Harpagophytum Species Root
Harpagophytum Species Root
Proposed For Development Version 0.1
Harpagophytum Species Root
The article consists of the dried tuberous secondary roots of Harpagophytum procumbens (Burch.) DC. ex Meisn. or Harpagophytum zeyheri Decne. (Family Pedaliaceae). It meets the Acceptance criteria under the Assay.
For H. procumbens
Harpagophytum burchellii Decne.
Uncaria procumbens Burch.
For H. zeyheri:
Harpagophytum zeyheri f. sublobatum Engl.
POTENTIAL CONFOUNDING MATERIALS
Old tubers of H. procumbens, Elephantorrhiza spp., and Acanthosicyos naudianus
SELECTED COMMON NAMES
African: Duiwelsklou, xwate, legatapitse, sengaparele, kanako, lekgagamare, ghamaghoe, lenatla (Botswana); Duiwelsklou, rankdoring, duivelsklou, !ao!aro, xamtsi-oro, khuripekhams, khurikham, elyata, ekakata, likakata, gomakhu (Namibia); Kanako, Khams, Khuripe, //x'aatataba, tloutaxaba
English: Devil’s Claw, grapple plant, harpago, wool- and woodspider, Windhoek's root, wood spider
French: Griffe du diable
German: Teufelskrallenwurzel, teufelskralle, trampelklette, südafrikanische teufelskrallenwurzel
Italian: Artiglio del diavolo, arpagofito
CONSTITUENTS OF INTEREST
Iridoid glycosides: Harpagoside, harpagide, p-coumarylharpagide, procumbide, and procumboside
Phenylethanoid glycosides: Acteoside and isoacteoside
● A. Botanical Characteristics
Macroscopic: It consists of thick, fan-shaped or rounded slices, or of roughly crushed discs. The darker outer surface is traversed by tortuous longitudinal wrinkles. The paler cut surface shows a dark cambial zone and xylem bundles distinctly aligned in radial rows. The central cylinder shows fine concentric striations. Observed under a lens, the cut surface presents yellow or brownish-red granules.
Microscopic: Thin cork, slightly suberized-wall cells; a developed phelloderm, thin-wall cells; thin cortex, large thin-wall parenchyma cells, isolated angular sclerenchymal cells, clusters of parenchymal cells filled with reddish-brown content, which stains dark brown in the presence of iron (lll) chloride and bright red with Schiff’s reagent, and isolated calcium oxalate crystals measuring up to 20 mm in size, mostly small needles but also regular cuboid to isodiametrical crystals; fibrovascular bundle organized in a continuous ring consists of secondary structure. Secondary phloem completed by narrow cones is separated by cellulosic pluriseriate rays. A dark cambial zone consists of small rectangular cells aligned in radial files. Secondary xylem includes parenchyma cells, reticulately thickened, or pitted vessels often isolated and/or grouped by two or three and divided into concentric zones, clusters of parenchymal cells filled with reddish-brown content. The pith consists of thin-wall parenchyma cells. No starch granules are detected.
● B. Thin-Layer Chromatography
Standard solution A: 1.0 mg/mL of USP Harpagoside RS (To Come) in methanol
Standard solution B: 1.0 mg/mL of USP Fructose RS in methanol
Standard solution C: Sonicate about 1.0 g of USP Powdered Harpagophytum spp. Root RS (To Come) in 10 mL of methanol at 60° for 10 min. Centrifuge and concentrate the supernatant to about 2 mL under reduced pressure at a temperature not exceeding 40°.
Sample solution: Sonicate about 1.0 g of Harpagophytum spp. Root, finely powdered, in 10 mL of methanol at 60° for 10 min. Centrifuge and concentrate the supernatant to about 2 mL under reduced pressure at a temperature not exceeding 40°.
(See Chromatography <621>, Thin-Layer Chromatography.)
Adsorbent: Chromatographic silica gel mixture with an average particle size of 5 µm (HPTLC plates)
Application volume: 5 µL each of Standard solution A, Standard solution B, and Standard solution C and 2 µL of Sample solution, as 8-mm bands
Relative humidity: Condition the plate to a relative humidity of about 30% using a suitable device.
Developing solvent system: Ethyl acetate, methanol, and water (77:15:8)
Developing distance: 6 cm
Derivatization reagent: Anisaldehyde reagent – 85 mL of ice-cooled methanol mixed with 10 mL glacial acetic acid, 5 mL of sulfuric acid, and 0.5 mL of p-anisaldehyde.
Samples: Standard solution A, Standard solution B, Standard solution C, and Sample solution
Apply the Samples as bands to a suitable HPTLC plate and dry in air. Develop the chromatograms in a saturated chamber, remove the plate from the chamber, and dry. Treat with Derivatization reagent and heat for 3 min at 100°. Examine under visible light.
System suitability: The chromatogram of Standard solution C exhibits the most intense band as a brown band at an RF corresponding to the harpagoside band in the chromatogram of Standard solution A. Other bands shown in the chromatogram of Standard solution C include a brown band at an RF below that of the fructose band in the chromatogram of Standard solution B, and two bands above the RF of the fructose band: an intense brown band and a blue band above.
Acceptance criteria: The chromatogram of the Sample solution exhibits a band corresponding in color and RF to the harpagoside band in the chromatogram of Standard solution A. It exhibits the following bands corresponding to similar bands in the chromatogram of Standard solution C: a brown band at an RF below that of the fructose band in the chromatogram of Standard solution B, and two bands above the RF of the fructose band: an intense brown band and a blue band above.
• Content of Iridiod Glycosides
CALL FOR SUBMISSION OF VALIDATED INFORMATION
Additional information including validation data will be required to complete the development of the Assay. For requirements, please see under "Composition" and related sections of the guidelines document “Monographs in the Herbal Medicines Compendium” at http://hmc.usp.org/about/general-noticesresources.
Interested parties are encouraged to submit their proposals to complete the monograph.
• Elemental Impurities—Procedures <233>
Arsenic: NMT 2 µg/g
Cadmium: NMT 0.3 µg/g
Lead: NMT 5 µg/g
Mercury: NMT 0.2 µg/g
• Articles of Botanical Origin, General Method for Pesticide Residues Analysis <561>: Meets the requirements
• Microbial Enumeration Tests <61>: The total aerobic bacterial count does not exceed 105 cfu/g, the total combined molds and yeasts count does not exceed 103 cfu/g, and the bile-tolerant Gram-negative bacteria does not exceed 103 cfu/g.
• Tests for Specified Microorganisms <62>: Meets the requirements of the tests for the absence of Salmonella species and Escherichia coli
• Articles of Botanical Origin, Test for Aflatoxins <561>: Meets the requirements
• Absence of Starch
Analysis: Examine powdered Harpagophytum spp. Root under a microscope using water as a mounting medium. Add a few drops of iodine and potassium iodide TS 1.
Acceptance criteria: No blue color is observed.
• Articles of Botanical Origin, Foreign Organic Matter <561>: NMT 2%
• Loss on Drying <731>
Analysis: Dry 1.0 g of Harpagophytum spp. Root, finely powdered, at 105° for 2 h.
Acceptance criteria: NMT 12%
• Articles of Botanical Origin, Total Ash <561>
Analysis: 1.0 g of Harpagophytum spp. Root, finely powdered
Acceptance criteria: NMT 10%
• Packaging and Storage: Preserve in well-closed containers, protected from light and moisture, and store at room temperature.
• Labeling: The label states the Latin binomial and the part of the plant contained in the article.
• USP Reference Standards <11>
USP Harpagoside RS (To Come)
USP Powdered Harpagophytum spp. Root RS (To Come)
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