天仙子

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

概述 Overview

本品为茄科植物莨菪Hyoscyamus niger L.的干燥成熟种子。夏、秋二季果皮变黄色时，采摘果实，暴晒，打下种子，筛去果皮、枝梗，晒干。
Hyoscyamus Seed is the dried ripe seed of Hyoscyamus niger L. (Fam. Solanaceae). The drug is collected in summer and autumn when the pericarp turns yellow, the fruit is picked, exposed to sunlight, the seeds are removed, and the pericarp and stalks are sieved out, then dried.

性状 Description

本品呈类扁肾形或扁卵形，直径约1 mm。表面棕黄色或灰黄色，有细密的网纹，略尖的一端有点状种脐。切面灰白色，油质，有胚乳，胚弯曲。气微，味微辛。
Seeds kidney-shaped or ovate, about 1 mm in diameter. Surface brownish-yellow or grayish-yellow, with fine reticulate veins, slightly pointed at one end with a dot-shaped hilum. Cut surface grayish-white, oily, with endosperm, embryo curved. Odour, slight; taste, slightly pungent.

鉴别 Identification

（1）本品粉末灰褐色。种皮外表皮细胞碎片众多，表面附着黄棕色颗粒状物，表面观不规则多角形或长多角形，垂周壁波状弯曲；侧面观呈波状突起。胚乳细胞类圆形，含糊粉粒及脂肪油滴。
(1) The powder is grayish-brown. Numerous fragments of epidermal cells of the seed coat are present, with adhering yellowish-brown granular substances. The surface view shows irregular polygonal or elongated polygonal cells, with wavy curved walls on the periphery; the side view shows wavy projections. The endosperm cells are nearly round, containing starch granules and oil droplets.

（2）取本品粉末1 g，加石油醚（30～60℃）10 ml，超声处理15分钟，弃去石油醚液，同上再处理一次，药渣挥干溶剂，加乙醇-浓氨试液（1∶1）混合溶液2 ml使湿润，加三氯甲烷20 ml，超声处理15分钟，滤过，滤液蒸干，残渣加无水乙醇0.5 ml使溶解，作为供试品溶液。另取氢溴酸东莨菪碱对照品、硫酸阿托品对照品，加无水乙醇制成每1 ml各含1 mg的混合溶液，作为对照品溶液。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，以乙酸乙酯-甲醇-浓氨试液（17∶2∶1）为展开剂，展开，取出，晾干，依次喷以碘化铋钾试液与亚硝酸钠乙醇试液。供试品色谱中，在与对照品色谱相应的位置上，显相同的两个棕色斑点。
(2) Take 1 g of the powder, add 10 ml of petroleum ether (30-60°C), treat with ultrasound for 15 minutes, discard the petroleum ether solution, repeat the above treatment, evaporate the solvent from the residue, moisten with a mixture of 2 ml of ethanol and concentrated ammonia solution (1:1), add 20 ml of chloroform, treat with ultrasound for 15 minutes, filter, evaporate the filtrate to dryness, dissolve the residue in 0.5 ml of anhydrous ethanol as the test solution. Take hyoscyamine hydrobromide CRS and atropine sulfate CRS, dissolve in anhydrous ethanol to produce a mixture 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 concentrated ammonia solution (17:2:1) 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 successively with a solution of bismuth potassium iodide and a solution of sodium nitrite in ethanol. The two brown spots in the chromatogram obtained with the test solution correspond in position to the spots in the chromatogram obtained with the Reference solution.

检查 Examination

总灰分 Total ash

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

酸不溶性灰分 Acid-insoluble ash

不得过3.0%（通则2302）。
Not more than 3.0 per cent <2302>.

含量测定 Assay

照高效液相色谱法（通则0512）测定。
Determine by high-performance liquid chromatography <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；以甲醇-乙腈-30 mmol/L醋酸钠缓冲液（含0.02%三乙胺、0.3%四氢呋喃，用冰醋酸调节pH值至6.0）（10∶5∶85）为流动相；检测波长为210 nm。理论板数按莨菪碱峰计算应不低于4000。
Use octadecylsilane-bonded silica gel as the filler; use methanol-acetonitrile-30 mmol/L sodium acetate buffer solution (containing 0.02% triethylamine, 0.3% tetrahydrofuran, adjust the pH value to 6.0 with glacial acetic acid) (10:5:85) as the mobile phase; detect at a wavelength of 210 nm. The theoretical plate number calculated based on the peak of hyoscyamine should not be less than 4000.

对照品溶液的制备 Preparation of reference solution

取氢溴酸东莨菪碱对照品、硫酸阿托品对照品适量，精密称定，加甲醇制成每1 ml含氢溴酸东莨菪碱0.17 mg、硫酸阿托品0.15 mg的混合溶液，即得（东莨菪碱重量=氢溴酸东莨菪碱重量×0.7894；莨菪碱重量=硫酸阿托品重量×0.8551）。
Take an appropriate amount of hyoscyamine hydrobromide reference substance and atropine sulfate reference substance, accurately weigh, add methanol to make a mixed solution containing 0.17 mg of hyoscyamine hydrobromide and 0.15 mg of atropine sulfate per 1 ml (hyoscyamine weight = hyoscyamine hydrobromide weight × 0.7894; scopolamine weight = atropine sulfate weight × 0.8551).

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，置索氏提取器中，加石油醚（30～60℃）适量，加热回流2小时，弃去石油醚液，药渣挥干溶剂，再加甲醇适量，加热回流6小时，提取液减压回收至干，残渣加浓氨试液（8→100）25 ml使溶解，转移至分液漏斗中，用少量三氯甲烷洗涤容器及残渣，并入分液漏斗中，用三氯甲烷提取5次，每次15 ml，合并三氯甲烷液，减压回收至干，残渣加无水乙醇使溶解，转移至10 ml量瓶中，加无水乙醇至刻度，摇匀，即得。
Take about 2 g of the powder of this product (passed through a No. 3 sieve), accurately weigh, place it in a Soxhlet extractor, add an appropriate amount of petroleum ether (30-60°C), heat reflux for 2 hours, discard the petroleum ether solution, dry the residue, add an appropriate amount of methanol, heat reflux for 6 hours, reduce the pressure of the extract to dryness, dissolve the residue in 25 ml of concentrated ammonia solution (8→100), transfer it to a separating funnel, wash the container and residue with a small amount of chloroform, and add it to the separating funnel, extract with chloroform 5 times, each time with 15ml, combine the chloroform solution, reduce the pressure to dryness, dissolve the residue in anhydrous ethanol, transfer it to a 10 ml volumetric flask, add anhydrous ethanol to the mark, shake well, and obtain the test solution.

测定法 Assay method

分别精密吸取对照品溶液与供试品溶液各5 μl注入液相色谱仪，测定，即得。
Precisely draw 5 μl of the reference solution and the test solution respectively into the liquid chromatograph for determination, and obtain the result.

本品按干燥品计算，含东莨菪碱（C17H21NO4）和莨菪碱（C17H23NO3）的总量不得少于0.080%。
Calculated on the dried product, the total content of hyoscyamine (C17H21NO4) and scopolamine (C17H23NO3) should not be less than 0.080%.

性 Property

温。
Warm.

毒性 Toxicity

有大毒。
Highly toxic.

味 Flavor

苦、辛。
Bitter、pungent.

归经 Meridian tropism

归心、胃、肝经。
Heart, stomach, and liver meridians.

功能 Actions

解痉止痛，平喘，安神。
Relieve spasms and pain, relieve asthma, calm the mind.

主治 Indications

用于胃脘挛痛，喘咳，癫狂。
Used for spasmodic pain in the epigastric region, asthma, and mania.

用法 Administration

无。
None.

用量 Dosage

0.06～0.6 g。
0.06-0.6 g.

注意 Precautions

心脏病、心动过速、青光眼患者及孕妇禁用。
Prohibited for patients with heart disease, tachycardia, glaucoma, and pregnant women.

贮藏 Storage

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

天仙子

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

概述 Overview

本品为茄科植物莨菪Hyoscyamus niger L.的干燥成熟种子。夏、秋二季果皮变黄色时，采摘果实，暴晒，打下种子，筛去果皮、枝梗，晒干。
Henbane Seed is the dried ripe seed of Hyoscya-mus niger L. (Fam. Solanaceae). The fruit is collected in summer and autumn when the pericarp turns yellow, exposed to the sun, and the seeds are tapped out, removed from pericarp and branch, dried in the sun.

性状 Description

本品呈类扁肾形或扁卵形，直径约1mm。表面棕黄色或灰黄色，有细密的网纹，略尖的一端有点状种脐。切面灰白色，油质，有胚乳，胚弯曲。气微，味微辛。
Flattened subreniform or flattened ovoid, about 1mm in diameter. Externally brownish-yellow or greyish-yellow, with fine reticulated striations, and a pointed hilum at the somewhat acute end. Section greyish white, oily, having endosperm, embryo curved. Odour, slight; taste, slightly pungent.

鉴别 Identification

（1）本品粉末灰褐色。种皮外表皮细胞碎片众多，表面附着黄棕色颗粒状物，表面观不规则多角形或长多角形，垂周壁波状弯曲；侧面观呈波状突起。胚乳细胞类圆形，含糊粉粒及脂肪油滴。
（2）取本品粉末1g，加石油醚（30～60℃）10ml，超声处理15分钟，弃去石油醚液，同上再处理一次，药渣挥干溶剂，加乙醇-浓氨试液（1：1）混合溶液2ml使湿润，加三氯甲烷20ml，超声处理15分钟，滤过，滤液蒸干，残渣加无水乙醇0.5ml使溶解，作为供试品溶液。另取氢溴酸东莨菪碱对照品、硫酸阿托品对照品，加无水乙醇制成每1ml各含1mg的混合溶液，作为对照品溶液。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，以乙酸乙酯-甲醇-浓氨试液（17：2：1）为展开剂，展开，取出，晾干，依次喷以碘化铋钾试液与亚硝酸钠乙醇试液。供试品色谱中，在与对照品色谱相应的位置上，显相同的两个棕色斑点。

检查 Examination

总灰分 Total ash

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

酸不溶性灰分 Acid-insoluble ash

不得过3.0%（通则2302）。
Not more than 3.0 per cent <2302>.

含量测定 Assay

照高效液相色谱法（通则0512）测定。
Carry out the method for high performance liquid chromatography<0512>.

色谱条件与系统适用性试验 Chromatography system and system suitability

以十八烷基硅烷键合硅胶为填充剂；以甲醇-乙腈-30mmol/L醋酸钠缓冲液（含0.02%三乙胺、0.3%四氢呋喃，用冰醋酸调节pH值至6.0）（10：5：85）为流动相；检测波长为210nm。理论板数按莨菪碱峰计算应不低于4000。
Use octadecylsilane bonded silica gel as the stationary phase and a mixture of methanol, acetonitrile and 30 mmol/L sodium acetate buffer (containing 0.02% triethylamine and 0.3% tetrahydrofuran, regulated to a pH value of 6.0 with acetic acid) (10:5:85) as the mobile phase. As detector a spectrophotometer set at 210 nm. The number of theoretical plates of the column is not less than 4000, calculated with reference to the peak of hyoscyamine.

对照品溶液的制备 Reference solution

取氢溴酸东莨菪碱对照品、硫酸阿托品对照品适量，精密称定，加甲醇制成每1ml含氢溴酸东莨菪碱0.17mg、硫酸阿托品0.15mg的混合溶液，即得（东莨菪碱重量=氢溴酸东莨菪碱重量×0.7894；莨菪碱重量=硫酸阿托品重量×0.8551）。
Weigh accurately a quantity of scopolamine hydrobromide CRS and atropine sulfate CRS, dissolved in methanol to produce a solution containing 0.17 mg and 0.15 mg per ml as the reference solution (Scopolamine = Scopolamine hydrobromide CRS × 0.7894; hyoscyamine= atropine sulfate CRS×0.8551).

供试品溶液的制备 Test solution

取本品粉末（过三号筛）约2g，精密称定，置索氏提取器中，加石油醚（30～60℃）适量，加热回流2小时，弃去石油醚液，药渣挥干溶剂，再加甲醇适量，加热回流6小时，提取液减压回收至干，残渣加浓氨试液（8→100）25ml使溶解，转移至分液漏斗中，用少量三氯甲烷洗涤容器及残渣，并入分液漏斗中，用三氯甲烷提取5次，每次15ml，合并三氯甲烷液，减压回收至干，残渣加无水乙醇使溶解，转移至10ml量瓶中，加无水乙醇至刻度，摇匀，即得。
Weigh accurately 2 g of the powder (through No.3 sieve) to a Soxhlet's extractor, add a quantity of petroleum ether (30-60℃), heat under reflux for 2 hours, discard petroleum ether solution, expel the solvent from the residue. Add a quantity of methanol to the residue, heat under reflux for 6 hours, recover the solvent in vacuum, Add 25 ml of ammonia concentrated TS (8→100), transfer to a separating funnel. Wash the container and residue with a few amount of chloroform, transfer to the separating funnel. Extract with five 15-ml of quantifies chloroform. Combine the chloroform layer and recover to dryness. Dissolve the residue in anhydrous ethanol and transfer to a 10 ml volumetric flask, dilute with anhydrous ethanol to volume and mix well.

测定法 Procedure

分别精密吸取对照品溶液与供试品溶液各5μl，注入液相色谱仪，测定，即得。
Inject accurately 5μl of each of the reference solution and the test solution, respectively, into the column, and calculate the content.

本品按干燥品计算，含东莨菪碱（C17H21NO4）和莨菪碱（C17H23NO3）的总量不得少于0.080%。
It contains not less than 0.080 per cent of the total amount of scopolamine (C17H21NO4) and hyoscyamine (C17H23NO3), calculated with reference to the dried drug.

性味与归经 Property and Flavor

苦、辛，温；有大毒。归心、胃、肝经。
Warm; bitter and pungent; highly toxic. Heart, stomach and liver meridians.

功能与主治 Actions

解痉止痛，平喘，安神。用于胃脘挛痛，喘咳，癫狂。
To arrest convulsions, relieve pain, relieve wheezing, and tranquilize the mind. Painful spasm in stomach duct, wheezing cough, depressive psychosis, and manic psychosis.

用法与用量 Administration and dosage

0.06～0.6g。
0.06-0.6g.

注意 Precautions and Warnings

心脏病、心动过速、青光眼患者及孕妇禁用。
Contraindicated in patients suffering from heart diseases, tachypragia, glaucoma, or pregnant woman.

贮藏 Storage

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