金银花

English text reference: *Chinese Pharmacopoeia (2020 Edition) *

Overview

Honeysuckle Flower is the dried flower bud or the flower with the initial opening of Lonicera japonica Thunb. (Fam. Caprifoliaceae). The drug is collected in early summer before the flowers open and dried.

Description

Flower buds are cylindrical, upper part thick and lower part thin, slightly curved, 2-3 cm long, upper part about 3 mm in diameter, lower part about 1.5 mm in diameter; surface yellowish-white or greenish-white (becoming darker on storage), densely covered with short, soft hairs; occasionally with leaf-like bracts. Calyx green, 5-lobed at apex, lobes hairy, about 2 mm long. Corolla tubular, 2-lipped at apex; stamens 5, adnate to corolla tube, yellow; ovary glabrous. Odour, fragrant; taste, mild and slightly bitter.

Identification

（1）The powder is light yellowish-brown or yellowish-green. There are more glandular hairs, with the head inverted conical, circular or slightly flattened, consisting of 4-33 cells, arranged in 2-4 layers, with a diameter of 30-64-108 μm, and the stalk consisting of 1-5 cells, up to 700 μm long. There are two types of non-glandular hairs: one is thick-walled non-glandular hairs, single-celled, up to 900 μm long, with micro-papillary or vesicular protrusions on the surface, some with spiral patterns; the other is thin-walled non-glandular hairs, single-celled, very long, curved or wrinkled, with micro-papillary protrusions on the surface. The diameter of calcium oxalate cluster crystal is 6-45 μm. Pollen grains are round or triangular, with fine short spines and granular sculptures on the surface and have 3 colpi.

（2）Take 0.2 g of the powder, add 5 ml of methanol, let it stand for 12 hours, filter, and take the filtrate as the test solution. Take chlorogenic acid reference substance, add methanol to make a solution containing 1 mg per ml as the reference solution. Carry out the method for thin layer chromatography <0502>, using silica gel H as the coating substance and the upper layer solution of ethyl acetate-butanoic acid-water (7: 2.5: 2.5) as the mobile phase. Apply separately to the plate 10-20 μl of the test solution and 10 μl of the reference solution. After developing and removal of the plate, dry in air. 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 solution.

Characteristic mapping

Determined by high performance liquid chromatography <0512>.

Chromatographic conditions and system suitability test

Same as under [Content Determination] Phenolic Acids except that the detection wavelength is 240 nm.

Preparation of reference solutions

Take the appropriate amount of chlorogenic acid control product, precision weighing, add methanol to make a solution containing 0.40 mg per ml, that is to obtain.

Preparation of test solution

Same as under [Content Determination] Phenolic Acids.

Determination method

Precisely aspirate 2 μl each of the reference solution and the test solution respectively, inject into liquid chromatograph and determine, it is obtained.

The characteristic profile of the test product should show seven characteristic peaks, and the peak corresponding to the reference peak is the S peak, calculate the relative retention time of each characteristic peak and the S peak, which should be within ±10% of the specified value, the retention time specified values are: 0.91 (peak 1), 1.00 [peak 2 (S)], 1.17 (peak 3), 1.38 (peak 4), 2.43 (peak 5), 2.81 (peak 6), 2.93 (Peak 7).

Examination

Water

Not more than 12.0 per cent <0832, method 4>.

Total ash

Not more than 10.0 per cent <2302>.

Acid-insoluble ash

Not more than 3.0 per cent <2302>.

Heavy metals and harmful elements

Determined by the method of lead, cadmium, arsenic, mercury, and copper (atomic absorption spectrophotometry or inductively coupled plasma mass spectrometry) <2321>. The limit of lead is not more than 5 mg/kg; the limit of cadmium is not more than 1 mg/kg; the limit of arsenic is not more than 2 mg/kg; the limit of mercury is not more than 0.2 mg/kg; the limit of copper is not more than 20 mg/kg.

Assay

Phenolic acids

Determined by high performance liquid chromatography <0512>.

Chromatographic conditions and system suitability test

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. The gradient elution was carried out according to the following table; the temperature of the column was not higher than 25 ℃; the flow rate was 0.7 ml per minute, and the detection wavelength was 327 nm. the number of theoretical plates should be not less than 10,000 according to the calculation of chlorogenic acid peak.

Preparation of reference solution

Take chlorogenic acid control, 3,5-di-O-caffeoylquinic acid control and 4,5-di-O-caffeoylquinic acid control in appropriate amount, weighed accurately, placed in a brown measuring flask, and added with 75% methanol to make a solution containing 0.28 mg, 0.15 mg, and 44 μg per ml, that is, obtained.

Preparation of test solution

Take the powder of this product (through the fourth sieve) about 0.5 g, precision weighing, placed in a stoppered conical flask, precision addition of 75% methanol 50 ml, weighing, ultrasonic treatment (power 500 W, frequency 40 kHz) for 30 minutes, cooled, and then weighing, 75% methanol to make up for the loss of weight, shaking, filtration, and take the filtrate, that is, the product is obtained.

Determination method

Pipette 2 μl each of control solution and test solution, inject into liquid chromatograph, and then determine, that is, obtain.

This product contains not less than 1.5% chlorogenic acid (C16H18O9) calculated as dried product, and not less than 3.8% phenolic acids calculated as the total amount of chlorogenic acid (C16H18O9), 3,5-di-O-caffeoylquinic acid (C25H24O12) and 4,5-di-O-caffeoylquinic acid (C25H24O12).

Luteoloside

Determined by high performance liquid chromatography <0512>.

Chromatographic conditions and system suitability test

Phenylsilane bonded silica gel was used as filler (Agilent ZORBAX SB-phenyl 4.6 mm×250 mm, 5 μm), with acetonitrile as mobile phase A and 0.5% glacial acetic acid solution as mobile phase B. Gradient elution was carried out in accordance with the following table; the detection wavelength was 350 nm. the theoretical plate counts calculated on the basis of the lignoceroside peaks should be not less than 20,000.

Preparation of reference solution

Take the appropriate amount of lignocaine control, precision weighing, add 70% ethanol to make a solution containing 40 μg per ml, that is to obtain.

Preparation of test solution

Take this product powder (through the fourth sieve) about 2 g, precision weighing, placed in a stoppered conical flask, precision addition of 70% ethanol 50 ml, weighing, ultrasonic treatment (power 250 W, frequency 35 kHz) for 1 hour, cooling, and then weighing, with 70% ethanol to make up for the loss of weight, shaking well, filtered. Precisely measure 10 ml of the filtrate, recover the solvent to dry, the residue was dissolved with 70% ethanol, transferred to a 5 ml measuring flask, add 70% ethanol to the scale, that is, obtained.

Determination method

Pipette 10 μl each of control solution and test solution, injected into liquid chromatograph, and then measured, it is obtained.

This product contains not less than 0.050% of lignocaine (C21H20O11) calculated as dried product.

Property

Cold.

Flavor

Sweet.

Meridian tropism

Lung, heart, and stomach meridians.

Actions and Indications

To clear heat and detoxify and disperse wind-heat.

Indications

Used for carbuncles and sores, sore throat, erysipelas, dysentery due to heat-toxin, wind-heat common cold, and febrile diseases.

Dosage

6-15 g.

Administration

None.

Storage

Preserve in a cool and dry place, moisture-proof, and mothproof.

黄连

English text reference: *Chinese Pharmacopoeia (2020 Edition) *

Overview

Coptis Rhizome is the dried rhizome of Coptis chinensis Franch., Coptis deltoidea C.Y.Cheng et Hsiao, or Coptis teeta Wall. (Fam. Ranunculaceae). The three kinds are respectively known as "Weilian", "Yalian", and "Yunlian". The drug is collected in autumn, removed from rootlets and sand, dried, and pounded to remove residual rootlets.

Description

Weilian

Clustered, often curved, resembling chicken claws; single-branched rhizome 3-6 cm long, 0.3-0.8 cm in diameter. Surface grayish-yellow or yellowish-brown, rough, with irregular nodular elevations, rootlets, and residual rootlet bases; some internodes have smooth surfaces like stems, known as "crossing the bridge". The upper part often retains brownish scales, and the top often retains residual stems or petioles. Texture hard, uneven fracture; orange-red or dark brown bark, fresh yellow or orange-yellow wood, arranged radially; some medullas are hollow. Odour, slight; taste, extremely bitter.

Yalian

Mostly single-branched, slightly cylindrical, slightly curved, 4-8 cm long, 0.5-1 cm in diameter; "crossing the bridge" is longer. The top has a few residual stems.

Yunlian

Curved and hooked, mostly single-branched, relatively small.

Identification

（1）Cross-section of the product:

Weilian

Cork cells arranged in rows, with epidermis outside, often exfoliating. Cortex relatively wide, stone cells scattered singly or in groups. Medullary sheath fibers in bundles or accompanied by a few stone cells, all yellow. Vascular bundles exarch, arranged in a ring. Xylem yellow, all lignified, wood fibers relatively well-developed. Medulla consists of thin-walled cells, without stone cells.

Yalian

Medulla contains stone cells.

Yunlian

Cortex, medullary sheath, and medulla do not contain stone cells.

（2）To 0.25 g of the powder add 25 ml of methanol, treat with ultrasound for 30 minutes, filter, and use the filtrate as the test solution. Take 0.25 g of the reference drug Huanglian, and prepare the reference drug solution in the same way. Take berberine hydrochloride CRS, add methanol to produce 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 mixture of n-hexane-acetic ether-isopropanol-methanol-water-triethylamine (3: 3.5: 1: 1.5: 0.5: 1) as the mobile phase. Place the plate in a developing tank pre-saturated with concentrated ammonia solution for 20 minutes, develop, remove, dry, and spray with a 2% solution of vanillin in sulfuric acid at 105 °C until the spots are clearly visible. In the chromatogram obtained with the test solution, there are fluorescent spots of the same color as those in the chromatogram obtained with the reference drug solution at corresponding positions; in the chromatogram obtained with the reference solution, there are fluorescent spots of the same color at corresponding positions.

Examination

Water

Not more than 14.0 per cent <0832, method 2>.

Total ash

Not more than 5.0 per cent <2302>.

Extractives

Carry out the method for determination of ethanol-soluble Extractives <2201, the hot maceration method>, using diluted ethanol as the solvent, not less than 15.0 per cent.

Assay

Weilian

Carry out the method for high performance liquid chromatography <0512>.

Chromatographic conditions and system suitability test

Use octadecylsilane-bonded silica gel as the filling material; use acetonitrile-0.05 mol/L potassium dihydrogen phosphate solution (50: 50) (add 0.4 g of dodecyl sodium sulfate to each 100 ml, then adjust the pH value to 4.0 with phosphoric acid) as the mobile phase; detection wavelength, 345 nm. The theoretical plate number calculated from the peak of berberine hydrochloride should not be less than 5000.

Preparation of reference solution

Take an appropriate amount of berberine hydrochloride CRS, accurately weigh, add methanol to produce a solution containing 90.5 μg per ml.

Preparation of test solution

Take about 0.2 g of the powder (passed through a No. 2 sieve), accurately weigh, place it in a stoppered conical flask, accurately add a mixed solution of methanol-hydrochloric acid (100: 1) 50 ml, seal tightly, weigh, treat with ultrasound (power 250 W, frequency 40 kHz) for 30 minutes, cool, weigh again, make up for the weight loss with methanol, shake well, filter, accurately take 2 ml of the filtrate, place it in a 10 ml volumetric flask, add methanol to the mark, shake well, filter, and take the filtrate.

Assay method

Accurately take 10 μl of the reference solution and the test solution, inject them into the liquid chromatograph, and determine the content. Take the peak area of berberine hydrochloride CRS as the reference, and calculate the content of berberine, palmatine, jatrorrhizine, and columbamine, respectively. Determine the relative retention time of the chromatographic peak of the component to the chromatographic peak of berberine hydrochloride.

The relative retention time of berberine, palmatine, jatrorrhizine, and columbamine should be within the range of ±5% of the specified value. Relative retention times are shown in the table below:

Calculated on the dried basis, with berberine hydrochloride (C20H18ClNO4) as the reference, the content of berberine (C20H17NO4) should not be less than 5.5%, the content of palmatine (C20H17NO4) should not be less than 0.80%, the content of jatrorrhizine (C19H13NO4) should not be less than 1.6%, and the content of columbamine (C21H21NO4) should not be less than 1.5%.

Yalian

Calculated on the dried basis, with berberine hydrochloride (C20H18ClNO4) as the reference, the content of berberine (C20H17NO4) should not be less than 4.5%.

Yunlian

Calculated on the dried basis, with berberine hydrochloride (C20H18ClNO4) as the reference, the content of berberine (C20H17NO4) should not be less than 7.0%.

Prepared slices

Slices of Coptis Rhizome

Processing

Coptis Rhizome: Eliminate Foreign matter, soak until thoroughly moistened, cut into thin slices, and dry in the sun, or crush when used.

性状 ｜ Description

In irregular thin slices. Externally greyish-yellow or yellowish-brown, coarse and with fine rootlets. Cut or broken surface fresh yellow or reddish-yellow, with radiate

检查 ｜ Examination

水分 ｜ Water

Not more than 12.0 per cent, following the method for the crude drug.

总灰分 ｜ Total ash

Not more than 3.5 per cent, following the method for the crude drug.

含量测定 ｜ Assay

It contains not less than 5.0 per cent of berberine (C20H17NO4), 3.3 per cent of the total amount of epiberberine （C20H17NO4), coptisine (C19H13NO4) and

鉴别 ｜Identification

As required for the crude drug except for the transverse section.

浸出物 ｜ Extractives

As required for the crude drug.

酒黄连 ｜ Coptidis Rhizorna (processed with wine)

Processing

Stir-bake the Coptidis Rhiwma as described under the method for stir-baking with wine <0213> to dryness.

Using 12.5 kg of yellow rice wine per 100 kg of Coptidis Rhizoma.

性状 ｜ Description

The shape similar to the slices, but deeper in colour, slightly with wine odour.

鉴别 ｜Identification

As required for Coptis Rhizome.

检查 ｜ Examination

As required for Coptis Rhizome.

浸出物 ｜ Extractives

As required for Coptis Rhizome.

含量测定 ｜ Assay

As required for Coptis Rhizome.

姜黄连 ｜ Coptidis Rhizoma ( processed with ginger)

Processing

Coptidis Rhizoma as described under the method for stirbaking with ginger juice <0213> to dryness.

Using 12.5 kg of ginger per 100 kg of Coptidis Rhizoma.

性状 ｜ Description

The shape similar to the slices, externally brownish-yellow, with the pungent taste of ginger.

鉴别 ｜Identification

As required for Coptis Rhizome.

检查 ｜ Examination

As required for Coptis Rhizome.

浸出物 ｜ Extractives

As required for Coptis Rhizome.

含量测定 ｜ Assay

As required for Coptis Rhizome.

萸黄连 ｜ Coptidis Rhizoma (Processed with Evodiae Fructus)

Processing

Decoct Evodiae Fructus with a quantity of water, mix the decoction with Coptidis Rhizoma, until the decoction is exhausted, then stir-bake to dryness.

To each 100 kg of Coptidis Rhizoma add 10 kg of Evoidae Fructus.

性状 ｜ Description

The shape similar to the slices, externally brownish-yellow, with the pungent odour of Evodiae Fructus.

鉴别 ｜Identification

To 2 g of the powder add 20 ml of chloroform, ultrasonicate for 30 minutes and filter, extract in the same manner again for 2 times, combine the filtrates and concentrate to dryness in vacuum, dissolve the residue in 1 ml of chloroform as the test solution. Prepare a solution of 0.5 g of Evodiae Fructus reference drug in the same manner as the reference drug solution. Dissolve obaculactone CRS in chloroform to produce a solution containing 1 mg per ml as the reference solution. Carry out the method for thin layer chromatography <0502>, using high performance silica gel G as the coating substance and a mixture of petroleum ether (60-90 °C), chloroform, acetone, methanol and diethylamine (5: 2: 2: 1: 0. 2) as the mobile phase. Apply separately to the plate 6 μl of the test solution, 3 μl of the reference drug solution and 2 μl of the reference solution. After developing in a chamber pre-equilibrated with the mobile phase for 30 minutes and removal of the plate, dry in air, spray with a 2% solution of vanillin in sulfuric acid, heat at 105 °C to the spots clear. The major spots in the chromatogram obtained with the test solution correspond in position and colour to the spots in the chromatogram obtained with the reference drug solution; and one of which corresponds to the spot in the chromatogram obtained with the reference solution.

检查 ｜ Examination

As required for Coptis Rhizome.

浸出物 ｜ Extractives

As required for Coptis Rhizome.

含量测定 ｜ Assay

As required for Coptis Rhizome.

Property

Cold.

Flavor

Bitter.

Meridian tropism

Heart, spleen, stomach, liver, gallbladder, and large intestine meridians.

Actions

To clear heat and dry dampness, relieve fire and detoxify.

Indications

Used for damp-heat accumulation in the middle energizer, vomiting, acid regurgitation, dysentery, jaundice, high fever with delirium, excessive heart fire, restlessness and insomnia, palpitations, blood heat vomiting nosebleed, red eyes, toothache, polydipsia, carbuncle and furuncle; externally for eczema, damp sores, and purulent discharge from the ear. Jiu Huanglian is good at clearing upper energizer fire. Used for red eyes and mouth sores. Jiang Huanglian clears the stomach and stops vomiting. Used for cold-heat mutual constraint, damp-heat obstruction in the middle energizer, and distention and vomiting. Yu Huanglian soothes the liver and stomach and stops vomiting. Used for disharmony between the liver and stomach, vomiting, and acid regurgitation.

Dosage

2-5 g. For external use, an appropriate amount.

用法 ｜ Administration

None.

Storage

Preserve in a well-ventilated and dry place.

胡椒

English text reference: *Chinese Pharmacopoeia (2020 Edition) *

Overview

Pepper is the dried nearly ripe or ripe fruit of Piper nigrum L. (Fam. Piperaceae). The drug is collected in late autumn to early spring when the fruit is dark green, dried to obtain black pepper; or collected when the fruit is red, soaked in water for several days, rubbed to remove the pericarp, and dried to obtain white pepper.

Description

Black Pepper

Black pepper is spherical, with a diameter of 3.5-5 mm. The surface is blackish-brown, with raised reticulate wrinkles, a small stigma residue at the apex, and a scar where the fruit stalk has fallen off at the base. The texture is hard, the outer pericarp can be peeled off, and the inner pericarp is grayish-white or pale yellow. The fracture is yellowish-white, powdery, with small cavities. It has a fragrant aroma and a pungent taste.

White Pepper

White pepper is grayish-white or pale yellowish-white on the surface, smooth, with numerous light-colored linear stripes between the apex and the base.

Identification

（1）Black pepper powder is dark gray. The stone cells of the outer pericarp are square, rectangular, or irregular in shape, with a diameter of 19-66 μm and a thick wall. The surface of the stone cells in the inner pericarp is polygonal, with a diameter of 20-30 μm; the side view is square, with one side of the wall thin. The seed coat cells are brown, polygonal, and the wall is thickened in a bead-like manner. There are fewer oil cells, which are round and have a diameter of 51-75 μm. The starch grains are small and often aggregated into clusters.

White pepper powder is yellowish-white. The seed coat cells, oil cells, and starch grains are the same as those of black pepper.

（2）Take a small amount of the powder, add 1 drop of sulfuric acid, it shows red, gradually changes to reddish-brown, and then turns brown.

（3）Take 0.5 g of the powder, add 5 ml of anhydrous ethanol, treat with ultrasound for 30 minutes, filter, and take the filtrate as the test solution. Take the piperine reference substance, place it in a brown volumetric flask, and add anhydrous ethanol to make a solution containing 4 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 toluene-acetic acid ethyl ester-acetone (7: 2: 1) as the mobile phase. Apply separately to the plate 2 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 until the spots are clearly visible, and examine under daylight and ultraviolet light at 365 nm. In the chromatogram obtained with the test solution, there are spots or fluorescent spots of the same color as those in the chromatogram obtained with the reference solution at corresponding positions.

Examination

Water

Not more than 14.0 per cent <0832, method 4>.

Assay

Carry out the method for high performance liquid chromatography <0512>.

Chromatographic conditions and system suitability test

Use octadecylsilane bonded silica gel as the filler; use methanol-water (77: 23) as the mobile phase; the detection wavelength is 343 nm. The theoretical plate number calculated based on the piperine peak should not be less than 1500.

Preparation of reference solution

Take an appropriate amount of piperine reference substance, accurately weigh it, place it in a brown volumetric flask, and add anhydrous ethanol to make a solution containing 20 μg per ml.

Preparation of test solution

Take about 0.1 g of the powder, accurately weigh it, place it in a 50 ml brown volumetric flask, add 40 ml of anhydrous ethanol, treat with ultrasound (power 250 W, frequency 20 kHz) for 30 minutes, cool, add anhydrous ethanol to the mark, shake well, filter, accurately measure 10 ml of the filtrate, place it in a 25 ml brown volumetric flask, add anhydrous ethanol to the mark, shake well, filter, and take the filtrate.

Assay method

Accurately aspirate 10 μl of the reference solution and the test solution, inject into the liquid chromatograph, and determine.

Calculated on the dried product, the content of piperine (C17H19NO3) should not be less than 3.3%.

Property

Hot.

味 ｜ Flavor

Pungent.

Meridian tropism

Stomach and Large Intestine meridians.

Actions

Warm the middle and dispel cold, descend qi, and resolve phlegm.

Indications

Used for vomiting due to gastric cold, abdominal pain and diarrhea, poor appetite, and epilepsy with excessive phlegm。

Dosage

0.6-1.5 g. For external use, use an appropriate amount.

用法 ｜ Administration

Grind into powder and take orally. For external use, use an appropriate amount.

Storage

Store in airtight containers in a cool and dry place.

降香

English text reference: *Chinese Pharmacopoeia (2020 Edition) *

Overview

Dalbergia Odorifera Wood is the dried heartwood of the trunk and root of Dalbergia odorifera T. Chen (Fam. Leguminosae). The drug is collected throughout the year, removed from the bark, and dried in the shade.

Description

Pieces cylindrical or irregularly shaped; surface purple-red or reddish-brown, with dense texture on cut surface; texture hard, oily. Odour, slight; taste, slightly bitter.

Identification

（1）Powder brownish-purple or yellowish-brown. Vessels with large bordered pits, diameter of complete ones about 300 μm, mostly broken, bordered pits large and distinct, containing reddish-brown or yellowish-brown substances in the lumen. Fibres in bundles, reddish-brown, diameter 8-26 μm, walls very thick, some fibres surrounded by cells containing calcium oxalate prisms, forming crystal fibres, walls of cells containing crystals unevenly lignified. Calcium oxalate prisms diameter 6-22 μm. Rays 1-2 cells wide, up to 15 cells high, walls slightly thick, pits rather dense. Pigment cells reddish-brown, yellowish-brown or pale yellow.

（2）To 1 g of the powder add 10 ml of methanol, treat with ultrasound for 30 minutes, allow to stand, and take the supernatant as the test solution. Prepare a solution of the reference drug, Dalbergia Odorifera Wood, in the same manner as the test solution. Carry out the method for thin layer chromatography <0502>, using silica gel G as the coating substance and a mixture of toluene, ethyl acetate, and chloroform (7: 2: 1) as the mobile phase. Apply separately to the plate 2 μl of each of the above two solutions. After developing and removal of the plate, dry in air. Spray with a mixture of a 1% solution of vanillin in sulfuric acid and anhydrous ethanol (1: 9), heat at 105 °C to the spots clear. The spots in the chromatogram obtained with the test solution correspond in position and colour to the spots in the chromatogram obtained with the reference drug.

（3）Take the test solution and the reference drug solution prepared under the item Identification, carry out the method for thin layer chromatography <0502>, using silica gel G as the coating substance and a mixture of toluene and ethyl acetate (2: 1) as the mobile phase. Apply separately to the plate 2 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 fluorescent spots in the chromatogram obtained with the test solution correspond in position and colour to the fluorescent spots in the chromatogram obtained with the reference drug.

Extractives

Carry out the method for determination of ethanol-soluble Extractives <2201, the hot maceration method>, using ethanol as the solvent, not less than 8.0 per cent.

Assay

Volatile oil

Carry out the method for determination of volatile oil <2204, method A>.

The volatile oil content of the drug is not less than 1.0% (ml/g).

Prepared slices

Dalbergia Odorifera Wood

Processing

Eliminate Foreign matter, split into small pieces, and grind into fine powder or slice.

Property

Warm.

Flavor

Pungent.

Meridian tropism

Liver and spleen meridians.

Actions

To promote blood circulation and stop bleeding, regulate qi and relieve pain.

Indications

Used for vomiting blood, nosebleed, bleeding due to trauma, liver depression causing pain in the hypochondrium, chest pain, stabbing pain in the chest, pain due to falls or blows, vomiting, and abdominal pain.

Dosage

9-15 g. For external use, an appropriate amount.

Administration

Add when the decoction is nearly done. For external use, an appropriate amount is ground into fine powder and applied to the affected area.

Storage

Preserve in a cool and dry place.

胡芦巴

English text reference: *Chinese Pharmacopoeia (2020 Edition) *

Overview

Fenugreek Seed is the dried mature seed of Trigonella foenum-graecum L. (Fam. Leguminosae). The drug is collected in summer when the fruit is ripe, removed from the plant, dried, and the seeds are separated and cleaned.

Description

Seeds slightly oblique-quadrate or rectangular, 3-4 mm long, 2-3 mm wide, and about 2 mm thick; externally yellowish-green or yellowish-brown, smooth, with a deep oblique groove on each side, the point of intersection bearing a dot-like hilum. Texture hard, not easily broken. Testa thin, endosperm semi-transparent, sticky; cotyledons 2, pale yellow, radicle curved, plump and long. Odour, aromatic; taste, slightly bitter.

Identification

（1）The powder is brownish-yellow. Epidermal cells in a single row, with the upper part of the outer and lateral walls thicker and finely longitudinally striated, the lower part of the cell cavity larger, with a bright band; surface view polygonal, with thicker walls and smaller cell cavities. Supporting cells in a single row, slightly dumbbell-shaped, with the upper end slightly narrower and the lower end wider, the vertical walls showing a streaked texture; basal view nearly circular or hexagonal, with dense radial striations thickened, resembling chrysanthemum-like patterns, and distinct cell cavities. Cotyledon cells contain starch grains and oil droplets.

（2）To 1 g of the powder add 30 ml of petroleum ether (30-60 °C）, ultrasonicate for 30 minutes, filter and discard the filtrate, evaporate the residue to dryness. Add 30 ml of ethanol, ultrasonicate for 30 minutes, filter and evaporate the filtrate to dryness. Dissolve the residue with 1 ml of methanol as the test solution. Dissolve trigonelline CRS in methanol to produce a solution containing 2 mg per ml as the reference solution. Carry out the method for thin layer chromatography <0502>, using silica gel Gas the coating substance and a mixture of n-butanol, hydrochloride and ethyl acetate (8: 3: 1) as the mobile phase. Apply separately 6 μl of each of the two solutions to the plate. After developing and removal of the plate, dry in air. Spray with a mixture solution of potassium iodobismuthate TS and ferric chloride TS (2: 1). 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.

（3）To the test solution obtained under Identification (2), add methanol to 10 ml as the test solution. Prepare a solution of 0. 1 g of Trigonellae Semen reference drug in the Same manner described under Identification (2) as the reference drug solution, carry out the method for thin layer chromatography <0502>, using polyarnide as the coating substance and a mixture of ethanol, butanone, acetylacetonate and water (3: 3: 1: 13) as the mobile phase. Apply separately 1 μl of each of the above two solutions to the film. After developing and removal of the plate, dry it in air, spray with aluminium trichloride TS, dry in a current of hot air for 5 minutes, and examine under ultraviolet light at 365 nm. The spots in the chromatogram obtained with the test solution correspond in position and colour to the spots in the chromatogram obtained with the reference drug solution.

Examination

Water

Not more than 15.0 per cent <0832, method 2>.

Total ash

Not more than 5.0 per cent <2302>.

Acid-insoluble ash

Not more than 1.0 per cent <2302>.

Extractives

Carry out the method for determination of ethanol-soluble Extractives <2201, the hot maceration method>, using diluted ethanol as the solvent, not less than 18.0 per cent.

Assay

Carry out the method for high performance liquid chromatography <0512>.

Chromatographic conditions and system suitability test

Use octadecylsilane bonded silica gel as the stationary phase and a mixture of methanol, 0. 05% sodium dodecyl sulfonate and glacial acetic acid (20:80:0.1) as the mobile phase. As detector a spectrophotometer set at 265 nm. The number of theoretical plates of the column is not less than 4000, calculated with the reference to the peak of trigonelline.

Preparation of reference solution

Dissolve a quantity of trigonelline CRS, accurately weighed, in 50% methanol to prepare a solution containing 60 μg per ml as the reference solution.

Preparation of test solution

Weigh accurately 0.5 g of the powder in a stoppered conical flask, add 50 ml of 50% methanol, and weigh. Allow to stand for 1 hour, ultrasonicate (power 300 W, frequency, 50 kHz) for 45 minutes, allow standing to cool and weigh again, replenish the loss of weight with 50% methanol and mix well. Filter and use the successive filtrate as the test solution.

Assay method

Inject accurately 10 μl of each of the reference solution and the test solution into the column and calculate the content.

This product shall not contain less than 0.45% of fenugreek alkaloids (C7H7NO2) when calculated as a dried product.

Prepared slices

Fenugreek Seed

Processing

Eliminate Foreign matter, wash clean, and dry.

性状 ｜ Description

As required for the crude drug.

Identification

As required for the crude drug.

Examination

As required for the crude drug.

Extractives

As required for the crude drug.

Assay

As required for the crude drug.

Salted Fenugreek Seed

炮制 ｜ Processing

Stir-bake the clean Semen Trigonellae as described under the method for stir-baking with salt-water <0213> until it becomes inflated and scenty. Break to pieces before use.

Description

Similar to Trigonellae Semen in shape, enternally yellowishbrown to brown, charred spots occasionally. Odour slightly aromatic; taste, slightly salty.

Examination

Water

Not more than 11.0 per cent, following the method for the crude drug.

Total ash

Not more than 7.5 per cent, following the method for the crude drug.

Identification

As required for the crude drug.

Extractives

As required for the crude drug.

Assay

As required for the crude drug.

性 ｜ Property

Warm.

味 ｜ Flavor

Bitter.

Meridian tropism

Kidney meridian.

功能 ｜ Actions

To warm the kidney, assist yang, dispel cold and relieve pain.

Indications

Deficiency of kidney yang, deficiency cold in low origin, cold pain in low abdomen, abdominal pain caused by cold, abdominal colic, and cold-dampness tinea pedis.

Dosage

5-10 g.

用法 ｜ Administration

None.

Storage

Keep in a dry place.

姜黄

English text reference: *Chinese Pharmacopoeia (2020 Edition) *

Overview

Turmeric Rhizome is the dried rhizome of Curcuma longa L. (Fam. Zingiberaceae). The drug is collected in winter when the stem and leaves wither, removed from rootlets, washed clean, boiled or steamed until thoroughly cooked, dried in the sun, and the rootlets removed.

Description

Rhizomes irregularly ovate, cylindrical or spindle-shaped, often curved, some with short forked branches, 2-5 cm long, 1-3 cm in diameter; externally deep yellow, rough, with wrinkled texture and distinct nodes, and circular branch scars and rootlet scars; texture hard, not easily broken, fracture brownish-yellow to golden yellow, horny, with a waxy luster; inner bark with distinct ring-like markings, vascular bundles scattered in dots. Odour, characteristically aromatic; taste, bitter and pungent.

Identification

（1）Transverse section of the rhizome: epidermal cells flattened, walls thin. Cortex wide, with leaf trace vascular bundles; 6-8 rows of cork cells near the outer epidermis, flattened; endodermal cells with Casparian strips distinct. Inner sheath of the vascular bundle 1-2 rows of thin-walled cells; vascular bundles exarch, scattered, more near the inner sheath, gradually decreasing inward. Thin-walled cells contain oil droplets, starch grains, and reddish-brown pigments.

（2）To 0.2 g of the powder add 20 ml of anhydrous ethanol, shake for 30 minutes, filter, evaporate the filtrate to dryness, dissolve the residue in 2 ml of anhydrous ethanol as the test solution. Take 0.2 g of the reference drug of turmeric, prepare the reference drug solution in the same manner. Take curcumin CRS, add anhydrous ethanol to produce 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 mixture of chloroform-methanol-formic acid (96: 4: 0.7) as the mobile phase. Apply separately to the plate 4 μl of each of the above three solutions. After developing and removal of the plate, dry in air. Examine under daylight and ultraviolet light at 365 nm. The spots or fluorescent spots in the chromatogram obtained with the test solution correspond in position and colour to the spots or fluorescent spots in the chromatograms obtained with the reference drug solution and the reference solution.

Examination

Water

Not more than 16.0 per cent <0832, method 4>.

Total ash

Not more than 7.0 per cent <2302>.

Extractives

Carry out the method for determination of ethanol-soluble Extractives <2201, the hot maceration method>, using diluted ethanol as the solvent, not less than 12.0 per cent.

Assay

Volatile oil Carry out the method for determination of volatile oil <2204>.

It contains not less than 7. 0 per cent (ml/g) of volatile oil.

Curcumin

Carry out the method for high performance liquid chromatography <0512>.

Chromatographic conditions and system suitability test

Use octylsilane bonded silica gel as the stationary phase and a mixture of acetonitrile and 4% solution of glacial acetic acid (48: 52) as the mobile phase. As detector a spectrophotometer set at 430 nm. The number of theoretical plates of the column is not less than 4000, calculated with reference to the peak of curcumin.

Preparation of reference solution

Weigh accurately a quantity of curcumin CRS, dissolve in methanol to produce a solution containing 10 μg per ml.

Preparation of test solution

Weigh accurately 0.2 g of the powder to a stoppered conical flask, add accurately 10 ml of methanol and weigh. Heat under reflux for 30 minutes, cool and weigh again, replenish the loss of weight with methanol, mix well and centrifuge. Measure accurately 1 ml of the supernatant to a 20 ml volumetric flask, dilute with methanol to volume and mix well.

Assay method

Inject accurately 5 μl of each of the reference solution and the test solution, respectively, into the column, and calculate the content.

It contains not less than 1.0 per cent of curcumin (C21H20O6), calculated with reference to the dried drug.

Prepared slices

Turmeric

Processing

Eliminate Foreign matter, soak briefly, wash clean, soften thoroughly, cut into thick slices, and dry.

性状 ｜ Description

In irregular or subrounded thick slices. Externally dark yellow, sometimes annular nodes visible. Cut surface brownish-yellow to golden yellow, horny, with an obvious endodermis ring, dotted vascular bundles scattered. Odour, characteristic and aromafic; taste, bitter and astringent.

Identification

As required for the crude drug.

Examination

Water

Not more than 13.0 per cent, following the method for the crude drug.

总灰分 ｜ Total ash

As required for the crude drug.

Extractives

As required for the crude drug.

Assay

It contains not less than 5.0 per cent (ml/g) of volatile oil and 0.90 per cent of curcumin (C21H20O6), following the method for the crude drug.

Property

Warm.

Flavor

Bitter and pungent.

Meridian tropism

Spleen and liver meridians.

Actions

To promote blood circulation and regulate Qi, regulate menstruation and relieve pain.

Indications

Used for stabbing pain in the chest and hypochondrium, chest pain, dysmenorrhea and amenorrhea, abdominal masses, rheumatic shoulder and arm pain, and traumatic swelling and pain.

Dosage

3-10 g. For external use, appropriate amount.

Administration

None.

Storage

Preserve in a cool and dry place.

金果榄

English text reference: *Chinese Pharmacopoeia (2020 Edition) *

Overview

Tinospora Root is the dried tuberous root of Tinospora sagittata (Oliv.) Gagnep. or Tinospora capillipes Gagnep. (Fam. Menispermaceae). The drug is collected in autumn and winter, removed from fibrous roots, washed clean, and dried in the sun.

Description

Tinospora Root is irregularly rounded or irregularly shaped tuberous pieces, 5-10 cm long and 3-6 cm in diameter. The surface is brownish-yellow or light brown, rough and uneven, with deep wrinkles. The texture is hard and not easily crushed or broken. The transverse section is pale yellowish-white, with slightly radiating arrangement of vascular bundles, and the color is darker. It has a slight odor and a bitter taste.

Identification

（1）The powder is yellowish-white or grayish-white. Numerous stone cells are present, pale yellow or yellow, elongated or polygonal, with a diameter of 18-66 μm, and the walls are thickened on three sides. The cell cavity contains calcium oxalate prisms. Calcium oxalate prisms are square or rectangular, with a diameter of 4-28 μm. Cork cells are yellow-brown or golden yellow, and the surface appears polygonal with slight lignification. There are many starch grains, which are spherical, helmet-shaped, or polygonal round with a diameter of 4-40 μm. The hilum is in the shape of a herringbone, short arc, or dot; compound grains consist of 2-5 sub-grains.

（2）Take 1 g of this product powder, add 20 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 1 g of the control herb, the same method into the control herb solution. Then take Gulenbin control, add methanol to make a solution containing 0.5 mg per ml, as the control solution. According to the thin layer chromatography <0502> test, absorb the above three solutions of 2 ~ 3 μl, were spotted on the same silica gel G thin layer plate, cyclohexane - ethyl acetate - methanol - concentrated ammonia solution (8: 9: 2: 1) of the upper solution as the unfolding agent, unfolding, remove, drying, sprayed with 10% sulfuric acid solution of ethanol, heated to 105 °C until the spot color clear, and placed in the daylight and ultraviolet light (365 nm) under the examination. In the chromatogram of the test article, in the corresponding position with the chromatogram of the control herb and the chromatogram of the control article, the same color spots were shown in daylight; the same color fluorescent spots were shown under ultraviolet light.

Examination

Water

Not more than 13.0 per cent <0832, method 2>.

Total ash

Not more than 7.0 per cent <2302>.

Extractives

Carry out the method for determination of ethanol-soluble Extractives <2201, the hot maceration method>, using ethanol as the solvent, not less than 7.0 per cent.

Assay

Carry out the method for high performance liquid chromatography <0512>.

Chromatographic conditions and system suitability test

Use octadecylsilane bonded silica gel as the filler; use acetonitrile-water (40: 60) as the mobile phase; detect at a wavelength of 210 nm. The theoretical number of plates calculated according to the peak of berberine should not be less than 2500.

Preparation of reference solution

Take an appropriate amount of berberine reference substance, accurately weigh, and prepare a solution containing 0.25 mg per ml with 70% methanol.

Preparation of test solution

Take about 0.5 g of the powder (passed through a No. 3 sieve) of the test substance, accurately weigh, accurately add 10 ml of 70% methanol, weigh, treat with ultrasound (power 200 W, frequency 59 kHz) for 20 minutes, cool, weigh again, make up for the lost weight with 70% methanol, shake well, filter, accurately take 1 ml of the filtrate, place it in a 10 ml volumetric flask, add 70% methanol to the mark, shake well, and obtain the test solution.

Assay method

Accurately take 10 μl of the reference solution and the test solution, inject them into the liquid chromatograph, and determine.

Calculated on the dried basis, the content of berberine (C20H22O6) should not be less than 1.0%.

Prepared slices

Tinospora Root

Processing

Eliminate Foreign matter, soak, soften thoroughly, cut into thick slices, and dry.

性状 ｜ Description

In subrounded or irregular thick slices. Externally brownishyellow to dark brown, wrinkled and uneven. Cut surface pale yellowish-white, sometimes sparse greyish-brown radial striations visible, sometimes with clefts. Odour slight; taste bitter.

鉴别 ｜ Identification

As required for the crude drug.

检查 ｜ Examination

As required for the crude drug.

浸出物 ｜ Extractives

As required for the crude drug.

Assay

As required for the crude drug.

Property

Cold.

Flavor

Bitter.

Meridian tropism

Lung and large intestine meridians.

Actions

To clear heat and detoxify, benefit the throat, and relieve pain.

Indications

Used for sore throat, carbuncle, furuncle, diarrhea, dysentery, and epigastric pain.

Dosage

3-9 g. For external use, appropriate amount.

Administration

For external use, appropriate amount is powdered and blown on the throat or vinegar is used to grind and apply to the affected area.

Storage

Store in a dry place and protect from moth.

金钱草

English text reference: *Chinese Pharmacopoeia (2020 Edition) *

Overview

Lysimachia Herb is the dried aerial part of Lysimachia christinae Hance (Fam. Primulaceae). The drug is collected in summer and autumn, removed from impurities, and dried.

Description

The drug is often tangled into a mass, hairless or sparsely pubescent. Stems twisted, surface brown or dark reddish-brown, with longitudinal ridges, sometimes with adventitious roots at lower nodes, solid in cross-section. Leaves opposite, mostly wrinkled and crumpled, when flattened, broadly ovate or cordate, 1-4 cm long, 1-5 cm wide, slightly concave at base, entire at margin; upper surface grayish-green or brownish-brown, lower surface lighter, main veins distinctly raised, when soaked in water, black or brown stripes visible by transmitted light; petiole 1-4 cm long. Some with flowers, yellow, solitary in leaf axils, with long pedicels. Capsule globose. Odour, faint; taste, insipid.

Identification

（1）Transverse section of stem: Epidermal cells covered with a cuticle, sometimes glandular hairs visible, head cells single, stalk cells 1-2. Cork layer wide[1], some cells containing reddish-brown secretions; secretory ducts scattered, surrounded by 5-10 secretory cells, containing reddish-brown block secretions; endodermis distinct. Medullary sheath fibres arranged in interrupted rings, walls slightly lignified. Phloem narrow. Xylem arranged in rings. Pith often hollow. Thin-walled cells containing starch grains.

Leaf surface: Glandular hairs reddish-brown, head cells single, nearly circular, 25 μm in diameter, stalk cells single. Secretory ducts scattered in leaf parenchyma, 45 μm in diameter, containing reddish-brown secretions. Non-glandular hairs visible on stems and leaf surfaces, 1-17 cells, straight or curved, some cells constricted, 59-1070 μm long, 13-53 μm in diameter at base, surface with fine striations, cell cavity containing yellowish-brown substance.

（2）To 1 g of the powder add 50 ml of 80% methanol, heat under reflux for 1 hour, cool, filter, evaporate the filtrate to dryness, dissolve the residue in 10 ml of water, extract with two 10-ml portions of ether, discard the ether layer, add 10 ml of dilute hydrochloric acid to the aqueous layer, heat in a water bath for 1 hour, remove, cool rapidly, extract with two 20-ml portions of ethyl acetate, combine the ethyl acetate layers, wash with 30 ml of water, discard the aqueous layer, evaporate the ethyl acetate layer to dryness, dissolve the residue in 1 ml of methanol as the test solution. Prepare a solution containing 0.5 mg of quercetin CRS and a solution containing 0.5 mg of kaempferol CRS in methanol 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 toluene-ethyl acetate-formic acid (10: 8: 1) as the mobile phase. Apply separately to the plate 5 μl of the test solution and 2 μl of each of the Reference solutions. After developing and removal of the plate, dry in air. Spray with a 3% solution of aluminium chloride in ethanol, heat at 105 °C for a few minutes, examine under ultraviolet light at 365 nm. The fluorescent spots in the chromatogram obtained with the test solution correspond in position and colour to the spots in the chromatogram obtained with the Reference solutions.

Examination

Impurities

Not more than 8.0 per cent <2301>.

Water

Not more than 13.0 per cent <0832, method 2>.

Total ash

Not more than 13.0 per cent <2302>.

Acid-insoluble ash

Not more than 5.0 per cent <2302>.

Extractives

Carry out the method for determination of ethanol-soluble Extractives <2201, the hot maceration method>, using 75% ethanol as the solvent, not less than 8.0 per cent.

Assay

Carry out the method for high performance liquid chromatography <0512>.

Chromatographic conditions and system suitability test

Use octadecylsilane bonded silica gel as the filler; use methanol-0.4% phosphoric acid solution (50: 50) as the mobile phase; detection wavelength is 360 nm. The theoretical plate number calculated from the quercetin peak should not be less than 2500.

Preparation of reference solution

Accurately weigh an appropriate amount of quercetin CRS and kaempferol CRS, add 80% methanol to make a solution containing 4 μg of quercetin and 20 μg of kaempferol per ml.

Preparation of test solution

Accurately weigh about 1.5 g of the powder (passed through a No. 3 sieve) of the drug, place it in a stoppered conical flask, accurately add 50 ml of 80% methanol, stopper tightly, weigh, heat under reflux for 1 hour, cool, weigh again, make up the loss in weight with 80% methanol, shake well, filter. Accurately measure 25 ml of the filtrate, accurately add 5 ml of hydrochloric acid, heat in a water bath at 90°C for 1 hour, remove, cool rapidly, transfer to a 50 ml volumetric flask, dilute with 80% methanol to the mark, shake well, filter, take the filtrate, and set aside.

Assay method

Accurately draw 10 μl of each of the reference solution and the test solution, inject into the liquid chromatograph, and determine.

Calculated on the dried basis, the total content of quercetin (C15H10O7) and kaempferol (C15H10O6) should not be less than 0.10%.

Prepared slices

Lysimachia Herb

Processing

Eliminate Foreign matter, rinse with Water, cut into sections, and dry.

Description

In irregular sections. Stems brown or dark brown, striated longitudinally, fracture solid. Leaves opposite, when whole, broadly ovate or cordate; the upper surface greyish-green or dark brown, the lower surface pale in colour, midrib distinctly prominent, the black or brown stripes visible against the light after soaking in water. Occasionally flowers, yellow, solitary vein. Odour, slight; taste, weak.

Identification

As required for the crude drug.

Examination

Water

As required for the crude drug.

Total ash

As required for the crude drug.

Acid-insoluble ash

As required for the crude drug.

Extractives

As required for the crude drug.

Assay

As required for the crude drug.

Property

Slightly cold.

Flavor

Sweet and salty.

Meridian tropism

Liver, gallbladder, kidney, and bladder meridians.

Actions

To eliminate dampness and relieve jaundice, promote diuresis and relieve stranguria, detoxify and reduce swelling.

Indications

Used for damp-heat jaundice, distension and pain in the hypochondrium, urinary calculi, hot stranguria, painful urination, carbuncles and furuncles, snake and insect bites.

Dosage

15-60 g.

Administration

None.

Storage

Preserve in a dry place.

金荞麦

English text reference: *Chinese Pharmacopoeia (2020 Edition) *

Overview

Rhizoma Fagopyri Dibotryis is the dried rhizome and root of Fagopyrum dibotrys (D.Don) Hara (Fam. Polygonaceae). The drug is collected in winter, removed from stem and root hairs, washed clean, and dried in the sun.

Description

Rhizomes irregularly massed or cylindrical, often with tuberous branches, 3-15 cm long, 1-4 cm in diameter; surface brownish-brown, with transverse nodes and longitudinal wrinkles, densely dotted with pustular pores, and with concave circular root scars and residual root hairs. Texture hard, not easily broken, fracture pale yellow-white or pale reddish-brown, with radial texture, central medullary part darker in color. Odour, slight; taste, slightly astringent.

Identification

（1）The powder is light brown. Numerous starch grains are present, single grains are spherical, elliptical or ovate, 5-48 μm in diameter, with hilum punctate, stellate, fissured or bird-like, located in the center or biased to one end, large grains show layering; compound grains consist of 2-4 sub-grains; half-compound grains are visible. Wood fibers are bundled, 10-38 μm in diameter, with oblique or cross-shaped pits. Calcium oxalate cluster crystals are 10-62 μm in diameter. Wood parenchyma cells are square or elliptical, 28-37 μm in diameter, up to about 100 μm in length, with slightly thickened walls and sparse pits. Vascular tracheids and libriform fibers are 21-83 μm in diameter.

（2）Take 2.5 g of the drug, add 20 ml of methanol, let stand for 1 hour, heat under reflux for 1 hour, cool, filter, concentrate the filtrate to 5 ml as the test solution. Take another 1 g of Rhizoma Fagopyri Dibotryis, prepare the reference solution in the same way. Take rutin 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 toluene-acetic acid-ethyl acetate-methanol-formic acid (1: 2: 0.2: 0.1) as the mobile phase. Apply separately to the plate 5-10 μl of each of the test solution, the reference solution, and the reference drug solution. After developing and removal of the plate, dry in air. Spray with a 25% solution of phosphomolybdic acid in ethanol, heat at 110 °C to the spots 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.

Examination

Water

Not more than 15.0 per cent <0832, method 2>.

Total ash

Not more than 5.0 per cent <2302>.

Extractives

Carry out the method for determination of ethanol-soluble Extractives <2201, the hot maceration method>, using diluted ethanol as the solvent, not less than 14.0 per cent.

Assay

Carry out the method for high performance liquid chromatography <0512>.

Chromatographic conditions and system suitability test

Use octadecylsilane bonded silica gel as the filler; use acetonitrile-0.004% phosphoric acid solution (10: 90) as the mobile phase; detection wavelength is 280 nm. The theoretical plate number calculated from the peak of rutin should not be less than 6000.

Preparation of reference solution

Take an appropriate amount of rutin CRS, accurately weigh, add the mobile phase to produce a solution containing 25 μg per ml, and mix well.

Preparation of test solution

Take about 2 g of the coarse powder of the drug, accurately weigh, place it in a stoppered conical flask, accurately add 50 ml of diluted ethanol, seal tightly, accurately weigh, let stand for 1 hour, heat under reflux for 1 hour, cool, weigh again, make up for the weight loss with diluted ethanol, shake well, filter, accurately take 25 ml of the filtrate, concentrate under reduced pressure (50-70 °C) to near dryness, wash the residue with a mixed solution of acetonitrile-water (10: 90) in portions, transfer the washing solution to a 10 ml volumetric flask, add a mixed solution of acetonitrile-water (10: 90) to the mark, shake well, centrifuge (at a speed of 3000 rpm) for 5 minutes, accurately take 5 ml of the supernatant, apply to a polyamide column (30-60 mesh, inner diameter 1.0 cm, column length 15 cm, wet packing), elute with 50 ml of water, discard the eluate, elute with 100 ml of ethanol, collect the eluate, concentrate under reduced pressure (50-70 °C) to near dryness, dissolve the residue with a mixed solution of acetonitrile-water (10: 90), transfer to a 10 ml volumetric flask, dilute with a mixed solution of acetonitrile-water (10: 90) to the mark, shake well, and obtain the test solution.

Assay method

Accurately take 20 μl of each of the reference solution and the test solution, inject into the liquid chromatograph, and determine.

Calculated on the dried basis, the content of rutin (C15H14O6) should not be less than 0.030%.

Prepared slices

Rhizoma Fagopyri Dibotryis

Processing

Eliminate Foreign matter, wash clean, soften briefly, cut into thick slices, and dry.

Description

In irregular thick slices. Externally brown, some falling off. Cut surface pale yellowish-white or pale brownish-red, radiately striated, some with pith in deeper colour. Odour slight; taste slightly astringent.

含量测定 ｜ Assay

It contains oot less than 0. 020 per cent of (-)-epicatechin (C15H14O6), following the method for the crude drug.

Identification

As required for the crude drug.

Examination

As required for the crude drug.

Extractives

As required for the crude drug.

Property

Cold.

Flavor

Slightly pungent and astringent.

Meridian tropism

Lung meridian.

Actions

To clear heat and detoxify, promote suppuration and eliminate stasis.

Indications

Used for lung abscess with expectoration of pus, lung heat with cough and dyspnea, and mastitis with swelling and pain.

Dosage

15-45 g.

Administration

Decocted with water or yellow rice wine in a sealed container over water.

Storage

Preserve in a dry place, protect from mold and moth.

洪连

English text reference: *Chinese Pharmacopoeia (2020 Edition) *

Overview

Lagotidis Herb is the dried aerial part of Lagotis brevituba Maxim. (Fam. Scrophulariaceae). The drug is collected in summer and autumn at flowering, removed from impurities, washed, and dried in the shade.

Description

The drug is 5-15 cm long. Rhizome cylindrical, slightly curved, internodes close together, resembling silkworm; surface grayish-brown or light purplish-brown; texture brittle, easily broken, fracture brownish or grayish-yellow, with 3-4 white dot-like vascular bundles arranged in a ring. Roots slender, cylindrical, twisted, surface light yellowish-brown or grayish-brown, with longitudinal wrinkles. Radical leaves with long petioles; leaf blades crumpled and broken, when whole, circular or ovate, blunt at apex, margin with rounded teeth, base broadly cuneate. Spike-like inflorescence terminal. Fruit elongate-ovoid, blackish-brown. Odour, slight; taste, slightly bitter.

Identification

（1）The powder is reddish-brown. Numerous starch grains, single grains are round, with a diameter of 3-7 μm, occasionally helmet-shaped, with a dot-like hilum; compound grains consist of 2-3 (6) component grains. Thin-walled cells are round or round-like, containing light brown round-like nuclear substances. Epidermal cells of the lower surface of the leaf have slightly curved periclinal walls, stomata are anomocytic and anisocytic. Vessels are mostly reticulate and spiral.

（2）To 0.5 g of the powder add 10 ml of methanol, treat with ultrasound for 15 minutes, filter, and use the filtrate as the test solution. Prepare separately a solution of the reference substances, arctiin and verbascoside, in methanol to contain 1 mg per ml as the Reference solution. Carry out the method for thin layer chromatography <0502>, using polyamide film as the coating substance and a mixture of methanol-acetic acid-water (2: 1: 7) 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. 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 solution.

Examination

Water

Not more than 8.0 per cent <0832, method 2>.

Total ash

Not more than 15.0 per cent <2302>.

Acid-insoluble ash

Not more than 10.0 per cent <2302>.

Extractives

Carry out the method for determination of ethanol-soluble Extractives <2201, the cold maceration method>, using ethanol as the solvent, not less than 8.0 per cent.

Assay

Carry out the method for high performance liquid chromatography <0512>.

Chromatographic conditions and system suitability test

Use octadecylsilane bonded silica gel as the filler; use acetonitrile-methanol-1% acetic acid solution (10: 15: 75) as the mobile phase; detection wavelength is 334 nm. The theoretical plate number calculated from the peak of arctiin should not be less than 4000.

Preparation of reference solution

Take an appropriate amount of arctiin reference substance, accurately weigh, place it in a brown volumetric flask, add the mobile phase to make a solution containing 0.25 mg per ml, and mix well.

Preparation of test solution

Take about 0.5 g of the powder (passed through a No. 4 sieve) of the test substance, accurately weigh, place it in a 50 ml brown volumetric flask, accurately add 25 ml of the mobile phase, weigh, soak for 30 minutes, treat with ultrasound (power 230 W, frequency 35 kHz) for 15 minutes, cool, weigh again, make up for the lost weight with the mobile phase, shake well, centrifuge, let stand, take the supernatant and place it in a brown bottle, and obtain the test solution.

Assay method

Accurately draw 10-20 μl of the reference solution and the test solution, respectively, inject into the liquid chromatograph, and determine.

Calculated on the dried basis, the content of arctiin (C33H46O20) should not be less than 0.80%.

Property

Cold.

Flavor

Bitter and sweet.

Meridian tropism

Lung, heart, and liver meridians.

功能 ｜ Actions

To clear heat, detoxify, promote diuresis, soothe the liver, promote blood circulation, and regulate menstruation.

Indications

Used for fever and thirst, lung heat cough, headache and dizziness, damp-heat jaundice, irregular menstruation, and poisoning by drugs and food.

Dosage

1-6 g.

用法 ｜ Administration

None.

Storage

Preserve in a well-ventilated and dry place.