- Chinese Pharmacopoeia (2020 Edition)Created date:Updated date:
橘核
English text reference: Chinese Pharmacopoeia (2020 Edition)
橘核JuheCitri Reticulatae SemenTangerine SeedOverview
Tangerine Seed is the dried mature seed of Citrus reticulata Blanco and its cultivated varieties (Fam. Rutaceae). The fruit is collected when ripe, cleaned, and dried.
Description
Seeds slightly ovate, 0.8-1.2 cm long, 0.4-0.6 cm in diameter. Surface pale yellowish-white or pale grayish-white, smooth, with a ridge line on one side, one end bluntly rounded, the other end gradually tapering into a small stalk. Outer seed coat thin and tough, inner seed coat thin and pale brown, cotyledons 2, yellowish-green, oily. Odour, slight; taste, bitter.
Identification
Transverse section of the seed: epidermal cells of the seed coat form a layer of mucilage cells; below it is a row of thick-walled cells arranged in a lattice, with the outer wall intact or the upper end in the form of a tail-like projection, the wall thick or thin and uneven, lignified, with cross-shaped or oblique pits; pigment layer cells contain orange-yellow or yellow-brown substances, and contain calcium oxalate prisms, 7-16 μm in diameter. Endosperm cells 3-4 rows, some walls thickened in a bead-like manner, containing fat droplets. Cotyledon cells contain small clusters or prisms of calcium oxalate, fat droplets, and needle-like hesperidin crystals.
Prepared Tangerine Seed
Tangerine Seed
Processing
Remove impurities, wash, and dry. Crush before use.
Description
Same as the crude drug.
Salted Tangerine Seed
Processing
Salted Tangerine Seed: Take clean Tangerine Seed, stir-fry with salt water according to the method of stir-frying with salt water (General Rule 0213), and dry. Crush before use.
Description
The drug is shaped like a Tangerine Seed. Cotyledons are pale brown or yellowish-green, with few pale green ones. Odour, slight; taste, slightly salty and bitter.
Property
Neutral.
Flavor
Bitter.
Meridian tropism
Enters the Liver and Kidney meridians.
Actions
Soothes the liver qi, disperses stagnation, and relieves pain.
Indications
Used for pain due to hernia, testicular swelling and pain, and breast abscess and breast lumps.
Dosage
3-9g.
Administration
None.
Storage
Store in a dry place, protected from mold and insects.
Note: The main cultivated varieties include Citrus reticulata ‘Dahongpao’ and Citrus reticulata ‘Tangerina’.
Review acceptedReviewed by:吴侨智 (WU Qiaozhi)Last reviewed date: - Chinese Pharmacopoeia (2020 Edition)Created date:Updated date:
九香虫
English text reference: Chinese Pharmacopoeia (2020 Edition)
九香虫JiuxiangchongAspongopusAspongopusOverview
Aspongopus is the dried body of Aspongopus chinensis Dallas (Fam. Pentatomidae). It is collected from November to March of the following year, placed in a suitable container, suffocated with a small amount of alcohol, taken out and dried; or killed by scalding in boiling water, taken out and dried.
Description
The drug is slightly hexagonal and flat-elliptical, measuring 1.6-2 cm long and about 1 cm wide. The surface is brownish-brown or brownish-black with a slight luster. The head is small and slightly triangular with the thorax. The compound eyes are prominent and oval, with a single pair of ocelli and a pair of antennae, each with 5 segments, most of which have fallen off. There are 2 pairs of wings on the back, the outer pair of which is hard at the base and the inner pair is membranous and transparent. There are 3 pairs of legs on the thorax, most of which have fallen off. The abdomen is reddish-brown to brownish-black, with small protrusions near the edges of each segment. The texture is brittle, and there is a light brown internal substance when broken. It has a peculiar odor and a slightly salty taste.
Identification
To 0.2g of the powder add 20 ml of petroleum ether (60-90°C) and treat with ultrasound for 20 minutes. Filter, wash the residue with petroleum ether 3 times, each time with 5 ml, combine the washings and the filtrate, and concentrate to 10 ml as the test solution. Take 0.2g of the reference drug of Aspongopus, and prepare the reference drug solution in the same way. Take the reference substance of oleic acid, add petroleum ether (60-90°C) to make a solution containing 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 petroleum ether (60-90°C), ether, and glacial acetic acid (36:9:0.9) as the mobile phase. Place the plate in a developing tank pre-saturated with the mobile phase for 20 minutes, develop, remove, dry, and expose to iodine vapor until the spots are clearly visible. The chromatogram obtained with the test solution shows spots of the same color at the corresponding positions as the chromatogram of the reference drug and the chromatogram of the reference solution.
Examination
Water
Not more than 9.0 per cent <0832,method 2>.
Total ash
Not more than 6.0 per cent <2302>.
Aflatoxin
Determine according to the method for determination of mycotoxins <2351>.
Take about 5g of the powder of this product (passed through a No.2 sieve), accurately weigh, add 3g of sodium chloride, prepare the test solution according to the method for preparation of test solution of aflatoxins, and then accurately take 10ml of the supernatant for determination and calculation.
The content of aflatoxin B1 in this product shall not exceed 5μg per 1000g, and the total content of aflatoxin G2, aflatoxin G1, aflatoxin B2, and aflatoxin B1 shall not exceed 10μg.
Extractives
Carry out the method for determination of ethanol-soluble Extractives <2201>, using diluted ethanol as the solvent, not less than 10.0 per cent.
Prepared slices
Fructus Evodiae
Processing
Remove impurities.
Description
Same as the crude drug.
Identification
Same as the crude drug.
Examination
Same as the crude drug.
Extractives
Same as the crude drug.
Stir-fried Fructus Evodiae
Processing
Take clean Fructus Evodiae, stir-fry according to the method of stir-frying <0213> until fragrant.
Description
This product is shaped like Fructus Evodiae. The surface is dark brown to black with a shiny oily luster. It has a slight fishy odor and a slightly burnt aroma, with a slightly salty taste.
Examination
Water
Water content, same as the crude drug, not more than 7.0 per cent.
Property
warm in nature.
Flavor
Salty.
Meridian tropism
It enters the liver, spleen, and kidney meridians.
Actions
Regulate qi and relieve pain, warm the middle and assist yang.
Indications
Used for stomach cold and distension pain, liver and stomach qi pain, kidney deficiency and impotence, and lumbago and knee pain.
Dosage
3-9g.
Administration
None.
Storage
Store in a wooden box lined with oil paper to prevent moisture and moth.
Review acceptedReviewed by:吴侨智 (WU Qiaozhi)Last reviewed date: - Chinese Pharmacopoeia (2020 Edition)Created date:Updated date:
矮地茶
English text reference: Chinese Pharmacopoeia (2020 Edition)
矮地茶AidichaArdisiae Japonicae HerbaArdisia HerbOverview
Ardisia Herb is the dried whole plant of Ardisia japonzca (Thunb.) Blume (Fam. Myrsinaceae). The drug is collected in summer and autumn when the stems and leaves are luxuriant, removed from sand and soil, and dried.
Description
Rhizome cylindrical, with sparse adventitious roots. Stem slightly flattened cylindrical, slightly twisted, 10-30 cm long, 0.2-0.5 cm in diameter; surface reddish-brown, with fine longitudinal wrinkles, leaf scars and nodes; texture hard, easily broken. Leaves alternate, clustered at the stem apex; leaf blades slightly curled or broken, elliptical when flattened, 3-7 cm long, 1.5-3 cm wide; grayish-green, brownish-brown or light reddish-brown; apex acute, base wedge-shaped, margin finely serrate; nearly leathery. Occasionally red spherical drupe at the top of the stem. Odour, slight; taste, slightly astringent.
Identification
Stem transverse section: epidermal cells with thick walls, glandular hairs present; cork layer visible in old stems. Cortex wide, with several rows of thick-walled cells on the outer side; some containing calcium oxalate prisms; secretory cavities present. Endodermis distinct. Phloem very narrow, with a few fibers on the outer side. Cambium ring indistinct. Xylem cells all lignified, vessels mostly arranged in a single row. Pith relatively large, with secretory cavities. Thin-walled cells containing calcium oxalate prisms and starch grains, some containing brown substances.
Leaf surface of the drug: epidermal cells with wavy periclinal walls; stomata anisocytic, occasionally anomocytic. Glandular scales with 8-10 cells at the head and a single cell at the stalk.
Powder of the drug brown. Spiral vessels more common, diameter 7.5-25 μm. Secretory cavities mostly broken, some containing yellowish-brown secretions, secretory cells containing brown substances visible. Fiber walls thick. Calcium oxalate prisms diameter 7.5-26 μm. Glandular hairs composed of a single-cell stalk and a two-cell head. Stomata anisocytic. Brownish lumps visible. Starch grains single, oval or round, diameter 3.8-23 μm, hilum punctate or fissured; compound grains composed of 2-3 sub-grains.
To 0.2 g of the powder add 20 ml of methanol, treat with ultrasound for 30 minutes, cool, filter, concentrate the filtrate to 1 ml as the test solution. Take another 1 ml of methanol to dissolve 0.5 mg of bergenin CRS 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-acetic ether-methanol (5:4:2) as the mobile phase. Apply separately to the plate 3 μl of each of the above two solutions. After developing and removal of the plate, dry in air. Spray with a mixed solution of 1% ferric chloride and 1% potassium ferricyanide (1:1). 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 13.0 per cent <0832,method 2>.
Total ash
Not more than 8.0 per cent <2302>.
Assay
Carry out the assay by high-performance liquid chromatography <0512>.
Chromatographic conditions and system suitability test
Use octadecylsilane-bonded silica gel as the filler; use methanol-water (20:80) as the mobile phase; detect at a wavelength of 275nm. The theoretical plate number calculated based on the peak of baicalin should not be less than 1500.
Preparation of reference solution
Take an appropriate amount of baicalin reference substance, accurately weigh, add methanol to make a solution containing 50μg per 1ml.
Preparation of test solution
Take about 0.2g of the powder of this product, accurately weigh, place it in a stoppered conical flask, accurately add 20ml of methanol, weigh, subject to ultrasonic treatment (power 200W, frequency 40kHz) for 40 minutes, cool, weigh again, make up for the weight loss with methanol, shake well, filter, and take the filtrate.
Assay method
Accurately take 5μl of the reference solution and the test solution, inject into the liquid chromatograph, and determine.
Calculated on the dried product, the content of baicalin (C14H16O9) should not be less than 0.50%.
Prepared slices
Ardisia Herb
Processing
Eliminate Foreign matter, wash, cut into sections, and dry in the sun.
Description
This product is in irregular segments. The rhizome is terete and curved, sparsely fibrous. The stem is slightly compressed cylindrical, with a reddish brown surface, with fine longitudinal lines, some with branches and alternate leaf scars. The cut surface has a light brown pith in the centre. Leaves more broken, grey-green to brown-green, apical more pointed, base cuneate, margin serrulate, subleathery. Slightly astringent taste.
Examination
Water
Same as the crude drug. Not more than 11.0 per cent.
Total ash
Same as the crude drug.
Identification
(except stem cross-section, leaf surface view) Same as the crude drug.
Assay
Same as the crude drug.
Property
Neutral.
Flavor
Pungent, and slightly bitter.
Meridian tropism
Lung and liver meridians.
Actions
To resolve phlegm and stop coughing, clear and eliminate damp-heat, activate blood circulation and resolve stasis.
Indications
Used for cough with phlegm, asthma with fullness, damp-heat jaundice, blood stasis due to menstrual disorders, rheumatic arthralgia, and traumatic injury.
Dosage
15-30 g.
Administration
None.
Storage
Preserve in a cool and dry place.
Review acceptedReviewed by:吴侨智 (WU Qiaozhi)Last reviewed date: - Chinese Pharmacopoeia (2020 Edition)Created date:Updated date:
薄荷
English text reference: Chinese Pharmacopoeia (2020 Edition)
薄荷BoheMenthae Haplocalycis HerbaField Mint HerbOverview
Field Mint Herb is the dried aerial part of Mentha haplocalyx Briq. (Fam. Labiatae). The drug is collected in summer and autumn when the stems and leaves are luxuriant or when the flowers are in full bloom, dried in the sun or in the shade.
Description
Stems square, with opposite branches, 15-40 cm long, 0.2-0.4 cm in diameter; surface purple-brown or pale green, with pubescence at the angles, internodes 2-5 cm long; texture brittle, fracture white, hollow in the pith. Leaves opposite, with short petioles; leaf blades wrinkled, curled, when whole, broadly lanceolate, long elliptical or ovate, 2-7 cm long, 1-3 cm wide; upper surface dark green, lower surface greyish-green, sparsely pubescent, with glandular scales in pitted depressions. Cymes axillary; calyx campanulate, 5-toothed at the apex; corolla pale purple. Odour, special and cool; taste, pungent and cool.
Identification
(1) Observation of the leaf surface: The head of glandular scales consists of 8 cells, with a diameter of about 90 μm, and the stalk is composed of a single cell; the head and stalk of non-glandular hairs are also single cells. Non-glandular hairs consist of 1-8 cells, often curved, with thick walls and slightly verrucose. Stomata of the lower epidermis are mostly of the paracytic type.
(2) Take a small amount of the powder of the drug, sublime it in a microquantity, add 2 drops of sulfuric acid and a small amount of vanillin crystals, initially showing yellow to orange-yellow, then add 1 drop of water, which turns purple-red.
(3) Take 1 g of the coarse powder of the drug, add 10 ml of anhydrous ethanol, treat with ultrasound for 20 minutes, filter, and take the filtrate as the test solution. Take 1 g of the reference drug of Field Mint Herb, and prepare the reference drug solution in the same way. Take the reference substance of Menthol, add anhydrous ethanol to make a solution containing 2 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 and ethyl acetate (9:1) as the mobile phase. Apply separately to the plate 5-10 μl of each of the above three solutions. After developing and removal of the plate, dry in air. Spray with a 40% solution of p-dimethylaminobenzaldehyde in 10% sulfuric acid in ethanol, heat at 80°C to the spots clear. Examine under ultraviolet light at 365 nm. The fluorescent spots in the chromatograms obtained with the test solution correspond in position and colour to the spots in the chromatograms obtained with the reference drug and the reference solution.
Examination
Leaf
Not less than 30 per cent.
Water
Not more than 15.0 per cent <0832,method 4>.
Total ash
Not more than 11.0 per cent <2302>.
Acid-insoluble ash
Not more than 3.0 per cent <2302>.
Assay
Volatile oil
Take an appropriate amount of this product, about 5mm in length. Add 600ml of water to 100g of the test product, and determine the volatile oil content by the method for determination of volatile oil <2204> under the condition of maintaining a slight boiling for 3 hours.
The content of volatile oil in this product shall not be less than 0.80% (ml/g).
Menthol
Determine by gas chromatography <0521>.
Chromatographic conditions and system suitability test
A capillary column with polyethylene glycol as the stationary phase (column length: 30m, inner diameter: 0.32mm, film thickness: 0.25μm); temperature program: initial temperature 70℃, hold for 4 minutes, then increase at a rate of 1.5℃ per minute to 120℃, then increase at a rate of 3℃ per minute to 200℃, finally increase at a rate of 30℃ per minute to 230℃, hold for 2 minutes; injection port temperature 200℃; detector temperature 300℃; split injection, split ratio 5:1; the theoretical number of plates calculated based on the peak of menthol should not be less than 10000.
Preparation of reference solution
Take an appropriate amount of the reference substance of menthol, accurately weigh, and add anhydrous ethanol to make a solution containing 0.2mg per 1ml.
Preparation of test solution
Take about 2g of the powder of this product (passed through a No. 3 sieve), accurately weigh, place it in a stoppered conical flask, accurately add 50ml of anhydrous ethanol, seal the flask, weigh it, subject it to ultrasonic treatment (power: 250W, frequency: 33kHz) for 30 minutes, let it cool, weigh it again, make up for the weight loss with anhydrous ethanol, shake well, filter, and take the filtrate to obtain the test solution.
Assay
Accurately take 1μl of the reference solution and the test solution, respectively, inject them into the gas chromatograph, determine, and obtain the result.
Calculated on the dried product, the content of menthol (C10H20O) shall not be less than 0.20%.
Prepared slices
Peppermint
Processing
Remove old stems and impurities, lightly spray with water, slightly moisten, cut into short sections, and dry at low temperature in time.
Description
The product is in irregular segments. The stem is square and cylindrical, the surface is purple-brown or light green, with longitudinal ribs, and the corners are velvety. The cut surface is white, hollow. Leaves are much broken, dark green on the upper surface, grey-green on the lower surface, sparsely velutinous. Verticillasters axillary, calyx campanulate, apex 5-toothed, corolla lavender. There is a special cool aroma after rubbing, and the taste is pungent and cool.
Examination
Water
Same as the crude drug.Not more than 13. 0 per cent.
total ash
Same as herbs.
acid-insoluble ash
Same as herbs.
Assay
volatile oil
Same herb, containing not less than 0.40% volatile oil (ml/g).
Menthol
The same herb, calculated according to the dry product, containing menthol (C10H20O) shall not be less than 0.13%.
Identification
Same as herbs.
Property
cool.
Flavor
Pungent.
Meridian tropism
Lung and liver meridians.
Actions
To disperse wind-heat, clear and benefit the head and eyes, promote throat, promote eruption, and regulate liver and qi.
Indications
Used for wind-heat common cold, early stage of wind-heat, headache, red eyes, sore throat, mouth ulcers, wind rash, measles, chest and hypochondriac distention.
Dosage
3~6g.
Administration
Add when the decoction is nearly done.
Storage
Store in a cool and dry place.
Review acceptedReviewed by:吴侨智 (WU Qiaozhi)Last reviewed date: - Chinese Pharmacopoeia (2020 Edition)Created date:Updated date:
蓖麻子
English text reference: Chinese Pharmacopoeia (2020 Edition)
蓖麻子BimaziRicini SemenCastor BeanOverview
Castor Bean is the dried mature seed of Ricinus communis L. (Fam. Euphorbiaceae). The drug is collected in autumn when the fruit is mature, dried in the sun, and the seeds are collected after removing the husk.
Description
Seeds are elliptical or ovate, slightly flattened, 0.9-1.8 cm long, 0.5-1 cm wide. Surface smooth, with gray-white and black-brown or yellow-brown and red-brown alternating spots. One side is relatively flat, the other side is slightly raised, with one raised seed ridge on the flatter side; one end has a gray-white or light brown protruding seed hilum. Seed coat thin and brittle. Endosperm thick, white, oily, cotyledons 2, thin. Odour, slight; taste, slightly bitter and pungent.
Identification
(1) The powder is grayish-yellow or yellowish-brown. The seed coat has reddish-brown, elongated columnar cells arranged closely, with fine pores and dense cavities containing reddish-brown substances. The cell walls of the outer endosperm tissue are not obvious, and they are densely covered with small round clusters of crystals, chrysanthemum-shaped or spherical, with a diameter of 8-20 mm. The cells of the inner endosperm are polygonal, and the cavities contain starch granules and fat droplets.
(2) Take 1g of the coarse powder, add 10ml of anhydrous ethanol, soak for 30 minutes, filter, and take the filtrate as the test solution. Take 1g of the reference drug Ricinus communis and prepare the reference drug solution in the same way. Take the reference substance ricinoleic acid, add anhydrous ethanol to make a solution containing 1μl per 1ml 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 petroleum ether(60-90°C), ethyl acetate, and formic acid (14:4:0.4) as the mobile phase. Apply separately to the plate 1μl of the test solution and the reference drug solution, and 2μl of the reference solution. After developing and removal of the plate, dry in air. Spray with a 1% solution of vanillin sulfuric acid, 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 and the reference solution.
Examination
Water
Not more than 7.0 per cent <0832,method 2>.
Acid value
Determine according to the method for determination of acid value <2303>.
Acid value
Not more than 35.0.
Carbonyl value
Not more than 7.0.
Peroxide value
Not more than 0.20.
Ricinine
Determine according to the method for determination of ricinine by high performance liquid chromatography <0512>.
Chromatographic conditions and system suitability test
Use octadecylsilane bonded silica gel as the filler; use acetonitrile-water-diethylamine (11:89:0.03) as the mobile phase; detect at a wavelength of 307nm. The theoretical plate number calculated based on the peak of ricinine should not be less than 3000.
Preparation of reference solution
Take an appropriate amount of ricinine reference substance, accurately weigh, add methanol to make a solution containing 0.125mg per 1ml.
Preparation of test solution
Take about 2.5g of the powder of this product (passed through a No. 2 sieve), accurately weigh, place it in a Soxhlet extractor, add an appropriate amount of petroleum ether (60-90℃), heat and reflux for 4 hours, discard the petroleum ether solution, evaporate the solvent from the residue, transfer it to a stoppered conical flask, accurately add 50% methanol 50ml, weigh, heat and reflux for 2 hours, cool, weigh again, make up for the lost weight with 50% methanol, shake well, filter, and take the filtrate.
Determination method
Accurately take 10μl of the reference solution and the test solution, inject them into the liquid chromatograph, and determine.
Calculated on the dried product, the content of ricinine (C8H8N2O2) should not exceed 0.32%.
Prepared slices
Castor Bean
Processing
Remove the shell when used, and crush.
Description
Same as the crude drug.
Identification
Same as the crude drug.
Examination
Same as the crude drug.
Property
Neutral.
Toxicity
Toxic.
Flavor
Sweet and pungent.
Meridian tropism
Large intestine and lung meridians.
Actions
To promote bowel movement, relieve constipation, reduce swelling, and detoxify.
Indications
Used for dry stool, carbuncle and swelling, sore throat, and scrofula.
Dosage
2-5g.
Administration
For external use, use an appropriate amount.
Storage
Preserve in a cool and dry place.
Review acceptedReviewed by:吴侨智 (WU Qiaozhi)Last reviewed date: - Chinese Pharmacopoeia (2020 Edition)Created date:Updated date:
蟾酥
English text reference: Chinese Pharmacopoeia (2020 Edition)
蟾酥ChansuBufonis VenenumVenenum BufonisOverview
Venenum Bufonis is the dried secretion of the auricular and skin glands of Bufo bufo gargarizans Cantor or Bufo melanostictus Schneider (Fam. Bufonidae). The drug is collected in summer and autumn, when the toads are abundant, and is squeezed out, washed, processed, and dried.
Description
Venenum Bufonis occurs as flattened roundish masses or pieces. The former is hard and not easily broken, with a brownish-brown fracture surface, horny and slightly lustrous; the latter is brittle and easily broken, with a reddish-brown fracture surface, semi-transparent. It has a slight fishy odor, initially sweet and then with a persistent spicy sensation. The powder causes sneezing when smelled.
Identification
When the section of the drug is moistened with water, it becomes raised and milky white.
Take 0.1g of the powder, add 5ml of methanol, soak for 1 hour, filter, add a small amount of solid p-dimethylaminobenzaldehyde to the filtrate, and then add a few drops of sulfuric acid. The solution turns blue-purple.
Take 0.1g of the powder, add 5ml of chloroform, soak for 1 hour, filter, evaporate the filtrate to dryness, dissolve the residue in a small amount of acetic anhydride, and then add sulfuric acid. The solution initially turns blue-purple and gradually changes to blue-green.
To prepare the test solution, take 10ml of the solution obtained in the Assay section, evaporate to dryness in a water bath, dissolve in 2ml of methanol. Prepare the reference solution by taking 0.2g of the reference drug, adding 10ml of methanol, heating under reflux for 30 minutes, filtering, and using the filtrate 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, chloroform, and acetone (4:3:3) as the mobile phase. Apply separately to the plate 10 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. The chromatogram obtained with the test solution shows spots or fluorescent spots of the same color as those obtained with the reference drug in corresponding positions.
Chromatographic Fingerprint
The determination is performed by high-performance liquid chromatography according to the method described in Assay.
Chromatographic conditions and system suitability test
Same as the Assay section.
Preparation of reference solutions
Take 25mg of the reference drug, prepare the reference solution of the reference drug according to the method described in the Assay section; take the reference solution of the reference drug described in the Assay section as the reference solution of the reference drug.
Preparation of test solution
Take the test solution described in the Assay section, and the test solution is obtained.
Assay method
Precisely aspirate 5μl of the reference solution and the test solution, inject into the liquid chromatograph, and determine.
The test solution should exhibit 5 characteristic peaks, which should correspond to the 5 characteristic peaks in the chromatogram of the reference drug. Peak 4 should have the same retention time as the peak of venenum bufonis toxin in the reference drug.
Examination
Water
Not more than 13.0 per cent <0832,method 2>.
Total ash
Not more than 5.0 per cent <2302>.
Acid-insoluble ash
Not more than 2.0 per cent <2302>.
Assay
Determine by high-performance liquid chromatography <0512>.
Chromatographic conditions and system suitability test
Use octadecylsilane-bonded silica gel as the filler; acetonitrile as mobile phase A, 0.3% acetic acid solution as mobile phase B, perform gradient elution according to the specified conditions in the table below; column temperature is 30°C; flow rate is 0.6 ml per minute; detection wavelength is 296 nm. The theoretical plate number calculated based on the peak of hucansu toxin should not be less than 10000.
Preparation of reference solution
Take an appropriate amount of hucansu toxin reference substance, accurately weigh, dissolve in methanol to obtain a solution containing 100 μg per 1 ml.
Preparation of test solution
Take about 25 mg of this product powder, accurately weigh, place it in a stoppered conical flask, accurately add 20 ml of methanol, weigh, heat under reflux for 1 hour, cool, weigh again, make up for the weight loss with methanol, shake well, filter, and take the filtrate.
Assay method
Precisely aspirate 10 μl of the above-mentioned reference solution and 10-20 μl of the test solution, inject into the liquid chromatograph for determination. Take hucansu toxin reference substance as the reference, and calculate the relative retention time of chansudin and lipophilic chansudin based on its corresponding peak. The relative retention time should be within the range of ±5% of the specified value. The relative retention time and correction factor are shown in the table below.
Take hucansu toxin reference substance as the reference, multiply by the correction factor respectively, and calculate the content of hucansu toxin, chansudin, and lipophilic chansudin.
Calculated on the dried product basis, the total content of chansudin (C24H34O4), hucansu toxin (C26H34O6), and lipophilic chansudin (C24H32O4) should not be less than 7.0%.
Prepared slices
Toad Venom powder
Processing
Take toad venom, crush it, soak it in white wine, stir it frequently until it becomes a thick paste, dry it, and grind it into powder.
For every 10kg of toad venom, use 20kg of white wine.
Property
This product is brownish-yellow to brown powder. It has a slight fishy odor and a sweet taste followed by a persistent spicy sensation. It can cause sneezing when smelled.
Examination
Water
Not more than 8.0 per cent, same as the crude drug.
Identification
(2)(3)(4) are the same as the crude drug.
Characterisation mapping
Same as the crude drug.
Assay
Same as the crude drug.
Property
warm.
Toxicity
Toxic.
Flavor
Pungent.
Meridian tropism
Meridian tropism: Heart meridian.
Actions
Detoxification, pain relief, opening the orifices and awakening the mind.
Indications
Used for carbuncles, furuncles, sore throat, heatstroke with loss of consciousness, abdominal distension, abdominal pain, vomiting, and diarrhea.
Dosage
0.015-0.03 g.
Administration
Often used in pill or powder form. For external use, use an appropriate amount.
Precautions
Caution for pregnant women.
Storage
Store in a dry place, protected from moisture.
Review acceptedReviewed by:吴侨智 (WU Qiaozhi)Last reviewed date: - Chinese Pharmacopoeia (2020 Edition)Created date:Updated date:
椿皮
English text reference: Chinese Pharmacopoeia (2020 Edition)
椿皮ChunpiAilanthi CortexAilanthus BarkOverview
Ailanthus Bark is the dried root bark or dried bark of Ailanthus altissima (Mill.) Swingle (Fam. Simaroubaceae). It can be collected and peeled off throughout the year, dried in the shade, or scraped off the rough bark and dried.
Description
Root bark
Irregularly shaped or rolled pieces, varying in size, 0.3-1 cm thick. Outer surface grayish-yellow or yellowish-brown, rough, with numerous longitudinal corky protuberances and irregular longitudinal and transverse fissures; when the rough bark is removed, it appears yellowish-white; inner surface pale yellow, relatively flat, densely dotted with oval or punctiform lenticels. Texture hard and brittle; fracture, granular in the outer layer and fibrous in the inner layer. Odour, slight; taste, bitter.
bark
Bark: Irregularly shaped plate-like pieces, varying in size, 0.5-2 cm thick. Outer surface grayish-black, extremely rough, deeply fissured.
Identification
(1) Powder of root bark: Pale grayish-yellow. Numerous stone cells, mostly rounded, square or irregular in shape, 24-96 μm in diameter, thick-walled, or with three thicker walls and one thinner wall, some containing calcium oxalate prisms in the cell cavity. Fibres 20-40 μm in diameter, with extremely thick walls, lignified. Calcium oxalate prisms 11-48 μm in diameter; cluster crystals up to about 48 μm in diameter. Starch grains mostly spheroidal or ellipsoidal, 3-13 μm in diameter.
Powder of bark: Grayish-yellow. Numerous fragments of cork cells, occasional calcium oxalate cluster crystals, no starch grains.
(2) To 2 g of the powder add 20 ml of ether, treat with ultrasound for 15 minutes, filter, evaporate the filtrate to dryness, dissolve the residue in 1 ml of ethanol as the test solution. Prepare a solution of the reference material of Ailanthus Bark 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 petroleum ether (60-90°C) and ethyl acetate (4:1) as the mobile phase. Apply separately to the plate 10 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 spot in the chromatogram obtained with the test solution corresponds in position and colour to the spot in the chromatogram obtained with the reference material.
Examination
Water
Not more than 13.0 per cent <0832,method 2>.
Total ash
Not more than 11.0 per cent <2302>.
Acid-insoluble ash
Not more than 2.0 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 5.0 per cent.
Prepared slices
Bark of Chinese Toon
Processing
Eliminate Foreign matter,wash clean, soften thoroughly, cut into shreds or sections, and dry in the sun.
Description
This product is irregular in shape, with a thread-like or segmental appearance. The outer surface is grayish-yellow or yellowish-brown, rough, with numerous longitudinal skin-like protrusions and irregular longitudinal and transverse cracks. When the rough skin is removed, it appears yellowish-white. The inner surface is light yellow, relatively flat, and densely covered with shuttle-shaped pores or small dots. It has a slight aroma and a bitter taste.
Examination
Water
Not more than 10.0 per cent.
Total ash
Same as the medicinal material.
Acid-insoluble ash
Same as the medicinal material.
Extractives
Not less than 6.0 per cent <2201>.
Identification
Same as the medicinal material.
Stir-fried Bark of Chinese Toon
Take the shredded (or sectioned) bark of Chinese Toon, stir-fry it according to the method of stir-frying with bran <0213> until it turns slightly yellow.
Description
This product is similar to shredded (or sectioned) bark of Chinese Toon, with a yellow or brown surface and a slight aroma.
Examination
Water
Same as the medicinal material. Not more than 10.0 per cent.
Extractives
Same as the medicinal material. Not less than 6.0 per cent.
Identification
Same as the medicinal material.
Examination
Identification (Total ash Acid-insoluble ash) same as the medicinal material.
Property
cold.
Flavor
Bitter and astringent.
Meridian tropism
Large Intestine, Stomach, and Liver meridians.
Actions
To clear heat and dry dampness, astringe and stop abnormal vaginal discharge, stop diarrhea, and stop bleeding.
Indications
Used for abnormal vaginal discharge (leukorrhea), damp-heat diarrhea, chronic diarrhea, bloody stool, and metrorrhagia and metrostaxis.
Dosage
6-9 g.
Administration
None.
Storage
Store in a well-ventilated and dry place, and protect against moth damage.
Review acceptedReviewed by:吴侨智 (WU Qiaozhi)Last reviewed date: - Chinese Pharmacopoeia (2020 Edition)Created date:Updated date:
磁石
English text reference: Chinese Pharmacopoeia (2020 Edition)
磁石CishiMagnetitumMagnetiteOverview
Magnetite is the oxide mineral of the spinel group, mainly composed of ferrous ferric oxide (Fe3O4). After mining, it is purified by removing impurities.
Description
Magnetite is a block-like aggregate, irregularly shaped or slightly square, often with edges and corners. It is gray-black or brownish-black, with a black streak and metallic luster. It is heavy, hard, and has an uneven fracture. It is magnetic and has an earthy odor and a mild taste.
Identification
Take about 0.1g of the powder, add 2ml of hydrochloric acid, shake and let it stand. The clear liquid shows the identification reaction of iron salt (General Rule 0301).
Content Determination
Take about 0.25g of the fine powder, accurately weigh it, place it in a conical flask, add 15ml of hydrochloric acid and 3ml of 25% potassium fluoride solution, cover with a surface dish, heat to a slight boil, add 6% stannous chloride solution dropwise, shake continuously, wait for complete decomposition, leaving only white residue at the bottom of the bottle, remove it, rinse the surface dish and the inner wall of the bottle with a small amount of water, and while it is still hot, add 6% stannous chloride solution dropwise until it appears light yellow (if stannous chloride is excessive, dropwise add potassium permanganate solution until it appears light yellow), add 100ml of water and 15 drops of 25% sodium tungstate solution, and dropwise add 1% titanium trichloride solution until it appears blue, then carefully add potassium dichromate titration solution (0.01667mol/L) until the blue color just fades away, immediately add 10ml of sulfuric acid-phosphoric acid-water (2:3:5) and 5 drops of sodium diphenylamine sulfonate indicator solution, and titrate with potassium dichromate titration solution (0.01667mol/L) until the solution appears stable blue-purple. Each 1ml of potassium dichromate titration solution (0.01667mol/L) is equivalent to 5.585mg of iron (Fe).
The iron (Fe) content in magnetite should not be less than 50.0%.
Prepared Slices
Magnetite
Processing
Remove impurities and crush.
Description
Magnetite prepared slices are irregular fragments. They are gray-black or brownish-black, with a black streak and metallic luster. They are hard in texture, magnetic, and have an earthy odor and a mild taste.
Identification
Same as the crude drug.
Content Determination
Same as the crude drug.
Calcined Magnetite
Processing
Take clean magnetite blocks, calcine them according to the calcination and quenching method (General Rule 0213) until they are red and translucent, quench with vinegar, and grind into coarse powder.
Vinegar 30 kg per 100 kg magnet.
Description
Calcined magnetite is irregular fragments or particles. The surface is black. It is hard and brittle in texture. It is non-magnetic. It has a vinegar aroma.
Content Determination
Same as the crude drug. The iron (Fe) content should not be less than 45.0%.
Identification
Same as the crude drug.
Property
cold.
Flavor
salty.
Meridian tropism
It enters the Liver, Heart, and Kidney meridians.
Actions
It calms the mind, soothes the Liver and suppresses Yang, sharpens the hearing and improves vision, and regulates Qi and relieves asthma.
Indications
It is used for palpitations and insomnia, dizziness and vertigo, blurred vision, tinnitus and deafness, and deficiency of the Kidney with Qi wheezing.
Dosage
9-30g.
Administration
decoct first.
Storage
Store in a dry place.
Review acceptedReviewed by:吴侨智 (WU Qiaozhi)Last reviewed date: - Chinese Pharmacopoeia (2020 Edition)Created date:Updated date:
刀豆
English text reference: Chinese Pharmacopoeia (2020 Edition)
刀豆DaodouCanavaliae SemenSword Bean SeedOverview
Sword Bean Seed is the dried mature seed of Canavalia gladiata (Jacq.) DC. (Fam. Leguminosae). The drug is collected in autumn when the fruit is mature, the seeds are removed, and dried in the sun.
Description
Seeds flattened-ovate or flattened-reniform, 2-3.5 cm long, 1-2 cm wide, 0.5-1.2 cm thick. Surface pale red to purplish-red, slightly wrinkled, slightly lustrous. Hilum linear, about 2 cm long, with 3 white lines. Texture hard, difficult to break. Seed coat leathery, inner surface brownish-green and lustrous; cotyledons 2, yellowish-white, oily. Odour, slight; taste, weak, with a beany flavour on chewing.
Identification
Transverse section of the seed: Epidermal cells in 1 row, 2 rows at the hilum, with an outer cuticle and a distinct hypodermal sclerenchymatous ring. Supporting cells 2-6 rows, dumbbell-shaped. Nutritive cells consisting of more than 10 rows of thin-walled cells elongated radially, with the inner cells collapsed; vascular bundles present, below the seed coat are several rows of polyhedral endosperm cells. Cotyledon cells containing numerous starch grains. Islands of sieve cells elliptical, with reticulate thickening of the walls, few bordered pits. Surrounding the islands are 4-5 layers of thin-walled cells, with stellate tissue on both sides, the cells being stellate with large intercellular spaces.
Prepared Slices
Sword Bean Seed
Processing
Remove impurities and crush before use.
Description
Same as the crude drug.
Identification
Same as the crude drug.
Property
warm.
Flavor
Sweet.
Meridian tropism
Enters the Stomach and Kidney meridians.
Actions
Warm, down, stop huh.
Indications
Used for deficiency-cold hiccups and vomiting.
Dosage
6-9g.
Administration
None.
Storage
Store in a well-ventilated and dry place, protected from moth.
Review acceptedReviewed by:吴侨智 (WU Qiaozhi)Last reviewed date: - Chinese Pharmacopoeia (2020 Edition)Created date:Updated date:
滇鸡血藤
English text reference: Chinese Pharmacopoeia (2020 Edition)
滇鸡血藤DianjixuetengKadsurae CaulisKadsura StemOverview
Kadsura Stem is the dried stem of Kadsura interior A. C. Smith (Fam. Magnoliaceae). The drug is collected in autumn, removed from branches and leaves, sliced, and dried.
Description
Slices circular, elliptical or irregular in shape, 1.8-6.5 cm in diameter. Surface greyish-brown, dark purple-red at places where cork has peeled off; cork thick, coarsely cracked in some, fissured; in others, longitudinally grooved, often with mosses and lichens attached. Texture hard, not easily broken. Transverse section: cork narrow, reddish-brown, fibrous; wood wide, light brown, with numerous pitted vessels; pith small, blackish-brown, hollow. Odour, distinctive; taste, bitter and astringent.
Identification
The powder is dark red. Crystal fibers are bundled or scattered, gradually pointed at the end, with a diameter of 21-62μm, extremely thick walls, indistinct cell cavities, and numerous small calcium oxalate crystals embedded in the walls, some of which protrude from the cell wall surface. Crystal stone cells are irregular or elongated, with a diameter of 38-92μm, thick walls, and numerous small calcium oxalate crystals embedded in the walls. Fiber vessel cells are bundled or scattered. Cork cells have a polygonal surface view, with straight and thin radial walls; side view is rectangular. Secretory cells are elliptical with large cell cavities, connected with thin-walled cell fragments. Vessels are ring-porous vessels, mostly broken. Brown blocks are scattered, reddish-brown or brown.
To 0.5g of the powder add 10ml of cyclohexane, treat with ultrasound for 30 minutes, filter, evaporate the filtrate to dryness, dissolve the residue in 0.5ml of cyclohexane as the test solution. Take Denshiso Ding Su as the reference substance, add cyclohexane to make a solution containing 1mg per ml as the reference solution. Carry out the method for thin layer chromatography<0502>, using silica gel GF254 as the coating substance and a mixture of petroleum ether (60-90°C) and ethyl acetate (2:1) as the mobile phase. Apply separately to the plate 5 μl of each of the above two solutions. After developing and removal of the plate, dry in air. Examine under ultraviolet light at 254 nm. 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.
Examination
Water
Not more than 14.0 per cent <0832,method 2>.
Total ash
Not more than 4.0 per cent <2302>.
Assay
Carry out the assay by high performance liquid chromatography <0512>.
Chromatographic conditions and system suitability test
Bonded silica gel with octadecylsilane as the filler; methanol-acetonitrile-water (10:48:42) as the mobile phase; detection wavelength at 230nm. The theoretical plate number calculated based on the peak of schisandrin C should not be less than 8000.
Preparation of reference solution
Taking an appropriate amount of schisandrin C reference substance, accurately weigh it, and dissolve it in methanol to obtain a solution containing 30μg per 1ml.
Preparation of test solution
Taking about 0.5g of the powder of this product (passed through a No. 3 sieve), accurately weigh it, place it in a stoppered conical flask, accurately add 50ml of hexane, weigh it, subject it to ultrasonic treatment (power 360W, frequency 40kHz) for 50 minutes, let it cool, weigh it again, make up for the weight loss with hexane, shake well, filter, accurately take 25ml of the filtrate, evaporate to dryness, dissolve the residue in methanol, transfer it to a 5ml volumetric flask, add methanol to the mark, shake well, filter, and take the filtrate.
Assay method
Precisely draw 10μl of the reference solution and the test solution, respectively, inject them into the liquid chromatograph, and determine.
Calculated on the dried product, the content of schisandrin C (C27H30O8) should not be less than 0.050%.
Property
warm.
Flavor
Bitter, sweet.
Meridian tropism
Liver and kidney meridians.
Actions
To promote blood circulation and nourish blood, regulate menstruation and relieve pain, and relax tendons and activate collaterals.
Indications
Used for irregular menstruation, dysmenorrhea, numbness and paralysis, rheumatic arthralgia, and deficiency of qi and blood.
Dosage
15-30g.
Administration
None.
Storage
Store in a dry place.
Review acceptedReviewed by:吴侨智 (WU Qiaozhi)Last reviewed date: