British Pharmacopoeia 2012 Updated

British Pharmacopoeia Volume IV Herbal Drugs, Herbal Drug Preparations and Herbal Medicinal Products

Aniseed
General Notices
Anise (Ph. Eur. monograph 0262) When Powdered Aniseed is prescribed or demanded, material complying with the requirements below, with the exception of Identification test A and the test for Foreign matter, shall be dispensed or supplied. Ph Eur DEFINITION Whole, dry cremocarp of Pimpinella anisum L. Content Minimum 20 mL/kg of essential oil (anhydrous drug). CHARACTERS Reminiscent odour of anethole. The fruit is a cremocarp and generally entire; a small fragment of the thin, rigid, slightly curved pedicel is frequently attached. IDENTIFICATION A. The cremocarp is ovoid or pyriform and slightly compressed laterally, yellowish-green or greenish-grey, 3-5 mm long and up to 3 mm wide, surmounted by a stylopod with 2 short, reflexed stylar points. The mericarps are attached by their tops to the carpophore with a plane commissural surface and a convex dorsal surface, the latter being covered with short, warty trichomes visible using a lens; each mericarp shows 5 primary ridges, running longitudinally, comprising 3 dorsal ridges and 2 lateral ridges, non-prominent, and lighter in colour. B. Microscopic examination (2.8.23). The powder is greenish-yellow or brownish-green. Examine under a microscope using chloral hydrate solution R. The powder shows the following diagnostic characters (Figure 0262.-1): fragments of epicarp in surface view [D] with a striated cuticle, occasional anomocytic stomata (2.8.3) [Da], bases of covering trichomes [Dc] and whole covering trichomes [Db], mostly unicellular, sometimes curved, with a blunt apex and a warty cuticle; isolated fragments of covering trichomes [E]; fragments [H] of numerous narrow, branched vittae [Ha], often accompanied by elongated cells of the commissural surface [Hb]; fragments of testa [B] consisting of a layer of brown, polyhedral, thin-walled cells; fragments of endosperm [G] containing oil droplets [Ga], aleurone grains and small cluster crystals of calcium oxalate [Gb]; oblong sclereids from the mesocarp [C] or the commissural surface of the fruit; bundles of short sclerenchymatous fibres [A] from the carpophore and the pedicel [Ab], accompanied by vessels with spiral or annular thickening [Aa, F].

1 de 3

10/02/2012 12:07 p.m.

British Pharmacopoeia 2012 Updated

C. Thin-layer chromatography (2.2.27). Test solution Shake 0.10 g of the powdered herbal drug (1400) (2.9.12) with 2 mL of methylene chloride R for 15 min. Filter and carefully evaporate the filtrate to dryness on a water-bath at 60 C. Dissolve the residue in 0.5 mL of toluene R. Reference solution Dissolve 3 L of anethole R and 40 L of olive oil R in 1 mL of toluene R. Plate TLC silica gel GF254 plate R. Mobile phase toluene R. Application 2 L and 3 L of the test solution, then 1 L, 2 L and 3 L of the reference solution, at 2 cm intervals. Development Over a path of 10 cm. Drying In air. Detection A Examine in ultraviolet light at 254 nm. Results A The chromatograms show a quenching zone (anethole) in the central part against a light background. Detection B Spray with a freshly prepared 200 g/L solution of phosphomolybdic acid R in ethanol (96 per cent) R, using 10 mL for a 200 mm square plate, and heat at 120 C for 5 min. Results B The spots due to anethole appear blue against a yellow background. In the chromatogram obtained with 2 L of the test solution, the spot due to anethole is intermediate in size between the corresponding spots in the chromatograms obtained with 1 L and 3 L of the reference solution. The chromatograms obtained with the test solution show in the lower third a blue spot (triglycerides) similar in position to the spot in the lower third of the chromatograms obtained with the reference solution (triglycerides of olive oil). TESTS Water (2.2.13) Maximum 70 mL/kg, determined on 20.0 g of the powdered herbal drug.

2 de 3

10/02/2012 12:07 p.m.

British Pharmacopoeia 2012 Updated

Total ash (2.4.16) Maximum 12.0 per cent. Ash insoluble in hydrochloric acid (2.8.1) Maximum 2.5 per cent. ASSAY Carry out the determination of essential oils in herbal drugs (2.8.12). Use 10.0 g of the herbal drug reduced to a coarse powder immediately before the determination, a 250 mL round-bottomed flask, and 100 mL of water R as the distillation liquid. Place 0.50 mL of xylene R in the graduated tube. Distil at a rate of 2.5-3.5 mL/min for 2 h. Ph Eur Crown Copyright 2011

3 de 3

10/02/2012 12:07 p.m.