Tormentil tincture EUROPEAN PHARMACOPOEIA
7.0Detection :spray with a freshly prepared 5g/L solution of fast blue B salt R .Reddish zones appear.Expo the plate
to ammonia vapour,the zones become more inten turning reddish-brown.Examine in daylight.Results :e below the quence of the zones prent in the chromatograms obtained with the reference solution and the
test solution.Furthermore,other fainter zones are prent
电脑电源选择in the chromatogram obtained with the test solution.Top of the plate Catechin:an inten reddish-brown zone A more inten reddish-brown zone (catechin)A fainter zone An inten zone Fainter zones
Reference solution Test solution TESTS Foreign matter (2.8.2):maximum 3per cent of root and stems as well as rhizomes with black fracture and maximum 2per cent of other foreign matter.Cadmium (2.4.27):maximum 2.0ppm.Loss on drying (2.2.32):maximum
12.0per cent,determined on 1.000g of the powdered drug (355)(2.9.12)by drying in an oven at 105°C
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for 2h.Total ash (2.4.16):maximum 5.0per cent.ASSAY Carry out the determination of tannins in herbal drugs (2.8.14).U 0.500g of the powdered drug (180)(2.9.12).01/2008:1895TORMENTIL TINCTURE Tormentillae tinctura DEFINITION Tincture produced from Tormentil (1478).Content :minimum 1.5per cent m/m of tannins,expresd as
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pyrogallol (C 6H 6O 3;M r 126.1).PRODUCTION The tincture is produced from 1part of comminuted drug and 5parts of ethanol (70per cent V/V )by a suitable procedure.CHARACTERS Red or reddish-brown liquid.IDENTIFICATION Thin-layer chromatography (2.2.27).Test solution .Mix 1.0mL of the tincture to be examined with 1.0mL of alcohol (70per cent V/V)R .Reference solution .Dissolve 1.0mg of catechin R in 1.0mL
of methanol R .Plate :TLC silica gel plate R .Mobile pha :ether R ,glacial acetic acid R ,hexane R ,
ethyl acetate R (20:20:20:40V/V/V/V ).Application :10μL as bands.Development :over a path of 10cm.Drying :in air for 10-15min.Detection
:spray with a freshly prepared 5g/L solution of fast blue B salt R .Reddish zones appear.Expo the plate to
ammonia vapour,the zones become more inten,turning reddish-brown.Examine in daylight.Results :e below the quence of the zones prent
in the chromatograms obtained with the reference solution and the test solution.Top of the plate
______________
Catechin:an inten zone An inten zone (catechin)
______________
A fainter zone
An inten zone
Fainter zones如何将旧手机所有资料导入新手机
Reference solution Test solution
TESTS Ethanol content (2.9.10):64per cent V/V to 69per cent V/V .Methanol
and 2-propanol (2.9.11):maximum 0.05per cent V/V of methanol and maximum 0.05per cent V/V of 2-propanol.ASSAY
Carry out the determination of tannins in herbal drugs (2.8.14).U 2.50g of the tincture to be examined.01/2009:0532TRAGACANTH
Tragacantha
[9000-65-1]
DEFINITION
Air-hardened,gummy exudate,flowing naturally or obtained by
incision from the trunk and branches of Astragalus gummifer Labill.and certain other species of Astra
galus from western
Asia.IDENTIFICATION
A.Tragacanth occurs in thin,flattened,ribbon-like,white or
pale
yellow,translucent strips,about 30mm long and 10
mm
wide and up to 1mm thick,more or less curved,horny,with a short fracture;the surface is marked by fine longitudinal striae and
concentric
transver
ridges.It may also contain pieces similar in shape but somewhat thicker,more opaque
and more difficult to fracture.B.Reduce to a powder
(355)(2.9.12).The powder is white or almost white and forms a mucilaginous gel with about 10
times its mass of water R
.Examine
under a microscope
using a 50per cent V/V solution of glycerol R .The powder
shows in the gummy mass numerous stratified cellular membranes that turn slowly violet when treated with
iodinated
zinc chloride solution R .The gummy mass includes starch grains,isolated or in small groups,usually rounded in shape
and sometimes
deformed,with
diameters
varying between 4μm and 10μm,occasionally up to 20μm,
and a central hilum visible between crosd nicol prisms.C.Examine the chromatograms obtained in the test for acacia.Results
:the chromatogram obtained with the test solution shows 3zones due to galacto,arabino and xylo.A
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faint
yellowish zone at the solvent front and a greyish-green zone between the zones due to galacto and arabino may
be prent.
D.Moisten 0.5g of the powdered drug (355)(2.9.12)with 1mL of ethanol (96per cent)R and add gradually,while shaking,50mL of water R until a homogeneous mucilage is 1256See the information ction on general monographs (cover pages)
EUROPEAN PHARMACOPOEIA 7.0Turmeric,
Javane obtained.To 5mL of the mucilage add 5mL of water R and 2mL of barium hydroxide solution R .A slight flocculent precipitate is formed.Heat on a water-bath for 10min.An inten yellow colour develops.TESTS Acacia .Thin-layer chromatography (2.2.27).Test solution .To 100mg of the powdered drug (355)(2.9.12)in a thick-walled centrifuge test-tube,add 2mL of a 100g/L solution of trifluoroacetic
acid R ,shake vigorously to dissolve the forming gel,stopper the test-tube and heat the mixture at 120°C for 1h.Centrifuge the resulting hydrolysate,transfer the clear supernatant carefully into a 50mL flask,add 10mL of water R and evaporate the solution to dryness under reduced pressure.To the resulting clear film add 0.1mL of water R and 0.9mL of methanol
R .花红易衰
Centrifuge to
parate the amorphous precipitate,collect the supernatant and,if necessary,dilute to 1mL with methanol R .Reference solution .Dissolve 10mg of arabino R ,10mg of galacto R ,10mg of rham
no R and 10mg of xylo R in 1mL of water R and dilute to 10mL with methanol R .Plate :TLC silica gel plate R .Mobile pha :16g/L solution of sodium dihydrogen phosphate R ,butanol R ,acetone R (10:40:50V/V/V ).Application :10μL as bands.Development A :over a path of 10cm.Drying A :in a current of warm air for a few minutes.Development B :over a path of 15cm using the same mobile pha.Drying B :at 110°C for 10min.Detection :spray with anisaldehyde solution R and dry at 110°C for 10min.Results :the chromatogram obtained with the reference
solution shows 4clearly parated coloured zones due to
galacto (greyish-green or green),arabino (yellowish-green),xylo (greenish-grey or yellowish-grey)and rhamno (yellowish-green),in order of increasing R F value;the chromatogram obtained with the test solution does not show a yellowish-green zone corresponding to the zone of rhamno in the chromatogram obtained with the reference solution.Methylcellulo .Examine the chromatograms obtained in the test for acacia.Results :the chromatogram obtained with the test solution does not show a red zone near the solvent front.Sterculia gum A.Place 0.2g of the powdered
drug
(355)(2.9.12
)in a 10mL ground-glass-stoppered cylinder graduated in 0.1mL.Add 10mL of ethanol (60per cent V/V)R and shake.Any gel formed occupies not more than 1.5mL.B.To 1.0g of the powdered drug (355)(2.9.12)add 100mL of water R and
shake.
Add 0.1
mL
of methyl red solution R .Not more than 5.0mL of 0.01M sodium hydroxide is required to change the
colour of the indicator.Foreign matter :maximum 1.0per cent.Place 2.0g of the powdered drug (355)(2.9.12)in a 250mL round-bottomed flask and add 95mL of methanol R .Swirl to moisten the powder and add 60mL of hydrochloric acid R1.Add a few glass beads about 4mm in diameter and heat on a water-bath under a reflux condenr for 3h,shaking occasionally.Remove the glass
beads and filter
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hot suspension in vacuo through a sintered-glass filter (160)(2.1.2).Rin the flask with a small quantity of water R and pass the rinsings through the filter.Wash the residue on the filter with about 40mL of methanol R and dry to constant mass at 110°C (about 1h).Allow to cool in a desiccator and weigh.The residue weighs a maximum of 20mg.Flow time :minimum 10s,or minimum 50s if the substance to be examined is to be ud for the preparation of emulsions.Place 1.0g of the powdered drug (125-250)(2.9.12)in a 1000mL round-bottomed flask with a ground-glass stopper,add 8.0mL of ethanol (96per cent)R and clo the flask.Disper the suspension over the inner surface of the flask by shaking,taking care not to wet the stopper.Open the flask and add as a single portion 72.0mL of water R .Stopper the flask and shake vigorously for 3min.Allow to stand for 24h and shake vigorousl
y again for 3min.Eliminate air bubbles by applying vacuum above the mucilage for 5min.Transfer
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mucilage to a 50mL cylinder.Dip in the mucilage a piece of glass tubing 200mm long and 6.0mm in internal diameter and graduated at 20mm and 120mm from the lower end;
the
tubing must not be rind with surface-active substances.When the mucilage has reached the upper mark,clo the tube with a finger.Withdraw the clod tube,remove the finger and
measure with a stop-watch the time needed for the meniscus to
reach the lower graduation.Carry out this operation 4times and determine
the average value of the last 3determinations.
Total ash (2.4.16):maximum 4.0per cent.
Microbial contamination
TAMC:acceptance criterion 104CFU/g (2.6.12).
TYMC:acceptance criterion 102CFU/g (2.6.12).
Abnce of Escherichia coli (2.6.13).
Abnce of Salmonella (2.6.13).
LABELLING
The label states whether or not the contents are
suitable for preparing emulsions.01/2008:1441TURMERIC,JAVANESE
Curcumae xanthorrhizae rhizoma DEFINITION
Dried rhizome,cut in slices,of Curcuma xanthorrhiza Roxb.
(C.xanthorrhiza D.Dietrich).
Content :
—
esntial oil :minimum 50mL/kg (anhydrous drug);
—dicinnamoyl methane derivatives,expresd as curcumin (C 21H 20O 6;
M r 368.4):minimum 1.0per cent (anhydrous drug).CHARACTERS
Aromatic odour.
IDENTIFICATION
A.Orange-yellow or yellowish-brown or greyish-brown slices,
mostly peeled 1.5-6mm thick and 15-50mm,more rarely up
to
70mm,in diameter.Fragments of the brownish-grey cork are sporadically prent.The transver surface is yellow with dark spots in the paler centre.The fracture is short and finely grained.
B.Reduce to a powder (355)(2.9.12).The powder is reddish-brown.Examine under a microscope,using chloral hydrate
solution R .The powder shows the following diagnostic characters:fragments of colourless parenchyma
with orange-yellow or yellowish-brown cretory cells;fragments of reticulate and other vesls;rare fragments of
cork
and epidermis and fragments of thick-walled unicellular acute trichomes.Examine under a microscope using a 50per
cent V/V solution of glycerol R .The powder shows numerous stratified,ovoid or irregular starch granules,about 30-50μm
long and about 10-30μm wide,with an eccentric hilum and marked,concentric striations.
C.Thin-layer chromatography (2.2.27)as described in the test for Curcuma domestica with the following modifications.
General Notices (1)apply to all monographs and other texts 1257
