufogenin CRS and cinobufagin CRS in ethanol separately to produce two solutions each containing 1 mg per ml as the reference solutions. Carry out the method for thin layer chromatography <0502>, using silica gel G as the coating substance and a mixture of cyclohexane, chloroform and acetone (4 : 3 : 3) as the mobile phase. Apply separately to the plate 10 μl of each of the above four solutions. After developing and removal of the plate, dry in air, spray with a 10% solution of sulfuric acid in ethanol, heat to spots clear. 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 drug solution, one green and one red spots shown in the chromatogram of the test solution correspond in position to the spots in the chromatogram obtained with the reference solutions.
（4）取本品粉末0.2g，加乙醇10ml，加热回流30分钟，滤过，滤液置10ml量瓶中，加乙醇至刻度，摇匀，作为供试品溶液。另取蟾酥对照药材0.2g，同法制成对照药材溶液。再取脂蟾毒配基对照品、华蟾酥毒基对照品，加乙醇分别制成每1ml含1μg的溶液，作为对照品溶液。照薄层色谱法（通则0502）试验，吸取上述四种溶液各10μl，分别点于同一硅胶G薄层板上，以环己烷-三氯甲烷-丙酮（4：3：3）为展开剂，展开，取出，晾干，喷以10%硫酸乙醇溶液，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；在与对照品色谱相应的位置上，显相同的一个绿色及一个红色斑点。

Examination 检查

Water 水分

Not more than 13.0 per cent <0832, method 2>.
不得过13.0%（通则0832第二法）。

Total ash 总灰分

Not more than 5.0 per cent <2302>.
不得过5.0%（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）。

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 Use octadecylsilane bonded silica gel as the stationary phase and a mixture of 0.5% solution of potassium dihydrogen phosphate and acetonitrile <5050> (adjust to pH 3.2 with phosphoric acid) as the mobile phase. As detector spectrophotometer set at 296 nm. The temperature of the column is 40℃. The numbers of theoretical plates of the column are not less than 4000, calculated with references to the peaks of cinobufagin and resibufogenin, respectively.
色谱条件与系统适用性试验 以十八烷基硅烷键合硅胶为填充剂；以乙腈-0.5%磷酸二氢钾溶液（50：50）（用磷酸调节pH值为3.2）为流动相；检测波长为296nm；柱温40℃。理论板数按华蟾酥毒基峰、脂蟾毒配基峰计算应分别不低于 4000。

Reference solution Dissolve a quantity of cinobufagin CRS and resibufogenin CRS respectively, weighed accurately, in methanol to prepare two solutions each containing 50 μg per ml.
对照品溶液的制备 取华蟾酥毒基对照品、脂蟾毒配基对照品适量，精密称定，加甲醇分别制成每1ml各含华蟾酥毒基、脂蟾毒配基50μg的溶液，即得。

Test solution Weigh accurately 25 mg of the fine powder into a stoppered conical flask, add accurately 20 ml of methanol and weigh. Heat under reflux for 1 hour, allow to stand to cool, weigh again, replenish the loss of the solvent with methanol and mix well. Filter and use the successive filtrate as the test solution.
供试品溶液的制备 取本品细粉约25mg，精密称定，置具塞锥形瓶中，精密加入甲醇20ml，称定重量，加热回流1小时，放冷，再称定重量，用甲醇补足减失的重量，摇匀，滤过，取续滤液，即得。

Procedures Accurately inject 2 μl of each of the above two reference solutions and the test solution into the column, and calculate the content.
测定法 分别精密吸取上述两种对照品溶液与供试品溶液各2μ1，注入液相色谱仪，测定，即得。

It contains not less than 6.0 per cent of the total amount of cinobufagin (C26H34O6) and resibufogenin (C24H32O4) calculated with reference to the dried drug.
本品按干燥品计算，含华蟾酥毒基（C26H34O6）和脂蟾毒配基（C24H32O4）的总量不得少于6.0%。

Prepared slices 饮片

Bufonis Venenum (powdered) 蟾酥粉

Processing Bufonis Venenum (powdered) Break Bufonis Venenum to pieces, macerate with white rice wine, frequently stir until become concentrated extract, dry and pulverize.
取蟾酥，捣碎，加白酒浸渍，时常搅动至呈稠膏状，干燥，粉碎。

To each 10 kg of Bufonis Venenum add 20 kg of white rice wine.
每10kg蟾酥，用白酒20kg。

Property 性

Warm; pungent; toxic.
辛，温；有毒。

Flavor 味

Sweet at first, persistently tingling and pungent latter.
初甜而后有持久的麻辣感。

Meridian tropism 归经

Heart meridian.
心经。

Actions 功能

To remove toxin, relieve pain, open the orifices and lighten the spirit.
解毒，止痛，开窍醒神。

Indications 主治

Abscesses and cellulitis, deep-rooted boil and sore, swollen sore throat, loss of consciousness caused by summerheat stroke, vomiting and diarrhea with abdominal pain in Shazhang (acute gastrointestinal infection).
用于痈疽疔疮，咽喉肿痛，中暑神昏，痧胀腹痛吐泻。

Dosage 用量

0.015-0.03 g, usually used in pills or powder. Appropriate amount for topical application.
0.015～0.03g，多入丸散用。外用适量。

Precautions and Warnings 注意

Use with caution during pregnancy.
孕妇慎用。

Storage 贮藏

Preserve in a dry place, and protect from moisture.
置干燥处，防潮。