ตำรายาของประเทศไทย
Thai Pharmacopoeia
สำนักยาและวัตถุเสพติด กรมวิทยาศาสตร์การแพทย์ กระทรวงสาธารณสุข
Bureau of Drug and Narcotic, Department of Medical Sciences, Ministry of Public HealthCategory Emetic; expectorant.
Ipecacuanha is the fragmented and dried underground organs of Carapichea ipecacuanha (Brot.) L. Anderson [Cephaelis ipecacuanha (Brot.) A. Rich., C. acuminata H. Karst]. (Family Rubiaceae), from Mato Grosso or Costa Rica. It contains not less than 2.0 per cent of total alkaloids, calculated as emetine (C29H40N2O4), and on the dried basis.
Origin of plant Ipecacuanha is native to Central America, such as Costa Rica and Nicaragua, and South America, particularly Brazil.
Constituents Ipecacuanha contains major isoquinoline alkaloids as emetine and cephaeline.
Description Odour, mild, characteristic and sternutatory; taste, bitter and unpleasant.
Macroscopical
Mato Grosso Ipecacuanha A mixture of whole or fragments of rhizomes and roots. Root somewhat tortuous, usually up to 15 cm long, 3 to 6.5(-9) mm in diameter and 6 mm thick; externally closely annulated, with rounded ridges completely encircling the root. Fragment of root, short in the bark and splintery in the wood; internally with a wide greyish bark and a small uniformly dense wood. Rhizome usually attached to root, short, cylindrical, up to 2 mm in diameter, with fine longitudinal wrinkles and pith occupying approximately one-sixth of the entire diameter.
Costa Rica Ipecacuanha Root generally resembles that of Mato Grosso Ipecacuanha, but often up to 9 mm thick; externally greyish or reddish brown with transverse ridges at intervals of usually 1 to 3 mm extending about half-way round the circumference and fading at the extremities into the general surface level.
Microscopical Powdered drug of Ipecacuanha shows parenchyma, raphide crystals of calcium oxalate, fragments of tracheids and vessels, larger vessels and sclereids from rhizome, cork, fragments of dermal tissue, fibres. Parenchyma, ovate cells, some containing starch granules. Starch granules, simple or 2- to 10- compound; the simple granules being up to 15 µm in diameter in Costa Rica ipecacuanha and up to 22 µm in diameter in Mato Grosso ipecacuanha. Raphide crystals of calcium oxalate, scattered or in bundles. Fragments of tracheids and vessels: bordered-pitted vessels accompanied by ligneous elongated parenchyma. Vessels and sclereids from rhizomes usually larger than those of the roots. Fragments of dermal tissue: reddish brown cork and phelloderm, some containing raphide crystals of calcium oxalate.
Other relevant information
1. It is contra-indicated in pregnant women.
2. It shall not be used to induce emesis following ingestion of corrosive substances (e.g., strong acid or alkali), central nervous system stimulants, strychnine, and petroleum distillate; and when airway-protective reflexes are compromised.
Packaging and storage Ipecacuanha shall be kept in well-closed container, protected from light, and stored in a dry place.
Identification Carry out the test as described in the “Thin-Layer Chromatography” (Appendix 3.1).
Standard solution Dissolve 2.5 mg of Emetine hydrochloride RS and 3 mg of Cephaeline hydrochloride RS in methanol and dilute to 20 mL with the same solvent.
Test solution To 100 mg, in No. 180 powder, in a test-tube add 50 µL of strong ammonia solution and 5 mL of ether and stir the mixture vigorously with a glass rod. Allow to stand for 30 minutes. Filter and use the filtrate.
Adsorbent Silica gel F254 (TLC or HPTLC plate).
Mobile phase Strong ammonia solution, methanol, ethyl acetate, and toluene (2:15:18:65).
Application Apply 10 µL (or 5 µL) each of Standard solution and Test solution as 10-mm (or 8-mm) bands.
Development and drying Allow the solvent front to ascend 10 cm (or 6 cm) above the line of application. Dry the developed plate in air.
Detection A Examine the plate under ultraviolet light (366 nm).
Results A When examined under ultraviolet light (366 nm), the test solution of Costa Rica Ipecacuanha shows a blue fluorescent band due to cephaeline and a blue fluorescent band due to emetine in the middle of the chromatogram, corresponding in colour and Rf to the bands shown by the standard solution. The test solution of Mato Grosso Ipecacuanha shows a faint blue fluorescent band due to cephaeline and a blue fluorescent band due to emetine in the middle of the chromatogram, corresponding in colour and Rf to the bands shown by the standard solution.
Detection B Spray the plate with a 0.5 per cent w/v solution of iodine in ethanol, heat at 60° for 10 minutes and examine under ultraviolet light (366 nm). Observe the result.
Results B When examined under ultraviolet light (366 nm), the test solution of Costa Rica Ipecacuanha or of Mato Grosso Ipecacuanha shows a blue fluorescent band due to cephaeline and a yellow fluorescent band due to emetine, clearly separated around the middle of the chromatogram. Both bands correspond in colour and Rf to the bands shown by the standard solution.
Loss on drying Not more than 10.0 per cent w/w after drying at 105° to constant weight; use 1 g (Appendix 4.15).
Foreign matter Not more than 2.0 per cent w/w (Appendix 7.2).
Acid-insoluble ash Not more than 3.0 per cent w/w (Appendix 7.6).
Total ash Not more than 5.0 per cent w/w (Appendix 7.7).
Assay To about 7.5 g, in fine powder and accurately weighed, in a dry flask add 100 mL of ether and shake for 5 minutes. Add 5 mL of 6 M ammonia, shake frequently for 1 hour, add 5 mL of water, shake vigorously, and decant the ethereal layer into a dry flask through a plug of absorbent cotton. Wash the residue in the flask with two 25-mL portions of ether, decanting each portion through the same plug of absorbent cotton. Combine the ethereal solutions and remove most of the ether by distillation and the remainder by gently warming in a current of air. Dissolve the residue in 2 mL of ethanol
(90 per cent), evaporate the ethanol and heat at 100° for
5 minutes. Dissolve the residue in 5 mL of previously neutralized ethanol (90 per cent) by warming on a water-bath, add 15 mL of 0.1 M hydrochloric acid VS and titrate the excess of acid with 0.1 M sodium hydroxide VS using 0.5 mL of methyl red-methylene blue TS as indicator. Each mL of 0.1 M hydrochloric acid VS is equivalent to 24.03 mg of total alkaloids, calculated as emetine.
IPECACUANHA, POWDERED
Powdered Ipecac; Powdered Ipecacuanha Root
Complies with the requirements for total alkaloids, Packaging and storage, Identification, Loss on drying, Foreign matter, Acid-insoluble ash, and Total ash stated under Ipecacuanha and with the following requirement.
Description Light grey to yellowish brown. Diagnostic structures: parenchyma, raphide crystals of calcium oxalate, fragments of tracheids and vessels, larger vessels and sclereids from rhizome, cork, fragments of dermal tissue, fibres. Parenchyma, ovate cells, some containing starch granules. Starch granules, simple or 2- to 10-compound; the simple granules being up to 15 µm in diameter in Costa Rica ipecacuanha and up to 22 µm in diameter in Mato Grosso ipecacuanha. Raphide crystals of calcium oxalate, scattered or in bundles. Fragments of tracheids and vessels: bordered-pitted vessels accompanied by ligneous elongated parenchyma. Vessels and sclereids from rhizomes usually larger than those of the roots. Fragments of dermal tissue: reddish brown cork and phelloderm, some containing raphide crystals of calcium oxalate.