冰片（合成龙脑）

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

性状 Description

本品为无色透明或白色半透明的片状松脆结晶；气清香，味辛、凉；具挥发性，点燃发生浓烟，并有带光的火焰。
Synthetic Borneol is colorless, transparent or white translucent flaky brittle crystals; odor, fragrant; taste, pungent and cool; volatile, burns with dense smoke and a flame with light.

本品在乙醇、三氯甲烷或乙醚中易溶，在水中几乎不溶。
It is soluble in ethanol, trichloromethane or ether and practically insoluble in water.

熔点 应为205～210°C(通则0612)。
The melting point should be 205-210°C <0612>.

鉴别 Identification

(1) 取本品10 mg，加乙醇数滴使溶解，加新制的1%香草醛硫酸溶液1～2滴，即显紫色。
(1) To 10 mg of the powder add a few drops of ethanol to dissolve, add 1-2 drops of freshly prepared 1% vanillin sulfuric acid solution, and it turns purple.

(2) 取本品3 g，加硝酸10 ml，即产生红棕色的气体，待气体产生停止后，加水20 ml，振摇，滤过，滤渣用水洗净后，有樟脑臭。
(2) To 3 g of the powder add 10 ml of nitric acid, which produces a reddish-brown gas. After the gas production stops, add 20 ml of water, shake, filter, wash the residue with water, and it has the smell of camphor.

检查 Examination

pH值 pH value

取本品2.5 g，研细，加水25 ml，振摇，滤过，分取滤液两份，每份10 ml，一份加甲基红指示液2滴，另一份加酚酞指示液2滴，均不得显红色。
Take 2.5 g of the sample, grind it finely, add 25 ml of water, shake well, filter, take two portions of the filtrate, each 10 ml, add 2 drops of methyl red indicator to one portion, and add 2 drops of phenolphthalein indicator to the other portion. Neither portion should show a red color.

不挥发物 Non-volatile matter

取本品10 g，置称定重量的蒸发皿中，置水浴上加热挥发后，在105°C干燥至恒重，遗留残渣不得过3.5 mg(0.035%)。
Take 10 g of the sample, place it in an evaporating dish with a known weight, heat it on a water bath to volatilize, and dry it at 105°C until a constant weight is obtained. The residue should not exceed 3.5 mg (0.035%).

水分 Water

取本品1 g，加石油醚10 ml，振摇使溶解，溶液应澄清。
Take 1 g of the sample, add 10 ml of petroleum ether, shake to dissolve, and the solution should be clear.

重金属 Heavy metals

取本品2 g，加乙醇23 ml溶解后，加稀醋酸2 ml，依法检查(通则0821第一法)，含重金属不得过5 mg/kg。
Take 2 g of the sample, dissolve it in 23 ml of ethanol, add 2 ml of dilute acetic acid, and carry out the test according to the law (General Rule 0821, method 1). The content of heavy metals should not exceed 5 mg/kg.

砷盐 Arsenic salt

取本品1 g，加氢氧化钙0.5 g与水2 ml，混匀，置水浴上加热使本品挥发后，放冷，加盐酸中和，再加盐酸5 ml与水适量使成28 ml，依法检查(通则0822)，含砷量不得过2 mg/kg。
Take 1 g of the sample, add 0.5 g of calcium hydroxide and 2 ml of water, mix well, heat on a water bath to volatilize the sample, cool, neutralize with hydrochloric acid, and then add 5 ml of hydrochloric acid and enough water to make 28 ml. Carry out the test according to the law (General Rule 0822). The content of arsenic should not exceed 2 mg/kg.

樟脑 Camphor

取本品细粉约0.15 g，精密称定，置10 ml量瓶中，加乙酸乙酯溶解并稀释至刻度，摇匀，滤过，取续滤液作为供试品溶液。另取樟脑对照品适量，精密称定，加乙酸乙酯制成每1 ml含0.3 mg的溶液，作为对照品溶液。照〔含量测定〕项下的方法测定，计算，即得。
Take about 0.15 g of the sample, accurately weigh it, place it in a 10 ml volumetric flask, dissolve it in ethyl acetate and dilute to the mark, shake well, filter, and take the subsequent filtrate as the test solution. Take an appropriate amount of camphor reference substance, accurately weigh it, dissolve it in ethyl acetate to make a solution containing 0.3 mg per 1 ml, and use it as the reference solution. Carry out the determination according to the method under the "Content Determination" section, calculate, and obtain the result.

本品含樟脑(C10H16O)不得过0.50%。
The content of camphor (C10H16O) in the sample should not exceed 0.50%.

含量测定 Content determination

照气相色谱法(通则0521)测定。
Carry out the determination according to the gas chromatography method (General Rule 0521).

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

以聚乙二醇20000(PEG-20M)为固定相，涂布浓度为10%；柱温为140°C。理论板数按龙脑峰计算应不低于2000。
Use polyethylene glycol 20000 (PEG-20M) as the stationary phase with a coating concentration of 10%; the column temperature is 140°C. The theoretical number of plates calculated based on the peak of borneol should not be less than 2000.

对照品溶液的制备 Preparation of reference solution

取龙脑对照品适量，精密称定，加乙酸乙酯制成每1 ml含5 mg的溶液，即得。
Take an appropriate amount of borneol reference substance, accurately weigh it, dissolve it in ethyl acetate to make a solution containing 5 mg per 1 ml, and obtain the reference solution.

供试品溶液的制备 Preparation of test solution

取本品细粉约50 mg，精密称定，置10 ml量瓶中，加乙酸乙酯溶解并稀释至刻度，摇匀，即得。
Take about 50 mg of the sample, accurately weigh it, place it in a 10 ml volumetric flask, dissolve it in ethyl acetate and dilute to the mark, shake well, and obtain the test solution.

测定法 Determination method

分别精密吸取对照品溶液与供试品溶液各1 μl，注入气相色谱仪，测定，即得。
Accurately draw 1 μl of the reference solution and the test solution, respectively, inject them into the gas chromatograph, and determine the content.

本品含龙脑(C10H18O)不得少于55.0%。
The content of borneol (C10H18O) in the sample should not be less than 55.0%.

性 Property

微寒。
slightly cold.

味 Flavor

辛、苦。
Pungent, bitter.

归经 Meridian tropism

归心、脾、肺经。
Meridian tropism: Heart, spleen, and lung meridians.

功能 Actions

开窍醒神，清热止痛。
To open the orifices and awaken the mind, clear heat and relieve pain.

主治 Indications

用于热病神昏、惊厥，中风痰厥，气郁暴厥，中恶昏迷，胸痹心痛，目赤，口疮，咽喉肿痛，耳道流脓。
Used for heat-induced coma, convulsions, wind-phlegm convulsions, qi stagnation-induced convulsions, coma due to internal evil, chest obstruction and heart pain, red eyes, mouth ulcers, sore throat, and otorrhea.

用量 Dosage

0.15～0.3 g。
0.15-0.3 g.

用法 Administration

入丸散用。外用研粉点敷患处。
Taken in pill or powder form. For external use, grind into powder and apply to the affected area.

注意 Precautions

孕妇慎用。
Caution: Avoid use during pregnancy.

贮藏 Storage

密封，置凉处。
Store in a sealed container in a cool place.

概述 | Overview

本品为无色透明或白色半透明的片状松脆结晶；气清香，味辛、凉；具挥发性，点燃发生浓烟，并有带光的火焰。
Borneolum Syntheticum is colorless, transparent or white translucent crystalline flakes; it has a clear fragrance, a pungent and cool taste; it is volatile, and when ignited, it produces dense smoke and a flame with light.

本品在乙醇、三氯甲烷或乙醚中易溶，在水中几乎不溶。
It is easily soluble in ethanol, chloroform, or ether, and almost insoluble in water.

熔点 | Melting point

应为205～210℃（通则0612）。
The melting point should be 205-210°C (General Rule 0612).

鉴别 | Identification

（1）取本品10mg，加乙醇数滴使溶解，加新制的1%香草醛硫酸溶液1～2滴，即显紫色。
(1) Take 10mg of the product, dissolve it in a few drops of ethanol, and add 1-2 drops of freshly prepared 1% vanillin sulfuric acid solution, which will turn purple.

（2）取本品3g，加硝酸10ml，即产生红棕色的气体，待气体产生停止后，加水20ml，振摇，滤过，滤渣用水洗净后，有樟脑臭。
(2) Take 3g of the product, add 10ml of nitric acid, which will produce a reddish-brown gas. After the gas production stops, add 20ml of water, shake, filter, and wash the residue with water. It should have the smell of camphor.

检查 | Examination

pH值 | pH value

取本品2.5g，研细，加水25ml，振摇，滤过，分取滤液两份，每份10ml，一份加甲基红指示液2滴，另—份加酚酞指示液2滴，均不得显红色。
Take 2.5g of the product, grind it finely, add 25ml of water, shake, filter, and divide the filtrate into two portions, each 10ml. Add 2 drops of methyl red indicator to one portion, and 2 drops of phenolphthalein indicator to the other portion. Neither should show a red color.

不挥发物 | Non-volatile matter

取本品10g，置称定重量的蒸发皿中，置水浴上加热挥发后，在105℃干燥至恒重，遗留残渣不得过3.5mg（0.035%）。
Take 10g of the product, place it in an evaporating dish with a predetermined weight, heat it on a water bath to evaporate, and dry at 105°C until a constant weight is reached. The residue should not exceed 3.5mg (0.035%).

水分 | Water

取本品1g，加石油醚10ml，振摇使溶解，溶液应澄清。
Take 1g of the product, add 10ml of petroleum ether, shake to dissolve, and the solution should be clear.

重金属 | Heavy metals

取本品2g，加乙醇23ml溶解后，加稀醋酸2ml，依法检查（通则0821第一法），含重金属不得过5mg/kg。
Take 2g of the product, dissolve it in 23ml of ethanol, add 2ml of dilute acetic acid, and carry out the test according to the regulations (General Rule 0821, Method 1). The content of heavy metals should not exceed 5mg/kg.

砷盐 | Arsenic salts

取本品1g，加氢氧化钙0.5g与水2ml，混匀，置水浴上加热使本品挥发后，放冷，加盐酸中和，再加盐酸5ml与水适量使成28ml，依法检查（通则0822），含砷量不得过2mg/kg。
Take 1g of the product, add 0.5g of calcium hydroxide and 2ml of water, mix well, heat on a water bath to evaporate the product, let it cool, neutralize with hydrochloric acid, and then add 5ml of hydrochloric acid and enough water to make 28ml. Carry out the test according to the regulations (General Rule 0822). The content of arsenic should not exceed 2mg/kg.

樟脑 | Camphor

取本品细粉约0.15g，精密称定，置10ml量瓶中，加乙酸乙酯溶解并稀释至刻度，摇匀，滤过，取续滤液作为供试品溶液。另取樟脑对照品适量，精密称定，加乙酸乙酯制成每1ml含0.3mg的溶液，作为对照品溶液。照〔含量测定〕项下的方法测定，计算，即得。
Take about 0.15g of the product, accurately weigh it, place it in a 10ml volumetric flask, dissolve it in ethyl acetate and dilute to the mark, shake well, filter, and take the filtrate as the test solution. Take an appropriate amount of camphor reference substance, accurately weigh it, and prepare a solution containing 0.3mg per ml in ethyl acetate as the reference solution. Carry out the test according to the method under "Content Determination", calculate, and obtain the result.

本品含樟脑（C10H16O）不得过0.50%。
The content of camphor (C10H16O) in the product should not exceed 0.50%.

含量测定 | Content Determination

照气相色谱法（通则0521）测定。
Carry out the determination according to the gas chromatography method (General Rule 0521).

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

以聚乙二醇20000（PEG-20M）为固定相，涂布浓度为10%；柱温为140℃。理论板数按龙脑峰计算应不低于2000。
Use polyethylene glycol 20000 (PEG-20M) as the stationary phase with a coating concentration of 10%; the column temperature is 140°C. The theoretical number of plates calculated based on the peak of camphor should not be less than 2000.

对照品溶液的制备 | Preparation of reference solution

取龙脑对照品适量，精密称定，加乙酸乙酯制成每1ml含5mg的溶液，即得。
Take an appropriate amount of camphor reference substance, accurately weigh it, and prepare a solution containing 5mg per ml in ethyl acetate as the reference solution.

供试品溶液的制备 | Preparation of test solution

取本品细粉约50mg，精密称定，置10ml量瓶中，加乙酸乙酯溶解并稀释至刻度，摇匀，即得。
Take about 50mg of the product, accurately weigh it, place it in a 10ml volumetric flask, dissolve it in ethyl acetate and dilute to the mark, shake well, and obtain the test solution.

测定法 | Determination method

分别精密吸取对照品溶液与供试品溶液各1µl，注入气相色谱仪，测定，即得。
Accurately draw 1µl of the reference solution and the test solution, respectively, inject them into the gas chromatograph, and determine the content.

本品含龙脑（C10H18O）不得少于55.0%。
The content of camphor (C10H18O) in the product should not be less than 55.0%.

性味与归经 | Property and Flavor

辛、苦，微寒。归心、脾、肺经。
Pungent, bitter, slightly cold. Belongs to the heart, spleen, and lung meridians.

功能与主治 | Actions and Indications

开窍醒神，清热止痛。用于热病神昏、惊厥，中风痰厥，气郁暴厥，中恶昏迷，胸痹心痛，目赤，口疮，咽喉肿痛，耳道流脓。
Opens the orifices, awakens the mind, clears heat, and relieves pain. Used for heat-induced coma, convulsions, wind-phlegm convulsions, qi stagnation convulsions, delirium due to internal heat, chest obstruction and heart pain, red eyes, mouth ulcers, swollen throat, and otorrhea.

用法与用量 | Administration and Dosage

0.15～0.3g，入丸散用。外用研粉点敷患处。
0.15-0.3g, taken in pill or powder form. For external use, grind into powder and apply to the affected area.

注意 | Precautions

孕妇慎用。
Caution should be exercised in pregnant women.

贮藏 | Storage

密封，置凉处。
Store in a sealed container in a cool place.