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For the Elaboration of Monographs on Herbal Drugs and Herbal Drug Preparations GGuideuide for the elaboration of monographs on herbal drugs and herbal drug preparations European Pharmacopoeia European Directorate for the Quality of Medicines & HealthCare Edition 2007 © Council of Europe, 67075 Strasbourg Cedex, France - 2007 All rights reserved Making copies of this fi le for commercial purposes or posting this fi le on a website that is open to public consultation is strictly prohibited. 3 CONTENTS HERBAL DRUGS ....................................................................................... 5 NOMENCLATURE..............................................................................................................5 English title .......................................................................................................................5 Latin title ...........................................................................................................................5 DEFINITION.......................................................................................................................6 CHARACTERS ...................................................................................................................7 Organoleptic characters.....................................................................................................7 Macroscopic and microscopic botanical characters..........................................................7 IDENTIFICATION ..............................................................................................................7 Macroscopic botanical characters .....................................................................................7 Microscopic botanical characters......................................................................................8 Thin-layer chromatography...............................................................................................8 TLC prescribed only for the identification of the herbal drug..........................................8 TLC prescribed under tests and identification................................................................11 Liquid or gas chromatography ........................................................................................12 Chemical reactions for identification..............................................................................12 TESTS ..............................................................................................................................13 Typical tests ....................................................................................................................13 Total ash (2.4.16) ............................................................................................................13 Ash insoluble in hydrochloric acid (2.8.1)......................................................................13 Thin-layer chromatography (2.2.27) ...............................................................................13 Gas chromatography (2.2.28) or liquid chromatography (2.2.29) ..................................13 Foreign matter (2.8.2)......................................................................................................14 Heavy metals...................................................................................................................14 Loss on drying (2.2.32) ...................................................................................................14 Water (2.2.13) .................................................................................................................14 Swelling index (2.8.4) .....................................................................................................15 Bitterness value (2.8.15) .................................................................................................15 Extractable matter ...........................................................................................................15 Other tests........................................................................................................................15 4 ASSAY..............................................................................................................................16 Ultraviolet and visible absorption spectrophotometry ....................................................16 Determination of tannins in herbal drugs (2.8.14) ..........................................................17 Volumetric titration.........................................................................................................17 Determination of essential oils in herbal drugs (2.8.12) .................................................17 Liquid chromatography (2.2.29) and gas chromatography (2.2.28) ...............................17 STORAGE.........................................................................................................................18 REAGENTS ......................................................................................................................19 CHEMICAL REFERENCE SUBSTANCES (CRSs) ..............................................................19 HERBAL DRUG PREPARATIONS....................................................... 20 EXTRACTS ............................................................................................... 20 TITLE...............................................................................................................................20 DEFINITION.....................................................................................................................20 PRODUCTION ..................................................................................................................21 CHARACTERS .................................................................................................................21 IDENTIFICATION ............................................................................................................21 TESTS ..............................................................................................................................21 Ethanol ............................................................................................................................21 Residual solvents in dry extracts.....................................................................................21 Loss on drying.................................................................................................................21 ASSAY..............................................................................................................................22 STORAGE.........................................................................................................................22 LABELLING .....................................................................................................................22 PREPARED DRUGS ..............................................................................................22 DEFINITION.....................................................................................................................22 TESTS ..............................................................................................................................22 ASSAY..............................................................................................................................22 HERBAL TEAS........................................................................................................22 5 1 A monograph on a herbal drug or a herbal drug preparation is drafted with the same overall 2 structure as a monograph on a chemical substance and both the latest versions of the 3 Technical guide for the elaboration of monographs and of the Style guide apply to 4 monographs on herbal drugs and herbal drug preparations. This Guide develops the specific 5 points that are relevant to herbal drugs and herbal drug preparations and that are not presented 6 in the above-mentioned general Guides. 7 It is recalled that all tests and assay methods described in a monograph must be validated 8 according to the procedures stated in the Technical guide. 9 The general monograph Herbal drugs (1433) applies to all herbal drugs for medicinal use and 10 its provisions must be taken into account when elaborating specific monographs. The general 11 monograph Herbal drug preparations (1434) applies to all herbal drug preparations for 12 medicinal use and its provisions must be taken into account when elaborating specific 13 monographs. 14 HERBAL DRUGS 15 NOMENCLATURE 16 ENGLISH TITLE 17 Many herbal drugs have a well-established name in English and this is usually used as the 18 title. 19 Example: Cascara 20 The plant part used may be included in the title, particularly where different herbal drugs are 21 derived from the same plant. 22 Example: Hawthorn leaf and flower 23 Hawthorn berries 24 Where there is no common name, the title is derived from the scientific name. 25 Example: Psyllium seed 26 LATIN TITLE 27 The Latin title is derived from the scientific name of the source plant. It is formed by the 28 genus (genitive) and/or species (genitive) names, followed by the name of the organ used 29 (nominative and singular). 30 Example: Belladonnae folium 31 A more common name may also be used. 32 Example: Chamomillae romanae flos 33 Where appropriate the state of the drug is indicated in the English and Latin titles. 34 Example: Bilberry fruit, dried 35 Myrtilli fructus siccus 36 Example: Bilberry fruit, fresh 37 Myrtilli fructus recens
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