急性子

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

概述 Overview

本品为凤仙花科植物凤仙花Impatiens balsamina L.的干燥成熟种子。夏、秋季果实即将成熟时采收，晒干，除去果皮和杂质。
Balsam Pear Seed is the dried mature seed of Impatiens balsamina L. (Fam. Balsaminaceae). The drug is collected in summer and autumn when the fruit is nearly ripe, dried in the sun, and the fruit coat and impurities are removed.

性状 Description

本品呈椭圆形、扁圆形或卵圆形，长2～3 mm，宽1.5～2.5 mm。表面棕褐色或灰褐色，粗糙，有稀疏的白色或浅黄棕色小点，种脐位于狭端，稍突出。质坚实，种皮薄，子叶灰白色，半透明，油质。气微，味淡、微苦。
Seeds elliptical, oblong or ovate, 2-3 mm long, 1.5-2.5 mm wide; surface brownish or greyish-brown, rough, with sparse white or pale yellow-brown dots; hilum at the narrow end, slightly prominent. Texture hard; seed coat thin; endosperm greyish-white, translucent, oily. Odour, slight; taste, slightly bitter.

鉴别 Identification

（1）本品粉末黄棕色或灰褐色。种皮表皮细胞表面观形状不规则，垂周壁波状弯曲。腺鳞头部类球形，4～5（～12）细胞，直径22～60 μm，细胞内充满黄棕色物。草酸钙针晶束存在于黏液细胞中，长16～60 μm。内胚乳细胞多角形，壁稍厚，内含脂肪油滴，常与种皮颓废组织相连。
（1）The powder is yellowish-brown or greyish-brown. The epidermal cells of the seed coat are irregular in shape, and the walls are wavy and curved. The glandular scale heads are spherical, consisting of 4-5 (up to 12) cells, with a diameter of 22-60 μm, and the cells are filled with yellowish-brown substances. Calcium oxalate prisms are present in the mucilage cells, measuring 16-60 μm in length. The endosperm cells are polygonal, with slightly thickened walls and containing fat droplets, often connected with the decayed tissue of the seed coat.

（2）取本品粉末4 g，加丙酮40 ml，加热回流1小时，弃去丙酮液，药渣挥干，加水饱和正丁醇40 ml，超声处理30分钟，滤过，滤液回收溶剂至干，残渣加甲醇1 ml使溶解，作为供试品溶液。另取急性子对照药材4 g，同法制成对照药材溶液。再取凤仙萜四醇皂苷K对照品、凤仙萜四醇皂苷A对照品，加甲醇制成每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，吸取上述三种溶液各2 μl，分别点于同一硅胶G薄层板上，以三氯甲烷-甲醇-水-甲酸（7∶3∶0.5∶0.5）为展开剂，展开，取出，晾干，喷以5%香草醛硫酸溶液，在105 °C加热至斑点显色清晰，置日光下检视。供试品色谱中，在与对照药材色谱和对照品色谱相应的位置上，显相同颜色的斑点。
（2）Take 4 g of the powder, add 40 ml of acetone, heat under reflux for 1 hour, discard the acetone solution, evaporate the residue to dryness, add 40 ml of saturated n-butanol under ultrasonic treatment for 30 minutes, filter, recover the solvent from the filtrate to dryness, dissolve the residue in 1 ml of methanol as the test solution. Take another 4 g of the reference drug of Balsam Pear Seed, prepare the reference drug solution by the same method. Take the reference substance of Impatiens balsamina saponin K and Impatiens balsamina saponin A, add methanol to prepare a mixed solution containing 1 mg of each 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 chloroform-methanol-water-formic acid (7: 3: 0.5: 0.5) as the mobile phase. Apply separately to the plate 2 μl of each of the above three solutions. After developing and removal of the plate, dry in air. Spray with a 5% solution of vanillin sulfuric acid, heat at 105 °C to the spots clear. Examine under daylight. The spots in the chromatogram obtained with the test solution correspond in position and colour to the spots in the chromatograms obtained with the reference drug and the reference solution.

检查 Examination

杂质 Impurities

不得过5%（通则2301）。
Not more than 5.0 per cent <2301>.

水分 Water

不得过11.0%（通则0832第二法）。
Not more than 11.0 per cent <0832, method 2>.

总灰分 Total ash

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

浸出物 Extractives

照醇溶性浸出物测定法（通则2201）项下的热浸法测定，用乙醇作溶剂，不得少于10.0%。
Carry out the method for determination of ethanol-soluble Extractives <2201, the hot maceration method>, using ethanol as the solvent, not less than 10.0 per cent.

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 Chromatographic conditions and system suitability test

以十八烷基硅烷键合硅胶为填充剂；以乙腈为流动相A，以水为流动相B，按下表中的规定进行梯度洗脱；蒸发光散射检测器检测。理论板数按凤仙萜四醇皂苷K峰计算应不低于3000。
Use octadecylsilane bonded silica gel as the filler; use acetonitrile as mobile phase A and water as mobile phase B, and perform gradient elution according to the specified conditions in the table; detect by evaporative light scattering detector. The theoretical plate number calculated from the peak of Impatiens balsamina saponin K should not be less than 3000.

对照品溶液的制备 Preparation of reference solution

取凤仙萜四醇皂苷K对照品、凤仙萜四醇皂苷A对照品适量，精密称定，加甲醇分别制成每1 ml各含凤仙萜四醇皂苷K0.5 mg、凤仙萜四醇皂苷A 0.25 mg的溶液，即得。
Take an appropriate amount of the reference substance of Impatiens balsamina saponin K and Impatiens balsamina saponin A, accurately weigh, and add methanol to prepare a solution containing 0.5 mg of Impatiens balsamina saponin K and 0.25 mg of Impatiens balsamina saponin A per ml, respectively.

供试品溶液的制备 Preparation of test solution

取本品粉末（过三号筛）约1 g，精密称定，置索氏提取器中，加石油醚（60～90 °C）适量，加热回流2小时，弃去石油酰液，药渣挥去溶剂，转移至具塞锥形瓶中，精密加入80%甲醇50 ml，称定重量，加热回流1小时，放冷，再称定重量，用80%甲醇补足减失的重量，摇匀，滤过，精密量取续滤液20 ml，回收溶剂至干，残渣加甲醇适量使溶解并转移至2ml量瓶中，加甲醇至刻度，摇匀，滤过，取续滤液，即得。
Take about 1 g of the powder (passed through a No. 3 sieve), accurately weigh, place it in a Soxhlet extractor, add an appropriate amount of petroleum ether (60-90 °C), heat under reflux for 2 hours, discard the petroleum ether solution, evaporate the residue to dryness, transfer it to a stoppered conical flask, accurately add 50 ml of 80% methanol, weigh, heat under reflux for 1 hour, cool, weigh again, make up for the loss in weight with 80% methanol, shake well, filter, accurately take 20 ml of the filtrate, recover the solvent to dryness, dissolve the residue in an appropriate amount of methanol and transfer it to a 2 ml volumetric flask, add methanol to the mark, shake well, filter, and take the filtrate, that is the test solution.

测定法 Assay method

分别精密吸取对照品溶液5 μl、15 μl，供试品溶液10 μl，注入液相色谱仪，测定，用外标两点法对数方程计算，即得。
Accurately take 5 μl and 15 μl of the reference solution, and 10 μl of the test solution, inject into the liquid chromatograph, determine, calculate by the logarithmic equation of the external standard two-point method, and obtain the result.

本品按干燥品计算，含凤仙萜四醇皂苷K（C54H92O25）和凤仙萜四醇皂苷A（C48H82O20）的总量不得少于0.20%。
Calculated on the dried basis, the total content of Impatiens balsamina saponin K (C54H92O25) and Impatiens balsamina saponin A (C48H82O20) should not be less than 0.20%.

性 Property

温。
Warm.

味 Flavor

微苦、辛。
Slightly bitter and pungent.

归经 Meridian tropism

归肺、肝经。
Lung and liver meridians.

功能 Actions

破血，软坚，消积。
To break blood stasis, soften hardness, and dissipate accumulation.

主治 Indications

用于癥瘕痞块，经闭，噎膈。
Used for abdominal masses, amenorrhea, and hiccup.

用量 Dosage

3～5 g。
3-5 g.

用法 ｜ Administration

无。
None.

注意 Precautions

孕妇慎用。
Caution for pregnant women.

贮藏 Storage

置干燥处。
Preserve in a dry place.

急性子

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

概述 Overview

本品为凤仙花科植物凤仙花 Impatiens balsamina L.的干燥成熟种子。夏、秋季果实即将成熟时采收，晒干，除去果皮和杂质。
Garden Balsam Seed is the dried ripe seed of Impatiens balsamina L. (Fam. Balsaminaceae). The drug is collected in summer and autumn when the fruit is nearly ripe, dried in the sun, removed from pericarp and foreign matter.

性状 Description

本品呈椭圆形、扁圆形或卵圆形，长2～3mm，宽1.5～2.5mm。表面棕褐色或灰褐色，粗糙，有稀疏的白色或浅黄棕色小点，种脐位于狭端，稍突出。质坚实，种皮薄，子叶灰白色，半透明，油质。气微，味淡、微苦。
Elliptic, oblate, or ovoid, 2-3 mm long, 1.5-2.5 mm wide.Externally brown or greyish-brown, rough, with sparse white or pale yellowish-brown spots. Raphe occurring at the narrow end, slightly prominent. Texture hard, testa thin, cotyledons greyish-white, translucent, oily. Odour, slight; taste, weak, slightly bitter.

鉴别 Identification

（1）本品粉末黄棕色或灰褐色。种皮表皮细胞表面观形状不规则，垂周壁波状弯曲。腺鱗头部类球形，4～5（～12）细胞，直径22～60μm，细胞内充满黄棕色物。草酸钙针晶束存在于黏液细胞中，长16～60μm。内胚乳细胞多角形，壁稍厚，内含脂肪油滴，常与种皮颓废组织相连。
（2）取本品粉末4g，加丙酮40ml加热回流1小时，弃去丙酮液，药渣挥干，加水饱和正丁醇40ml，超声处理30分钟，滤过，滤液回收溶剂至干，残渣加甲醇1ml使溶解，作为供试品溶液。另取急性子对照药材4g，同法制成对照药材溶液。再取凤仙萜四醇皂苷K对照品、凤仙萜四醇皂苷A对照品，加甲醇制成每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，吸取上述三种溶液各2μl，分别点于同一硅胶G薄层板上，以三氯甲烷-甲醇- 水-甲酸（7：3：0.5：0.5）为展开剂，展开，取出，晾干，喷以5%香草醛硫酸溶液，在105℃加热至斑点显色清晰，在日光下检视。供试品色谱中，在与对照药材色谱和对照品色谱相应的位置上，显相同颜色的斑点。

检查 Examination

杂质 Foreign matter

不得过5%（通则2301）。
Not more than 5 per cent<2301>.

水分 Water

不得过11.0%（通则0832第二法）。
Not more than 11.0 per cent<0832, method 2>.

总灰分 Total ash

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

浸出物 Extractives

照醇溶性浸出物测定法（通则2201）项下的热浸法测定，用乙醇作溶剂，不得少于10.0%。
Carry out the method for determination of ethanol-soluble extractives <2201, the hot extraction method>, using dehydrated ethanol as solvent, not less than 10.0 per cent.

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 以十八烷基硅烷键合硅胶为填充剂；以乙腈为流动相A，以水为流动相B，按下表中的规定进行梯度洗脱；蒸发光散射检测器检测。理论板数按凤仙萜四醇皂苷K峰计算应不低于3000。

时间（分钟）
流动相A（%）
流动相B（%）
0～15
15～25
25～30 24→28
28
28→40 76→72
72
72→60

对照品溶液的制备 取凤仙萜四醇皂苷K对照品、凤仙萜四醇皂苷A对照品适量，精密称定，加甲醇分别制成每1ml各含凤仙萜四醇皂苷K0.5mg、凤仙萜四醇皂苷A0.25mg的溶液，即得。
供试品溶液的制备 取本品粉末（过三号筛）约1g，精密称定，置索氏提取器中，加石油醚（60～90℃）适量，加热回流2小时，弃去石油醚液，药渣挥去溶剂，转移至具塞锥形瓶中，精密加入80%甲醇50ml， 称定重量，加热回流1小时，放冷，再称定重量，用80%甲醇补足减失的重量，摇匀，滤过，精密量取续滤液20ml，回收溶剂至干，残渣加甲醇适量使溶解并转移至2ml量瓶中，加甲醇至刻度，摇匀，滤过，取续滤液，即得。

性味与归经 Property and Flavor

微苦、辛，温；有小毒。归肺、肝经。
Warm; mild bitter, pungent; slighlty toxic. Lung and liver meridians.

功能与主治 Actions and Indications

破血，软坚，消积。用于癥瘕痞块，经闭，噎膈。
To break blood, soften hardness, and eliminate accumulation. Abdominal masses, glomus, amenorrhea, and dysphagia-occlusion.

用法与用量 Administration and dosage

3～5g。
3-5 g.

注意 Precautions and Warnings

孕妇慎用。
Used with caution during pregnancy.

贮藏 Storage

置干燥处。
Preserve in a dry place.