Psyllium Husk
»Psyllium Husk is the cleaned,dried seed coat (epidermis)separated by winnowing and thrashing from the seeds of Plantago ovataForskal,known in commerce as Blond Psyllium or Indian Psyllium or Ispaghula,or from Plantago psylliumLinnéor from Plantago indicaLinné(Plantago arenariaWaldstein et Kitaibel)known in commerce as Spanish or French Psyllium (Fam.Plantaginaceae),in whole or in powdered form.
Packaging and storage— Preserve in well-closed containers,secured against insect attack (see Preservationunder Vegetable and Animal Drugsin the General Notices).
Botanic characteristics—
Histology—Husk— The epidermis is composed of large cells having transparent walls filled with mucilage,and the cells swell rapidly in aqueous mounts and appear polygonal to slightly rounded in a surface view,when viewed from above (from below they appear elongated to rectangular).The swelling takes place mainly in the radial direction.The mucilage of the epidermal cells stains red with ruthenium red and lead acetate TS.The very occasional starch granules that are present in some of the epidermal cells,and that may be found embedded in the mucilage,are small and simple or compounded with four or more components.
Powdered Psyllium Seed Husk— It is a pale to medium buff-colored powder,having a slight pinkish tinge and a weak characteristic odor.Occasional single and 2-to 4-compound starch granules,the individual grains being spheroidal plano to angular convex from 2to 10µm in diameter,are found embedded in the mucilage.Entire or broken epidermal cells are filled with mucilage.In surface view,the epidermal cells appear polygonal to slightly rounded.Mucilage stains red with ruthenium red TSand lead acetate TS.Some of the elongated and rectangular cells representing the lower part of epidermis and also radially swollen epidermal cells can be found.
Identification—
A: Mounted in cresol—Cells,viewed microscopically,are composed of polygonal prismatic cells having 4to 6straight or slightly wavy walls.
B: Mounted in alcohol and irrigated with water—Viewed microscopically,the mucilage in the outer part of the epidermal cells swells rapidly and goes into solution.
Microbial limits á61ñ— The total combined molds and yeasts count does not exceed 1000cfu per g,and it meets the requirements of the test for absence of Salmonellaspecies and Escherichia coli.
Total ash á561ñ: not more than 4.0%.
Acid-insoluble ash á561ñ: not more than 1.0%.
Water,Method IIá921ñ: not more than 12.0%.
Light extraneous matter— [note—Perform this test in a well-ventilated hood.]Transfer 15.0g to a 250-mLseparator.Add about 90mLof a liquid mixture of carbon tetrachloride and ethylene dichloride (about 2:1),having a specific gravity of 1.45.Shake for 30seconds,and allow to settle for 30seconds.Repeat the shaking and settling twice more.Drain all the material and liquid except the floating layer.Add 25mLof the liquid mixture,stir carefully,allow to settle,and drain as before.Repeat the washing of the floating layer twice more,but use only 10mLof the liquid mixture each time.Transfer the washed floating layer to a tared beaker,heat on a steam bath until the odor of the liquid no longer persists,dry at 40for 3hours,allow to cool in a desiccator,and weigh:the limit is 15%.
Heavy extraneous matter— [note—Perform this test in a well-ventilated hood.]Transfer 10.0g to a 250-mLseparator.Add about 80mLof carbon tetrachloride,and shake for 1minute.Allow to stand for 5minutes.Drain into a tared 1000-mLbeaker the nonmucilaginous material that sinks to the bottom,taking care not to drain any of the floating material.Heat in a hot air oven,at a temperature not exceeding 90,until the odor of the liquid no longer persists,allow to cool in a desiccator,and weigh:the limit is 1.1%.
Insect infestation— Transfer 25g to a 250-mLbeaker,add sufficient solvent hexane to saturate,add an additional 75to 100mLof solvent hexane,and allow to stand for 10minutes,stirring occasionally with a stirring rod.Wet a sheet of filter paper with alcohol,and filter the mixture with the aid of vacuum.Discard the filtrate.Transfer the residue to the original beaker with the aid of alcohol.Add alcohol to bring the volume to 150mLabove the level of the transferred residue.Boil for 10minutes.Filter through alcohol-wetted paper as above.Prepare a trap flask,consisting of a 2000-mLgraduated,narrow-mouth conical flask into which is inserted a rubber disk supported on a stiff metal rod about 4mm in diameter and longer than the height of the flask,the rod being threaded at the lower end and furnished with nuts and washers to hold the disk in place,and the disk being of the proper shape and size to prevent liquid in the body of the flask from spilling when it is pressed up against the neck from the inside.Transfer the residue to the trap flask,completing the transfer with the aid of hot water.Add sufficient hot water to bring the volume to 1000mL.Add 20mLof hydrochloric acid.Raise the rod,and support it so that the rubber disk is held above the liquid level.Rinse the rubber disk with hot water.Spray the inside of the neck of the flask with an antifoam spray.Boil for 30minutes,and cool to room temperature.Add 40mLof solvent hexane,and agitate for 1minute by tilting the flask and moving the rod vertically with wrist action.Allow to stand for 5minutes.Add water to bring the level of liquid to the neck of the flask,and allow to stand for 20minutes.Simultaneously rotate the disk to free it from settled material,and raise it as far as possible into the neck of the flask.Prepare a sheet of ruled filter paper,with lines approximately 5mm apart for filtration by moistening it with water and placing it on a vacuum funnel.Transfer the material trapped in the neck of the flask to the filter with the aid of water.If necessary,wash the paper with alcohol to remove traces of hexane.Place the paper on a 100-mm petri dish that has been wetted with a solution containing equal volumes of glycerin and alcohol.Add 35mLof solvent hexane to the flask,and gently stir with the trapping rod.Add water to bring the liquid level into the neck of the flask.Allow to stand for 15minutes.Using the same technique as before,transfer the trapped material onto a separate paper.Examine the papers at 30×magnification:in the case of powdered Psyllium Husk,not more than 400insect fragments,including mites and psocids,can be seen;in the case of whole Psyllium Husk,not more than 100insect fragments,including mites and psocids,can be seen.
Swell volume— Transfer 250mLof simulated intestinal fluid TSwithout enzymes to a glass-stoppered,500-mLgraduated cylinder.Gradually,with shaking,add 3.5g of the Psyllium Husk until a uniform,smooth suspension is obtained.Dilute with the same fluid to 500mL.Shake the cylinder for about 1minute every 30minutes for 8hours.Allow the gel to settle for 16hours (total time 24hours).Determine the volume of the gel:it is not less than 40mLper g for powdered Psyllium Husk,and not less than 35mLper g for whole Psyllium Husk.
Auxiliary Information— Staff Liaison:Gabriel I.Giancaspro,Ph.D.,Senior Scientist and Latin American Specialist
Expert Committee:(DSB)Dietary Supplements:Botanicals
USP28–NF23Page 1677
Phone Number:1-301-816-8343