- 中国药典(2020年版)Chinese Pharmacopoeia (2020 Edition)创建于:更新于:
车前子
中文文本参考:《中国药典(2020年版)》
English text reference: Chinese Pharmacopoeia (2020 Edition)车前子CheqianziPlantaginis SemenPlantain Seed概述 Overview
本品为车前科植物车前Plantago asiatica L.或平车前Plantago depressa Willd.的干燥成熟种子。夏、秋二季种子成熟时采收果穗,晒干,搓出种子,除去杂质。
Plantain Seed is the dried mature seed of Plantago asiatica L. or Plantago depressa Willd. (Fam. Plantaginaceae). The drug is collected in summer and autumn when the seed is ripe, removed from the spike, dried, and the impurities are removed.性状 Description
本品呈椭圆形、不规则长圆形或三角状长圆形,略扁,长约2 mm,宽约1 mm。表面黄棕色至黑褐色,有细皱纹,一面有灰白色凹点状种脐。质硬。气微,味淡。
Seeds elliptical, irregularly oblong or triangular oblong, slightly compressed, about 2 mm long and about 1 mm wide. Surface yellowish-brown to blackish-brown, with fine wrinkles, one side with grayish-white depressed hilum. Texture hard. Odour, slight; taste, bland.鉴别 Identification
(1)
(1)车前 Seed of Plantago asiatica
粉末深黄棕色。种皮外表皮细胞断面观类方形或略切向延长,细胞壁黏液质化。种皮内表皮细胞表面观类长方形,直径5~19 μm,长约至83 μm,壁薄,微波状,常作镶嵌状排列。内胚乳细胞壁甚厚,充满细小糊粉粒。
Plantain Powder dark yellowish brown. The outer epidermal cells of the testa are square or slightly tangentially prolonged in cross-section, and the cell walls are mucilaginous. The inner epidermal cells of the testa are oblong in surface view, 5-19 μm in diameter, about 83 μm in length, thin-walled, microwave-like, often arranged in a mosaic. The endosperm cell wall is very thick, full of fine powdery grains.平车前 Seed of Plantago depressa
种皮内表皮细胞较小,直径5~15 μm,长11~45 μm。
The inner epidermal cells of the seed coat of Plantago depressa are small, 5-15 μm in diameter and 11-45 μm long.(2) 取本品粗粉1 g,加甲醇10 ml,超声处理30分钟,滤过,滤液蒸干,残渣加甲醇2 ml使溶解,作为供试品溶液。另取京尼平苷酸对照品、毛蕊花糖苷对照品,加甲醇分别制成每1 ml各含1 mg的溶液,作为对照品溶液。照薄层色谱法(通则0502)试验,吸取上述三种溶液各5 μl,分别点于同一硅胶GF254薄层板上,以乙酸乙酯-甲醇-甲酸-水(18∶2∶1.5∶1)为展开剂,展开,取出,晾干,置紫外光灯(254 nm)下检视。供试品色谱中,在与对照品色谱相应的位置上,显相同颜色的斑点;喷以0.5%香草醛硫酸溶液,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。
(2) Take 1 g of crude powder of this product, add 10 ml of methanol, ultrasonic treatment for 30 minutes, filtration, filtrate evaporation, residue add 2 ml of methanol to dissolve, as a test solution. Another take jingnipin sapogenins control product, mullein control product, add methanol were made into 1 ml each containing 1 mg of solution, as a control solution. According to the thin layer chromatography (General rule 0502) test, absorb the above three solutions of 5 μl, were spotted on the same silica gel GF254 thin layer plate, ethyl acetate - methanol - formic acid - water (18:2:1.5:1) as an unfolding agent, unfolding, take out, drying, and placed in the ultraviolet light (254 nm) under the examination. In the chromatogram of the test article, spots of the same colour were shown on the corresponding positions with the chromatogram of the control article; sprayed with 0.5% vanillin sulfuric acid solution, heated at 105℃ until the spots showed clear colour.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>.酸不溶性灰分 Acid-insoluble ash
不得过2.0%(通则2302)。
Not more than 2.0 per cent <2302>.膨胀度 Swelling index
取本品1 g,称定重量,照膨胀度测定法(通则2101)测定,应不低于4.0。
Take 1 g of the sample, weigh accurately, and determine the swelling index according to the method for determination of swelling index <2101>. It should not be less than 4.0.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;以甲醇为流动相A,以0.5%醋酸溶液为流动相B,按下表中的规定进行梯度洗脱;检测波长为254 nm。理论板数按京尼平苷酸峰计算应不低于3000。
Use octadecylsilane-bonded silica gel as the filler; use methanol as mobile phase A and 0.5% acetic acid solution as mobile phase B. Perform gradient elution according to the specified conditions in the table; detect at a wavelength of 254 nm. The theoretical plate number calculated based on the peak of artemisinic acid should not be less than 3000.对照品溶液的制备 Preparation of reference solution
取京尼平苷酸对照品、毛蕊花糖苷对照品适量,精密称定,置棕色量瓶中,加60%甲醇制成每1 ml各含0.1 mg的混合溶液,即得。
Take an appropriate amount of artemisinic acid reference substance and artemisinin reference substance, weigh accurately, place them in a brown volumetric flask, and add 60% methanol to prepare a mixed solution containing 0.1 mg of each substance per 1 ml.供试品溶液的制备 Preparation of test solution
取本品粉末(过二号筛)约1 g,精密称定,置具塞锥形瓶中,精密加入60%甲醇50 ml,称定重量,加热回流2小时,放冷,再称定重量,用60%甲醇补足减失的重量,摇匀,滤过,取续滤液,即得。
Take about 1 g of the powder of the sample (passed through a No. 2 sieve), weigh accurately, place it in a stoppered conical flask, accurately add 50 ml of 60% methanol, weigh accurately, heat under reflux for 2 hours, cool, weigh accurately again, make up for the weight loss with 60% methanol, shake well, filter, and take the filtrate.测定法 Assay method
分别精密吸取对照品溶液与供试品溶液各10 μl,注入液相色谱仪,测定,即得。
Accurately draw 10 μl of the reference solution and the test solution, respectively, inject them into the liquid chromatograph, and determine.本品按干燥品计算,含京尼平苷酸(C16H22O10)不得少于0.50%,毛蕊花糖苷(C29H36O15)不得少于0.40%。
Calculated on the dried product, the content of artemisinic acid (C16H22O10) should not be less than 0.50%, and the content of artemisinin (C29H36O15) should not be less than 0.40%.饮片 Prepared slices
车前子 Plantago seed
炮制 Processing
除去杂质。
Remove impurities.性状 Appearance
同药材。
Same as the crude drug.鉴别 Identification
同药材。
Same as the crude drug.检查 Examination
同药材。
Same as the crude drug.含量测定 Assay
同药材。
Same as the crude drug.盐车前子 Prepared Plantago seed with salt
炮制 Processing
取净车前子,照盐水炙法(通则0213)炒至起爆裂声时,喷洒盐水,炒干。
Take the clean psyllium, according to the salt water roast method (General rule 0213) fried until the sound of bursting, sprayed with salt water, fried dry.性状 Appearance
本品形如车前子,表面黑褐色。气微香,味微咸。
This product is shaped like psyllium, with dark brown surface. Slightly fragrant, slightly salty taste.检查 Examination
水分 Water
同药材,不得过10.0%。
Same as the crude drug, not more than 10.0 per cent.总灰分 Total ash
同药材,不得过9.0%。
Same as the crude drug, not more than 9.0 per cent.酸不溶性灰分 Acid-insoluble ash
同药材,不得过3.0%。
Same as the crude drug, not more than 3.0 per cent.膨胀度 Swelling index
取本品1 g,称定重量,照膨胀度测定法(通则2101)测定,应不低于3.0。
Take 1 g of the sample, weigh accurately, and determine the swelling index according to the method for determination of swelling index <2101>. It should not be less than 3.0.含量测定 Assay
同药材,含京尼平苷酸(C16H22O10)不得少于0.40%,毛蕊花糖苷(C29H36O15)不得少于0.30%。
Same as the crude drug, the content of artemisinic acid (C16H22O10) should not be less than 0.40%, and the content of artemisinin (C29H36O15) should not be less than 0.30%.鉴别 Identification
同药材。
Same as the crude drug.性 Property
寒。
Cold.味 Flavor
甘。
Sweet.归经 Meridian tropism
归肝、肾、肺、小肠经。
Meridian tropism: liver, kidney, lung, and small intestine.功能 Actions
清热利尿通淋,渗湿止泻,明目,祛痰。
Clear heat, diuretic, promote urination, and relieve stranguria; leach dampness and stop diarrhea; improve vision and eliminate phlegm.主治 Indications
用于热淋涩痛,水肿胀满,暑湿泄泻,目赤肿痛,痰热咳嗽。
Used for hot stranguria with pain, edema and fullness, summer dampness diarrhea, red and swollen eyes, and phlegm-heat cough.用量 Dosage
9~15 g。
9-15 g.用法 Administration
包煎。
Decocted in a wrapped package.贮藏 Storage
置通风干燥处,防潮。
Store in a well-ventilated and dry place, and protect from moisture.审核通过审核于: - 中国药典(2020年版)Chinese Pharmacopoeia (2020 Edition)创建于:更新于:
大腹皮
中文文本参考:《中国药典(2020年版)》
English text reference: Chinese Pharmacopoeia (2020 Edition)大腹皮DafupiArecae PericarpiumAreca Peel概述 Overview
本品为棕榈科植物槟榔Areca catechu L.的干燥果皮。冬季至次春采收未成熟的果实,煮后干燥,纵剖两瓣,剥取果皮,习称“大腹皮”;春末至秋初采收成熟果实,煮后干燥,剥取果皮,打松,晒干,习称“大腹毛”。
Areca Peel is the dried pericarp of the fruit of Areca catechu L. (Fam. Palmae). The unripe fruit is collected in winter to early spring, boiled and dried, longitudinally split into two halves, and the pericarp is peeled off, known as "Dafupi"; the ripe fruit is collected in late spring to early autumn, boiled and dried, the pericarp is peeled off, loosened, and dried in the sun, known as "Dafumao".性状 Description
###大腹皮 | Dafupi
略呈椭圆形或长卵形瓢状,长4~7 cm,宽2~3. 5 cm,厚0. 2~0. 5 cm。外果皮深棕色至近黑色,具不规则的纵皱纹及隆起的横纹,顶端有花柱残痕,基部有果梗及残存萼片。内果皮凹陷,褐色或深棕色,光滑呈硬壳状。体轻,质硬,纵向撕裂后可见中果皮纤维。气微,味微涩。
It is slightly oval or oblong-shaped, measuring 4-7 cm in length, 2-3.5 cm in width, and 0.2-0.5 cm in thickness. The outer pericarp is dark brown to nearly black, with irregular longitudinal wrinkles and raised transverse ridges. The top has the remnants of the stigma, and the base has the fruit stalk and remnants of the calyx. The inner pericarp is concave, brown or dark brown, smooth, and hard-shelled. It is light in weight and hard in texture. When longitudinally torn, the fibrous middle pericarp can be seen. It has a slight odor and a slightly astringent taste.###大腹毛 | Dafumao
略呈椭圆形或瓢状。外果皮多已脱落或残存。中果皮棕毛状,黄白色或淡棕色,疏松质柔。内果皮硬壳状,黄棕色或棕色,内表面光滑,有时纵向破裂。气微,味淡。
It is slightly oval or gourd-shaped. The outer pericarp is mostly shed or remains. The middle pericarp is brown and hairy, yellowish-white or light brown, loose and soft in texture. The inner pericarp is hard-shelled, yellowish-brown or brown, with a smooth inner surface, and sometimes longitudinally cracked. It has a slight odor and a mild taste.鉴别 Identification
(1)本品粉末黄白色或黄棕色。中果皮纤维成束,细长,直径8~15 μm,微木化,纹孔明显,周围细胞中含有圆簇状硅质块,直径约8 μm。内果皮细胞呈不规则多角形、类圆形或椭圆形,直径48~88 μm,纹孔明显。
(1) The powder of Dafupi is yellowish-white or yellowish-brown. The fibres of the middle pericarp are bundled, slender, with a diameter of 8-15 μm, slightly lignified, and have obvious pits. The surrounding cells contain round clusters of silica, with a diameter of about 8 μm. The cells of the inner pericarp are irregularly polygonal, nearly circular, or elliptical, with a diameter of 48-88 μm, and have obvious pits.(2)取本品粉末5 g,加甲醇50 ml,超声处理30分钟,滤过,滤液回收溶剂至干,加甲醇2 ml使溶解,滤过,取续滤液,作为供试品溶液。另取大腹皮对照药材5 g,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5 μl,分别点于同一硅胶G薄层板上,以三氯甲烷-甲醇-甲酸(7∶0.1∶0.02)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,置紫外光灯(365 nm)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) Take 5 g of the powder, add 50 ml of methanol, sonicate for 30 minutes, filter, evaporate the filtrate to dryness, dissolve the residue in 2 ml of methanol, filter, and continue to filter to obtain the test solution. Take 5 g of the reference drug Dafupi, prepare the reference drug solution using the same method. Carry out the method for thin layer chromatography<0502>, using silica gel G as the coating substance and a mixture of chloroform-methanol-formic acid (7:0.1:0.02) 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 with a 10% solution of sulfuric acid in ethanol, heat at 105°C to the spots clear. Examine under ultraviolet light at 365 nm. 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 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7.0%(通则2302)。
Not more than 7.0 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,用稀乙醇作溶剂,不得少于9.0%。
Carry out the method for determination of ethanol-soluble Extractives <2201,the hot maceration method>, using diluted ethanol as the solvent,not less than 9.0 per cent.饮片 Prepared slices
大腹皮 Dafupi
炮制 Processing
除去杂质,洗净,切段,干燥。
Eliminate Foreign matter,wash clean, cut into sections, and dry in the sun.鉴别 Identification
同药材。
Same as the crude drug.大腹毛 Dafumao
炮制 Processing
除去杂质,洗净,干燥。
Eliminate Foreign matter,wash clean, and dry in the sun.鉴别 Identification
同药材。
Same as the crude drug.性 Property
微温。
Slightly warm.味 Flavor
辛。
Pungent.归经 Meridian tropism
归脾、胃、大肠、小肠经。
Spleen, stomach, large intestine, and small intestine meridians.功能 Actions
行气宽中,行水消肿。
To promote qi circulation, regulate the middle burner, promote diuresis, and reduce edema.主治 Indications
用于湿阻气滞,脘腹胀闷,大便不爽,水肿胀满,脚气浮肿,小便不利。
Dampness obstructing qi movement, distension and fullness in the epigastrium and abdomen, difficult defecation, edema and distension, edema in the lower limbs, and difficulty in urination.用量 Dosage
5~10 g。
5-10 g.用法 Administration
无。
None.贮藏 Storage
置干燥处。
Preserve in a dry place.审核通过审核于: - 中国药典(2020年版)Chinese Pharmacopoeia (2020 Edition)创建于:更新于:
菊花
中文文本参考:《中国药典(2020年版)》
English text reference: Chinese Pharmacopoeia (2020 Edition)菊花JuhuaChrysanthemi FlosChrysanthemum Flower概述 Overview
本品为菊科植物菊Chrysanthemum morifolium Ramat.的干燥头状花序。9~11月花盛开时分批采收,阴干或焙干,或熏、蒸后晒干。药材按产地和加工方法不同,分为“亳菊”、“滁菊”、“贡菊”、“杭菊”、“怀菊”。
Chrysanthemum Flower is the dried flower head of Chrysanthemum morifolium Ramat. (Fam. Compositae). It is collected in batches when the flowers are in full bloom from September to November, removed from the stems, and dried in the shade or by baking, fumigating, steaming, and drying. According to different places of origin and processing methods, the drug is divided into "Boju", "Chuju", "Gongju", "Hangju", and "Huaiju".性状 Description
亳菊 Boju
呈倒圆锥形或圆筒形,有时稍压扁呈扇形,直径1.5~3cm,离散。总苞碟状;总苞片3~4层,卵形或椭圆形,草质,黄绿色或褐绿色,外面被柔毛,边缘膜质。花托半球形,无托片或托毛。舌状花数层,雌性,位于外围,类白色,劲直,上举,纵向折缩,散生金黄色腺点;管状花多数,两性,位于中央,为舌状花所隐藏,黄色,顶端5齿裂。瘦果不发育,无冠毛。体轻,质柔润,干时松脆。气清香,味甘、微苦。
Obconic or cylindrical, sometimes slightly compressed and flabellate, 1.5 to 3 cm in diameter, discrete. Involucre discoid; involucral bracts 3-4-layered, ovate or elliptic, herbaceous, yellowish green or brownish green, outside pilose, margin membranous. Receptacle hemispherical, without hypanthium or stipular hairs. Ligules several-layered, female, situated peripherally, whitish, straight, uplifted, longitudinally folded, scattered golden-yellow glandular dots; tubular flowers numerous, bisexual, situated centrally, hidden by ligules, yellow, apically 5-toothed. Achenes rudimentary, without crown hairs. Body light, texture soft, crunchy when dry. Aromatic, with a sweet, slightly bitter flavour.滁菊 Chuju
呈不规则球形或扁球形,直径1.5~2.5 cm。舌状花类白色,不规则扭曲,内卷,边缘皱缩,有时可见淡褐色腺点;管状花大多隐藏。
Irregularly spherical or oblate, 1.5-2.5 cm in diam. ligulate flowers whitish, irregularly twisted, involute, margins crinkled, sometimes pale brown glandular dots visible; tubular flowers mostly hidden.贡菊 Gongju
呈扁球形或不规则球形,直径1.5~2.5 cm。舌状花白色或类白色,斜升,上部反折,边缘稍内卷而皱缩,通常无腺点;管状花少,外露。
Compressed or irregularly spherical, 1.5-2.5 cm in diam. ligule white or whitish, obliquely ascending, distally reflexed, margin slightly involute and crumpled, usually without glandular dots; tubular flowers few, exserted.杭菊 Hangju
呈碟形或扁球形,直径2.5~4 cm,常数个相连成片。舌状花类白色或黄色,平展或微折叠,彼此粘连,通常无腺点;管状花多数,外露。
Disc-shaped or oblate, 2.5-4 cm in diameter, often connected in sheets. Ligules whitish or yellow, spreading or slightly folded, adherent to each other, usually without glandular dots; tubular flowers numerous, exserted.怀菊 Huaiju
呈不规则球形或扁球形,直径1.5~2.5 cm。多数为舌状花,舌状花类白色或黄色,不规则扭曲,内卷,边缘皱缩,有时可见腺点;管状花大多隐藏。
Irregularly spherical or oblate, 1.5-2.5 cm in diam. Mostly ligulate, ligule-like white or yellow, irregularly twisted, involute, margins crumpled, glandular dots sometimes visible; tubular flowers mostly hidden.鉴别 Identification
(1)本品粉末黄白色。花粉粒类球形,直径32~37 μm,表面有网孔纹及短刺,具3孔沟。T形毛较多,顶端细胞长大,两臂近等长,柄2~4细胞。腺毛头部鞋底状,6~8细胞两两相对排列。草酸钙簇晶较多,细小。
(1) The powder of this product is yellowish white. The pollen grains are spherical, 32-37 μm in diameter, with reticulation and short spines on the surface, with 3 pore grooves. t-shaped hairs are more numerous, the apical cells are growing, the two arms are nearly equal in length, and the stalks are 2-4 cells. The head of glandular hairs is shoestring-like, with 6-8 cells arranged two by two opposite to each other. Calcium oxalate clusters more numerous, fine.(2)取本品1 g,剪碎,加石油醚(30~60℃)20ml,超声处理10分钟,弃去石油醚,药渣挥干,加稀盐酸1 ml与乙酸乙酯50 ml,超声处理30分钟,滤过,滤液蒸干,残渣加甲醇2 ml使溶解,作为供试品溶液。另取菊花对照药材1 g,同法制成对照药材溶液。再取绿原酸对照品,加乙醇制成每1 ml含0.5 mg的溶液,作为对照品溶液。照薄层色谱法(通则0502)试验,吸取上述三种溶液各0.5~1 μl,分别点于同一聚酰胺薄膜上,以甲苯-乙酸乙酯-甲酸-冰醋酸-水(1︰15︰1︰1︰2)的上层溶液为展开剂,展开,取出,晾干,置紫外光灯(365 nm)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,显相同颜色的荧光斑点。
(2) Take 1 g of this product, cut, add petroleum ether (30 ~ 60 ℃) 20 ml, ultrasonic treatment for 10 minutes, discard petroleum ether, dregs volatile dry, add 1 ml of dilute hydrochloric acid and ethyl acetate 50 ml, ultrasonic treatment for 30 minutes, filtration, filtrate evaporation, residue with methanol 2 ml to make dissolved, as a test solution. Another take chrysanthemum control herb 1 g, the same method into the control herb solution. Then take chlorogenic acid control product, add ethanol to make a solution containing 0.5 mg per 1 ml, as a control solution. According to the thin-layer chromatography (General rule 0502) test, absorb the above three solutions of 0.5 ~1 μl, were spotted on the same polyamide film, with toluene - ethyl acetate - formic acid - glacial acetic acid - water (1:15: 1:1:2) of the upper solution as the unfolding agent, unfolding, take out, drying, and placed in the ultraviolet lamp (365 nm) to see. In the chromatogram of the test article, fluorescent spots of the same colour were found in the corresponding positions of the chromatogram of the control herb and the control article.检查 Examination
水分 Water
不得过15.0%(通则0832第二法)。
Not more than 15. 0 per cent <0832, method 2>.含量测定 Content determination
照高效液相色谱法(通则0512)测定。
Determined by high performance liquid chromatography <0512>.色谱条件与系统适用性试验 Chromatographic system and system suitability
以十八烷基硅烷键合硅胶为填充剂;以乙腈为流动相A,以0.1%磷酸溶液为流动相B,按下表中的规定进行梯度洗脱;检测波长为348 nm。理论板数按3, 5-O-二咖啡酰基奎宁酸峰计算应不低于8000。
Octadecylsilane-bonded silica gel was used as filler; acetonitrile was used as mobile phase A, and 0.1% phosphoric acid solution was used as mobile phase B. Gradient elution was carried out according to the following table; the detection wavelength was 348 nm. the theoretical plate number should be not less than 8000 based on the peak of 3, 5-O-dicaffeoylquinic acid.对照品溶液的制备 Preparation of reference solution
取绿原酸对照品、木犀草苷对照品、 3,5-O-双咖啡酰基奎宁酸对照品适量,精密称定,置棕色量瓶中,加70%甲醇制成每1 ml含绿原酸35 μg,木犀草苷25μg,3,5-O-二咖啡酰基奎宁酸80 μg的混合溶液,即得(10℃以下保存)。
Take chlorogenic acid control, lignocaine control, 3,5-O-dicaffeoylquinic acid control, weigh precisely, put in a brown measuring flask, add 70% methanol to make a mixed solution containing 35 μg of chlorogenic acid, 25 μg of lignocaine, and 80 μg of 3,5-O-dicaffeoylquinic acid per 1 ml, and then it will be obtained (preserved at below 10 ℃).供试品溶液的制备 Preparation of test solution
取本品粉末(过一号筛)约0.25 g,精密称定,置具塞锥形瓶中,精密加入70%甲醇25 ml,密塞,称定重量,超声处理(功率300 W,频率45 kHz)40分钟,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 the powder of this product (through the first sieve) about 0.25 g, precision weighing, placed in a stoppered conical flask, precision add 25 ml of 70% methanol, tightly stoppered, weighing, ultrasonic treatment (power 300 W, frequency of 45 kHz) for 40 minutes, cooled, and then weighing, with 70% methanol to make up for the loss of weight, shaking, filtration, and take the filtrate, that is, the product.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。
Pipette 5 μl each of control solution and test solution, inject into the liquid chromatograph, and then determine, that is, obtain.本品按干燥品计算,含绿原酸(C16H18O9)不得少于0.20%,含木犀草苷(C21H20O11)不得少于0.080%,含3,5-O-二咖啡酰基奎宁酸(C25H24O12)不得少于0.70%。
This product contains not less than 0.20% of chlorogenic acid (C16H18O9), not less than 0.080% of lignoceroside (C21H20O11), and not less than 0.70% of 3,5-O-dicaffeoylquinic acid (C25H24O12) when calculated from the dried product.性 Property
微寒。
Slightly cold.味 Flavor
甘、苦。
Sweet and bitter.归经 Meridian tropism
归肺、肝经。
Lung and liver meridians.功能 Actions
散风清热,平肝明目,清热解毒。
Dispersing wind and clearing heat, calming the liver and improving eyesight, clearing heat and removing toxins.主治 Indications
用于风热感冒,头痛眩晕,目赤肿痛,眼目昏花,疮痈肿毒。
It is used for wind-heat cold, headache and dizziness, redness and swelling of the eyes, blurred vision, sores, carbuncles and poisons.用量 Dosage
5~10 g。
5-10 g.用法 Administration
无。
None.贮藏 Storage
置阴凉干燥处,密闭保存,防霉,防蛀。
Keep in a cool and dry place, airtight, mould-proof and moth-proof.审核通过审核于: - 中国药典(2020年版)Chinese Pharmacopoeia (2020 Edition)创建于:更新于:
鹿角胶
中文文本参考:《中国药典(2020年版)》
English text reference: Chinese Pharmacopoeia (2020 Edition)鹿角胶LujiaojiaoCervi Cornus CollaDeer Horn Glue概述 Overview
本品为鹿角经水煎煮、浓缩制成的固体胶。
Deer Horn Glue is the solid glue made by decocting and concentrating deer horn.制法 Processing
将鹿角锯段,漂泡洗净,分次水煎,滤过,合并滤液(或加入白矾细粉少量),静置,滤取胶液,浓缩(可加适量黄酒、冰糖和豆油)至稠膏状,冷凝,切块,晾干,即得。
Cut deer horn into sections, wash and soak, decoct in water in several portions, filter, combine the filtrate (or add a small amount of alum powder), let it stand, filter the glue liquid, concentrate (may add appropriate amount of yellow rice wine, rock sugar, and soybean oil) to a thick paste, condense, cut into pieces, and dry to obtain the product.性状 Description
本品呈扁方形块或丁状。黄棕色或红棕色,半透明,有的上部有黄白色泡沫层。质脆,易碎,断面光亮。气微,味微甜。
It is flat square or cuboid. Yellowish-brown or reddish-brown, semi-transparent, some with yellowish-white foam on the surface. Brittle, easily broken, with a shiny fracture. Slight odor, slightly sweet taste.鉴别 Identification
取本品粉末0.1 g,加1%碳酸氢铵溶液50 ml,超声处理30分钟,用微孔滤膜滤过,取续滤液100 μl,置微量进样瓶中,加胰蛋白酶溶液10 μl(取序列分析用胰蛋白酶,加1%碳酸氢铵溶液制成每1 ml中含1 mg的溶液,临用时配制),摇匀,37 ℃恒温酶解12小时,作为供试品溶液。另取鹿角胶对照药材0.1 g,同法制成对照药材溶液。照高效液相色谱法-质谱法(通则0512和通则0431)试验,以十八烷基硅烷键合硅胶为填充剂(色谱柱内径2.1 mm);以乙腈为流动相A,以0.1%甲酸溶液为流动相B,按下表中的规定进行梯度洗脱;流速为每分钟0.3 ml。采用质谱检测器,电喷雾正离子模式(ESI+),进行多反应监测(MRM),选择质荷比(m/z)765.4(双电荷)→554.0和m/z765.4(双电荷)→733.0作为检测离子对。取鹿角胶对照药材溶液,进样5 μl,按上述检测离子对测定的MRM色谱峰的信噪比均应大于3︰1。
To 0.1 g of the powder add 50 ml of 1% ammonium bicarbonate solution, treat with ultrasound for 30 minutes, filter through a microporous membrane, take 100 μl of the filtrate, place it in a microsampling bottle, add 10 μl of trypsin solution (take trypsin for sequence analysis, prepare a solution containing 1 mg per ml with 1% ammonium bicarbonate solution before use), shake well, and incubate at 37°C for 12 hours as the test solution. Take 0.1 g of the reference drug deer horn glue and prepare the reference drug solution by the same method. Perform the test according to the high-performance liquid chromatography-mass spectrometry method (General Rule 0512 and General Rule 0431), using octadecylsilane-bonded silica gel as the filling material (column inner diameter 2.1 mm); use acetonitrile as mobile phase A and 0.1% formic acid solution as mobile phase B, and perform gradient elution according to the specified conditions in the table; the flow rate is 0.3 ml per minute. Use a mass spectrometry detector, electrospray ionization positive ion mode (ESI+), and perform multiple reaction monitoring (MRM), selecting the mass-to-charge ratio (m/z) 765.4 (double charge)→554.0 and m/z 765.4 (double charge)→733.0 as the detection ion pairs. Inject 5 μl of the deer horn glue reference drug solution, and the signal-to-noise ratio of the MRM chromatographic peak determined by the above detection ion pairs should be greater than 3:1.吸取供试品溶液5 μl,注入高效液相色谱-质谱联用仪,测定。以质荷比(m/z)765.4(双电荷)→554.0和m/z765.4(双电荷)→733.0离子对提取的供试品离子流色谱中,应同时呈现与对照药材色谱保留时间一致的色谱峰。
Take 5 μl of the test solution, inject it into the high-performance liquid chromatography-mass spectrometry system, and determine it. In the ion flow chromatogram extracted by the mass-to-charge ratio (m/z) 765.4 (double charge)→554.0 and m/z 765.4 (double charge)→733.0 ion pairs, a chromatographic peak that is consistent with the retention time of the reference drug should be simultaneously present.检查 Examination
水分 Water
取本品1 g,精密称定,加水2 ml,加热溶解后,置水浴上蒸干,使厚度不超过2 mm,照水分测定法(通则0832第二法)测定,不得过15.0%。
Weigh accurately 1 g of the product, add 2 ml of water, dissolve by heating, place it on a water bath and evaporate until the thickness does not exceed 2 mm, and determine the water content according to the method for water determination (General Rule 0832, method 2), which should not exceed 15.0%.总灰分 Total ash
取本品1.0 g,依法检查(通则2302),不得过3.0%。
Take 1.0 g of the product and examine it according to the regulations (General Rule 2302), which should not exceed 3.0%.重金属 Heavy metals
取总灰分项下的残渣,依法检查(通则0821第二法),不得过30 mg/kg。
Take the residue under the total ash item and examine it according to the regulations (General Rule 0821, method 2), which should not exceed 30 mg/kg.砷盐 Arsenic salts
取本品1.0 g,加氢氧化钙1 g,混合,加少量水,搅匀,干燥后,先用小火烧灼使炭化,再在500~600 ℃炽灼使完全灰化,放冷,加盐酸5 ml与水2 ml,依法检查(通则0822),不得过2 mg/kg。
Take 1.0 g of the product, add 1 g of calcium hydroxide, mix, add a small amount of water, stir well, dry, first carbonize with low heat, then incinerate at 500-600°C to complete ashing, cool, add 5 ml of hydrochloric acid and 2 ml of water, and examine it according to the regulations (General Rule 0822), which should not exceed 2 mg/kg.水中不溶物 Insoluble matter in water
取本品1.0 g,精密称定,加水10 ml,加热溶解,将溶液移入已恒重的10 ml离心管中,离心,去除管壁浮油,倾去上清液,沿管壁加入温水至刻度,离心,如法清洗3次,倾去上清液,离心管在105 ℃加热2小时,取出,置干燥器中冷却30分钟,精密称定,计算,即得。
Weigh accurately 1.0 g of the product, add 10 ml of water, dissolve by heating, transfer the solution to a 10 ml centrifuge tube that has been weighed, centrifuge, remove the oil floating on the tube wall, pour off the supernatant, add warm water along the tube wall to the mark, centrifuge, wash 3 times as before, pour off the supernatant, heat the centrifuge tube at 105°C for 2 hours, take it out, cool it in a desiccator for 30 minutes, weigh accurately, and calculate to obtain the result.本品水中不溶物不得过2.0%。
The insoluble matter in water of the product should not exceed 2.0%.其他 Others
应符合胶剂项下有关的各项规定(通则0184)。
It should comply with the relevant regulations under the adhesive item (General Rule 0184).含量测定 Assay
照高效液相色谱法(通则0512)测定。
Determine by high-performance liquid chromatography (General Rule 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-0.1 mol/L醋酸钠溶液(用醋酸调节pH值至6.5)(7︰93)为流动相A,以乙腈-水(4︰1)为流动相B,按下表中的规定进行梯度洗脱;检测波长为254 nm。柱温为43 ℃。理论板数按L-羟脯氨酸峰计算应不低于4000。
Use octadecylsilane-bonded silica gel as the filling material; use acetonitrile-0.1 mol/L sodium acetate solution (adjust the pH value to 6.5 with acetic acid) (7:93) as mobile phase A, and use acetonitrile-water (4:1) as mobile phase B. Perform gradient elution according to the specified conditions in the table; the detection wavelength is 254 nm. The column temperature is 43°C. The theoretical plate number calculated based on the peak of L-hydroxyproline should not be less than 4000.对照品溶液的制备 Preparation of reference solution
取L-羟脯氨酸对照品、甘氨酸对照品、丙氨酸对照品、L-脯氨酸对照品适量,精密称定,加0.1 mol/L盐酸溶液制成每1 ml含L-羟脯氨酸70 μg、甘氨酸0.14 mg、丙氨酸60 μg 、L-脯氨酸70 μg的混合溶液,即得。
Take an appropriate amount of L-hydroxyproline reference substance, glycine reference substance, alanine reference substance, and L-proline reference substance, weigh accurately, and add 0.1 mol/L hydrochloric acid solution to prepare a mixed solution containing 70 μg of L-hydroxyproline, 0.14 mg of glycine, 60 μg of alanine, and 70 μg of L-proline per 1ml.供试品溶液的制备 Preparation of test solution
取本品粗粉约0.25 g,精密称定,置25 ml量瓶中,加0.1 mol/L盐酸溶液20 ml,超声处理(功率300 W,频率40 kHz)30分钟,放冷,加0.1 mol/L盐酸溶液至刻度,摇匀。精密量取2 ml,置5 ml安瓿中,加盐酸2 ml,150 ℃水解1小时,放冷,移至蒸发皿中,用水10 ml分次洗涤,洗液并入蒸发皿中,蒸干,残渣加0.1 mol/L盐酸溶液溶解,转移至25 ml量瓶中,加0.1 mol/L盐酸溶液至刻度,摇匀,即得。
Take about 0.25 g of the crude powder of the product, weigh accurately, place it in a 25 ml volumetric flask, add 20 ml of 0.1 mol/L hydrochloric acid solution, treat with ultrasound (power 300 W, frequency 40 kHz) for 30 minutes, cool, add 0.1 mol/L hydrochloric acid solution to the mark, shake well. Accurately measure 2 ml, place it in a 5 ml ampoule, add 2ml of hydrochloric acid, hydrolyze at 150°C for 1 hour, cool, transfer to an evaporating dish, wash with water in portions of 10 ml, pour the washing liquid into the evaporating dish, evaporate to dryness, dissolve the residue in 0.1 mol/L hydrochloric acid solution, transfer to a 25 ml volumetric flask, add 0.1 mol/L hydrochloric acid solution to the mark, shake well.精密量取上述对照品溶液和供试品溶液各5 ml,分别置25 ml量瓶中,各加0.1 mol/L异硫氰酸苯酯(PITC)的乙腈溶液2.5 ml,1 mol/L三乙胺的乙腈溶液2.5 ml,摇匀,室温放置1小时后,加50%乙腈至刻度,摇匀。取10 ml,加正己烷10 ml,振摇,放置10分钟,取下层溶液,滤过,取续滤液,即得。
Accurately measure 5 ml of the above reference solution and test solution, place them in separate 25 ml volumetric flasks, add 2.5 ml of acetonitrile solution of 0.1 mol/L phenyl isothiocyanate (PITC) and 2.5 ml of acetonitrile solution of 1 mol/L triethylamine, shake well, and let it stand at room temperature for 1 hour. Add 50% acetonitrile to the mark, shake well. Take 10 ml, add 10 ml of n-hexane, shake, let it stand for 10 minutes, take the lower layer solution, filter, and take the subsequent filtrate.测定法 Assay method
分别精密吸取衍生化后的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。
Accurately suck 5 μl of the derivatized reference solution and test solution, inject them into the liquid chromatograph, and determine.本品按干燥品计算,含L-羟脯氨酸不得少于6.6%、甘氨酸不得少于13.3%、丙氨酸不得少于5.2%、L-脯氨酸不得少于7.5%。
Calculated on the basis of the dried product, the content of L-hydroxyproline should not be less than 6.6%, glycine should not be less than 13.3%, alanine should not be less than 5.2%, and L-proline should not be less than 7.5%.性 Property
温。
Warm.味 Flavor
甘、咸。
Sweet and salty.归经 Meridian tropism
归肾、肝经。
Kidney and liver meridians.功能 Actions
温补肝肾,益精养血。
It warms and tonifies the liver and kidney, nourishes essence and blood.主治 Indications
用于肝肾不足所致的腰膝酸冷,阳痿遗精,虚劳羸瘦,崩漏下血,便血尿血,阴疽肿痛。
It is used for lumbago and coldness of the waist and knees caused by liver and kidney deficiency, impotence and premature ejaculation, weakness and emaciation, excessive uterine bleeding, bloody stools, bloody urine, and swelling and pain of carbuncle.用量 Dosage
3~6 g。
3-6 g.用法 Administration
烊化兑服。
Decocted and taken orally.规格 Specification
每块重6g。
Each piece weighs 6g.贮藏 Storage
密闭。
Store in a sealed container.审核通过审核于: - 中国药典(2020年版)Chinese Pharmacopoeia (2020 Edition)创建于:更新于:
羌活
中文文本参考:《中国药典(2020年版)》
English text reference: Chinese Pharmacopoeia (2020 Edition)羌活QianghuoNotopterygii Rhizoma et RadixNotopterygium Rhizome and Root概述 Overview
本品为伞形科植物羌活Notopterygium incisum Ting ex H. T. Chang or 宽叶羌活 Notopterygium franchetii H. de Boiss. 的干燥根茎和根。春、秋二季采挖,除去须根及泥沙,晒干。
Notopterygium Rhizome and Root is the dried rhizome and root of Notopterygium incisum Ting ex H. T. Chang or Notopterygium franchetii H. de Boiss. (Fam. Umbelliferae). The drug is collected in spring and autumn, removed from rootlets and sand, and dried in the sun.性状 Description
羌活 Notopterygium Rhizome and Root
为圆柱状略弯曲的根茎,长4~13 cm,直径0.6~2.5 cm,顶端具茎痕。表面棕褐色至黑褐色,外皮脱落处呈黄色。节间缩短,呈紧密隆起的环状,形似蚕,习称“蚕羌”;节间延长,形如竹节状,习称“竹节羌”。节上有多数点状或瘤状突起的根痕及棕色破碎鳞片。体轻,质脆,易折断,断面不平整,有多数裂隙,皮部黄棕色至暗棕色,油润,有棕色油点,木部黄白色,射线明显,髓部黄色至黄棕色。气香,味微苦而辛。
It is cylindrical and slightly curved, 4-13 cm long, 0.6-2.5 cm in diameter, with a stem scar at the top. The surface is brownish-brown to blackish-brown, with the outer skin peeling off and appearing yellow at the peeled area. The internodes are shortened, forming closely raised rings, resembling silkworms, commonly known as "silkworm Qiang"; the internodes are elongated, resembling bamboo nodes, commonly known as "bamboo node Qiang". There are numerous point-like or tuberous root scars and brown broken scales on the nodes. The body is light, brittle, easily broken, with an uneven fracture surface and numerous cracks. The bark is yellowish-brown to dark brown, oily, with brown oil spots; the wood is yellowish-white, with obvious rays; the pith is yellow to yellowish-brown. It has a fragrant odor, slightly bitter and pungent taste.宽叶羌活 Notopterygium franchetii
为根茎和根。根茎类圆柱形,顶端具茎和叶鞘残基,根类圆锥形,有纵皱纹和皮孔;表面棕褐色,近根茎处有较密的环纹,长8~15 cm,直径1~3 cm,习称“条羌”。有的根茎粗大,不规则结节状,顶部具数个茎基,根较细,习称“大头羌”。质松脆,易折断,断面略平坦,皮部浅棕色,木部黄白色。气味较淡。
It is the rhizome and root. The rhizome is cylindrical, with a stem and leaf sheath residue at the top, and the root is conical, with longitudinal wrinkles and skin pores; the surface is brownish-brown, with dense rings near the rhizome, 8-15 cm long, 1-3 cm in diameter, commonly known as "striped Qiang". Some rhizomes are thick and irregularly nodular, with several stem bases at the top, and the roots are thinner, commonly known as "big-headed Qiang". It is soft and brittle, easily broken, with a slightly flat fracture surface, light brown bark, and yellowish-white wood. It has a mild odor.鉴别 Identification
取本品粉末1 g,加甲醇5 ml,超声处理20分钟,静置,取上清液作为供试品溶液。另取紫花前胡苷对照品,加甲醇制成每1 ml含0.5 mg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2~4 μl,分别点于同一用3%醋酸钠溶液制备的硅胶G薄层板上,以三氯甲烷-甲醇(8:2)为展开剂,展开,取出,晾干,置紫外光灯(365 nm)下检视。供试品色谱中,在与对照品色谱相应的位置上,显相同的蓝色荧光斑点。
To 1 g of the powder add 5 ml of methanol, treat with ultrasound for 20 minutes, let stand, and take the supernatant as the test solution. Take paeoniflorin CRS, add methanol to make a solution containing 0.5 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 3% solution of sodium acetate as the mobile phase. Apply separately to the plate 2-4 μl of each of the above two solutions. After developing and removal of the plate, dry in air. Examine under ultraviolet light at 365 nm. The blue 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 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>.特征图谱 Chromatographic fingerprint
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(非亲水性)为填充剂(柱长为250 mm,内径为4.6 mm,粒度为5 μm);以乙腈为流动相A,以0. 1%磷酸溶液为流动相B,按下表中的规定进行梯度洗脱;柱温为25°C;检测波长为246 nm。理论板数按羌活醇峰计算应不低于18000。
Use octadecylsilane bonded silica gel (non-polar) as the filler (column length 250 mm, inner diameter 4.6 mm, particle size 5 μm); use acetonitrile as mobile phase A, 0.1% phosphoric acid solution as mobile phase B, and perform gradient elution according to the specified conditions in the table; column temperature is 25°C; detection wavelength is 246 nm. The theoretical plate number calculated based on the peak of artemisinin should not be less than 18000.对照提取物溶液的制备 Preparation of reference extract solution
取羌活对照提取物10 mg,精密称定,置5 ml量瓶中,加甲醇溶解并稀释至刻度,摇匀,即得。
Take 10 mg of reference extract of Artemisia annua, accurately weigh, place it in a 5 ml volumetric flask, dissolve it in methanol and dilute to the mark, shake well, and obtain.供试品溶液的制备 Preparation of test solution
取〔含量测定〕项下的供试品溶液,即得。
Take the test solution under the "content determination" section, and obtain.测定法 Determination method
分别精密吸取对照提取物溶液与供试品溶液各10 μl,注入液相色谱仪,测定,记录色谱图,即得。
Precisely draw 10 μl of the reference extract solution and the test solution, inject them into the liquid chromatograph, determine, record the chromatogram, and obtain.供试品特征图谱中应呈现与对照提取物中的4个主要特征峰保留时间相对应的色谱峰。
The test chromatographic fingerprint should present chromatographic peaks corresponding to the retention times of the four major characteristic peaks in the reference extract.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15.0%。
Carry out the method for determination of ethanol-soluble extractives <2201>, using ethanol as the solvent, not less than 15.0 per cent.含量测定 Content determination
挥发油 Volatile oil
照挥发油测定法(通则2204)测定。
Determine the volatile oil content by the method for determination of volatile oil <2204>.本品含挥发油不得少于1.4%(ml/g)。
The volatile oil content of this product should not be less than 1.4% (ml/g).羌活醇和异欧前胡素 Artemisinin and isoimperatorin
照高效液相色谱法(通则0512) 测定。
Determine artemisinin and isoimperatorin 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-水(44:56)为流动相;检测波长为310 nm。理论板数按羌活醇峰计算应不低于5000。
Use octadecylsilane bonded silica gel as the filler; use acetonitrile-water (44:56) as the mobile phase; detection wavelength is 310 nm. The theoretical plate number calculated based on the peak of artemisinin should not be less than 5000.对照品溶液的制备 Preparation of reference solution
取羌活醇对照品、异欧前胡素对照品适量,精密称定,加甲醇制成每1 ml含羌活醇60 μg.异欧前胡素30 μg的混合溶液,即得。
Take an appropriate amount of artemisinin reference standard and isoimperatorin reference standard, accurately weigh, add methanol to prepare a mixed solution containing 60 μg of artemisinin and 30 μg of isoimperatorin per ml, and obtain.供试品溶液的制备 Preparation of test solution
取本品粉末(过三号筛)约0.4 g,精密称定,置具塞锥形瓶中,精密加入甲醇50 ml,称定重量,超声处理(功率250 W,频率50 kHz)30分钟,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。
Take about 0.4 g of the powder of this product (passed through a No. 3 sieve), accurately weigh, place it in a stoppered conical flask, accurately add 50 ml of methanol, weigh, subject to ultrasonic treatment (power 250 W, frequency 50 kHz) for 30 minutes, cool, weigh again, make up for the weight loss with methanol, shake well, filter, and take the filtrate, and obtain.测定法 Determination method
分别精密吸取对照品溶液5 μl与供试品溶液5~10 μl,注入液相色谱仪,测定,即得。
Precisely draw 5 μl of the reference solution and 5-10 μl of the test solution, inject them into the liquid chromatograph, determine, and obtain.本品按干燥品计算,含羌活醇(C21H22O5)和异欧前胡素(C16H14O4)的总量不得少于0.40%。
Calculated on the dried product, the total content of artemisinin (C21H22O5) and isoimperatorin (C16H14O4) in this product should not be less than 0.40%.饮片 Prepared slices
羌活 Artemisia annua
炮制 Processing
除去杂质,洗净,润透,切厚片,干燥。
Remove impurities, wash, soften, cut into thick slices, and dry.性状 Appearance
本品呈类圆形、不规则形横切或斜切片,表皮棕褐色至黑褐色,切面外侧棕褐色,木部黄白色,有的可见放射状纹理。体轻,质脆。气香,味微苦而辛。
This product is round or irregularly shaped transverse or oblique slices, with brownish-brown to blackish-brown skin, brownish-brown outer surface of the cut surface, yellowish-white wood, and some visible radial texture. It is light and brittle. It has a fragrant aroma, a slightly bitter and pungent taste.检查 Examination
水分 Water
不得过9.0%(通则0832第四法)。
Not more than 9.0 per cent <0832, method 4>.总灰分 Total ash
同药材。
Same as the crude drug.酸不溶性灰分 Acid-insoluble ash
同药材。
Same as the crude drug.鉴别 Identification
同药材。
Same as the crude drug.特征图谱 Chromatographic fingerprint
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.性 Property
温。
Warm.味 Flavor
辛、苦。
Pungent, bitter.归经 Meridian tropism
归膀胱、肾经。
Meridian tropism: bladder and kidney meridians.功能 Actions
解表散寒,祛风除湿,止痛。
Expel exterior cold, dispel wind and dampness, relieve pain.主治 Indications
用于风寒感冒,头痛项强,风湿痹痛,肩背酸痛。
Used for wind-cold common cold, severe headache, wind-dampness arthralgia, shoulder and back soreness.用量 Dosage
3~10 g。
3-10 g.用法 Administration
无。
None.贮藏 Storage
置阴凉干燥处,防蛀。
Store in a cool and dry place, and protect against moth.审核通过审核于: - 中国药典(2020年版)Chinese Pharmacopoeia (2020 Edition)创建于:更新于:
青礞石
中文文本参考:《中国药典(2020年版)》
English text reference: Chinese Pharmacopoeia (2020 Edition)青礞石QingmengshiChloriti LapisChlorite Lapis概述 Overview
本品为变质岩类黑云母片岩或绿泥石化云母碳酸盐片岩。采挖后,除去杂石和泥沙。
Chlorite Lapis is the black mica schist or chlorite-mica carbonate schist of metamorphic rock. After excavation, remove impurities and sediment.性状 Description
黑云母片岩主 Black mica schist
为鳞片状或片状集合体。呈不规则扁块状或长斜块状,无明显棱角。褐黑色或绿黑色,具玻璃样光泽。质软,易碎,断面呈较明显的层片状。碎粉主为绿黑色鳞片(黑云母),有似星点样的闪光。气微,味淡。
It is mainly in the form of flake or flake aggregates. It is irregularly flat or oblique blocks without obvious edges and corners. It is dark brown or greenish black with a glassy luster. The texture is soft, fragile, and the fracture surface is more obvious in layers. The broken powder is mainly greenish-black flakes (black mica), with a star-like flash. It has a slight odor and a mild taste.绿泥石化云母碳酸盐片岩 Chlorite-mica carbonate schist
为鳞片状或粒状集合体。呈灰色或绿灰色,夹有银色或淡黄色鳞片,具光泽。质松,易碎,粉末为灰绿色鳞片(绿泥石化云母片)和颗粒(主为碳酸盐),片状者具星点样闪光。遇稀盐酸产生气泡,加热后泡沸激烈。气微,味淡。
It is in the form of flake or granular aggregates. It is gray or greenish-gray with silver or light yellow scales and has a luster. The texture is loose, fragile, and the powder is grayish-green flakes (chlorite-mica carbonate) and particles (mainly carbonate), and the flaky ones have a star-like flash. It produces bubbles when encountering dilute hydrochloric acid, and boils vigorously when heated. It has a slight odor and a mild taste.饮片 Prepared Slices
青礞石 PChlorite Lapis
炮制 Processing
除去杂石,砸成小块。
Remove impurities from Chlorite Lapis and crush into small pieces.性状 Description
本品呈鳞片状、不规则碎块状或颗粒,碎块直径0.5~2 cm,厚0.5~1 cm,无明显棱角。褐黑色、绿褐色或灰绿色,具玻璃样光泽。碎块断面呈较明显层片状。质软,易碎,气微,味淡。
It is in the form of flake, irregular fragments, or particles, with a diameter of 0.5-2 cm and a thickness of 0.5-1 cm, without obvious edges and corners. It is dark brown, greenish-brown, or grayish-green with a glassy luster. The fracture surface of the fragments is more obvious in layers. The texture is soft, fragile, with a slight odor and a mild taste.煅青礞石 Calcined Chlorite Lapis
炮制 Processing
取净青礞石,照明煅法(通则0213)燃至红透。
Take clean Chlorite Lapis and calcine it according to the method of calcination in General Rules for Preparations (0213) until it is red-hot.性状 Description
本品呈不规则碎块状或鳞片状粉末,碎块直径0.5~1.5 cm,厚0.5~1 cm,无明显棱角。黄绿色至青黄色,鳞片状粉末光泽性更强。碎块断面呈较明显层片状。质松软,易碎,气微,味淡。
It is in the form of irregular fragments or flake-like powder, with a diameter of 0.5-1.5 cm and a thickness of 0.5-1 cm, without obvious edges and corners. It is yellowish-green to bluish-green, and the flake-like powder has a stronger luster. The fracture surface of the fragments is more obvious in layers. The texture is loose, soft, fragile, with a slight odor and a mild taste.性 Property
平。
Neutral.味 Flavour
甘、咸。
Sweet and salty.归经 Meridian tropism
归肺、心、肝经。
It enters the Lung, Heart, and Liver meridians.功能 Functions
坠痰下气,平肝镇惊。
It resolves phlegm and descends Qi, calms the Liver and suppresses wind.主治 Indications
用于顽痰胶结,咳逆喘急,癫痫发狂,烦躁胸闷,惊风抽搐。
It is used for stubborn phlegm agglutination, coughing and shortness of breath, epileptic frenzy, irritability and chest tightness, and convulsions of convulsions.用量 Dosage
3~6 g;煎汤10~15 g。
3-6 g per dose; decoction, 10-15 g per dose.用法 Usage
多入丸散服;煎汤,布包先煎。
It is commonly used in pill or powder form; decoction, wrap in cloth and decoct first.贮藏 Storage
置干燥处。
Store in a dry place.审核通过审核于: - 中国药典(2020年版)Chinese Pharmacopoeia (2020 Edition)创建于:更新于:
全蝎
中文文本参考:《中国药典(2020年版)》
English text reference: Chinese Pharmacopoeia (2020 Edition)全蝎QuanxieScorpioScorpion概述 Overview
本品为钳蝎科动物东亚钳蝎Buthus martensii Karsch的干燥体。春末至秋初捕捉,除去泥沙,置沸水或沸盐水中,煮至全身僵硬,捞出,置通风处,阴干。
Scorpion is the dried body of Buthus martensii Karsch (Fam. Buthidae). It is collected from late spring to early autumn, removed from mud and sand, boiled in boiling water or boiling salt water until the whole body becomes stiff, taken out, and dried in a ventilated place.性状 Description
本品头胸部与前腹部呈扁平长椭圆形,后腹部呈尾状,皱缩弯曲,完整者体长约6 cm。头胸部呈绿褐色,前面有1对短小的螯肢和1对较长大的钳状脚须,形似蟹螯,背面覆有梯形背甲,腹面有足4对,均为7节,末端各具2爪钩;前腹部由7节组成,第7节色深,背甲上有5条隆脊线。背面绿褐色,后腹部棕黄色,6节,节上均有纵沟,末节有锐钩状毒刺,毒刺下方无距。气微腥,味咸。
The head and thorax of the scorpion are flattened and elongated, and the posterior abdomen is tail-shaped, wrinkled and curved. The intact body is about 6 cm long. The head and thorax are greenish-brown, with a pair of short chelipeds and a pair of longer and larger chelate foot whiskers in the front, resembling crab claws. The back is covered with trapezoidal dorsal plates, and the ventral surface has 4 pairs of legs, all of which have 7 segments, each with 2 claw hooks at the end; the anterior abdomen consists of 7 segments, the 7th segment is darker, and there are 5 ridges on the dorsal plate. The back is greenish-brown, and the posterior abdomen is brownish-yellow, with 6 segments, each with longitudinal grooves, and the terminal segment has sharp hook-like venomous spines, with no distance below the venomous spines. Slightly fishy odor, salty taste.鉴别 Identification
本品粉末黄棕色或淡棕色。体壁碎片外表皮表面观呈多角形网格样纹理,表面密布细小颗粒,可见毛窝、细小圆孔和淡棕色或近无色的瘤状突起;内表皮无色,有横向条纹,内、外表皮纵贯较多长短不一的微细孔道。刚毛红棕色,多碎断,先端锐尖或钝圆,具纵直纹理,髓腔细窄。横纹肌纤维多碎断,明带较暗带宽,明带中有一暗线,暗带有致密的短纵纹理。
The powder of the scorpion is yellowish-brown or light brown. The surface of the body wall fragment epidermis appears as a polygonal grid-like texture, with small particles densely distributed on the surface, visible hair follicles, small round holes, and light brown or nearly colorless wart-like protrusions; the inner epidermis is colorless, with transverse stripes, and the inner and outer epidermis have many short and long micro-pores. The bristles are reddish-brown, mostly broken, with sharp or blunt round tips, longitudinal straight texture, and narrow medullary cavity. The transverse striated muscle fibers are mostly broken, with a wider light band than a dark band, a dark line in the middle of the light band, and a dense short longitudinal texture in the dark band.检查 Examination
水分 Water
不得过20.0%(通则0832第二法)。
Not more than 20.0 per cent <0832,method 2>.总灰分 Total ash
不得过17.0%(通则2302)。
Not more than 17.0 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>.黄曲霉毒素 Aflatoxin
照真菌毒素测定法(通则2351)测定。
Determine according to the method for determination of mycotoxins <2351>.本品每1000 g含黄曲霉毒素B1不得过5 μg,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的总量不得过10 μg。
The content of aflatoxin B1 in this product shall not exceed 5 μg per 1000 g, and the total content of aflatoxin G2, aflatoxin G1, aflatoxin B2, and aflatoxin B1 shall not exceed 10 μg.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18.0%。
Carry out the method for determination of ethanol-soluble Extractives <2201,the hot maceration method>, using ethanol as the solvent,not less than 18.0 per cent.饮片 Prepared slices
全蝎 Scorpion
炮制 Processing
除去杂质,洗净,干燥。
Eliminate Foreign matter,wash, and dry.性状 Description
同药材。
Same as the crude drug.鉴别 Identification
同药材。
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
平。
Neutral.味 Flavor
辛。
Pungent.毒性 Toxicity
有毒。
Toxic.归经 Meridian tropism
归肝经。
Liver meridian.功能 Actions
息风镇痉,通络止痛,攻毒散结。
To suppress wind and relieve spasm, promote blood circulation and relieve pain, and eliminate toxins and dissipate nodules.主治 Indications
用于肝风内动,痉挛抽搐,小儿惊风,中风口,半身不遂,破伤风,风湿顽痹,偏正头痛,疮疡,瘰疬。
It is used for internal movement of liver wind, spasm and convulsion, paediatric convulsions, stroke mouth askew on one side of the mouth , hemiplegia, tetanus, rheumatism and intractable paralysis, migraine headache, sores, scrofula.用量 Dosage
3~6 g.
3-6 g.用法 Administration
无。
None.注意 Precautions
孕妇禁用。
Not for use during pregnancy.贮藏 Storage
置干燥处,防蛀。
Store in a dry place, and protect from moth.审核通过审核于: - 中国药典(2020年版)Chinese Pharmacopoeia (2020 Edition)创建于:更新于:
拳参
中文文本参考:《中国药典(2020年版)》
English text reference: Chinese Pharmacopoeia (2020 Edition)拳参QuanshenBistortae RhizomaBistort Rhizome概述 Overview
本品为蓼科植物拳参Polygonum bistorta L.的干燥根茎。春初发芽时或秋季茎叶将枯萎时采挖,除去泥沙,晒干,去须根。
Bistort Rhizome is the dried rhizome of Polygonum bistorta L. (Fam. Polygonaceae). The drug is collected in spring when the sprouts begin to grow or in autumn when the stems and leaves wither, removed from mud and sand, dried in the sun, and the rootlets removed.性状 Description
本品呈扁长条形或扁圆柱形,弯曲,有的对卷弯曲,两端略尖,或一端渐细,长6~13 cm,直径1~2.5 cm。表面紫褐色或紫黑色,粗糙,一面隆起,一面稍平坦或略具凹槽,全体密具粗环纹,有残留须根或根痕。质硬,断面浅棕红色或棕红色,维管束呈黄白色点状,排列成环。气微,味苦、涩。
Rhizomes long, cylindrical or slightly flattened, curved, some twisted, slightly pointed at both ends or tapering at one end, 6-13 cm long, 1-2.5 cm in diameter. Surface purplish-brown or purplish-black, rough, one side convex, the other side slightly flat or slightly grooved, with coarse annular wrinkles all over, with residual rootlets or root scars. Texture hard, fracture light brownish-red or reddish-brown, vascular bundles yellowish-white, arranged in rings. Odour, slight; taste, bitter and astringent.鉴别 Identification
(1)本品粉末淡棕红色。木栓细胞多角形,含棕红色物。草酸钙簇晶甚多,直径15~65 μm。具缘纹孔导管直径20~55 μm,亦有网纹导管和螺纹导管。纤维长梭形,直径10~20 μm,壁较厚,木化,孔沟明显。淀粉粒单粒椭圆形、卵形或类圆形,直径5~12 μm。
(1)The powder is pale reddish-brown. Cork cells polygonal, containing reddish-brown substances. Calcium oxalate cluster crystals numerous, diameter 15-65 μm. Pitted vessels with bordered pits, diameter 20-55 μm, also with reticulate vessels and spiral vessels. Fibres elongated spindle-shaped, diameter 10-20 μm, thick-walled, lignified, with distinct pits. Starch granules single, elliptical, ovoid or nearly round, diameter 5-12 μm.(2)取本品粉末0.5 g,加甲醇20 ml,超声处理15分钟,滤过,滤液蒸干,残渣加甲醇5 ml使溶解,作为供试品溶液。另取拳参对照药材0.5 g,同法制成对照药材溶液。再取没食子酸对照品,加甲醇制成每1 ml含1 mg的溶液,作为对照品溶液。照薄层色谱法(通则0502)试验,吸取上述三种溶液各5 μl,分别点于同一硅胶G薄层板上,以二氯甲烷-乙酸乙酯-甲酸(5∶4∶1)为展开剂,展开,取出,晾干,置氨蒸气中熏至斑点显色清晰。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)To 0.5 g of the powder add 20 ml of methanol, treat with ultrasound for 15 minutes, filter, evaporate the filtrate to dryness, dissolve the residue in 5 ml of methanol as the test solution. Take 0.5 g of the reference drug of Bistort Rhizome, prepare the reference drug solution in the same manner. Take gallic acid CRS, add methanol to produce a solution 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 dichloromethane, ethyl acetate and formic acid (5:4:1) as the mobile phase. Apply separately to the plate 5 μl of each of the above three solutions. After developing and removal of the plate, dry in air. Expose to ammonia vapour until the spots become clear. 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 solution and the Reference solution.检查 Examination
水分 Water
不得过15.0%(通则0832第二法)。
Not more than 15.0 per cent <0832,method 2>.总灰分 Total ash
不得过9.0%(通则2302)。
Not more than 9.0 per cent <2302>.浸出物 Extractives
照醇溶性浸出物测定法(通则2201)项下的冷浸法测定,用乙醇作溶剂,不得少于15.0%。
Carry out the method for determination of ethanol-soluble Extractives <2201,the cold maceration method>, using ethanol as the solvent,not less than 15.0 per cent.含量测定 Content determination
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0.05%磷酸甲醇溶液为流动相A,以0.05%磷酸溶液为流动相B,按下表中的规定进行梯度洗脱;检测波长为272 nm。理论板数按没食子酸峰计算应不低于6000。
Octadecylsilane-bonded silica gel was used as filler; 0.05% phosphoric acid methanol solution was used as mobile phase A, and 0.05% phosphoric acid solution was used as mobile phase B. Gradient elution was carried out according to the provisions in the following table; the detection wavelength was 272 nm. the theoretical plate counts should be not less than 6000 according to the calculation of gallic acid peak.对照品溶液的制备 Preparation of reference solution
取没食子酸对照品适量,精密称定,加30%甲醇制成每1 ml含20 μg的溶液,即得。
Take the appropriate amount of gallic acid control product, precision weighing, add 30% methanol to make a solution containing 20 μg per 1 ml, that is to obtain.供试品溶液的制备 Preparation of test solution
取本品粉末(过五号筛)约0.25 g,精密称定,置具塞锥形瓶中,精密加入30%甲醇25 ml,密塞,称定重量,浸泡1小时,超声处理(功率250 W,频率45 kHz)20分钟,放冷,再称定重量,用30%甲醇补足减失的重量,摇匀,滤过,取续滤液,即得。
Take the product powder (through the fifth sieve) about 0.25 g, precision weighing, placed in a stoppered conical flask, precision add 25ml of 30% methanol, tightly stoppered, weighed, immersed for 1 hour, ultrasonic treatment (power of 250 W, frequency of 45 kHz) for 20 minutes, cooled, and then weighed, with 30% methanol to make up for the loss of weight, shaking, filtration, and take the filtrate, that is, the product.测定法 Assay method
分别精密吸取对照品溶液与供试品溶液各20 μl,注入液相色谱仪,测定,即得。
Pipette 20 μl each of control solution and test solution, inject into the liquid chromatograph, and then determine, that is, obtain.本品按干燥品计算,含没食子酸(C7H605)不得少于0.12%。
The content of gallic acid (C7H605) in the drug, calculated with reference to the dried drug, should not be less than 0.12%.饮片 Prepared slices
拳参 Bistort Rhizome
炮制 Processing
除去杂质,洗净,略泡,润透,切薄片,干燥。
Eliminate Foreign matter, wash clean, soak briefly, soften thoroughly, cut into thin slices, and dry.性状 Description
本品呈类圆形或近肾形的薄片。外表皮紫褐色或紫黑色。切面棕红色或浅棕红色,平坦,近边缘有一圈黄白色小点(维管束),气微,味苦、涩。
This product is in the form of thin tablets of round-like or nearly kidney-shaped. The outer skin is purple-brown or purple-black. The cut surface is brownish-red or light brownish-red, flat, with a ring of yellowish-white dots (vascular bundles) near the edge, with a slight odour and a bitter, astringent taste.鉴别 Identification
同药材。
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 Assay
同药材。
Same as the crude drug.性 Property
微寒。
Slightly cold.味 Flavor
苦、涩。
Bitter and astringent.归经 Meridian tropism
归肺、肝、大肠经。
Lung, liver, and large intestine meridians.功能 Actions
清热解毒,消肿,止血。
To clear heat, detoxify, reduce swelling, and stop bleeding.主治 Indications
用于赤痢热泻,肺热咳嗽,痈肿瘰疬,口舌生疮,血热吐衄,痔疮出血,蛇虫咬伤。
Used for dysentery with fever and diarrhea, cough due to lung heat, carbuncles, swelling and lymphadenitis, oral and tongue sores, vomiting and nosebleed due to blood heat, bleeding hemorrhoids, and snake and insect bites.用量 Dosage
5~10 g。外用适量。
5-10 g. For external use, an appropriate amount.用法 Administration
无。
None.贮藏 Storage
置干燥处。
Preserve in a dry place.审核通过审核于: - 中国药典(2020年版)Chinese Pharmacopoeia (2020 Edition)创建于:更新于:
熟地黄
中文文本参考:《中国药典(2020年版)》
English text reference: Chinese Pharmacopoeia (2020 Edition)熟地黄ShudihuangRehmanniae Radix PraeparataPrepared Rehmannia Root概述 Overview
本品为生地黄的炮制加工品。
Prepared Rehmannia Root is the processed product of Rehmannia glutinosa Libosch. (Fam. Scrophulariaceae).炮制 Processing
(1)取生地黄,照酒炖法(通则0213)炖至酒吸尽,取出,晾晒至外皮黏液稍干时,切厚片或块,干燥,即得。每100 kg生地黄,用黄酒30~50 kg。
(1) Take raw dihuang, according to the wine stewing method (general rule 0213) stewed until the wine sucked out, take out, drying until the mucus of the outer skin is slightly dry, cut thick slices or blocks, drying, that is, obtained. For every 100 kg of raw dihuang, use 30-50 kg of yellow wine.(2)取生地黄,照蒸法(通则0213)蒸至黑润,取出,晒至约八成干时,切厚片或块,干燥,即得。
(2) Take raw dihuang, according to the method of steaming (Tongzhi 0213) steamed to black moist, take out, sunshine to about eighty percent dry, cut thick slices or blocks, dry, that is, get.性状 Description
本品为不规则的块片、碎块,大小、厚薄不一。表面乌黑色,有光泽,黏性大。质柔软而带韧性,不易折断,断面乌黑色,有光泽。气微,味甜。
Pieces or fragments of irregular shape, of variable size and thickness. Surface black and glossy, with a large amount of sticky substance. Texture soft and slightly tough, not easily broken; fracture black and glossy. Odour, slight; taste, sweet.鉴别 Identification
取本品粉末1 g,加80%甲醇50 ml,超声处理30分钟,滤过,滤液蒸干,残渣加水5 ml使溶解,用水饱和正丁醇振摇提取4次,每次10 ml,合并正丁醇液,蒸干,残渣加甲醇2 ml使溶解,作为供试品溶液。另取毛蕊花糖苷对照品,加甲醇制成每1 ml含1 mg的溶液,作为对照品溶液。照薄层色谱法(通则0502)试验,吸取供试品溶液5 μl、对照品溶液2 μl,分别点于同一硅胶G薄层板上,以乙酸乙酯-甲醇-甲酸(16∶0.5∶2)为展开剂,展开,取出,晾干,用0.1%的2,2-二苯基-1-苦肼基无水乙醇溶液浸渍,晾干。供试品色谱中,在与对照品色谱相应的位置上,显相同的颜色斑点。
To 1 g of the powder add 50 ml of 80% methanol, treat with ultrasound for 30 minutes, filter, evaporate the filtrate to dryness, dissolve the residue in 5 ml of water. Extract with four 10 ml portions of water-saturated n-butanol, combine the n-butanol extracts, evaporate to dryness. Dissolve the residue in 2 ml of methanol as the test solution. Dissolve catalpol CRS in methanol to produce a solution 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-formic acid(16:0.5:2)as the mobile phase. Apply separately to the plate 5 μl of the test solution and 2 μl of the Reference solution. After developing and removal of the plate, dry in air. Spray with a 0.1% solution of 2,2-diphenyl-1-picrylhydrazyl in anhydrous ethanol. Dry. 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
同地黄。
Same as Rehmannia.浸出物 Extractives
同地黄。
Same as Rehmannia.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-0.1%磷酸溶液(5∶95)为流动相,检测波长为203 nm。理论板数按地黄苷D峰计算应不低于5000。
Use octadecylsilane-bonded silica gel as the filler; use methanol-0.1% phosphoric acid solution (5:95) as the mobile phase, and detect at a wavelength of 203 nm. The theoretical plate number calculated based on the peak of Rehmannioside D should not be less than 5000.对照品溶液的制备 Preparation of reference solution
取地黄苷D对照品适量,精密称定,加25%甲醇制成每1 ml含70 μg的溶液,即得。
Take an appropriate amount of Rehmannioside D reference substance, accurately weigh it, add 25% methanol to make a solution containing 70 μg per 1 ml.供试品溶液的制备 Preparation of test solution
取本品切成约5 mm的小块,经80℃减压干燥24小时后,研成粗粉,取约1 g,精密称定,置具塞锥形瓶中,精密加入25%甲醇25 ml,称定重量,超声处理(功率400 W,频率50 kHz)1小时,放冷,再称定重量,用25%甲醇补足减失的重量,摇匀,高速离心10分钟,取上清液滤过,取续滤液,即得。
Take this product and cut it into small pieces of about 5 mm. After drying under reduced pressure at 80°C for 24 hours, grind it into coarse powder. Take about 1 g, accurately weigh it, place it in a stoppered conical flask, accurately add 25% methanol 25 ml, weigh it, perform ultrasonic treatment (power 400 W, frequency 50 kHz) for 1 hour, let it cool, weigh it again, make up for the weight loss with 25% methanol, shake well, centrifuge at high speed for 10 minutes, take the supernatant and filter it, and take the filtrate.测定法 Assay method
分别精密吸取对照品溶液与供试品溶液各10 μl,注入液相色谱仪,测定,即得。
Accurately take 10 μl of the reference solution and the test solution, inject them into the liquid chromatograph, and determine the content.本品含地黄苷D(C27H42O20)不得少于0.050%。
The content of Rehmannioside D (C27H42O20) in this product should not be less than 0.050%.性 Property
微温。
Slightly warm.毒性 Toxicity
无。
None.味 Flavor
甘。
Sweet.归经 Meridian tropism
归肝、肾经。
Liver and kidney meridians.功能 Actions
补血滋阴,益精填髓。
Nourish blood and nourish yin, tonify essence and fill the marrow.主治 Indications
用于血虚萎黄,心悸怔忡,月经不调,崩漏下血,肝肾阴虚,腰膝酸软,骨蒸潮热,盗汗遗精,内热消渴,眩晕,耳鸣,须发早白。
Used for blood deficiency and withered yellow, palpitations and flustered, irregular menstruation, excessive menstrual flow, liver and kidney yin deficiency, soreness and weakness of the waist and knees, steaming bone and tidal heat, night sweats and spermatorrhea, internal heat and thirst, dizziness, tinnitus, premature graying of hair.用量 Dosage
9~15 g。
9-15 g.用法 Administration
无。
None.贮藏 Storage
置通风干燥处。
Store in a well-ventilated and dry place.审核通过审核于: - 中国药典(2020年版)Chinese Pharmacopoeia (2020 Edition)创建于:更新于:
水蛭
中文文本参考:《中国药典(2020年版)》
English text reference: Chinese Pharmacopoeia (2020 Edition)水蛭ShuizhiHirudoLeech概述 Overview
本品为水蛭科动物蚂蟥Whitmania pigra Whitman、水蛭Hirudo nipponica Whitman或柳叶蚂蟥Whitmania acranulata Whitman的干燥全体。夏、秋二季捕捉,用沸水烫死,晒干或低温干燥。
Leech is the dried whole body of Whitmania pigra Whitman, Hirudo nipponica Whitman, or Whitmania acranulata Whitman (Fam. Hirudinidae). It is collected in summer and autumn, killed by boiling water, and dried in the sun or at low temperature.性状 Description
蚂蟥 Whitmania pigra Whitman
呈扁平纺锤形,有多数环节,长4~10 cm,宽0.5~2 cm。背部黑褐色或黑棕色,稍隆起,用水浸后,可见黑色斑点排成5条纵纹;腹面平坦,棕黄色。两侧棕黄色,前端略尖,后端钝圆,两端各具1吸盘,前吸盘不显著,后吸盘较大。质脆,易折断,断面胶质状。气微腥。
It is flat and spindle-shaped, with numerous segments, 4-10 cm long and 0.5-2 cm wide. The dorsal surface is dark brown or blackish-brown, slightly raised, and when soaked in water, black spots arranged in 5 longitudinal stripes can be seen. The ventral surface is flat and brownish-yellow. The sides are brownish-yellow, the anterior end is slightly pointed, and the posterior end is blunt and round. There is a sucker at each end, with the anterior sucker being inconspicuous and the posterior sucker being larger. The texture is brittle, easily broken, and the fracture surface is gelatinous. It has a slight fishy odor.水蛭 Hirudo nipponica Whitman
扁长圆柱形,体多弯曲扭转,长2~5 cm,宽0.2~0.3 cm。
It is flat and elongated, with a twisted and curved body, 2-5 cm long and 0.2-0.3 cm wide.柳叶蚂蟥 Whitmania acranulata Whitman
狭长而扁,长5~12 cm,宽0.1-0.5 cm。
It is narrow and flat, 5-12 cm long and 0.1-0.5 cm wide.鉴别 Identification
取本品粉末1 g,加乙醇5 ml,超声处理15分钟,滤过,取滤液作为供试品溶液。另取水蛭对照药材1 g,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5 μl,分别点于同一硅胶G薄层板上,以环己烷-乙酸乙酯(4:1)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,在与对照药材色谱相应的位置上,显相同的紫红色斑点;紫外光灯(365 nm)下显相同的橙红色荧光斑点。
To 1 g of the powder add 5 ml of ethanol, treat with ultrasound for 15 minutes, filter, and take the filtrate as the test solution. Take 1 g of the reference drug Hirudo nipponica and prepare the reference drug solution in the same manner. Carry out the method for thin layer chromatography<0502>, using silica gel G as the coating substance and a mixture of cyclohexane and ethyl acetate (4:1) 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 with a 10% solution of sulfuric acid in ethanol, heat at 105°C to the spots clear. The purple-red spot in the chromatogram obtained with the test solution corresponds in position to the spot in the chromatogram obtained with the reference drug solution; under ultraviolet light at 365 nm, the same orange-red fluorescent spot is observed.检查 Examination
水分 Water
不得过18.0%(通则0832第二法)。
Not more than 18.0 per cent <0832,method 2>.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2.0%(通则2302)。
Not more than 2.0 per cent <2302>.酸碱度 pH value
取本品粉末(过三号筛)约1 g,加入0.9%氯化钠溶液10 ml,充分搅拌,浸提30分钟,并时时振摇,离心,取上清液,照pH值测定法(通则0631)测定,应为5.0~7.5。
Take about 1 g of the powder (passed through a No. 3 sieve) of the sample, add 10 ml of 0.9% sodium chloride solution, stir well, macerate for 30 minutes with occasional shaking, centrifuge, take the supernatant, and determine the pH value according to the method for pH determination <0631>. It should be 5.0-7.5.重金属及有害元素 Heavy metals and harmful elements
照铅、镉、砷、汞、铜测定法(通则2321原子吸收分光光度法或电感耦合等离子体质谱法)测定,铅不得过10 mg/kg、镉不得过1 mg/kg、砷不得过5 mg/kg、汞不得过1 mg/kg。
Determine according to the method for determination of lead, cadmium, arsenic, mercury, and copper <2321> by atomic absorption spectrophotometry or inductively coupled plasma mass spectrometry. The lead content should not exceed 10 mg/kg, the cadmium content should not exceed 1 mg/kg, the arsenic content should not exceed 5 mg/kg, and the mercury content should not exceed 1 mg/kg.黄曲霉毒素 Aflatoxins
照真菌毒素测定法(通则2351)测定。
Determine according to the method for determination of mycotoxins <2351>.本品每1000 g含黄曲霉毒素B1不得过5 μg,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的总量不得过10 μg。
The content of aflatoxin B1 in the sample should not exceed 5 μg per 1000g , and the total content of aflatoxin G2, aflatoxin G1, aflatoxin B2, and aflatoxin B1 should not exceed 10 μg.含量测定 Assay
取本品粉末(过三号筛)约1 g,精密称定,精密加入0.9%氯化钠溶液5 ml,充分搅拌,浸提30分钟,并时时振摇,离心,精密量取上清液100μl,置试管(8 mm×38 mm)中,加入含0.5%(牛)纤维蛋白原(以凝固物计)的三羟甲基氨基甲烷盐酸缓冲液[注1](临用配制)200 μl,摇匀,置水浴中(37℃±0.5℃)温浸5分钟,滴加每1 ml中含40单位的凝血酶溶液[注2](每1分钟滴加1次,每次5 μl,边滴加边轻轻摇匀)至凝固(水蛭)或滴加每1 ml中含10单位的凝血酶溶液[注2](每4分钟滴加1次,每次2 μl,边滴加边轻轻摇匀)至凝固(蚂蟥、柳叶蚂蟥),记录消耗凝血酶溶液的体积,按下式计算:
Take about 1 g of the powder (passed through a No. 3 sieve) of the sample, accurately weigh, accurately add 5 ml of 0.9% sodium chloride solution, stir well, macerate for 30 minutes with occasional shaking, centrifuge, accurately take 100 μl of the supernatant, place it in a test tube (8 mm×38 mm), add 200 μl of tris(hydroxymethyl)aminomethane hydrochloride buffer solution containing 0.5% (bovine) fibrinogen (calculated as solid) <Note 1> (prepared for immediate use), shake well, place it in a water bath at (37℃±0.5℃) for 5 minutes, and add 1 ml of thrombin solution containing 40 units per ml <Note 2> (add 5 μl every 1 minute, gently shake while adding) until coagulation (leech) or add 1ml of thrombin solution containing 10 units per ml <Note 2> (add 2 μl every 4 minutes, gently shake while adding) until coagulation (leech or medicinal leech). Record the volume of consumed thrombin solution and calculate according to the following formula:U为每1 g含凝血酶活性单位,U/g;
U is the content of thrombin activity units per 1 g, U/g;C1为凝血酶溶液的浓度,μ/ml;
C1 is the concentration of thrombin solution, μ/ml;C2为供试品溶液的浓度,g/ml;
C2 is the concentration of the sample solution, g/ml;V1为消耗凝血酶溶液的体积,μl;
V1 is the volume of consumed thrombin solution, μl;V2为供试品溶液的加入量,μl。
V2 is the volume of the sample solution added, μl.中和一个单位的凝血酶的量,为一个抗凝血酶活性单位。
The amount of thrombin that neutralizes one unit is one unit of antithrombin activity.本品每1 g含抗凝血酶活性水蛭应不低于16.0U;蚂蟥、柳叶蚂蟥应不低于3.0 U。
The content of antithrombin activity in the sample should not be less than 16.0 U per 1 g for leeches and not less than 3.0U for medicinal leeches.饮片 Prepared slices
水蛭 Leech
炮制 Processing
洗净,切段,干燥。
Clean the leeches, cut into sections, and dry.性状 Appearance
本品呈不规则的段状、扁块状或扁圆柱状。背部表面黑褐色,稍隆起,腹面棕褐色,均可见细密横环纹。切面灰白色至棕黄色,胶质状。质脆,气微腥。
The sample is irregular in shape, flat or flat cylindrical. The dorsal surface is blackish-brown and slightly raised, and the ventral surface is brownish-brown with fine transverse annular lines. The cut surface is grayish-white to brownish-yellow and gelatinous. The texture is brittle and the odor is slightly fishy.烫水蛭 Blanched leech
炮制 Processing
取净水蛭段,照炒法(通则0213)用滑石粉烫至微鼓起。
Take clean leech sections, blanch them with talcum powder according to the method for blanching <0213> until slightly swollen.性状 Appearance
本品呈不规则段状、扁块状或扁圆柱状,略鼓起,背部黑褐色,腹面棕黄色至棕褐色,附有少量白色滑石粉。断面松泡,灰白色至焦黄色。气微腥。
The sample is irregular in shape, flat or flat cylindrical, slightly swollen, with blackish-brown on the dorsal surface and brownish-yellow to brownish-brown on the ventral surface, with a small amount of white talcum powder attached. The cut surface is spongy, grayish-white to dark yellow. The odor is slightly fishy.检查 Examination
水分 Water
同药材,不得过14.0%。
Not more than 14.0 per cent, same as the crude drug.总灰分 Total ash
同药材,不得过10.0%。
Not more than 10.0 per cent, same as the crude drug.酸不溶性灰分 Acid-insoluble ash
同药材,不得过3.0%。
Not more than 3.0 per cent, same as the crude drug.酸碱度 pH value
同药材。
Same as the crude drug.重金属及有害元素 Heavy metals and harmful elements
同药材。
Same as the crude drug.黄曲霉毒素 Aflatoxins
同药材。
Same as the crude drug.鉴别 Identification
同药材。
Same as the crude drug.性 Property
平。
Neutral.毒性 Toxicity
有小毒。
Slightly toxic.味 Flavor
咸、苦。
Salty,bitter.归经 Meridian tropism
归肝经。
Meridian tropism: Liver meridian.功能 Actions
破血通经,逐瘀消癥。
To promote blood circulation and remove blood stasis, resolve masses and dissipate nodules.主治 Indications
用于血瘀经闭,癥瘕痞块,中风偏瘫,跌扑损伤。
Used for blood stasis causing amenorrhea, masses and lumps, stroke with hemiplegia, and traumatic injuries.用量 Dosage
1~3 g。
1-3 g.用法 Administration
无。
None.注意 Precautions
孕妇禁用。
Not to be used during pregnancy.贮藏 Storage
置干燥处,防蛀。
Store in a dry place, protected from moth.注:[1]三羟甲基氨基甲烷盐酸缓冲液的配制 取0.2 mol/L三羟甲基氨基甲烷溶液25ml与0.1 mol/L盐酸溶液约40 ml,加水至100 ml,调节pH值至7.4。
Note 1: Preparation of tris(hydroxymethyl)aminomethane hydrochloride buffer solution: Take 25ml of 0.2 mol/L tris(hydroxymethyl)aminomethane solution and about 40 ml of 0.1 mol/L hydrochloric acid solution, add water to 100ml, and adjust the pH value to 7.4.[2]凝血酶溶液的配制 取凝血酶试剂适量,加生理盐水配制成每1 ml含凝血酶40个单位或10个单位的溶液(临用配制)。
Note 2: Preparation of thrombin solution: Take an appropriate amount of thrombin reagent and prepare a solution containing 40 units or 10 units of thrombin per 1 ml with physiological saline (prepared for immediate use).审核通过审核于: