ตำรายาของประเทศไทย
Thai Pharmacopoeia
สำนักยาและวัตถุเสพติด กรมวิทยาศาสตร์การแพทย์ กระทรวงสาธารณสุข
Bureau of Drug and Narcotic, Department of Medical Sciences, Ministry of Public HealthThai name เทียนสัตตบุษย์ (THIAN SATTABUT)
Category Carminative.
Anise is the dried whole cremocarp of Pimpinella anisum L. (Anisum vulgare Gaertn.) (Family Apiaceae). It contains not less than 2 per cent v/w of volatile oil, calculated on the anhydrous basis.
Origin of plant Anise is native to Egypt and eastern Mediterranean region, western Asia and Europe.
Constituents Anise contains volatile oil, of which trans-anethole is its major component with g-himachalene and estragole. It also contains coumarins, flavonoids, fixed oils, etc.
Description Odour, reminiscent of that of anethole; taste, sweet and aromatic.
Macroscopical Cremocarp ovoid or pyriform, 3 to 6 mm long, 1 to 3 mm wide, slightly compressed on the lateral sides, yellowish green or greenish grey. Mericarps frequently separated; each in crescent-shaped and slightly pubescent; dorsal side convex with 5 primary longitudinal ridges which are non-prominent and lighter in colour, and a short conical stylopodium with 2 short, reflexed stylar points; commissural side almost flat with persisting carpophore and pedicel.
Microscopical Transverse section of the mericarp through the cotyledon shows epicarp, mesocarp, endocarp, spermoderm and endosperm, and cotyledon. Epicarp comprises epidermal cells with numerous papillae and frequently unicellular trichomes, and covered with striated cuticle. Mesocarp consists of elongated parenchyma cells, small lignified vascular bundle under the ridge, and elliptic and brown vittae surrounded by small epithelial secretory cells; small vittae forming a line along the dorsal side and 2 large vittae surrounded by elongated cells in the commissural side. Endocarp characterized by elongated thin-wall cells. Spermoderm attached to the cremocarp and consisting of elongated cells with some collapsed cells. Endosperm composed of thick-walled polygonal cells containing oil globules and aleurone grains with small cluster crystals of calcium oxalate. Cotyledon with thin-walled cells containing oil globules and aleurone grains.
Packaging and storage Anise shall be kept in tightly closed containers, protected from light and stored at a temperature not exceeding 25°.
Identification Carry out the test as described in the “Thin-Layer Chromatography” (Appendix 3.1).
Standard solution Dissolve 3 µL of anethole and 40 µL of olive oil in 1 mL of toluene.
Test solution Shake 100 mg of the powdered drug with 2 mL of dichloromethane for 15 minutes. Filter and carefully evaporate the filtrate to dryness on a water-bath at 60°. Dissolve the residue in 0.5 mL of toluene. Adsorbent Silica gel GF254
Mobile phase Toluene
Application Apply separately to the plate, 1 µL, 2 µL and 3 µL of Standard solution and 2 µL and 3 µL of Test solution, as spots.
Development and drying Allow the solvent front to ascend 10 cm above the line of application. Dry the developed plate in air.
Detection Examine the plate under ultraviolet light (254 nm). Spray the plate with a freshly prepared 20 per cent w/v solution of phosphomolybdic acid in ethanol, heat at 120° for 5 minutes and observe the result. Examine the plate under visible light.
Results When examined under ultraviolet light (254 nm), the test solution shows a quenching spot due to anethole at about the middle of the chromatogram, corresponding in Rf to the spot shown by the standard solution.
When examined under visible light, the test solution shows a blue spot due to anethole against a yellow background; the spot is intermediate in size between the corresponding spots obtained with 1 µL and 3 µL of the standard solution; a blue spot due to triglycerides of olive oil is also obtained at about the lower third of each of the chromatograms obtained with the test solution and the standard solution.
Water Not more than 9.0 per cent v/w (Azeotropic Distillation Method, Appendix 4.12); use 20.0 g, in coarse powder, freshly prepared and accurately weighed.
Foreign matter Not more than 2 per cent w/w (Appendix 7.2).
Acid-insoluble ash Not more than 2.5 per cent w/w (Appendix 7.6).
Total ash Not more than 12.0 per cent w/w (Appendix 7.7).
Assay Carry out the “Determination of Volatile Oil” (Appendix 7.3). Use 10 g, in coarse powder, freshly prepared and accurately weighed. Use 100 mL of water as the distillation liquid and a 250-mL round-bottomed flask. Distil at a rate of 2.5 to 3.5 mL per minute for 2 hours. Use 0.5 mL of xylene in the graduated tube. Calculate the content of volatile oil, in mL, in the portion of the Anise taken.
ANISE, POWDERED
Powdered Aniseed
Thai name เทียนสัตตบุษย์ผง (THIAN SATTABUT PHONG)
Complies with the requirements for content of anise oil, Packaging and storage, Identification, Water, Acid-insoluble ash, Total ash and Foreign matter stated under Anise and with the following requirement.
Description Greenish yellow or brownish green; odour, reminiscent of anethole; taste, sweet and aromatic. Diagnostic structures show whole or broken trichomes, mostly unicellular, sometimes curved with blunt apex and papillae; fragments of epidermis with striated cuticle, occasional anomocytic stomata, fragments of numerous narrow vittae, fragments of endosperm containing aleurone grains and small cluster crystals of calcium oxalate; oblong sclereids from the commissural zone and bundles of short sclerenchymatous fibres from the carpophore and pedicel.
ANISE WATER, CONCENTRATED
Category Carminative; pharmaceutic aid (flavouring agent).
Anise Oil 20 mL
Ethanol (90 Per Cent) 700 mL
Purified Water sufficient to produce 1000 mL
Dissolve the Anise Oil in the Ethanol (90 Per Cent) and add gradually, with vigorous shaking after each addition, sufficient Purified Water to produce 1000 mL. Add 50 g of previously sterilized Purified Talc, or other suitable filtering aid, allow to stand for a few hours, shaking occasionally, and filter.
Dose 0.3 to 1 mL.
Weight per millilitre 0.898 to 0.908 g (Appendix 4.9).
Ethanol content 60 to 64 per cent v/v (Method II, Appendix 6.5).
Other requirements Complies with the requirements described under “Aromatic Waters” (Appendix 1.16).