Homoeopathy and Homoeopathy and European Pharmacopoeia: European Pharmacopoeia: current status and future current status and future development development Isabelle Mercier Isabelle Mercier EDQM EDQM
Homoeopathy Working Party Homoeopathy Working Party � Homoeopathic Directive 92/73/EEC � Homoeopathic Directive 92/73/EEC � Reference to European Pharmacopoeia � Reference to European Pharmacopoeia � Working Party fully established 1997 � Working Party fully established 1997 � Membership restricted to national � Membership restricted to national authorities authorities � To prepare monographs for European use � To prepare monographs for European use (harmonisation of national German and (harmonisation of national German and French monographs) French monographs) � Working Party not reappointed in Nov. � Working Party not reappointed in Nov. 2004 2004 but call for candidates in September but call for candidates in September 2006 2006
Homoeopathic section of the Homoeopathic section of the European Pharmacopoeia European Pharmacopoeia Introduction Introduction All general texts and monographs of All general texts and monographs of the Ph. Eur. that are relevant to the Ph. Eur. that are relevant to homoeopathy are applicable. homoeopathy are applicable. The “Homoeopathy” chapter of the Ph. The “Homoeopathy” chapter of the Ph. Eur. contains general monographs Eur. contains general monographs and individual monographs on and individual monographs on starting materials and stocks… starting materials and stocks…
Achievements: Achievements: general monographs general monographs Homoeopathic preparations � Mother tinctures for homoeopathic � preparations Herbal drugs for homoeopathic � preparations Apply to all relevant homoeopathic preparations (having a Ph. Eur. specific monograph or not)
Achievements: Achievements: inorganic monographs inorganic monographs � Arsenious trioxide � Arsenious trioxide � Barium chloride dihydrate � Barium chloride dihydrate � Cadmium sulphate 2.7 hydrate � Cadmium sulphate 2.7 hydrate � Calcium iodide tetrahydrate � Calcium iodide tetrahydrate � Copper � Copper � Copper acetate monohydrate � Copper acetate monohydrate � Iron � Iron
Achievements: Achievements: herbal and other monographs herbal and other monographs � Common stinging nettle � Common stinging nettle � Garlic � Garlic � Hedera helix � Hedera helix � Hyoscyamus � Hyoscyamus � Hypericum � Hypericum � Oriental cashew � Oriental cashew � Saffron � Saffron � Honey bee � Honey bee
Sticking points Sticking points � Parts of plants used: differences � Parts of plants used: differences � Freshness of plants: � Freshness of plants: � Visual inspection � Visual inspection � Loss on drying � Loss on drying � Foreign matter: � Foreign matter: � Visual inspection to minimise � Visual inspection to minimise � Measurement: default limit max. 2% � Measurement: default limit max. 2%
Sticking points Sticking points � Mother tinctures � Mother tinctures � Density � Density � Ethanol content � Ethanol content � Time of maceration � Time of maceration � Methanol content of mother � Methanol content of mother tincture tincture
Sticking points Sticking points � Pillules � Pillules � Composition of core - � Composition of core - undiluted stocks? undiluted stocks? � Tests - uniformity of mass � Tests - uniformity of mass - impregnation - impregnation - disintegration - disintegration � Nomenclature � Nomenclature
Symposium Feb. 2005: results Symposium Feb. 2005: results � General monograph on methods � General monograph on methods of preparation described in of preparation described in HAB and Ph. Fr. = HAB and Ph. Fr. = harmonisation harmonisation � HAB methods 1a to 4 b + 2 Ph. � HAB methods 1a to 4 b + 2 Ph. Fr. methods adopted June 2006 Fr. methods adopted June 2006 (implementation 1.07.2007) (implementation 1.07.2007)
Symposium Feb. 2005: results Symposium Feb. 2005: results � Twin-track monographs where � Twin-track monographs where differences between HAB and differences between HAB and Ph. Fr. (method of Ph. Fr. (method of preparation; density/ethanol preparation; density/ethanol content; foreign matter…) content; foreign matter…) � List of specific monographs � List of specific monographs based on proposals made by based on proposals made by industry with respect to MRP industry with respect to MRP priorities priorities
Symposium Feb. 2005: results Symposium Feb. 2005: results � Pending: � Pending: � consensus on fresh/dried � consensus on fresh/dried material to be found with material to be found with HMPWG (two monographs?) HMPWG (two monographs?) � pillules � pillules � nomenclature: list of materia � nomenclature: list of materia medica medica
Future developments Future developments � Harmonise other HAB and Ph.Fr. � Harmonise other HAB and Ph.Fr. methods of preparation (nosodes = methods of preparation (nosodes = low priority) low priority) � Draft specific monographs on � Draft specific monographs on basis of priorities listed by basis of priorities listed by Industry Industry
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