• British Pharmacopoeia Volume III
  • Herbal Drugs, Herbal Drug Preparations and Herbal Medicinal Products

Gentian

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General Notices

(Gentian Root, Ph Eur monograph 0392)

Preparation

Compound Gentian Infusion

When Powdered Gentian is prescribed or demanded, material complying with the requirements below with the exception of Identification test A shall be dispensed or supplied.

Ph Eur

DEFINITION

Dried, fragmented underground organs of Gentiana lutea L.

CHARACTERS

Characteristic odour.

Strong and persistent bitter taste.

Gentian root occurs as single or branched subcylindrical pieces of various lengths and usually 10-40 mm thick but occasionally up to 80 mm thick at the crown.

IDENTIFICATION

A.  The surface is brownish-grey, and the colour of a transverse section is yellowish or reddish-yellow, but not reddish-brown. The root is longitudinally wrinkled and bears occasional rootlet scars. The branches of the rhizome frequently bear a terminal bud and are always encircled by closely arranged leaf scars. The rhizome and root are brittle when dry and break with a short fracture but they absorb moisture readily to become flexible. The smoothed, transversely cut surface shows a bark, occupying about one-third of the radius, separated by the well-marked cambium from an indistinctly radiate and mainly parenchymatous xylem.

B.  Reduce to a powder (355) (2.9.12). The powder is light brown or yellowish-brown. Examine under a microscope using chloral hydrate solution R. The powder shows the following diagnostic characters: fragments of the subero-phellodermic layer, consisting of thin-walled yellowish-brown cork cells and thick-walled collenchyma (phello-derm); fragments of cortical and ligneous parenchymatous cells with moderately thickened walls containing droplets of oil and small prisms and minute needles of calcium oxalate; fragments of lignified vessels with spiral or reticulate thickening.

C.  Thin-layer chromatography (2.2.27).

Test solution  To 1.0 g of the powdered drug (355) (2.9.12) add 25 ml of methanol R, shake for 15 min and filter. Evaporate the filtrate to dryness under reduced pressure, at a temperature not exceeding 50  °C. Take up the residue with small quantities of methanol R so as to obtain 5 ml of a solution, which may contain a sediment.

Reference solution  Dissolve 5 mg of phenazone R and 5 mg of hyperoside R in 10 ml of methanol R.

Plate  TLC silica gel F254 plate R.

Mobile phase  water R, anhydrous formic acid R, ethyl formate R (4:8:88 V/V/V).

Application  20 µl, as bands.

Development  In an unsaturated tank, over a path of 8 cm.

Drying  In air.

Detection A  Examine in ultraviolet light at 254 nm.

Results A  See below the sequence of the zones present in the chromatograms obtained with the reference solution and the test solution. Furthermore, other zones may be present in the chromatogram obtained with the test solution.

bp2010_v3_07_02_herbal_drugs_and_herbal_drug_preparations gentianroot_1_2009_60_tb.png


Detection B  Spray with a 100 g/l solution of potassium hydroxide R in methanol R and then with a freshly prepared 2 g/l solution of fast blue B salt R in a mixture of 50 volumes of anhydrous ethanol R and 50 volumes of water R. Examine in daylight.

Results B  See below the sequence of the zones present in the chromatograms obtained with the reference solution and the test solution. Furthermore, other zones may be present in the chromatogram obtained with the test solution.

bp2010_v3_07_02_herbal_drugs_and_herbal_drug_preparations gentianroot_2_2009_60_tb.png


TESTS
Other species of Gentiana

Examine the chromatograms obtained in identification test C, detection B.

Results  The chromatogram obtained with the test solution does not show violet zones immediately above the zone due to amarogentine.

Maximum 6.0 per cent.

Bitterness value (2.8.15)

Minimum 10 000.

Water-soluble extractive

Minimum 33 per cent.

To 5.0 g of powdered drug (710) (2.9.12) add 200 ml of boiling water R. Allow to stand for 10 min, shaking occasionally. Allow to cool, dilute to 200.0 ml with water R and filter. Evaporate 20.0 ml of the filtrate to dryness on a water-bath. Dry the residue in an oven at 100-105  °C. The residue weighs a minimum of 0.165 g.

Ph Eur

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