Ash Not more than 7.0%.
Acid-insoluble Ash Not more than 0.5%.
Essential Oil Content Not less than 1.6 mL (10.0 g). Packaging and Storage Preserve in tight containers.
Cnidium Rhizome
Cnidii Rhizoma
Cnidium Rhizome is the rhizome or the rhizome passed
through hot water of Cnidium officinale Makino or Li- gusticum chuanxiong Hort. (Umbelliferae).
Description Cnidium Rhizome is irregular massive, knotted rhizome, occasionally cut lengthwise, 5 cm to 10 cm in length and 3 cm to 5 cm in diameter. External surface is grayish brown to dark brown, with gathered nodes and with knobbed protrusions on the node. Mar- gin of the vertical section irregularly branched. Interior is grayish white to grayish brown, semi-translucent and occasionally with hollows. Texture is dense and hard. Under a microscope, a transverse section reveals cortex and pith with scattered oil canals. In the xylem, thick- walled and lignified xylem fibers appear in groups of various sizes. Starch grains are usually gelatinized, but rarely remaining as grains of 5 μm to 25 μm in
diame- ter. Crystals of calcium oxalate are not obsered. Cnidium Rhizome has characteristic odor and slightly bitter taste.
Ash Not more than 6.0%.
Acid-insoluble Ash Not more than 1.0%.
Codonopsis Pilosula Root
Codonopsis Pilosulae Radix
Codonopsis Pilosula Root is the root of Codonopsis pi- losula Nannfeldt, Codonopsis pilosula Nannfeldt var. modesta L. T. Shen or Codonopsis tangshen Oliver (Campanulaceae).
Description (1) Root of Codonopsis pilosula - Co- donopsis Pilosula Root from Codonopsis pilosula con- sists of the root, long cylindrical, slightly curved, 10 cm to 35 cm in length and 4 mm to 20 mm in diameter. External surface is yellowish brown to grayish brown, with numerous warty prominent stem scars and buds on the root stock, and the apex of each stem scar is sun- kenly dotted. Dense transverse annulations are occur- ring below the root stock, gradually sparse downwards. Some is up to half length of the root while the trans- verse annulations are rare or absent in some cultivars.
KP VIII 1023 Whole root is showing longitudinal wrinkles and scat- tered transverse lenticel-like protrudings, frequently with blackish brown gelatinous substances at the frac- tured area of the rootlet. Texture is slightly hard or te- nacious. Fractured surface is somewhat evenly, rela- tively cleft or radial, the bark is pale yellowish white or pale brown and the wood is pale yellow.
Codonopsis Pilosula Root has the characteristic odor and slightly sweet taste.
(2) Root of Codonopsis pilosula var. modesta - Codo- nopsis Pilosula Root from Codonopsis pilosula var. modesta consists of the root, 10 cm to 35 cm in length and 5 mm to 25 mm in diameter. External surface is yellowish white to grayish white. Dense transverse an- nulations are occurring below the root stock, frequently up to over half length of the root. Fractured surface is more cleft and the bark is grayish yellow or pale brown. (3) Root of Codonopsis tangshen - Codonopsis Pilosu- la Root from Codonopsis tangshen consists of the root, 10 cm to 45 cm in length and 5 mm to 20 mm in di- ameter. External surface is grayish yellowe to yellowish brown, with distinctly longitudinal wrinkles. Texture is slightly soft and campact, the fractured surface is less cleft, and the bark is yellowish white.
Identification Weigh 1 g of pulverized Codonopsis Pilosula Root, add 10 mL of water, boil and cool. Pour this solution to test tube and shake vigorously: the fine persistent foam is rising.
Loss on Drying Not more than 13.0% . Ash Not more than 6.0%.
Acid-insoluble Ash Not more than 2.0%
Essential Oil Content Not less than 0.2 mL (50 g). Extract Content Dilute ethanol-soluble extract— Not less than 35.0%.
Coix Seed
Coicis Semen
Coix Seed is the ripe seed of Coix lachryma-jobi Linné var. ma-yuen Stapf (Gramineae), from which the seed coat has been removed.
Description Coix Seed is ovoid or broad ovoid seed, about 6 mm in length and about 5 mm in width with a slightly hollowed apex and base. Dorsal side is dis- tended and ventral side is longitudinally and deeply fur- rowed in the center. Dorsal side is mostly white and powdery. In the furrow on the ventral surface, brown and membranous pericarp and seed coat are attached. Under a magnifying glass, a transverse section reveals white endosperm in the dorsal side and pale yellow scu- tellum in the hollow of the ventral side. Under a micro-
1024 Monographs, Part II scope, a transverse section reveals irregular, cylindrical cells in the middle layer of pericarp, polygonal cells in endosperm, and thin and numerous starch grains in the cell wall.
Coix Seed has slightly characteristic odor and slightly sweet taste. Coix Seed adheres to the teeth on chewing.
Identification (1) Add iodine TS drop-wise to a transverse section of Coix Seed: a dark red-brown color develops in the endosperm and a dark gray color devel- ops in the scutellum.
(2) Place a small amount of Coix Seed on a slide glass, add drop-wise iodine TS and examine under a microscope: nearly equi-diameter and obtuse polygonal simple starch grains, usually 10 μm to 15 μm in diame- ter and compound starch grains have a reddish brown color, and small spheroidal starch grains, coexisting with fixed oil and with aleuron grains in parenchyma
cells, have a blue purple color.
(3) Weigh 1 g of pulverized Coix Seed, add 10 mL of methanol, heat on a water bath for 10 minutes, and filter. Evaporate the filtrate to make 2 mL, and use this solution as the test solution. Perform the test with the test solution as directed under the Thin-layer Chroma- tography. Spot 5 μL of the test solution on the plate of silica gel for thin-layer chromatography. Develop the plate with a mixture of petroleum ether, ethylacetate, and acetic acid (10 : 3 : 0.1) to a distance of about 10 cm and air-dry the plate. Spray the iodide steam to the plate; the yellowish spot shows the Rf value about 0.63
Loss on Drying Not more than 14.0% (6 hours). Ash Not more than 3.0%.
Packaging and Storage Preserve in tight containers.
Condurango
Condurango Cortex
Condurango is the bark of the trunk of Marsdenia con- durango Reichenbach fil. (Asclepiadaceae).
Description Condurango is tubular or semi-tubular pieces of bark, 4 cm to 15 cm in length and 1 mm to 6 mm in thickness. External surface is grayish brown to dark brown, nearly smooth and with numerous lenticels, or more or less scaly and rough. Inner surface is pale grayish brown and longitudinally striated. Fractured surface is fibrous on the outer region and generally gra- nular in the inner region.
Under a microscope, a transverse section reveals a cork layer composed of several layers of thin-walled cells. Primary cortex has numerous stone cell groups and sec- ondary cortex contains phloem fiber bundles scattered inside the starch sheath consisting of one-cellular layer.
Articulate latex tubes are scattered in both cortices. Pa- renchyma cells contain starch grains, 3 μm to 20 μm in diameter, or rosette aggregates of calcium oxalate. Condurango has slight odor and bitter taste.
Identification Weigh l g of pulverized Condurango, add 5 mL of water, cool and filter: the clear filtrate be- comes turbid on heating, but becomes clear again upon cooling.
Purity Foreign matter—The xylem and other foreign matter do not exceed 2.0%. Ash Not more than 12.0%.
Condurango Fluid Extract
Method of preparation Take medium powder of Condurango and the fluid extract as directed under Flu- id Extracts using a suitable quantity of a mixture of pu- rified water, ethanol and glycerin (5 : 3 : 2) as the first solvent and a suitable quantity of a mixture of purified water and ethanol (3 : 1) as the second solvent. Description Condurango Fluide extract is brown liq- uid. Condurango Fluidextract has characteristic odor and bitter taste.
Identification Mix 1 mL of Condurango Fluidextract with 5 mL of water, filter, if necessary, and heat the clear solution: turbidity is produced, but it becomes al- most clear upon cooling.
Packaging and Storage Preserve in tight containers.
Coptis Rhizome
Coptidis Rhizoma
Coptis Rhizome is the rhizome of Coptis japonica Ma- kino, Coptis chinensis Franchet, Coptis deltoidea C. Y. Cheng et Hsiao or Coptis teeta Wallich (Ranuncula- ceae), from which the roots have been removed practi- cally.
Coptis Rhizome contains not less than 4.2% of berbe- rine [as berberine chloride (C20H18CINO4: 371.81)], calculated on the dried basis.
Description Coptis Rhizome is irregular, cylindrical rhizome, 2 cm to 4 cm, rarely up to 10 cm in length and 2 mm to 7 mm in diameter, slightly curved and often branched. External surface is grayish yellowish brown, with ring nodes and with numerous remains of rootlets. Generally, remains of petiole are present at one end. Fractured surface is rather fibrous. Cork layer is pale grayish brown, cortex is yellowish brown to reddish-
yellowish brown, xylem is yellow to reddish yellow,
and pith is yellowish brown. Under a microscope, a transverse section of Coptis Rhizome reveals a cork layer, composed of thin-walled cork cells. Parenchyma cell of the cortex usually exhibits groups of stone cells near the cork layer and yellow phloem fibers near the cambium. Xylem consists chiefly of vessels, tracheae and wood fibers, and meullary ray is distinct. Pith is large. In pith, stone cells or stone cells with thick and lignified cells are sometimes recognized. Parenchyma cells contain minute starch grains.
Coptis Rhizome has slight odor and extremely bitter and lasting taste. Coptis Rhizome colors the saliva yel- low on chewing.
Identification (1) Weigh 0.5 g of pulverized Coptis
Rhizome, add 10 mL of water, allow to stand for 10 minutes with occasional shaking and filter. To 2 to 3 drops of the filtrate, add l mL of hydrochloric acid and l to 2 drops of hydrogen peroxide TS and shake: a red- purple color develops.
(2) Weigh 0.5 g of pulverized Coptis Rhizome, add 20 mL of methanol, shake for 2 minutes, filter and use the filtrate as the test solution. Separately, weigh l mg of Berberine Chloride RS, dissolve in l mL of methanol and use this solution as the standard solution. Perform the test with the test solution and the standard solution as directed under the Thin-layer Chromatography. Spot 5 μL each of the test solution and the standard solution on a plate of silica gel with a fluorescent indicator for thin-layer chromatography. Develop the chromatogram with a mixture of n-butanol, water and acetic anhydride (7 : 2 : 1) to a distance of about 10 cm and air-dry the plate. Examine under ultraviolet light (main wave- length: 365 nm): one spot among the spots from the test solution and a yellow to yellow-green fluorescence spot from the standard solution show the same color and the same Rf value.
Loss on Drying Not more than 11.0% (105 o C , 6 hours).
Ash Not more than 4.0%.
Acid-insoluble Ash Not more than 1.0%
Assay Weigh accurately about 0.5 g of pulverized Coptis Rhizome, add 30 mL of a mixture of methanol and dilute hydrochloric acid (100 : 1), heat under a ref- lux condenser on a water-bath for 30 minutes, cool and filter. Repeat the above procedure twice with the resi- due, using 30 mL and 20 mL volumes of a mixture of methanol and dilute hydrochloric acid (100 : 1). To the last residue, add 10 mL of methanol, shake well and fil- ter. Combine all filtrates, add methanol to make exactly 100 mL and use this solution as the test solution. Sepa- rately, weigh accurately about 10 mg of Berberine Chloride RS (previously determine the water content), dissolve in methanol to make exactly 100 mL and use
KP VIII 1025 this solution as the standard solution. Perform the test with 20 μL each of the test solution and the standard solution as directed under the Liquid Chromatography according to the following operating conditions. De- termine the peak areas, AT and AS, of berberine for the test solution and the standard solution, respectively. Amount (mg) of berberine [berberine chloride
(C20H18ClNO4)] = amount (mg) of Berberine Chloride RS, calculated on the anhydrous basis × A TA S
Operating conditions
Detector: An ultraviolet absorption photometer (wavelength: 345 nm).
Column: A stainless steel column, 4 mm to 6 mm in inside diameter and 15 cm to 25 cm in length, packed with octadecylsilyl silica gel (5 μm to 10 μm in particle diameter).
Column temperature: A constant temperature of about 40 o C .
Mobile phase: Dissolve 3.4 g of monobasic potas- sium phosphate and 1.7 g of sodium lauryl sulfate in l000 mL of a mixture of water and acetonitrile (1 : 1).
Flow rate: Adjust the flow rate so that the retention time of berberine is about 10 minutes.
System suitability
System performance: Dissolve 1 mg each of Berberine Chloride RS and Palmatine RS in 10 mL of methanol. When the procedure is run with 20 μL of this solution under the above operating conditions, palma- tine and berberine are eluted in this order and clearly dividing each peak.
System repeatability: When the test is repeated 6 times with the standard solution under the above oper- ating conditions, the relative deviation of the peak area of berberine is not more than 1.5%.
Cornus Fruit
Corni Fructus
Cornus Fruit is the ripe fruit of Cornus officinalis Sie- bold et Zuccarini (Cornaceae), from which the seeds have been removed. Cornus Fruit contains not less than 0.5% of loganin (C17H26O10: 390.38).
Description Cornus Fruit is the fruit, flattened ob- long, 15 mm 20 mm in length, and about 1 cm in width. External surface is dark red-urple to dark purple, lustr- ous and with coarse wrinkles. A crack-ike scar is formed by removal of true fruit. A scar of calyx is present at upper part and a scar of fruit stalk at base. The texture is soft.
Cornus Fruit has slight odor and sour and slightly sweet taste.
1026 Monographs, Part II Identification Weigh 1 g each of pulverized Cornus Fruit or Cornus Fruit RMPM, add 10 mL each of etha- nol, shake for 5 minutes, filter and use these solutions as the test solution or Cornus Fruit RMPM standard so- lution. Seperately, weigh 1 mg of Loganin RS, dissolve in 2 mL of ethanol and use this solution as the standard solution. Perform the test with the test solution, Cornus Fruit RMPM standard solution and the standard solu- tion as directed under the Thin-layer Chromatography. Spot 10 μL each of the test solution, Cornus Fruit RMPM standard solution and the standard solution on a plate of silica gel for thin-layer chromatography. De- velop the plate with a lower layer of a mixture of dich- loromethane, methanol and water (60 : 35 : 15) to a dis- tance of about 10 cm and air-dry the plate. Spray even- ly diluted sulfuric acid TS and heat at 105 o C for 10 minutes: the spots from the test solution and the spots from Cornus Fruit RMPM standard solution show the same color and the same Rf value, and one spot among the spots from the test solution and a spot from the standard solution show the same color and the same Rf value.
Purity Foreign matter—The amount of fruit stalk and other foreign matter contained in Cornus Fruit is less than 2.0%.
Ash Not more than 5.0%.
Assay Weigh accurately about 1 g of pulverized Cor- nus Fruit, add 50 mL of methanol, extract with a reflux condenser on a water-bath for 2 hours and filter. To the filtrate, add methanol to make exactly 100 mL and use this solution as the test solution. Weigh accurately about 10 mg of Loganin RS, dissolve in 100 mL of me- thanol and use this solution as the standard solution. Perform the test with 10 μL each of the test solution and the standard solution as directed under the Liquid Chromatography according to the following operating conditions and determine the peak areas, AT and AS, of loganin for the test solution and the standard solution, respectively.
Amount(mg)of loganin(C17H26O10 )
= amount(mg)of LoganinRS × A
TA S
Operating conditions
Detector: An ultraviolet absorption photometer (wave- length: 240 nm).
Column: A stainless steel column, 4 mm to 6 mm in in- side diameter and 15 cm to 25 cm in length, packed with octadecylsilyl silica ge1 (5 μm to 10 μm in par- ticle diameter).
Column temperature: A room temperature.
Mobile phase: A mixture of methanol and water (30 : 70).
Flow rate: 1.0 mL/minute.
Corydalis Tuber
Corydalis Tuber
Corydalis Tuber is the tuber of Corydalis ternata Nakai or other species of the same genus (Papaveraceae). Description Corydalis Tuber is nearly flattened spherical or polygonal tuber, l cm to 2 cm in diameter, with stem scar at one end and with several warty pro- trusion at the base. External surface is grayish yellow to grayish brown. Texture is hard. Fractured surface is smooth or granular and yellow to grayish yellowish brown.
Corydalis Tuber is almost odorless and has bitter taste. Identification Weigh 0.5 g of pulverized Corydalis Tuber, add 10 mL of dilute acetic acid, heat on a water- bath for 3 minutes with occasional shaking, cool and filter. To 5 mL of the filtrate, add 3 drops of Meyer’s TS: an orange-yellow precipitate is produced. Ash Not more than 3.0%.
Croton Seed
Crotonis Semen
Croton Seed is the seed of Croton tiglium Linné (Eu- phorbiaceae), from which the testa has been removed. Description Croton Seed is slightly ovate, triangular seed, 10 mm to 15 mm in length, and 7 mm to 9 mm in width and 5 mm to 6 mm in thickness. The weight of one seed is approximately 0.2 g. External surface of the testa is dark reddish brown to grayish brown with spo- radic black spots. The back surface of the seed is slightly curved, a pointed hilum which is not distinct. A pointed hilum and a caruncle scar are present at one end, a slightly dented chalaza at the other end. A raphe makes a distinct line from hilum to chalaza. Testa is thin and brittle, endosperm is covered with a membran- ous perisperm. Under a magnifying glass, transverse section shows a cavity like a lens and two thin cotyle- dons are contained in the cavity.
Under a microscope, a transverse section reveals epi- dermal cells of seed coat are long quadangular, irregu- lar sawlike and bented beneath primary layer. Endos- perm cells are almost circular, filled with aleurone grains and fatty oil, and with crystals of calcium oxa- late.
Croton Seed is odorless and tastes oily at first and pun- gent later.
Ash Not more than 3.5%.
Extract Content Dilute ethanol–soluble extract—
Not less than 18.0%.
Curcuma Longa Rhizome
Curcumae Longae Rhizoma
Curcuma Longa Rhizome is the rhizome, boiled or steamed thoroughly, and dried, of Curcuma longa Linné (Zingiberaceae). Description Curcuma Longa Rhizome consists of primary rhizome, and often secondary rhizome. The rhizome is irregularly ovoid, cylindrical, or fusiform, 1 cm to 3 cm in diameter and 2 cm to 5 cm in length. Secondary rhizome is cylindrical with two obtuse ends, slightly curved, about 1 cm in diameter and 2 cm to 6 cm in length, with ring-nodes. The rhizome with cork layer is yellowish red and lustrous. The rhizome with- out cork layer is dark yellowish red and powdery. The texture is hard and difficult to break and the fractured surface is horny and lustrous like wax. Under a magni- fying glass, endodermis ring is distinct and parenchyma is star-like scattered. Under a microscope, the outer- most layer usually consists of cortex layer with 4 to 10 layers or a part of cortex. One layer of endodermis di- vides cortex and stele. The cortex and stele consist of parenchyma tissues and vascular bundles scattered. Oil cells are scattered in parenchyma tissue. Yellow sub- stances, sand crystals or solitary crystals of calcium oxalate and gelatinized starch grains are observed in the parenchyma cells.
Curcuma Longa Rhizoma has characteristic odor and bitter and irritating taste and the color of saliva be- comes yellow.
Identification (1) Weigh 0.5 g of pulverized Curcu- ma Longa Rhizoma, add 1 drop each of sulfuric acid and ethanol and mix them on the glass : a purplish red color develops.
(2) Take a small amount of pulverized Curcuma Longa Rhizoma and add 1 drop each of ethanol and ether on the filter paper. Removed with powder when the filter paper is dried : the filter paper becomes yellow. Add sa- turated boric acid solution and boil : reddish orange color develops. Add 1 drop of ammonia TS : the color develops as dark blue-black immediately, gradually changes into brown color and returns to reddish orange color when it keeps long.
(3) Weigh 1 g of pulverized Curcuma Longa Rhizoma, add 3 mL of methanol, sonicate for 1 hour, filter and use filtrate as the test solution. Separately, dissolve 1 mg of Curcumin RS in 10 mL methanol and use this as the standard solution. Perform the test with the test so- lution and the standard solution as directed under the Thin-layer Chromatography. Spot 10 μL each of the test solution and the standard solution on a plate of sili- ca gel for thin-layer chromatography. Develop the plate with a mixture of dichloromethane, methanol and for- mic acid (94 : 4 : 0.7) to a distance of about 10 cm and
KP VIII 1027 air-dry the plate. Spray evenly the plate with diluted
sulfuric acid TS and heat at 105 o C for 10 minutes: one spot among the spots from the test solution and a spot from the standard solution show the same color and the same Rf value. Ash Not more than 7.0%.
Acid-insoluble Ash Not more than 1.0%.
Curcuma Root
Curcumae longae Radix
Curcuma Root is the dried steamed root tuber, or the root tuber from which the periderm has been removed, of Curcuma wenyujin Y. H. Chen et C. Ling., Curcuma longa Linné, Curcuma kwangsiensis S. G. Lee et C. F. Liang, or Curcuma phaeocaulis Val. (Zingiberaceae). Description 1) Curcuma wenyujin—Curcuma Root from Curcuma wenyujin is ellipsoidal and ovoid root tuber, 35 mm to 70 mm in length, 12 mm to 25 mm in diameter, slightly flat, curved, or both ends tapering. External surface is grayish brown, with uneven longi- tudinal and pale brown wrinkles. Texture is hard and a transverse section is grayish brown with horn. Endo- dermis ring is distinct.
Curcuma Root from Curcuma wenyujin has characteris- tic odor and slight bitter taste.
2) Curcuma longa—Curcuma Root from Curcuma longa is pyramidal root tuber, 25 mm to 45 mm in length, 10 mm to 15 mm in diameter, one end thin or long. External surface is grayish brown, or grayish yel- low with longitudinal winkles. A transverse section is orange in center, and yellowish brown to reddish brown in outer surface.
Curcuma Root from Curcuma longa has characteristic odor and very pungent taste.
3) Curcuma kwangsiensis—Curcuma Root from Cur- cuma kwangsiensis is long conical, or long globular root tuber, 20 mm to 65 mm in length, 10 mm to 18 mm in diameter. External surface is shallow longitudin- al, or coarse reticular wrinkled.
Curcuma Root from Curcuma kwangsiensis has charac- teristic odor and slight pungent and bitter taste.
4) Curcuma phaeocaulis—Curcuma Root from Cur- cuma phaeocaulis is long ellipsoidal root tuber, 15 mm to 35 mm in length, 10 mm to 12 mm in diameter, slightly thick and big.
Curcuma Root from Curcuma phaeocaulis has charac- teristic odor and weak taste
Loss on Drying Not more than 16.0%. Ash Not more than 9.0%.