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Pine Bark Extract-USP34


Accessed from 118.69.244.91 by gsk on Fri Oct 28 05:43:02 EDT 2011 USP 34
105 for about 15 minutes. Examine the plate under white light. Disintegration and dissolution of dietary supplem

ents 2040 : meet the requirements for binomial and, following minutes. 2091 : meet Weight variation of dietary supplements the requirements. Assay Weigh and finely powder not fewer than 20 Tablets. Transfer about 75mg of lysine hydrochloride, accurately weighed, to a 125-mL flask, and dissolve in 5mL of mercuric acetate TS with gentle heating. Cool, then add 50mL of glacial acetic acid and 3 drops of crystal violet TS, and titrate with 0.1N perchloric acid VS, determining the endpoint potentiometrically. Perform a blank determination, and make any necessary correction. Each mL of 0.1N perchloric acid is equivalent to 9.133mg of L-lysine hydrochloride (C 6H14N2O2 V-shaped

Dietary Supplements / Maritime1195
Store at 25 , excursion permitted Packaging and storage between 15 and 30 . Preserve in a well-closed container, and protect from moisture and excessive heat. Disintegration only, 20Labeling LabelingThe label states the Latin Labeling the official name, the part of the plant contained in the article. USP Reference standards 11 USP Maritime Pine Extract RS Botanical characteristics Macroscopic Bark pieces are typically 1 to 3cm thick. The inner bark is plane to slightly concave, whitish to light brown, striped longitudinally; shiny and of slightly irregular surface, only a few millimeters thick. Abrupt change to a sequence of hard, convex, nearly parallel layers alternating with smooth, light brown layers. Up to 50 or more layers present, depending on the age of the bark. Outer surface of bark is dark reddish HCl).brown composed of irregular scaly patches, with deep fissures. Outer surface may also be gray, gray-green, or greenyellow due to presence of lichens.

Magnesium Gluconate
has

sees Magnesium

Microscopic (transverse section of bark)Light inner bark
irregular lateral stripes consisting of three to five cell layers of long, slender sieve cells with large pitted horizontal cell walls and large polygonal parenchyma cells containing single, irregular, rounded starch grain, 3 to 15mm wide. Lateral stripes are

Gluconate General Monographs

Magnesium Gluconate Tablets

see

separated from each other by ray parenchyma cells. Ray parenchyma cells are homogeneous in appearance, one to four cell layers thick and four and twenty cell layers high, each cell con-

Magnesium Gluconate Tablets General Monographs

taining single, irregular, rounded starch grain, 3 to 15mm wide. Cylindrical parenchyma cells with thin cell wall arranged in vertical rows with calcium oxalate prisms are also present. Outer part of the inner bark contains plate-shaped cells of undifferentiated periderm and older periderm with multiple layers of phellogen. The phellogen grows three to seven rows of phel- lum to the exterior and two to four rows of small cell phelloderm to the interior. The oldest and outermost part of the bark is composed of lignified sections of phelloderm and phellum

Magnesium Oxide Capsules

see

Magnesium Oxide Capsules General Monographs
reddish-

cells, 15 to 35mm thick, separated by collapsed phellogen. Phelloderm and phellum cells are up to 100mm wide, square, rectangular, polygonal, or irregularly shaped. The cell walls are colorless. Phelloderm cells are moderately pitted with a brown content. Phellum cells have a thicker cell wall, strongly pitted, undulated contour, and a yellowish-brown to brownishred content. Radially in between layers of phelloderm and phel- lum are layers of ray parenchyma cells, five to eight cells thick, rounded to radially stretched, thin walled, strongly pitted with

Magnesium Oxide Tablets

see

Magnesium Oxide Tablets General Monographs

collapsed cells and dead sieve cells. Identification A:Pulverize 1g of the dried Maritime Pine. Add 10mg of the powdered material to 1mL of methanol. Add 6mL of a mixture of butanol and hydrochloric acid (95:5 v/v). Heat for 2 minutes in a water bath: the solution turns red.

Manganese Gluconate

see Manganese

B. Chromatographic Identification Test

Thin-Layer
201

mixture.

Adsorbent: 0.25-mm layer of chromatographic silica gel

Gluconate General Monographs

Evaporate the ethyl acetate layer to dryness under a stream of nitrogen, with gentle heating. Dissolve the residue so obtained

Test solution Add 2g of the powdered dried material to 20mL of water. Place in a water bath for 20 minutes, and centrifuge. Extract the supernatant with 40mL of ethyl acetate.
in 0.25mL of alcohol.

Pine Maritime Pine
?Maritime Pine consists of the bark of stems of
Iden-

.

Standard solution Prepare a solution of USP Maritime Pine Extract RS in alcohol, having a concentration of about 25mg
per mL. [
NOTE

Pinus pinaster

Aiton ( Pinus maritima Pinaceae. It contains not less than 8.0 percent and not more than 12.0 percent of procyanidins, calculated on the dried basis. preparation of extracts only and is not for direct human consumption.
NOTE formic

Poir.) Fam. tification test C.]
Application volume: 5 ?L. Developing solvent system:a mixture of ethyl acetate,
acid, and water (100:10:6).

Spray reagent: a mixture of alcohol and phosphoric acid
(1:1), containing 1% of vanillin.

Procedure Proceed as directed in the chapter, except to dry the plate with the aid of a current of air, spray the plate with and heat at 115 for 15 the Spray reagent, minutes. Three red

Official from August 1, 2011 Copyright (c) 2011 The United States Pharmacopeial Convention. All rights reserved.

Accessed from 118.69.244.91 by gsk on Fri Oct 28 05:43:02 EDT 2011 1196Maritime

/ Dietary Supplements

USP 34
10-mL volumetric flasks, dilute with Reagent to volcorresponding to two dimeric procyanidinsume, and mix. Determine

the absorbance of the solutions oband catechin. The chromatogram of the Standard solution also tained from the Standard solution and the Test solution at exhibits a blue band between the upper band due to upper 551nm, using the methanol-containing solution as the blank. dimeric procyanidins and the band due to catechin. The chroCalculate the percentage of total procyanidins in the portion of matogram of the Test solution contains bands that correspond Maritime Pine taken by the formula: to those found in the chromatogram of the Standard solution.

solution A Standard solution

bands appear in the middle third of the chromatogram of the

200(AU/AS)(CS/W) C. Thin-Layer Chromatographic Identification Test 201 Adsorbent: 0.25-mm layer of chromatographic silica gel in which AU and AS are the absorbances of the solutions from mixture. the Test solution and the Standard solution, respectively; CS is the Test solution Use the Test solution prepared as directed for concentration, in ?g per mL, Standard solution; and W is of the Identification test B. the weight, in mg, of Maritime Pine powder used to prepare Standard solution 1 Use the Standard solution prepared asthe Test solution, corrected for the water content. directed for Identification test B. Standard solution 2 Prepare a solution of ferulic acid and protocatechuic acid containing 1mg of each per mL.

Application volume: 10 ?L. Developing solvent system:
methanol, glacial acetic acid, and water (80:15:2:2).

.. ..

Spray reagent Prepare a 5% ferric chloride solution in
methanol.

Procedure Proceed as directed in the chapter, except to dry the plate at 110 and to examine the plate under short-wavelength and long-wavelength UV light. The chromatograms of Standard solution 1 and Standard solution 2 permitted between 15 and 30 . Protect middle third and upper third that correspond to protocatechuic acid and ferulic acid, respectively. Spray the plate with the Spray reagent, and heat at 115 plant from which the article to ferulic acid and protocatechuic acid turn grayish green. Grayish-green bands become visible in the chromatogram of dard solution 1 above and below protocatechuic acid, indicating the presence of caffeic acid and catechin, respectively. The chromatogram of the Test solution echin, protocatechuic acid, caffeic acid, and ferulic acid that correspond in color and RF values to those in the chromatogram of Standard solution 1 and Standard solution 2 561 : not more than 35.0%. Water content 561 : not more than 5%. Foreign organic matter Total ash 561 : not more than 1.5%. Content of procyanidins Reagent solution A Prepare a mixture of butanol and hydrochloric acid (95:5). [ NOTE use.] Reagent solution B Dissolve 2g of ferric ammonium sulfate in a mixture of 100mL of water and 17.5mL of hydrochloric acid. [ NOTE ration.] Standard solution Prepare a solution of USP Maritime Pine Extract RS in methanol having a concentration of about 95 of procyanidins per mL.

?Maritime Pine Extract is prepared from the pulverized Maritime Pine using suitable solvents. It contains between 65 and 75 percent of procyanidins, calculated on the dried basis.
Packaging and storage exhibit bands in the

a mixture of methylene chloride,Maritime

Pine Extract

Preserve in tight containers, and store at 25, excursion

from light. Labeling The label states the official name of the article, the for 15 minutes. The bands dueLatin binomial, and the part of the was prepared, in addition to the information required for LabelStaning under Botanical Extracts 565. USP Reference standards 11 exhibits bands due to cat-USP Maritime Pine Extract RS Identification .A:Dissolve 50mg of Extract in 6mL of a mixture of butanol and hydrochloric acid (95:5). Heat in a water bath for 2 minutes: the solution turns dark red. B: Thin-Layer Chromatographic Identification Test 201 Adsorbent: 0.25-mm layer of chromatographic silica gel mixture. Test solution Dissolve a quantity of Extract in methanol to obtain a solution having a concentration of about 25mg per mL. Standard solution 1 Prepare a solution of USP Maritime Pine Extract RS in methanol having a concentration of about 25mg per mL. Standard solution 2 Prepare a solution of ferulic acid and ?gprotocatechuic acid in methanol having a concentration of about 1mg per mL of each.

Test solution Dry crushed Maritime Pine at 110 for 3 Application volume:5 ?L. Developing solvent system:a mixture of methylene chloride, hours. Place about 1.9g of the crushed material, accurately weighed, in a 20-mL vial, and add 10mL of methanol. Crimp methanol, glacial acetic acid, and water (80:15:2:2). the vial, and sonicate for 2 minutes. Heat in boiling water for Spray reagent Prepare a 5% ferric chloride solution in 10 minutes. Cool to room temperature, allow the sediment to methanol. settle, and transfer the supernatant to a 100-mL volumetric Procedure Proceed as directed in the chapter, except to dry flask, passing it through a filter having a 0.45?m porosity. the plate at 110 and to examine the plate under short-waveWash the sediment two times with 10mL of methanol, and length and long-wavelength UV light. The chromatograms of transfer the solution into the same 100-mL volumetric flask, Standard solution 1 and Standard solution 2 exhibit bands in the again passing it through a filter having a 0.45?m porosity. Di-middle third and upper third that correspond to protocatechuic lute with methanol to volume, and mix. Transfer 1.0mL of that acid and ferulic acid, respectively. Spray the plate with the Spray reagent, and heat at 115 for 15 minutes. The solution into a 20-mL volumetric flask, dilute with methanol to bands due volume, and mix. to ferulic acid and protocatechuic acid turn grayish green. GrayProcedure Transfer 1.0mL of the Standard solution, 1.0mL Stanish-green bands become visible in the chromatogram of of the Test solution, and 1.0mL of methanol to three separate dard solution 1 above and below protocatechuic acid, indicating 10-mL vials. To each vial add 6.0mL of Reagent solution A andthe presence of caffeic acid and catechin, respectively. The 0.25mL of Reagent solution B. Seal the vials with crimp caps. chromatogram of the Test solution exhibits bands due to catMix, and heat in a water bath for 40 minutes. Quickly cool to echin, protocatechuic acid, caffeic acid, and ferulic acid that room temperature in an ice bath. Quantitatively transfer these correspond in color and RF values to those in the chromatogram solutions, with the aid of Reagent solution A, to three separate of Standard solution 1 and Standard solution 2 .

Official from August 1, 2011 Copyright (c) 2011 The United States Pharmacopeial Convention. All rights reserved.


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