Pharmacopoeia

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A pharmacopoeia (early Middle High German arzenîbuoch , Middle High German arzetbuoch ; loan translation from Middle Latin liber medicinalis : " Medicinal compendia of comprehensive indications, composed of recipes or short tracts") also referred to as pharmacopoeia (from the Greek pharmacopoeia , a collection of recognized medicines is 'to prepare') or recognized pharmaceutical rules on the quality, testing, storage and designation of medicinal products and the substances , materials and methods used in their manufacture and testing . In terms of pharmaceutical history, one differentiates:

  • Official pharmacopoeias or modern pharmacopoeias as standard works or regulations books applicable to pharmacy operations and industrial drug production. They are based on a legislative act and are binding.
  • Prescriptions (also recipe books ): The rules described are based on agreement between health care professions. This also includes pharmacopoeias on veterinary drugs . So-called folk medicinal books can be distinguished as existing independently of recognized methods .

This distinction is independent of the actual title of a pharmacopoeia.

history

Pharmacopoea Coloniense 1627
Pharmacopoea Austriaco-Provincialis 1794

Writings dealing with herbal medicine were already known in ancient Egypt . The Edwin Smith papyrus is one of the oldest documents on medical healing methods and the Ebers papyrus describes around 800 recipes. De Materia Medica is another collection of texts on medicinal plants dating from around 50 BC. Was written by Pedanios Dioscurides . The series of pharmacopoeial literature also includes the writings of Galenus , who coined the term antidote , which gave its name to the specialist prose genre Antidotarium . The Persian doctor Avicenna, in turn, wrote the canon of medicine in the 11th century AD , which also deals with pharmaceutical science, and this work was regarded as the standard work until the middle of the 19th century.

At the latest at the beginning of the 12th century, the German-language Arzenîbuoch Ipocratis , which was written in the Alemannic region and used the name Hippokrates effectively, was created , an anatomically ordered recipe that contained 59 medical instructions from early medieval sources ( e.g. Pliny , Pseudo-Apuleius , Marcellus Empiricus , Cassius Felix , Gargilius Martialis and Pseudo-Democritus). In contrast to the “antidotaries” with full prescriptions, in the pre-Salernitan period the nameless short recipe functioned as a structural element of the so-called “prescriptions”, as they later found their way into national-language folk medicine books. Both recipe types can be found within five recipe books in the Lorsch Pharmacopoeia of the 8th century. The Upper German Benedikturer recipe , which was created in the 11th century from early medieval recipe literature and was translated in the Bavarian region before 1200 , a pharmacopoeia that has been verifiable since the end of the 13th century on the basis of primarily South German textual witnesses, as well as the so-called " Bartholomäus " from the East Central German area, was also widespread found. At the end of the 13th century, Ortolf von Baierland wrote his pharmacopoeia , which shows the diagnostic and therapeutic knowledge of the time in German and was widely spread over the Middle Ages and its place of origin Würzburg .

Even less widespread medical publications referred to themselves in the early modern period as "pharmacopoeia" (early mhd. Arzenîbuoch ; Low German around 1487 Arsedige-bûk ) or - with thematic restrictions - as "pharmacopoeia". In 1577 a new Artzney book by Tabernaemontanus was published in Frankfurt am Main .

In 1546, the doctor Valerius Cordus compiled a collection of formulations for medicinal products, which - similar to the Luminare majus of the Italian pharmacist Johannes Jacobus Manlius de Bosco, a forerunner of later pharmacopoeias - is considered to be the forerunner of the German pharmacopoeia. The Pharmakopeia Augustana is the second edition of Cordus' work. The term pharmacopeia (Greek: remedies, to make poisons ) is used for the first time . In 1570 a “Collegium” of Viennese doctors published a dispensatory pro pharmacopeis .

In the 18th century, attempts were made in various places to create binding pharmacopoeias or pharmacopoeias. The first German pharmacopoeia DAB1 was created in 1872 ( Pharmacopoea Germanica , from 1890 German Pharmacopoeia ). The Pharmacopoeia Commission will meet for the first time. In Austria, the Pharmacopoea Austriaca was valid from 1812 , which was replaced by the German Pharmacopoeia in 1940. The Austrian Pharmacopoeia has been in force since 1960 .

European Pharmacopoeia

European Pharmacopoeia, 10th Edition, Basic 2020, Volume 1

The basis for the European Pharmacopoeia ( Pharmacopoea Europaea , Ph. Eur., Referred to as the European Pharmacopoeia in Switzerland ) was laid in 1965. The preparation of the European Pharmacopoeia is the responsibility of the European Pharmacopoeia Commission. This consists of national delegations with a maximum of three members per country. The seat of the European Pharmacopoeia Commission ( European Directorate for the Quality of Medicines , EDQM) is the Council of Europe in Strasbourg.

The European Pharmacopoeia appears in English and French and is translated into German by the competent authorities in Germany, Austria and Switzerland. The current version is version 10.

The German-language official edition consists of four parts:

  • European Pharmacopoeia - General Part, Monograph Groups (Ph.Eur., Volume 1)
  • European Pharmacopoeia - Monographs A – J (Ph. Eur., Volume 2)
  • European Pharmacopoeia - Monographs K – Z (Ph. Eur., Volume 3)
  • European Pharmacopoeia - Supplements

The general part and monographs form the basic work.

United States of America Pharmacopoeia

Historical Pharmacopoeia Pharmacopoeia of the United States of America , 1831

The United States Pharmacopeia is the official pharmacopoeia of the United States of America . The United States Pharmacopeial Convention is a non-profit organization that owns the rights to the trademark and the copyright to this pharmacopoeia. USP-NF is a combination of the Pharmacopoeia and the National Formulary (NF) and is issued annually with two supplements each.

The pharmacopoeia consists of individual monographs (compilation of tests on active ingredients or dosage forms as well as specifications), general chapters on tests that are referenced in several monographs, and a general part that describes the terminology and terms from the monographs and provides assistance in correct interpretation which includes monographs. The USP Pharmacopeia is published in four volumes:

  • Volume 1: Foreword, general descriptions and definitions, general chapters on tests
  • Volume 2: Monographs from A – I
  • Volume 3: Monographs from J – Z
  • Volume 4: Monographs on food supplements, excipients and NF monographs

Experts from industry, science and government officials are working together to update the pharmacopoeia.

Pharmacopoeia in Germany

The legal basis for the pharmacopoeia in Germany is § 55 of the German Medicines Act .

It consists of three pharmacopoeias:

  • European Pharmacopoeia (9th edition, with supplementary volumes)
  • German Pharmacopoeia (DAB 2019)
  • Homeopathic Pharmacopoeia (HAB 2018)

The respective official version is published in the Federal Gazette . Numerous unofficial comments have appeared on the pharmacopoeias.

German Pharmacopoeia

The German Pharmacopoeia (DAB), which emerged from the Pharmacopoeia Germanica (see below) via the Pharmacopoeia for the German Empire , contains regulations that supplement those of the European Pharmacopoeia. For example, analytical methods or drugs that are not common in all states of the European Pharmacopoeia are regulated. The European Pharmacopoeia specifies areas that are common in Europe or that require uniform regulation.

The pharmacopoeias usually consist of a general part, in which general provisions and procedures from the various areas of pharmacy are laid down, and monographs , which contain definitions, test methods for identity and purity and storage regulations for drugs and chemicals .

The rules of the pharmacopoeia are determined by commissions and published by the Federal Institute for Drugs and Medical Devices . The office of the Pharmacopoeia Commissions is based at the Federal Institute for Drugs and Medical Devices.

The German Medicines Codex ( DAC 99), which contains manufacturing regulations, is not part of the pharmacopoeia and is also not an official work . It is standard procedure for Defektur and recipe .

History of publication
Pharmacopoea Germanica 1872

The German Pharmacopoeia has appeared in more than ten editions. The edition from 1872 was the first unified German pharmacopoeia ( Pharmacopoea Germanica ) after the establishment of the German Empire in 1871. Both the first edition and its predecessor, the Pharmacopoea Germaniae from 1865, were still written in Latin. Later editions up to DAB 6 were named Pharmacopoeia for the German Empire .

  • Pharmacopoea Germanica, editio I, 1872 (Pharm. Germ. Edit. I = DAB 1)
  • Pharmacopoea Germanica, editio altera, 1883 (Pharm. Germ. Edit. II = DAB 2)
  • Pharmacopoea Germanica, editio III, 1890 (Pharm. Germ. Edit. III = DAB 3)
  • German Pharmacopoeia 4 (DAB 4), 1900
  • German Pharmacopoeia 5 (DAB 5), 1910
  • German Pharmacopoeia 6 (DAB 6), 1926
  • German Pharmacopoeia 7 (DAB 7), 1964 (GDR), 1968 (FRG)
  • German Pharmacopoeia 8 (DAB 8), 1978
  • German Pharmacopoeia 9 (DAB 9), 1986
  • German Pharmacopoeia 10 (DAB 10), 1991

In the GDR, the German Pharmacopoeia 7 appeared as a separate edition. Thereafter, in 1978, 1983, 1985 and 1987 pharmacopoeias were published under the name of the Pharmacopoeia of the German Democratic Republic (AB-GDR with indication of the year or also 2nd AB-GDR with year).

In addition to the main editions, some official supplementary books (Erg.-B.) have been published; these contain "medicinal products that are not included in the German Pharmacopoeia":

  • Supplementary Book 3 to DAB, Erg.-B. 3, 1894
  • Supplementary Book 4 to DAB, Erg.-B. 4, 1916
  • Supplementary book 5 to DAB, Erg.-B. 5, 1930
  • Supplementary book 6 to DAB, Erg.-B. 6, 1941 (Berlin), ed. from the German Pharmacists' Association

In the course of the further development of the European Community, the importance of the DAB in relation to the European Pharmacopoeia is steadily decreasing. Newer editions of the DAB with updates at short annual intervals are now designated according to the year of issue, for example:

  • German Pharmacopoeia 2004 (DAB 2004)
  • German Pharmacopoeia 2006 (DAB 2006)

Homeopathic Pharmacopoeia

The Homeopathic Pharmacopoeia (HAB) has a similar structure to other pharmacopoeias and comprises a general section and a section with monographs. In addition to their usual quality standards, the monographs of the starting materials also contain information on potentiation up to the potency from which forty-three percent ethanol continues to potentiate. The chapter procedural techniques in the general part contains, among other things, the description of manufacturing processes of homeopathy , partly according to Hahnemann , anthroposophy , organ therapy (or organotherapy) and spagyric , which are based on historical preparation processes or conventional methods.

The most important manufacturing regulations of the German and French homeopathic pharmacopoeia have found their way into the European Pharmacopoeia. The HAB is part of the pharmacopoeia according to § 55 of the German Medicines Act. It only contains rules that are not contained in the European Pharmacopoeia (Pharmacopoea Europaea). There is currently no online edition. The official edition of the HAB can be obtained as a loose-leaf collection .

Switzerland

The valid pharmacopoeia in Switzerland is the 8th edition of the European Pharmacopoeia (Ph. Eur. 8) with its supplements and the 11th edition of the Swiss Pharmacopoeia (Ph. Helv. 11; Pharmacopoea Helvetica 11) with its supplements.

Austria

In Austria, in addition to the Ph. Eur., The Austrian Pharmacopoeia (ÖAB - Pharmacopoeia Austriaca) and the German HAB (Homeopathic Pharmacopoeia) also apply .

See also

literature

  • Karl Heinz Bartels : The Würzburg "Pharmacopoeia". In: Würzburg medical history reports. Volume 25, 2006, pp. 75-112.
  • Gundolf Keil : Pharmacopoeia. In: Lexicon of the Middle Ages . Volume 1. 1980, Col. 1091-1094.
  • Gundolf Keil: Pharmacopoeia. In: Werner E. Gerabek, Bernhard D. Haage, Gundolf Keil, Wolfgang Wegner (eds.): Enzyklopädie Medizingeschichte. De Gruyter, Berlin 2005, ISBN 3-11-015714-4 , p. 104 f.
  • Thomas Richter: Pharmacopoeia. In: Werner E. Gerabek, Bernhard D. Haage, Gundolf Keil, Wolfgang Wegner (eds.): Enzyklopädie Medizingeschichte. De Gruyter, Berlin 2005, ISBN 3-11-015714-4 , p. 1149 f.
  • Rudolf Schmitz : The essence of the pharmacopoeia from the perspective of the historian. In: Pharmaceutical newspaper. Volume 103, 1958, pp. 1333-1337.
  • Dirk Arnold Wittop Koning: What is a pharmacopoeia? In: Publications of the International Society for the History of Pharmacy. New Series, Volume 22, 1963, pp. 181-191.

Web links

Wikisource: Announcement regarding the Pharmacopoea Germanica. From June 1, 1872.  - Sources and full texts

Individual evidence

  1. ^ Ortrun Riha : Knowledge organization in medical collective manuscripts. Classification criteria and combination principles for texts without a work character. (Habilitation thesis Würzburg 1990) Reichert, Wiesbaden 1992 (= knowledge literature in the Middle Ages. Writings of the Collaborative Research Center 226 Würzburg / Eichstätt. Volume 9). ISBN 3-88226-537-X , pp. 7-18.
  2. ↑ Thomas Richter (2005), p. 1149 (quoted).
  3. ^ Karl Heinz Bartels: The Würzburg "Pharmacopoeia". In: Würzburg medical history reports. Volume 25, 2006, pp. 75-112; here: pp. 75–78 and 106 f.
  4. ↑ Pharmacopoeia . Duden; accessed June 17, 2015.
  5. ↑ a b Wolfgang Schneider: Dictionary of Pharmacy . Volume 4: History of Pharmacy . Scientific Publishing Company, 1985.
  6. ↑ on historical “pharmacopoeias” and prescriptions cf. for example Gerhard Eis , Wolfram Schmitt (Ed.): Das Asanger Aderlaß- und recipe booklet (1516–1531). Stuttgart 1967 (= publications of the International Society for the History of Pharmacy. New Series, Volume 31); Carl Külz, E. Külz-Trosse, Jos. Klapper (Ed.): The Breslau Pharmacopoeia. R [hedigeranus] 291 of the city library, part I: text. Dresden 1908 (Codex today in the University Library in Breslau) - digitized ; Hartmut Broszinski and Gundolf Keil: 'Kassel Pharmacopoeia'. In: Author's Lexicon . 2nd Edition. Volume 4, Col. 1048-1050 (collective manuscript created between 1390 and 1425); Christian Tenner, Gundolf Keil (ed.): The 'Darmstadt Pharmacopoeia'. Marginal notes on a collective manuscript from the Upper Rhine from the turn of the century. In: Library and Science. Volume 18, 1984, pp. 85-234 (on Darmstadt, Landesbibliothek, Hs. 2002, Bl. 1–72, 2 receptions); Helny Alstermark: The pharmacopoeia of Johan van Segen . Stockholm 1977 (= Acta Universitatis Stockholmiensis, Stockholm German Research. Volume 22); Agi Lindgren (ed.): A Stockholm Middle Low German pharmacopoeia from the second half of the 15th century. (Philosophical dissertation Stockholm) Stockholm / Göteborg / Upsala 1967 (= Acta universitatis Stockholmiensis. Stockholm German Research. Volume 5), with Gundolf Keil: marginal notes on the 'Stockholm Pharmacopoeia'. In: Studia neophilologica. Volume 44, 1972, pp. 238-262 .; and Ernst Windler (ed.): The Bremen Middle Low German Pharmacopoeia of Arnoldus Doneldey. With introduction and glossary, Neumünster 1932 (= Low German Monuments. Volume 7), cf. also Franz Willeke: The Pharmacopoeia of Arnoldus Doneldey. (Philosophical dissertation) Münster 1912 (= research and findings. III, 5); as well as Günther Jaeschke: Anna von Diesbach's Bernese 'Pharmacopoeia' in the Erlacher version of Daniel von Werdts (1658). Part I: Text , Würzburg 1978 (= Würzburg medical-historical research. Volume 16); or Hermann Fischer : Middle High German recipes from Bavarian monasteries and their medicinal plants. In: Communications of the Bavarian Botanical Society for the research of the native flora. Volume IV, 6, 1926, pp. 69–75, also in: Medicine in the Middle Ages Occident. Edited by Gerhard Baader and Gundolf Keil, Darmstadt 1982 (= ways of research. Volume 363), pp. 83-94 .; as well as Hans Michael Wellmer: The 'Würzburg surgical prescription'. Investigations into a collection of medical formulas from the late 15th century with text output. In: Specialized prose research - Crossing borders. Volume 1, 2005 (2007), pp. 35-103.
  7. ↑ Eberhard Wolff: Volksmedizin, Volksarzneibücher. In: Werner E. Gerabek , Bernhard D. Haage, Gundolf Keil , Wolfgang Wegner (eds.): Enzyklopädie Medizingeschichte. Walter de Gruyter, Berlin and New York 2005, ISBN 3-11-015714-4 , pp. 1454–1458, here: p. 1457 ( “Volksarzneibücher” ).
  8. ↑ Pharmacopoeia sive Dispensatorium Coloniensis , Birckmann, Köln1627 (digitized version )
  9. ↑ Pharmacopoea Austriaco-Provincialis emendate. Ad Mandatum SCR Apost. Majestatis , Christian Friedrich Wappler, Vienna 1794 (digitized version)
  10. ^ Nunn: Ancient Egyptian Medicine. 1996.
  11. ↑ Thomas Richter (2005), p. 1149.
  12. ↑ Gundolf Keil: 'Arzenîbuoch Ipocratis'. In: Burghart Wachinger u. a. (Ed.): The German literature of the Middle Ages. Author Lexicon . 2nd, completely revised edition, volume 1: 'A solis ortus cardine' - Colmar Dominican chronicler. De Gruyter, Berlin / New York 1978, ISBN 3-11-007264-5 , Sp. 505.
  13. ↑ Christina Becela-Deller: Ruta graveolens L. A medicinal plant in terms of art and cultural history. (Mathematical and natural scientific dissertation Würzburg 1994) Königshausen & Neumann, Würzburg 1998 (= Würzburg medical-historical research. Volume 65). ISBN 3-8260-1667-X , pp. 74-76.
  14. ↑ Cf. Julius Jörimann (Ed.): Early Middle Ages Prescriptions. (Medical dissertation Zurich) Zurich / Leipzig 1925 (= contributions to the history of medicine. Volume 1); Reprint Vaduz 1977.
  15. ↑ Gundolf Keil: 'Benediktbeuer recipe'. In: Werner E. Gerabek , Bernhard D. Haage, Gundolf Keil , Wolfgang Wegner (eds.): Enzyklopädie Medizingeschichte. De Gruyter, Berlin / New York 2005, ISBN 3-11-015714-4 , p. 164.
  16. ^ Gundolf Keil: Benediktbeurer recipe. In: Burghart Wachinger u. a. (Ed.): The German literature of the Middle Ages. Author Lexicon . 2nd, completely revised edition, volume 1: 'A solis ortus cardine' - Colmar Dominican chronicler. De Gruyter, Berlin / New York 1978, ISBN 3-11-007264-5 , Sp. 691-693.
  17. ^ Gundolf Keil: The pharmacopoeia of Ortolf von Baierland: Its scope and influence on the 'Cirurgia magistri Petri de Ulma'. In: Sudhoff's archive. Volume 43, 1959, pp. 20-20.
  18. ↑ Karl Heinz Barthels (2006), pp. 78–80 ( The 'Würzburg Pharmacopoeia' by Ortolf von Baierland ).
  19. ^ Gundolf Keil: Johan van Seghen (Siegen). In: Encyclopedia of Medical History. 2005, p. 698.
  20. ↑ Artzney Buchlein, against all sorts of kranckeyten and broken tzeen […]. Leipzig (Michael Blum) 1530 (later editions under the title Zene Artzney ). Reprint, with an afterword by Hannelore Schwann. Leipzig 1984.
  21. ↑ B (ernhard) Schumacher (ed. And transl .): The Luminare majus by Joannes Jacobus Manlius de Bosco (Johannes Crespinus, Lyon) 1536. Arthur Neymayer, Mittenwald / Bavaria 1938 (= publications of the International Society for the History of Pharmacy , 34 ).
  22. ↑ a b c Brief history of the German and European Pharmacopoeia. Laboratory Dr. Liebich, accessed October 31, 2014 .
  23. ↑ See also Pharmacopoea Augustana, auspiciis amplissimi senatus. Vienna 1640; and Pharmacopoia Augustana renovata. Vienna 1734.
  24. ↑ Otto Zekert (Ed.): Dispensatorium pro pharmacopoeis Viennensibus in Austria 1570. Edited by the Austrian Pharmacists' Association and the Society for the History of Pharmacy, edited by Otto Zekert, Berlin 1938.
  25. ^ Karl Heinz Bartels: The Würzburg "Pharmacopoeia". In: Würzburg medical history reports. Volume 25, 2006, pp. 75-112; here: pp. 80–82.
  26. ^ Ralf Bröer: Medical legislation / medical law. In: Werner E. Gerabek , Bernhard D. Haage, Gundolf Keil , Wolfgang Wegner (eds.): Enzyklopädie Medizingeschichte. Walter de Gruyter, Berlin and New York 2005, ISBN 3-11-015714-4 , pp. 942-950; here: p. 943 f. ( Pharmaceuticals ).
  27. ^ Pharmacopoeia in the Vienna History Wiki of the City of Vienna
  28. ↑ a b c USP-NF. USP, accessed October 29, 2014 .
  29. ^ Mission and Preface. (PDF) (No longer available online.) USP, archived from the original on December 2, 2013 ; accessed on October 29, 2014 (English).
  30. ↑ Karl Heinz Barthel (2006), p. 77.
  31. ↑ Pharmacopoea Germanica , R. von Decker, Berlin 1872 (digitized version)
  32. ↑ Max Höfler: The folk medical organotherapy and its relationship to the cult victim. Stuttgart / Berlin / Leipzig 1908.
  33. ↑ Hermann Schelenz : organotherapy over the millennia. In: Sudhoff's archive. Volume 4, 1911, pp. 138-156.
  34. ^ Henner pre-election Elze: On the history of organotherapy. In: Sudhoff's archive. Volume 17, 1925, pp. 201-203.
  35. ↑ Deutscher Apotheker Verlag : here current issue .