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Showing posts with label Herbal Pharmacopoeia. Show all posts
Showing posts with label Herbal Pharmacopoeia. Show all posts

0 Acanthopanacis Cortex (Wujiapi)

Acanthopanacis Cortex (Wujiapi)

Slenderstyle Acanthopanax Bark


Slenderstyle Acanthopanax Bark is the dried root bark of Acanthopanax gracilistylus W. W. Smith ( Fam. Araliaceae). The root is collected in summer and autumn, washed clean, the bark is stripped off, and dried in the sun.

Description:

Irregular quills, 5-15 cm long, 0. 4-1. 4 cm in diameter, about 2 mm thick. Outer surface greyish-brown, with slightly twisted longitudinal wrinkles and transverse lenticel-like scars; inner surface pale yellow or greyish- yellow, with fine longitudinal striations. Texture light, fragile, easily broken, fracture irregular, greyish-white Odour, slightly aromatic; taste, slightly pungent and bitter.

Identification:

Transverse- section: Cork cells several layers. Phellem narrow, scattered with a few secretory canals. Phloem broad, with clefts in the outer part, rays 15 cells wide; secretory canals fairly frequent, so;rounded with 4-11 secretory cells. Parenchymatous cells containing clusters of calcium oxalate and small starch granules.

Powder:

Greyish-white. Clusters of calcium oxalate 8-64 µm in diameter, sometimes the crystal cells linked together, with clusters arranged in rows. Cork cells rectangular or polygonal, thin-walled; sometimes the walls of cork cells of older root barks unevenly thickened, less pitted. Fragments of secretory canals containing colourless or pale yellow secretion. Starch granules abundant, simple granules polygonal or subspherical, 2-8 µm in diameter; compound granules consisting of 2 to tens of components.

Water:

Not more than 13.0 per cent (Appendix K H, method 1).

Total ash:

Not more than 12. 0 per cent (Appendix IX K).

Prepared slices:

Processing Eliminate foreign matter, wash clean, soften thoroughly, cut into thick slices, and dry in the sun.

Property and Flavor:

Warm; pungent and bitter.

Meridian tropism:

Liver and kidney meridians.

Actions:

To dispel wind and remove dampness, tonify and replenish the liver and kidney, strengthen sinew and bone, promote urination to alleviate edema.

Indications:

Wind-dampness impediment disease, limp wilting sinew and bone, infantile walk retardation, weak constitution and lack of strength, edema, tinea pedis.

Administration and dosage:

5-10 g.

Storage:

Preserve in a dry place, protected from mould and moth.
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0 Abutili Semen (Qingmazi)

Abutili Semen (Qingmazi)

Chingma Abutilon Seed

Chingma Abutilon Seed is the dried ripe seed of Abutilon theophrastii Medic. (Fam. Malvaceae). The fruit is collected in autumn when ripe, dried in the sun, and the seed is trapped out, removed from foreign matter.

Description:

Triangular reniform, 3. 5-6 mm long, 2. 54. 5 mm wide, 1-2 mm thick. Externally greyish-black or dark brown, bearing sparse white tomenta, a subelliptical hilum at the dented part, pale brown, radially striated around the edges. Testa hard, cotyledons 2, folded, oily. Odour, slight; taste, weak.

Identification:

(1) Transverse section: Epidermal cells 1 layer, flattened-rectangular, sometimes differentiated to unicellu-lar non-glandular hairs; hypodermal cells 1 layer, slightly radially prolated. Palisade cells 1 row, cylindrical, up to about 88 µm long, heavily thick-walled, linear lumina visible at the upper part, the terminal end expended, containing small globular crystals. Pigment cells 4-5 layers, containing yellowish-brown or reddish-brown contents. Cells of endosperm and cotyledons, containing fatty oil droplets and aleurone grains, cells of cotyledons also containing a few of fine clusters of calcium oxalate. :
(2) Add 2 g of the powder to a Soxhlet’s extractor, and add appropriate quantity of petroleum ether (60-90oC), heat under reflux to the extract colourless, cool, discard the petroleum ether. Evaporate the residue to dryness, add 30 ml of ethanol, ultrasonicate for 30 minutes, cool, filter, concentrate the filtrate to 2 ml as the test solution. Prepare a solution of 2 g of Abutili Semen in the same manner as the reference drug solution Carry out the method for thin layer chromatography (Appendix VI B ) , using silica gel G as the coating substance and a mixture of chloroform, acetone, methanol and formic acid (3 : 1 : 0. 5 : 0.1) as the mobile phase. Apply separately 5 µl of each of the above two solutions to the plate. After developing and removal of the plate, dry it in air, spray with a 10% solution of sulfuric acid in ethanol, heat at 110°C to the spots clear. 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 solution.

Foreign matter:

Not more than 1 percent (Appendix IX A).

Water:

Not more than 10.0 percent (Appendix IX H, method 2).

Total ash :

Not more than 7. 0 percent (Appendix IX K).

Extractives:

Carry out the hot extraction method for determination of ethanol-soluble extractives (Appendix X A), using anhydrous ethanol as solvent, not less than 17. 0 percent

Property and Flavor:

Neutral; bitter.

Meridian tropism:

Large intestine, small intestine and bladder meridians.

Actions:

To clear heat and remove toxin, drain dampness, relieve nebula.

Indications:

Red or white dysentery, stranguria with slow pain, swelling abscess, sore and toxin, nebula.

Administration and dosage:

3-9 g.

Storage:

Preserve in a cool and dry place.
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0 Abri Herba (Jigucao) Canton Love-pea Vine

Abri Herba

(Jigucao)

Canton Love-pea Vine


Canton Love-pea Vine is the dried herb of Ahrus cantoniensis Hance (Fam. Leguminosae). The drug is collected all the year round, removed from soil, and dried.

Description:

Roots mostly conical, the upper part thick and the lower part thin, branched, varying in length, 0.5-1.5 cm in diameter. Externally greyish-brown, rough, with fine, longitudinal striations, rootlets extremely slender, some fallen off or with remaining texture hard. Stems caespitose, 50-100 cm long, about 0.2 cm in diameter; greyish-brown to purplish-brown, branchlets slender, sparsely pubescent. Leaves pinnately compound, alternate, leaflets in 8-11 pairs, mostly fallen off, oblong, 0.81.2 cm long, apex truncate, mucronulate, the lower surface with pronated hairs. Odour, slightly aromatic; taste, slightly bitter.

Identification:

(1) Powder: Greyish-green. Non glandular hairs unicellular> acute or acuminate at the apex, 60-970 pm long, 12-22 pm in diameter, walls 3-6 pm thick, with distinct striations and warty prominences. Stomata paracytic. Fibre bundles surrounded by cells containing prisms of calcium oxalate, forming crystal fibres, walls of crystal cells irregularly thickened. Stone cells subrounded, subsquare or oblong, 16-40 pm in diameter, some with slightly thickened walls. Cork cells yellowish-brown. Prisms of calcium oxalate 5-11 pm in diameter.
(2) To 2 g of the powder add 50 ml of methanol, ultrasonicate for 1 hour, and filter. Evaporate the filtrate to dryness, dissolve the residue in 10 ml of n-butanol, extract by shaking with three 10-ml quantities of 2% solution of hydrochloric acid, combine the hydrochloric acid extracts, and adjust pH to 7 with 5% solution of sodium hydroxide Extract by shaking with three 5-ml quantities of n-butanol, combine the n-butanol extracts, evaporate to dryness, and dissolve the residue in 1 ml of methanol as the test solution. Dissolve abrine CRS in 80% methanol to produce a solution containing 0. 1 mg per ml as the reference solution. Carry out the method for thin layer chromatography (Appendix VI B), using silica gel G as the coating substance and the upper layer of a mixture of n-butanol, acetic acid and water (4 : 1 : 5) as the mobile phase. Apply separately to the plate 5-10 pi of the test solution and 2 pi of the reference solution. After developing and removal of the plate, dry in air. Spray with ninhydrin solution TS, heat at 105oC to the spots clear. The spot in the chromatogram obtained with the test solution corresponds in position and colour to the spot in the chromatogram obtained with the reference solution.

Water:

Not more than 15.0 per cent (Appendix K H, method 1).

Total ash:

Not more than 7. 5 per cent (Appendix IX K).

Extractives:

Carry out the method for determination of ethanol-soluble extractives (Appendix X A, the hot extraction method), using dilute ethanol as the solvent, not less than 6. 0 per cent

Processing:

Eliminate foreign matter and legumes, and cut into sections.

Property and Flavor

Cool; sweet and mild bitter.

Meridian tropism

Liver and stomach meridians.

Actions:

To drain dampness to abate jaundice, clear heat and remove toxin, soothe the liver to relieve paia

Indications:

Dampness-heat jaundice, discomfort in the rib- sides, distending pain in the stomach duct, acute mastitis with swelling and pain.

Administration and dosage:

15-30 g.

Storage:

Preserve in a dryplace.
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0 Abelmosichi Corolla (Huangshukuihua) Sunset Abelmoschus Flower

Abelmosichi Corolla

(Huangshukuihua)

Sunset Abelmoschus Flower


Sunset Abelmoschus Flower is the dried corolla of Abelmoschus manihot (L ) Medic. (Fam Malvaceae). The drug is collected at flowering in summer and autumn, and dried in time.

Description:

Mostly crum'pled arid broken, when whole, petal triangular broad-obovate, 7-19 cm long, 7-12 cm wide, externally with longitudinal winkles, radial, pale green, margin slightly sinuous; the inner surface base purpish-brown, stameus numerous, aggregated to a tube, 1.5-2. 5 cm long, anther almost sessible, stigma purplish- black, whorl-orbiculate 5-lobed. Odour, slightly aromatic; taste, sweet and weak.

Identification:

(1) Powders: Pale yellow to brownish- yellow, epidermal cells of corolla subrectangular or irregular, anticlinal walls slightly sinuous. Pollen grains subrounded, about 170 µm in diameter, scattered with 3240 germinal pores, externally with spines, whole glandular hairs long-conical, 510-770 pm long, head of glandular hair somewhat long clavate, 6-14 cellular, glandular stalk 3 cellular, containing purplish-red secretion; non-glandular hairs unicellular, 140-180 pm long, walls smooth. Cells of inner walls of pollen sac subrectangular in facture surface, walls stripe-like thickened, subpolygonal in surface view, anticlinal walls bead-like thickened. Clusters of calcium oxalate minute, 9-19 pm in diameter, angular acute.
(2) To 1 g of the powder add 20 ml of 0.18% solution of hydrochloric acid in ethanol, heat under reflux for 1 hour, filter, concentrate the filtrate to 5 ml and use as the test solution. Dissolve quercetin CRS in ethanol to produce a solution containing 0.5 mg per ml as the reference solution. Carry out the method for thin layer chromatography (Appendix VI B), using silica gel G mixed with 0.5% solution of sodium hydroxide as the coating substance and a mixture of toluene, ethyl acetate arid formic acid (5 : 4 : 1) as the mobile phase. Apply separately 1 pi of each of the above two solutions to the plate. After developing and removal of the plate, dry it in air, spray with aluminum chloride TS, and 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.

Water:

Not more than 12.0 per cent (Appendix IX H, method 1).

Total ash:

Not more than 8.0 per cent (Appendix IX K). Acid-insoluble ash Not more than 2.0 per cent (Appendix IX K).
Extractives Carry out the method for determination of ethanol-soluble extractives (Appendix X A, the cold maceration extraction method), not less than 18.0 per cent, using ethanol as the solvent.

Assay:

 Carry out the method for high performance liquid chromatography (Appendix VI D).
Chromatographic system and system suitability Use octadecylsilane bonded silica gel as the stationary phase and a mixture of acetonitrile and 0.1% phosphoric acid solution (15:85) as the mobile phase. As detector a spectrophotometer set at 360 nm. The number of theoretical plates of the column is not less than 10 000, calculated with reference to the peak of hyperoside.
Reference solution Dissolve a quantity of garlicin CRS in methanol, accurately weighed, to produce a solution containing 0.1 mg per ml as the reference solution.
Test solution Weigh accurately 0.2 g of the powder (through No. 4 sieve) in a 25 ml measuring flask, add 15 ml of methanol, ultrasonicate (power, 250 W; frequency, 30 kHz) for 30 minutes, cool and replenish the loss of weight with methanol, mix well, filter and use the successive filtrate as the test solution.
Procedure Inject accurately 10 µl of each of the reference solution and the test solution, into the column, and calculate the content.
It contains not less than 0.50 per cent of hyperoside (C21H20O12) , calculated with reference to the dried drug.

Prepared slices

Processing:

Eliminate foreign matter as well as dust and scrap.

Description and Identification:

As required for the crude drug.

Water, Total Ash, Acid-insoluble ash, and Extractives:

As required for the crude drug.

Assay:

As required for the crude drug.

Property and Flavor:

Cold; sweet.

Meridian tropism:

Kidney and bladder meridians.

Actions:

To clear and drain dampness-heat, disperse swelling and remove toxin.

Indications:

Obstruction of dampness-heat, turbid stranguria, edema; Topical application, abscesses and cellulitis, swelling and toxin, scald and bum.

Administration and dosage:

10-30 g; Ground into powder for oral administration, 3-5 g; Appropriate amount for topical application, ground into powder for applyment.

Contraindication:

Used cautiously for pregnant woman. Storage Preserve in a dry place.
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0 A HERBAL PHARMACOPOEIA LISTS

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0 Aloe-Aloe africana Miller or Aloe spicata Baker

Aloe

Aloe

Aloe is the dried juice of the leaves mainly of Aloe ferox Miller, or of hybrids of the species with Aloe africana Miller or Aloe spicata Baker (Liliaceae).
It contains not less than 4.0z of barbaloin, calculated on the basis of dried material.

Description:

Aloe occurs as blackish brown to dark brown, irregular masses; sometimes the external surface covered with a yellow powder; the fractured surface smooth and glassy.
Odor, characteristic; taste, extremely bitter.

Identification:

(1) Dissolve 0.5 g of pulverized Aloe in 50 mL of water by warming. After cooling, add 0.5 g of siliceous earth, and filter. Perform the following tests using the filtrate as the sample solution.
(i) Dissolve 0.2 g of sodium tetraborate decahydrate in 5 mL of the sample solution by warming in a water bath. Add a few drops of this solution into 30 mL of water, and shake: a green fluorescence is produced.
(ii) Shake 2 mL of the sample solution with 2 mL of nitric acid: a yellow-brown color which changes gradually to green is produced. Then warm this colored solution in a water bath: the color of the solution changes to red-brown.
(2) To 0.2 g of pulverized Aloe add 10 mL of methanol, shake for 5 minutes, filter, and use the filtrate as the sample solution. Separately, dissolve 1 mg of barbaloin for thin- layer chromatography in 1 mL of methanol, and use this solution as the standard solution. Perform the test with these solutions as directed under Thin-layer Chromatography. Spot 10 mL each of the sample solution and standard solution on a plate of silica gel for thin-layer chromatography. Develop the plate with a mixture of ethyl acetate, acetone, water and acetic acid (100) (20:5:2:2) to a distance of about 10 cm, and air-dry the plate. Examine under ultraviolet light (main wavelength: 365 nm): one spot among several spots from the sample solution and a red fluorescent spot from the standard solution show the same color tone and the same Rf value.

Purity:

(1) Resin.Warm 0.5 g of pulverized Aloe with 10 mL of diethyl ether on a water bath, and filter. Wash the residue and the filter paper with 3 mL of diethyl ether. Combine the filtrate and the washing, and evaporate the diethyl ether solution: the mass of the residue is not more than 5.0 mg.
(2) Ethanol-insoluble substances.Boil 1.0 g of pulverized Aloe with 50 mL of ethanol (95) on a water bath for 30 minutes under a reflux condenser. Filter the warm mixture through a tared glass filter (G4), and wash the residue on the filter with ethanol (95) until the last washing becomes colorless. Dry the residue at 105oC for 5 hours, and weigh: the mass of the residue is not more than 0.10 g.

Loss on drying:

Not more than 12.0z.

Total ash:

Not more than 2.0z.

Extract content:

Water-soluble extract: not less than 40.0z. Assay Weigh accurately about 0.1 g of pulverized Aloe, add 40 mL of methanol, and heat under a reflex condenser on a water bath for 30 minutes. After cooling, filter, and add methanol to the filtrate to make exactly 50 mL. Pipet 5 mL of the solution, add methanol to make exactly 10 mL, and use this solution as the sample solution. Separately, weigh accurately about 10 mg of barbaloin for assay, previously dried in a desiccator (in vacuum, phosphorus (V) oxide) for 24 hours, add 40 mg of oxalic acid dihydrate, an issolve in methanol to make exactly 100 mL. Pipet 5 mL of the solution, add methanol to make exactly 10 mL, and use this solution as the standard solution. Perform the test with exactly 5 mL each of the sample solution and standard solution as directed under Liquid Chromatography according to the following conditions, and determine the peak areas of barbaloin, AT and AS, of both solutions.
Amount (mg) of barbaloin MS × AT/AS × 1/2
MS: Amount (mg) of barbaloin for assay
Operating conditions.
Detector: An ultraviolet absorption photometer (wave-length: 360 nm).
Column: A stainless steel column 6 mm in inside diameter and 15 cm in length, packed with octadecylsilanized silica gel for liquid chromatography (5 mm in particle diameter).
Column temperature: A constant temperature of about 30oC.
Mobile phase: A mixture of water, acetonitrile and acetic acid (100) (74:26:1).
Flow rate: Adjust the flow rate so that the retention time of barbaloin is about 12 minutes.
System suitability.
System performance: Dissolve 10 mg of barbaloin for assay add 40 mg of oxalic acid dihydrate, in methanol to make 100 mL. To 5 mL of the solution add 1 mL of a solution of ethenzamide in methanol (1 in 2000) and methanol to make 10 mL. When the procedure is run with 5 mL of this solution under the above operating conditions except the wavelength of 300 nm, barbaloin and ethenzamide are eluted in this order with the resolution between these peaks being not less than 2.0.
System repeatability: When the test is repeated 6 times with 5 mL of the standard solution under the above operating conditions, the relative standard deviation of the peak area of barbaloin is not more than 1.5z.

Containers and storage:

Containers.Well-closed containers.
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0 Powdered Atractylodes Rhizome Atractylodis Rhizoma-Pulveratum

Powdered Atractylodes Rhizome

Atractylodis Rhizoma Pulveratum

Powdered Atractylodes Rhizome is the powder of Atractylodes Rhizome.

Description:

Powdered Atractylodes Rhizome occurs as a light brown to yellow-brown powder, and has a characteristic odor and a slightly bitter or slightly sweet taste, followed by a slightly bitter aftertaste.
Under a microscope, Powdered Atractylodes Rhizome reveals mainly parenchyma cells, crystals of inulin and fragments of parenchyma cells containing small needle crystals of calcium oxalate; fragments of light yellow thick walled fibers, stone cells and cork cells; a few fragments of reticulate and scalariform vessels; small yellow-brown se- crete masses or oil droplets; starch grains absent.

Identification:

Macerate 0.5 g of Powdered Atractylodes Rhizome with 5 mL of ethanol (95) by warming in a water bath for 2 minutes, and filter. To 2 mL of the filtrate add 0.5 mL of vanillin-hydrochloric acid TS, and shake immediately: a red to red-purple color develops and persists.

Purity:

(1) Arsenic. Prepare the test solution with 0.40 g of Powdered Atractylodes Rhizome according to Method 4, and perform the test (not more than 5 ppm).
(2) Atractylodes lancea rhizome.To 2.0 g of Powdered Atractylodes Rhizome add exactly 5 mL of hexane, shake for 5 minutes, filter, and use this filtrate as the sample solution. Perform the test with the sample solution as directed under Thin-layer Chromatography. Spot 10 μL of the solution on a plate of silica gel for thin-layer chromatography. Develop the plate with a mixture of hexane and acetone (7:1) to a distance of about 10 cm, and air-dry the plate. Spray evenly 4-dimethylaminobenzaldehyde TS for spraying on the plate, and heat at 1000C for 5 minutes: no green to grayish green spot appears at the Rf value of between 0.3 and 0.6.

Total ash:

Not more than 7.0z.

Acid-insoluble ash:

Not more than 1.0z.

Essential oil content:

Perform the test with 50.0 g of Powdered Atractylodes Rhizome: the volume of essential oil is not less than 0.4 mL.

Containers and storage:

Containers.Tight containers.
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0 Atractylodes Rhizome-Atractylodis Rhizoma-Atractylodes japonica-Atractylodes macrocephala-Atractylodes ovata

Atractylodes Rhizome

Atractylodis Rhizoma

Atractylodes Rhizome is the rhizome of Atractylodes japonica Koidzumi ex Kitamura (Wa-byakujutsu), or is the rhizome of Atractylodes macrocephala Koidzumi (Atractylodes ovata De Candolle) (Kara-byakujutsu) (Compositae).

Description:

(1) Wa-byakujutsu.Periderm-removed rhizome is irregular masses or irregularly curved cylinder, 3 – 8 cm in length, 2 . 3 cm in diameter; externally light grayish yellow to light yellowish white, with scattered grayish brown parts. The rhizome covered with periderm is externally grayish brown, often with node-like protuberances and coarse wrinkles. Difficult to break, and the fractured surface is fibrous. A transverse section, with fine dots of light yellow-brown to brown secrete.
Odor, characteristic; taste, somewhat bitter.
Under a microscope, a transverse section reveals periderm with stone cell layers; fiber bundles in the parenchyma of the cortex, often adjoined to the outside of the phloem; oil sacs containing light brown to brown substances, situated at the outer end of medullary rays; in the xylem, radially lined vessels, surrounding large pith, and distinct fiber bundle surrounding the vessels; in pith and in medullary rays, oil sacs similar to those in cortex, and in parenchyma, crystals of inulin and small needle crystals of calcium oxalate.
(2) Kara-byakujutsu.Irregularly enlarged mass, 4 - 8 cm in length, 2 - 5 cm in diameter; externally grayish yellow to dark brown, having sporadic, knob-like small protrusions. Difficult to break; fractured surface has a light brown to dark brown xylem remarkably fibrous.
Odor, characteristic; taste, somewhat sweet, but followed by slight bitterness.
Under a microscope, a transverse section usually reveals periderm with stone cells, absence of fibers in the cortex; oil sacs containing yellow-brown contents in phloem ray and also at the outer end of it; xylem with radially lined vessels surrounding large pith, and distinct fiber bundle surrounding the vessels; pith and medullary ray exhibit oil sacs as in cortex; parenchyma contains crystals of inulin and small needle crystals of calcium oxalate.

Identification:

Macerate 0.5 g of pulverized Atractylodes Rhizome with 5 mL of ethanol (95) by warming in a water bath for 2 minutes, and filter. To 2 mL of the filtrate add 0.5 mL of vanillin-hydrochloric acid TS, and shake immediately: a red to red-purple color develops and persists.
Purity:
(1) Arsenic . Prepare the test solution with 0.40 g of pulverized Atractylodes Rhizome according to Method 4, and perform the test (not more than 5 ppm).
(2) Atractylodes lancea rhizome.To 2.0 g of pulverized Atractylodes Rhizome add exactly 5 mL of hexane, shake for 5 minutes, filter, and use this filtrate as the sample solution. Perform the test with the sample solution as directed under Thin-layer Chromatography. Spot 10 μL of the solution on a plate of silica gel for thin-layer chromatography. Develop the plate with a mixture of hexane and acetone (7:1) to a distance of about 10 cm, and air-dry the plate. Spray evenly 4-dimethylaminobenzaldehyde TS for spraying on the plate, and heat at 100oC for 5 minutes: no green to grayish green spot appears at the Rf value of between 0.3 and 0.6.

Total ash:

Not more than 7.0z.

Acid-insoluble:

Not more than 1.0z.

Essential oil content:

Perform the test with 50.0 g of pulverized Atractylodes Rhizome: the volume of essential oil is not less than 0.5 mL.

Containers and storage:

Containers.Well-closed containers.
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0 Powdered Atractylodes Lancea Rhizome-Atractylodis Lanceae Rhizoma Pulveratum

Powdered Atractylodes Lancea Rhizome

Atractylodis Lanceae Rhizoma Pulveratum
Powdered Atractylodes Lancea Rhizome is the powder of Atractylodes Lancea Rhizome.

Description:

Powdered Atractylodes Lancea Rhizome occurs as a yellow-brown powder. It has a characteristic odor, and a slightly bitter taste.
Under a microscope, Powdered Atractylodes Lancea Rhizome reveals mainly parenchyma cells, spherocrystals of inulin, fragments of parenchyma cells containing fine needle crystals of calcium oxalate as their contents; and further fragments of light yellow thick-walled fibers, stone cells and cork cells; a few fragments of reticulate and scalariform vessels, and small yellow-brown secreted masses or oil drops; starch grains absent.

Purity:

(1) Heavy metals. Proceed with 3.0 g of Powdered Atractylodes Lancea Rhizome according to Method 3, and perform the test. Prepare the control solution with 3.0 mL of Standard Lead Solution (not more than 10 ppm).
(2) Arsenic <1.11>.Prepare the test solution with 0.40 g of Powdered Atractylodes Lancea Rhizome according to Method 4, and perform the test (not more than 5 ppm).
(3) Powdered atractylodes rhizome.To 0.5 g of Powdered Atractylodes Lancea Rhizome add 5 mL of ethanol (95), macerate by warming in a water bath for 2 minutes, and filter. To 2 mL of the filtrate add 0.5 mL of vanillin hydrochloric acid TS, and shake immediately: no red to red-purple color develops within 1 minute.

Total ash:

Not more than 7.0z.

Acid-insoluble ash:

Not more than 1.5z.

Essential oil content

Perform the test with 50.0 g of Powdered Atractylodes Lancea Rhizome: the volume of essential oil is not less than 0.5 mL.

Containers and storage:

Containers.Tight containers.
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0 Atractylodes Lancea Rhizome-Atractylodis Lanceae Rhizoma-Atractylodes lancea-Atractylodes chinensis

Atractylodes Lancea Rhizome

Atractylodis Lanceae Rhizoma
Atractylodes Lancea Rhizome is the rhizome of Atractylodes lancea De Candolle, Atractylodes chinensis Koidzumi or their interspecific hybrids (Compositae).

Description:

Irregularly curved, cylindrical rhizome, 3 - 10 cm in length, 1 - 2.5 cm in diameter; externally dark grayish brown to dark yellow-brown; a transverse section nearly orbicular, with light brown to red-brown secretes as fine points.
Often white cotton-like crystals produced on its surface.
Odor, characteristic; taste, slightly bitter.
Under a microscope, a transverse section usually reveals periderm with stone cells; parenchyma of cortex, usually without any fiber bundle; oil sacs, containing light brown to yellow-brown substances, located at the end region of medullary rays; xylem exhibits vessels surrounded by fiber bundles and arranged radially on the region adjoining the cambium; pith and medullary rays exhibit the same oil sacs as in the cortex; parenchyma cells contain spherocrystals of inulin and fine needle crystals of calcium oxalate.

Purity:

(1) Heavy metals. Proceed with 3.0 g of pulverized Atractylodes Lancea Rhizome according to Method 3, and perform the test. Prepare the control solution with 3.0 mL of Standard Lead Solution (not more than 10 ppm).
(2) Arsenic. Prepare the test solution with 0.40 g of pulverized Atractylodes Lancea Rhizome according to Method 4, and perform the test (not more than 5 ppm).
(3) Atractylodes rhizome. Macerate 0.5 g of pulverized Atractylodes Lancea Rhizome with 5 mL of ethanol (95) by warming in a water bath for 2 minutes, and filter. To 2 mL of the filtrate add 0.5 mL of vanillin-hydrochloric acid TS, and shake immediately: no red to red-purple color develops within 1 minute.

Total ash:

Not more than 7.0z.

Acid-insoluble ash: 

Not more than 1.5z.

Essential oil content:

Perform the test with 50.0 g of pulverized Atractylodes Lancea Rhizome: the volume of essential oil is not less than 0.7 mL.

Containers and storage:

Containers.Well-closed containers.
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0 Astragalus Root-Astragali Radix-Astragalus membranaceus

Astragalus Root

Astragali Radix

Astragalus Root is the root of Astragalus membranaceus Bunge or Astragalus mongholicus Bunge (Leguminosae).

Description:

Nearly cylindrical root, 30 - 100 cm in length, 0.7 - 2 cm in diameter, with small bases of lateral root dispersed on the surface, twisted near the crown; externally light grayish yellow to light yellow-brown, and covered with irregular, dispersed longitudinal wrinkles and horizontal lenticel-like patterns; difficult to break; fractured surface fibrous. Under a magnifying glass, a transverse section reveals an outer layer composed of periderm; cortex light yellowish white, xylem light yellow, and zone near the cambium somewhat brown in color; thickness of cortex from about one-third to one-half of the diameter of xylem; white medullary ray from xylem to cortex in thin root, but often appearing as radiating cracks in thick root; usually pith unobservable.
Odor, slight; taste, sweet.

Identification:

Put 1 g of pulverized Astragalus Root in a glass-stoppered centrifuge tube, add 5 mL of potassium hydroxide TS and 5 mL acetonitrile, and stop the vial tightly. After shaking this for 10 minutes, centrifuge, and use the upper layer as the sample solution. Separately, dissolve 1 mg of astragaloside IV for thin-layer chromatography in 2 mL of methanol, and use this solution as the standard solution. Perform the test with these solutions as directed under Thin-layer Chromatography. Spot 10 μL of the sample solution and standard solution on a plate of silica gel for thin-layer chromatography. Develop the plate with a mixture of ethyl acetate, methanol and water (20:5:4) to a distance of about 10 cm, and air-dry the plate. Spray evenly diluted sulfuric acid on the plate, heat at 105oC for 5 minutes, and examine under ultraviolet light (main wavelength: 365 nm): one of the spot among the several spots from the sample solution has the same color tone and Rf value with the brownish yellow fluorescent spot from the standard solution.

Purity:

(1) Root of Hedysarum species and others.Under a microscope, a vertical section of Astragalus Root reveals no crystal fiber containing solitary crystals of calcium oxalate outside the fiber bundle.
(2) Heavy metals. Proceed with 3.0 g of pulverized Astragalus Root according to Method 3, and perform the test. Prepare the control solution with 3.0 mL of Standard Lead Solution (not more than 10 ppm).
(3) Arsenic. Prepare the test solution with 0.40 g of pulverized Astragalus Root according to Method 4, and perform the test (not more than 5 ppm).
(4) Total BHC's and total DDT's. Not more than 0.2 ppm, respectively.

Loss on drying:

Not more than 13.0z (6 hours).

Total ash:

Not more than 5.0z.

Acid-insoluble ash:

Not more than 1.0z.

Containers and storage:

Containers.Well-closed containers.
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0 Asparagus Tuber-Asparagi Tuber-Asparagus cochinchinensis Merrill

Asparagus Tuber

Asparagi Tuber

Asparagus Tuber is the tuber of Asparagus cochinchinensis Merrill (Liliaceae), from which most of the cork layer is removed, usually, after being steamed.

Description:

Asparagus Tuber is a fusiform to cylindrical tuber, 5 - 15 cm in length, 5 - 20 mm in diameter; externally light yellow-brown to light brown, translucent and often with longitudinal wrinkles; flexible, or hard and easily broken in texture; fractured surface, grayish yellow, glossy and horny.
Odor, characteristic; taste, sweet at first, followed by a slightly bitter aftertaste.
Under a microscope, a transverse section of Asparagus Tuber reveals stone cells and bundles of them on outer layer of cortex; mucilaginous cells containing raphides of calcium oxalate in the parenchyma cells of cortex and stele; no starch grains.

Identification:

To 1 g of coarsely cut Asparagus Tuber add 5 mL of a mixture of 1-butanol and water (40:7), shake for 30 minutes, filter, and use the filtrate as the sample solution.
Perform the test with the sample solution as directed under
Thin-layer Chromatography. Spot 10 μL of the sample solution on a plate of silica gel for thin-layer chromatography, develop the plate with a mixture of 1-butanol, water and acetic acid (100) (10:6:3) to a distance of about 10 cm, and air-dry the plate. Spray evenly dilute sulfuric acid on the plate, and heat at 105oC for 2 minutes: the spot of a red-brown at first then changes to brown color appears at an Rf value of about 0.4.

Purity:

(1) Heavy metals. Proceed with 3.0 g of pulverized Asparagus Tuber according to Method 3, and perform the test. Prepare the control solution with 3.0 mL of
Standard Lead Solution (not more than 10 ppm).
(2) Arsenic. Prepare the test solution with 0.40 g of pulverized Asparagus Tuber according to Method 4, and perform the test (not more than 5 ppm).

Loss on drying:

Not more than 18.0z (6 hours).

Total ash:

Not more than 3.0z.

Containers and storage:

Containers.Well-closed containers.
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0 Asiasarum Root-Asiasari Radix-Asiasarum sieboldii-Asiasarum heterotropoides (aristolochic acid)

Asiasarum Root

Asiasari Radix

Asiasarum Root is the root with rhizome of Asiasarum sieboldii F. Maekawa or Asiasarum heterotropoides F. Maekawa var. mandshuricum F. Maekawa (Aristolochiaceae).

Description:

Asiasarum Root is a nearly cylindrical rhizome with numerous thin and long roots, externally light brown to dark brown. The root, about 15 cm in length, about 0.1 cm in diameter, with shallow longitudinal wrinkles on the surface, and brittle. The rhizome, 2 . 4 cm in length, 0.2 . 0.3 cm in diameter, often branched, with longitudinal wrinkles on the surface; internode short; each node has several scars of petiole and peduncle, and several thin and long roots.
Odor, characteristic; taste, acrid, with some sensation of numbness on the tongue.

Purity:

(1) Terrestrial part.When perform the test of foreign matter, any terrestrial parts are not found.
(2) Arsenic. Prepare the test solution with 0.40 g of pulverized Asiasarum Root according to Method 4, and perform the test (not more than 5 ppm).
(3) Foreign matter <5.01>.The amount of foreign matter other than terrestrial part contained in Asiasarum Root is not more than 1.0z.
(4) Aristolochic acid I.To exactly 2.0 g of pulverized Asiasarum Root add exactly 50 mL of diluted methanol (3 in 4), shake for 15 minutes, filter, and use the filtrate as the sample solution. Separately, dissolve exactly 1.0 mg of aristolochic acid I for crude drugs purity test in diluted methanol (3 in 4) to make exactly 100 mL. Pipet 1 mL of this solution, add diluted methanol (3 in 4) to make exactly 25 mL, and use this solution as the standard solution. Perform the test with exactly 20 μL each of the sample solution and standard solution as directed under Liquid Chromatography, according to the following conditions: the sample solution shows no peak at the retention time corresponding to aristolochic acid I from the standard solution. If the sample solution shows such a peak, repeat the test under different conditions to confirm that the peak in question is not aristolochic acid I.
Operating conditions.
Detector: An ultraviolet or visible absorption photometer (wavelength: 400 nm).
Column: A stainless steel column 4.6 mm in inside diameter and 25 cm in length, packed with octadecylsilanized silicagel for liquid chromatography (5 μm in particle diameter).
Column temperature: A constant temperature of about 400C.
Mobile phase: A mixture of a solution prepared by dissolving 7.8 g of sodium dihydrogen phosphate dihydrate and 2 mL of phosphoric acid in water to make 1000 mL and acetonitrile (11:9).
Flow rate: Adjust the flow rate so that the retention time of aristolochic acid I is about 15 minutes.
System suitability.
Test for required detectability: Measure exactly 1 mL of the standard solution, and add diluted methanol (3 in 4) to make exactly 10 mL. Confirm that the ratio, S/N, of the signal (S) and noise (N) of aristolochic acid I obtained from 20 μL of this solution is not less than 3. In this case, S means the peak height on the chromatogram not including noise obtained by drawing an average line of the detector output, and N is 1/2 of the difference between the maximum and minimum output signals of the baseline around the peak in the range of 20 times the width at half-height of the peak.
System repeatability: When the test is repeated 6 times with 20 μL of the standard solution under the above operating conditions, the relative standard deviation of the peak
area of aristolochic acid I is not more than 5.0z.
(5) Total BHC's and total DDT's. Not more than 0.2 ppm, respectively.

Total ash:

Not more than 10.0z.

Acid-insoluble ash:

Not more than 3.0z.

Essential oil content:

Perform the test with 30.0 g of pulverized Asiasarum Root: the volume of essential oil is not less than 0.6 mL.
Containers and storage:
Containers.Well-closed containers.
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