远志

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

概述 Overview

本品为远志科植物远志Polygala tenuifolia Willd. 或卵叶远志Polygala sibirica L.的干燥根。春、秋二季采挖，除去须根和泥沙，晒干或抽取木心晒干。
Polygala Root is the dried root of Polygala tenuifolia Willd. or Polygala sibirica L. (Fam. Polygalaceae). The drug is collected in spring and autumn, removed from root hairs and impurities, dried in the sun or extracted and dried.

性状 Description

本品呈圆柱形，略弯曲，长2～30cm，直径0.2～1cm。表面灰黄色至灰棕色，有较密并深陷的横皱纹、纵皱纹及裂纹，老根的横皱纹较密更深陷，略呈结节状。质硬而脆，易折断，断面皮部棕黄色，木部黄白色，皮部易与木部剥离，抽取木心者中空。气微，味苦、微辛，嚼之有刺喉感。
Roots cylindrical, slightly curved, 2-30cm long, 0.2-1cm in diameter; surface greyish-yellow to greyish-brown, with relatively dense and deeply furrowed transverse wrinkles, longitudinal wrinkles and cracks, the transverse wrinkles of old roots denser and more deeply furrowed, slightly nodular; texture hard and brittle, easily broken; fracture yellowish-brown in the bark, yellowish-white in the wood; bark easily separated from the wood; hollow in the wood of the root with the pith removed; odour, slight; taste, bitter and slightly pungent, causing a tingling sensation in the throat when chewed.

鉴别 Identification

（1）本品横切面：木栓细胞10余列。栓内层为20余列薄壁细胞，有切向裂隙。韧皮部较宽广，常现径向裂隙。形成层成环。有木心者木质部发达，均木化，射线宽1～3列细胞。薄壁细胞大多含脂肪油滴；有的含草酸钙簇晶和方晶。
（1）Transverse section: cork cells more than 10 rows; cork cells in the inner layer more than 20 rows, thin-walled, with tangential fissures; phloem relatively wide, often with radial fissures; cambium ring-shaped; wood well-developed in roots with pith, all cells lignified, rays 1-3 cells wide; thin-walled cells mostly containing fat droplets; some containing calcium oxalate cluster crystals and square crystals.

（2）取本品粉末0.5g，加70%乙醇5ml，超声处理15分钟，滤过，滤液作为供试品溶液。另取远志对照药材0.5g，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2μl，分别点于同一硅胶G薄层板上，以乙酸乙酯-冰醋酸-水（55 : 13 : 13）为展开剂，展开，取出，晾干，置紫外光灯（365nm）下检视。供试品色谱中，在与对照药材色谱相应的位置上，显相同颜色的荧光斑点。
（2）To 0.5g of the powder add 5ml of 70% ethanol, treat with ultrasound for 15 minutes, filter, and use the filtrate as the test solution. Prepare a solution of the reference drug, Yuanzhi, in the same manner. Carry out the method for thin layer chromatography<0502>, using ethyl acetate-glacial acetic acid-water (55:13:13) as the mobile phase. Apply separately to the plate 2μl of each of the above two solutions. After developing and removal of the plate, dry in air. Examine under ultraviolet light at 365nm. The fluorescent spot in the chromatogram obtained with the test solution corresponds in position and colour to the spot in the chromatogram obtained with the reference drug.

（3）取细叶远志皂苷〔含量测定〕项下的供试品溶液20μl和对照品溶液4μl，分别点于同一硅胶G薄层板上，以三氯甲烷-甲醇-水（6 : 3 : 0.5）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，在与对照品色谱相应的位置上，显相同颜色的斑点。
（3）To 20μl of the test solution for determination of saponins of Polygala tenuifolia and 4μl of the reference solution add separately to the same silica gel G thin layer plate. Carry out the method for thin layer chromatography<0502>, using chloroform-methanol-water (6:3:0.5) as the mobile phase. 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 spot in the chromatogram obtained with the test solution corresponds in position and colour to the spot in the chromatogram obtained with the reference solution.

检查 Examination

水分 Water

不得过12.0%（通则0832第二法）。
Not more than 12.0 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>.

黄曲霉毒素 Aflatoxins

照真菌毒素测定法（通则2351）测定。
Carry out the method for determination of aflatoxins <2351>.

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总量不得过10μg。
The content of aflatoxin B1 in the drug shall not exceed 5μg per 1000g; the total content of aflatoxin G2, aflatoxin G1, aflatoxin B2 and aflatoxin B1 shall not exceed 10μg per 1000g.

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70%乙醇作溶剂，不得少于30.0%。
Carry out the method for determination of ethanol-soluble extractives <2201>, the hot maceration method, using 70% ethanol as the solvent, not less than 30.0 per cent.

含量测定 Content determination

细叶远志皂苷 Saponin

照高效液相色谱法（通则0512）测定。
It was determined 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-0.05%磷酸溶液（70 : 30）为流动相；检测波长为210nm。理论板数按细叶远志皂苷峰计算应不低于3000。
The chromatographic conditions and system suitability test shall be carried out as specified in the method for high performance liquid chromatography <0512>, using octadecylsilane bonded silica gel as the stationary phase, methanol-0.05% phosphoric acid solution (70:30) as the mobile phase, and a detection wavelength of 210nm. The theoretical number of plates calculated from the peak of saponins of Polygala tenuifolia shall not be less than 3000.

对照品溶液的制备 Preparation of reference solution

取细叶远志皂苷对照品适量，精密称定，加甲醇制成每1ml含1mg的溶液，即得。
Prepare a solution of the reference substance of saponins of Polygala tenuifolia by accurately weighing an appropriate amount, dissolving in methanol to produce a solution containing 1 mg per ml.

供试品溶液的制备 Preparation of test solution

取本品粉末（过三号筛）约1g，精密称定，置具塞锥形瓶中，精密加入70%甲醇50ml，称定重量，超声处理（功率400W，频率40kHz）1小时，放冷，再称定重量，用70%甲醇补足减失的重量，摇匀，滤过，精密量取续滤液25ml，置圆底烧瓶中，蒸干，残渣加10%氢氧化钠溶液50ml，加热回流2小时，放冷，用盐酸调节pH值为4～5，用水饱和的正丁醇振摇提取3次，每次50ml，合并正丁醇液，回收溶剂至干，残渣加甲醇适量使溶解，转移至25ml量瓶中，加甲醇至刻度，摇匀，即得。
Take about 1g of the powder of this product (through the No. 3 sieve), weigh it accurately, place it in a corked Erlenmeyer flask, add 50ml of 70% methanol accurately, weigh it, sonicate it (power 400W, frequency 40kHz) for 1 hour, let it cool, weigh it again, make up for the weight loss with 70% methanol, shake it well, filter it, take 25ml of the filtrate with precision, put it in a round-bottom flask, evaporate it, add 50ml of 10% sodium hydroxide solution to the residue, heat and reflux for 2 hours, let it cool, adjust the pH value with hydrochloric acid to 4~5, Shake with water-saturated n-butanol to extract 3 times, 50ml each time, combine n-butanol solution, recover the solvent to dry, add an appropriate amount of methanol to the residue to dissolve, transfer to a 25ml measuring flask, add methanol to the scale, shake well, and obtain.

测定法 Assay method

分别精密吸取对照品溶液与供试品溶液各10μl，注入液相色谱仪，测定，即得。
Respectively, 10μl of the reference solution and the test solution were accurately absorbed, injected into the liquid chromatograph, and measured.

本品按干燥品计算，含细叶远志皂苷（C36H56O12），不得少于2.0%。
Calculate the content of saponins of Polygala tenuifolia (C36H56O12) in the drug on the dried basis, which shall not be less than 2.0%.

远志𠮿酮Ⅲ和3，6＇-二芥子酰基蔗糖 Polygalaxanthone III and 3,6'-diacetyl sucrose

照高效液相色谱法（通则0512）测定。
It was determined 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；以乙腈-0.05%磷酸溶液（18 : 82）为流动相；检测波长为320nm。理论板数按3，6＇-二芥子酰基蔗糖峰计算应不低于3000。
Octadecylsilane bonded silica gel is used as filler; acetonitrile-0.05% phosphoric acid solution (18:82) as mobile phase; The detection wavelength is 320nm. The number of theoretical plates should not be less than 3000 based on the calculation of the 3,6'-dimustinoylsucrose peak.

对照品溶液的制备 Preparation of reference solution

取远志𠮿酮Ⅲ对照品、3，6＇-二芥子酰基蔗糖对照品适量，精密称定，加甲醇制成每1ml含远志𠮿酮Ⅲ 0.15mg、含3，6＇-二芥子酰基蔗糖0.2mg的混合溶液，即得。
Take an appropriate amount of Polygalaxanthone III. reference substance and 3,6'-dimyroyl sucrose reference substance, weigh it accurately, and add methanol to make a mixed solution containing 0.15mg of Yuanzhi Ketone III. and 0.2mg of 3,6'-dimyroylsucrose per ml.

供试品溶液的制备 Preparation of test solution

取本品粉末（过三号筛）约1g，精密称定，置具塞锥形瓶中，精密加入70%甲醇25ml，称定重量，加热回流1.5小时，放冷，再称定重量，用70%甲醇补足减失的重量，摇匀，滤过，取续滤液，即得。
Take about 1g of the powder of this product (through the No. 3 sieve), weigh it accurately, place it in a plugged Erlenmeyer flask, add 25ml of 70% methanol accurately, weigh it, heat and reflux it for 1.5 hours, let it cool, weigh it again, make up for the lost weight with 70% methanol, shake it well, filter it, and take the filtrate to obtain it.

测定法 Assay method

分别精密吸取对照品溶液与供试品溶液各10μl，注入液相色谱仪，测定，即得。
Respectively, 10μl of the reference solution and the test solution were accurately absorbed, injected into the liquid chromatograph, and measured.

本品按干燥品计算，含远志𠮿酮Ⅲ（C25H28O15）不得少于0.15%，含3，6＇-二芥子酰基蔗糖（C36H46O17）不得少于0.50%。
Calculate the content of polygalaxanthone III (C25H28O15) and 3,6'-diacetyl sucrose (C36H46O17) in the drug on the dried basis, which shall not be less than 0.15% and 0.50%, respectively.

饮片 Prepared slices

远志 Polygala Root

炮制 Processing

取抽去木心者，除去杂质，略洗，润透，切段，干燥。
Take the root with the pith removed, remove impurities, wash briefly, soften until thoroughly moistened, cut into sections, and dry.

性状 Description

本品呈圆筒形的段。外表皮灰黄色至灰棕色，有横皱纹。切面棕黄色。气微，味苦、微辛，嚼之有刺喉感。
This product has a cylindrical segment. The outer skin is grayish-yellow to grayish-brown with transverse wrinkles. The cut-out surface is brownish-yellow. The breath is slight, the taste is bitter and slightly pungent, and the chewing has a pungent feeling.

鉴别 Identification

（除横切面外）同药材。
（Except for cross-sections）Same as the crude drug.

检查 Examination

同药材。
Same as the crude drug.

浸出物 Extractives

同药材。
Same as the crude drug.

含量测定 Content determination

同药材。
Same as the crude drug.

制远志 Concocted Polygala Root

炮制 Processing

取甘草，加适量水煎汤，去渣，加入净远志，用文火煮至汤吸尽，取出，干燥。
Take Licorice, add an appropriate amount of water to decoction, remove the slag, add Jingyuanzhi, simmer until the soup is absorbed, take it out, and dry it.

每100kg远志，用甘草6kg。
For every 100 kg of achi, 6 kg of Licorice is used.

性状 Description

本品形如远志段，表面黄棕色。味微甜。
This product is shaped like Polygala Root section, and the surface is yellowish-brown. The taste is slightly sweet.

检查 Examination

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 Content determination

同药材。含远志𠮿酮Ⅲ（C25H28O15）不得少于0.10%，含3，6＇-二芥子酰基蔗糖（C36H46O17）不得少于0.30%。含细叶远志皂苷（C36H56O12）不得少于2.0%。
Same as the crude drug. The content of Polygalaxanthone III (C25H28O15) should not be less than 0.10%, the content of 3,6'-dimyroyl sucrose (C36H46O17) should not be less than 0.30%, the content of Saponin (C36H56O12) should not be less than 0.20%.

鉴别 Identification

（除横切面外）同药材。
（Except for cross-sections）Same as the crude drug.

检查 Examination

同药材。
Same as the crude drug.

浸出物 Extractives

同药材。
Same as the crude drug.

性 Property

温。
Warm.

味 Flavor

苦、辛。
Bitter and pungent.

归经 Meridian tropism

归心、肾、肺经。
Heart, kidney, and lung meridians.

功能 Actions

安神益智，交通心肾，祛痰，消肿。
To calm the mind and improve intelligence, regulate the heart and kidney, resolve phlegm, and reduce swelling.

主治 Indications

用于心肾不交引起的失眠多梦、健忘惊悸、神志恍惚，咳痰不爽，疮疡肿毒，乳房肿痛。
Used for insomnia with excessive dreaming, forgetfulness, palpitations, and mental confusion due to the failure of communication between the heart and kidney, cough with phlegm difficult to expectorate, sores and abscesses, and swelling and pain in the breasts.

用量 Dosage

3～10g。
3-10g.

用法 Administration

无。
None.

贮藏 Storage

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

远志

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

概述 Overview

本品为远志科植物远志Polygala tenuifolia Willd.或卵叶远志Polygala sibirica L.的干燥根。春、秋二季采挖，除去须根和泥沙，晒干。
Thinleaf Milkwort Root is the dried root of Polygala tenuifolia Willd. or Polygala sibirica L. (Fam. Polygalaceae). The drug is collected in spring or autumn, removed from rootlet and soil, and dried in the sun.

性状 Description

本品呈圆柱形，略弯曲，长3～15cm，直径0.3～0.8cm。表面灰黄色至灰棕色，有较密并深陷的横皱纹、纵皱纹及裂纹，老根的横皱纹较密更深陷，略呈结节状。质硬而脆，易折断，断面皮部棕黄色，木部黄白色，皮部易与木部剥离。气微，味苦、微辛，嚼之有剌喉感。
Cylindrical, somewhat curved, 3-15 cm long, 3-8 mm in diameter. Externally greyish-yellow to greyish-brown, with dense and dented transverse wrinkles, longitudinal wrinkles and fissures, old roots with dense and deeply dented transverse wrinkles, somewhat nodular. Texture hard and fragile, easily broken, fracture brownish-yellow in bark, yellowish-white in wood, bark easily separating from wood. Odour slight; taste, bitter and slightly pungent, with an irritative sensation in the throat on chewing.

鉴别 Identification

（1）本品橫切面：木栓细胞10余列。栓内层为20余列薄壁细胞，有切向裂隙。韧皮部较宽广，常现径向裂隙。形成层成环。木质部发达，均木化，射线宽1～3列细胞。薄壁细胞大多含脂肪油滴；有的含草酸钙簇晶和方晶。
（2）取本品粉末0.5g，加70%甲醇20ml，超声处理30分钟，滤过，滤液蒸干，残渣加甲醇1ml使溶解，作为供试品溶液。另取远志𠮿酮Ⅲ对照品，加甲醇制成每1ml含0.5mg的溶液，作为对照品溶液。照薄层色谱法（通则0502）试验，吸取上述两种溶液各2μl，分别点于同一硅胶G薄层板上，以三氯甲烷-甲醇-水（7：3：1）的下层溶液为展开剂，展开，取出，晾干，置紫外光灯（365mn）下检视。供试品色谱中，在与对照品色谱相应的位置上，显相同颜色的荧光斑点。

检查 Examination

水分 Water

不得过12.0%（通则0832第二法）。
Not more than 12.0 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>.

黄曲霉毒素 Aflatoxins

照黄曲霉毒素测定法（通则2351）测定。
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总量不得过10μg。

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70%乙醇作溶剂，不得少于30.0%。
Carry out the method for determination of ethanol-soluble extractives<2201, the hot extraction method>, using 70% ethanol as the solvent, not less than 30.0 per cent.

含量测定 Assay

细叶远志皂苷 照高效液相色谱法（通则0512）测定。
色谱条件与系统适用性试验

饮片 Prepared slices

远志 Thinleaf Milkwort

炮制 Processing

除去杂质，略洗，润透，切段，干燥。
Eliminate foreign matter, wash briefly, soften thoroughly, cut into sections, and dry.

本品呈圆柱形的段。外表皮灰黄色至灰棕色，有橫皱纹。切面棕黄色，中空。气微，味苦、微辛，嚼之有刺喉感。
In cylindrical sections. Externally greyish-yellow to greyish-brown, exhibiting transverse striations. Cut surface brownish-yellow, hollow in central part. Odour slight; taste bitter and slightly pungent, with an irritating sensation in the throat on chewing.

鉴别 Identification

（除横切面外）【检查】【浸出物】【含量测定】
同药材。

性味与归经 Property and Flavor

苦、辛，温。归心、肾、肺经。
Warm; bitter and pungent. Heart, kidney, and lung meridians.

功能与主治 Actions and Indications

安神益智，交通心肾，祛痰，消肿。用于心肾不交引起的失眠多梦、健忘惊悸、神志恍惚，咳痰不爽，疮疡肿毒，乳房肿痛。
To tranquilize the mind, improve intelligence, coordinate the heart and kidney, dispel phlegm, and disperse swelling. Used for insomnia, dream-disturbed sleep, forgetfulness and fright palpitations caused by heart-kidney non-interaction pattern; absent-mindedness, ungratifying expectoration of phlegm, sore and ulcer, swelling, toxin, breast swelling and pain.

用法与用量 Administration and dosage

3～10g。
3-10 g.

贮藏 Storage

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