CZECH PHARMACOPOEIA

  

Pharmacopoeia publications have a long history in the Czech Republic. It began with issuing the Czechoslovak Pharmacopoeia 1st Edition (PHARMACOPOEA BOHEMOSLOVENICA ED. PRIMA). This pharmacopoeia was prepared before World War II in 1937 but was published as late as 1947 due to Nazi occupation. This publication had one Supplement published in 1953. The 2nd Edition (PHARMACOPOEA BOHEMOSLOVENICA ED. SECUNDA) was published in 1954 with Supplement issued in the year 1959 and the 3rd Edition (PHARMACOPOEA BOHEMOSLOVENICA ED. TERTIA) in 1970 in two volumes with one Supplement in 1976.

 

The 4th Edition (PHARMACOPOEA BOHEMOSLOVACA ED. QUARTA) was published in 1987 as the last authentic and teamwork pharmacopoeia for the Czech and Slovak Republic. It has three volumes: general part with 11 tables, 601 monographs of active substances and excipients and 483 monographs on medical preparations. Its Supplement 1991 bears the new control methods, new international nomenclature. It covers 53 new active substances and 67 medical preparations.

 

On 20. 6. 1998 the Czech Republic signed the Convention on the Elaboration of a European Pharmacopoeia.

 

That is why next Pharmacopeias contained mainly the European Pharmacopoeia (Ph. Eur.) monographs in the Czech translation and monographs of the national origin. The Czech Pharmacopoeia 1997 (PHARMACOPOEA BOHEMICA MCMXCVII) containing the monographs of the Ph. Eur. 3rd Ed. was published in 1998, and its Supplements in the years 1999, 2000 and 2001. The Czech Pharmacopoeia 2002 (PHARMACOPOEA BOHEMICA MMII) and its Supplements 2003, 2004 and 2005 contained the monographs of the Ph. Eur. 4th Ed. The Czech Pharmacopoeia 2005 (PHARMACOPOEA BOHEMICA MMV) and its Supplements 2006 and 2007 covers the monographs of the Ph. Eur. 5th Ed.

 

The Czech Pharmacopoeia 2009 (PHARMACOPOEA BOHEMICA MMIX) contains the monographs of the Ph. Eur. Ed. 6th and its 1st and 2nd Supplements, it was implemented from 1. 5. 2009. 

The Supplement 2010 contains the monographs of the  Ed. Ph. Eur. 6th from 3rd to 8th Supplements. The date of implementation in the Czech Republic is 1. 9. 2010.

The Supplement 2011 contains the monographs of the Ph. Eur. Ed. 7th and its 1st and the 2nd Supplements, it was implemented from 1. 9. 2011. 

The Supplement 2012 contains the monographs of the  Ed. Ph. Eur. 7th from 3rd to 5th Supplements. The date of implementation in the Czech Republic is 1. 9. 2012.

The Supplement 2013 contains the monographs of the  Ed. Ph. Eur. 7th from 6th to 8th Supplements. The date of implementation in the Czech Republic is 1. 9. 2013.

The Supplement 2014 contains the monographs of the  8th Ed. Ph. Eur. and its 1st and 2nd Supplements. The date of implementation in the Czech Republic is 1. 9. 2014.

The Supplement 2015 contains the monographs of the  Ed. Ph. Eur. 8th from 3rd to 5th Supplements. The date of implementation in the Czech Republic is 1. 9. 2015.

The Supplement 2016 contains the monographs of the  Ed. Ph. Eur. 8th from 6th to 8th Supplements. The date of implementation in the Czech Republic is 1. 9. 2016.

 

The Czech Pharmacopoeia 2017 (PHARMACOPOEA BOHEMICA MMXVII) contains the monographs of the Ph. Eur. Ed. 9th, it was implemented from 1. 12. 2017. 

The Supplement 2018 contains the monographs of the Ph. Eur. Ed. 9th from 1st to 5th Supplements, it was implemented from 1. 12. 2018. 

The Supplement 2019 contains the monographs of the  Ed. Ph. Eur. 9th from 6th to 8th Supplements. The date of implementation in the Czech Republic is 1. 12. 2019.

The Supplement 2020 contains the monographs of the  Ed. Ph. Eur. 10th and its 1st and 2nd Supplements. The date of implementation in the Czech Republic is 1. 12. 2020.

The Supplement 2021 contains the monographs of the  Ed. Ph. Eur. 10th from 3rd to 5th Supplements. The date of implementation in the Czech Republic is 1. 12. 2021.

 

At the present time is prepared the Supplement 2022, which contains the monographs of the  Ed. Ph. Eur. 10th from 6th to 8th Supplements. The date of implementation in the Czech Republic is 1. 12. 2022.

 

  

The Czech Pharmacopoeia National parts include texts which are necessary for the Czech producers and pharmacies. PHARMACOPOEA BOHEMICA has 150 monographs of active substances and excipients (decreasing tendency in order to be replaced by European monographs) and monographs of preparations (increasing tendency due to unification of prescription) and 16 tables facilitate the work in local industry and pharmacies.

 

 

Contents of the National part of the Czech Pharmacopoeia:

·   General part (Alternative methods of control o radiopharmaceuticalsReagents used in     national monographs, References substance used in national monographs)

·   Tables:

Table I: Narcotics and psychotropic substances

Table II: Venena

Table III: Separanda

Table IV: Recommended therapeutic doses for adults

Table V: Recommended therapeutic doses for children

Table VI: Recommended doses some officinal actives substances used by animals

Table VII: Dependence relative density on ethanol content (alcoholimetric table II)

Table VIII: Isotonisation water solutions of actives substances prepared in appothecary

Table IX: Latin, English and Czech names of general chapters and monographs (only on   web)

Table X: Standard terms pharmaceutical dosage forms, routes of administrations and containers

Table XI: Relative atomic mass elements

Table XII: Czech-English names of reference standards used in the Czech Pharmacopoeia

Table XIII: Molar concentration of actives substances

Table XIV: Transfer of mass and volume quantities of liquid substances

Table XV: Displacement coefficients for suppositories

Table XVI: Storage and shelf life of preparations prepared in a pharmacy


·   Actives substances, excipients and Medicinal products (Acaciae mucilago, Acidi borici aqua ophthalmica, Acidi borici et acidi salicylici solutio ethanolica cum glycerolo, Acidi borici et acidi salicylici solutio ethanolica cum resorcinolo, Acidi borici oculoguttae, Acidi borici solutio 3%, Acidi borici solutio ethanolica, Acidi borici unguentum 10%, Acidi salicylici solutio ethanolica, Acidi salicylici solutio ethanolica cum resorcinolo, Acidi salicylici unguentum, Acidi salicylici unguentum 1% cum etheroleo lavandulae, Acidum peraceticum 4%, Acidum peraceticum 15%, Acidum peraceticum 35%, Adeps suillus, Adeps suillus stabilisatus, Alcoholis cetylici cremor, Alcoholis cetylici unguentum, Alcoholum adipis lanae cremor, Alcoholum adipis lanae unguentum, Althaeae sirupus, Aluminii acetotartratis cremor, Aluminii acetotartratis otoguttae, Aluminii acetotartratis solutio, Ammoniae solutio 10%, Anisi spiritus compositus, Aqua carminativa, Aqua carminativa rubra, Aqua conservans, Argenti diacetyltannas albuminatus, Argenti diacetyltannatis albuminati rhinoguttae, Argenti nitratis unguentum compositum, Atropini sulfatis oculoguttae, Aurantii pericarpium dulce, Bentoniti dispersio, Bergamottae etheroleum, Butamirati citras, Calcii hydroxidi solutio, Calcii chloridi solutio, Calcii oxidum, Calcii sulfas hemihydricus, Camphorae spiritus, Cannabis sativae oleum, Carbethopendecinii bromidum, Chloramphenicoli oculoguttae, Cremor anionicus, Cremor nonionicus, Cremor refrigerans  Darrowi infusio, Dexamethasoni acetas solutio 1%, Dextrani 40 infusio, Dextrani 70 infusio, Ergotamini tartras trituratus, Ethacridini lactatis solutio, Ethanolum 60%, Ethanolum 70%, Ethanolum 85%, Ethanolum benzino denaturatum, Ethylmorphini hydrochloridi oculoguttae Farfarae folium, Fluoresceini natrici oculoguttae, Formaldehydi Kutvirti gargarisma, Galla,  Gallarum tinctura, Geranii etheroleum, Glucosi infusio, Glyceroli unguentum, Hartmanni infusio, Homatropini hydrobromidi oculoguttae, Homatropini hydrobromidi oculoguttae euacida, Ibuprofeni suppositorium, Ichthammoli unguentum, Iodi solutio aquosa, Iodi solutio ethanolica, Iodi solutio glycerolica, Jecoris aselli unguentum compositum, Kalii et natrii iodidi oculoguttae, Kalii iodidi oculoguttae, Macrogoli unguentum, Magnesii sulfatis solutio 20%, Mannitoli infusio, Melissae herba, Menthae piperitae herba, Methylcellulosi mucilago, Methylrosanilinii chloridi solutio, Natrii chloridi infusio isotonica, Natrii chloridi infusio isotonica cum glucoso, Natrii tetraboratis globulus, Natrii tetraboratis oculoguttae cum acido borico, Natrii tetraboratis oculoguttae sine acido borico, Natrii tetraboratis solutio glycerolica, Natrii tetraboratis solutio glycerolica cum trimecaino hydrochlorido, Oculoguttae viscosae isotonicae, Paracetamoli suppositorium, Paracetamoli suppositorium pro infantibus, Petroselini radix, Phenolum liquefactum, Pilocarpini hydrochloridi oculoguttae, Pilocarpini hydrochloridi oculoguttae cum natrii chlorido, Plantaginis extractum fluidum, Plantaginis sirupus, Propranololi hydrochloridi solutio cum acido citrico, Propranololi hydrochloridi solutio cum natrii hydrogenophosphate, Ringeri infusio, Ringeri infusio cum glucoso, Ringeri infusio cum natrii lactate, Salia pro gargarismate pulvis, Salviae herba, Sapo kalinus, Sinapis etheroleum artificiale, Sirupus simplex, Solutio Castellani sine fuchsino, Solutio Fraeser, Solutio Jarisch, Solutio phenoli camphorata, Spiritus ethereus, Spiritus saponatus, Spiritus saponis kalini, Sulfathiazoli globulus, Sulfuris pasta 50%, Sulfuris pasta composita, Sulfuris suspensio, Suxamethonii diiodidum, Tetracaini hydrochloridi oculoguttae, Thymi extractum fluidum, Tinctura amara, Trimecaini hydrochloridum, Unguentum constituens pro antibioticis, Unguentum emulsificans anionicum, Unguentum emulsificans nonionicum, Unguentum molle, Unguentum ophthalmicum simplex, Unguentum simplex, Unguentum Whitfield, Veratri albi radix, Zinci oxidi gelatina mollis, Zinci oxidi pasta, Zinci oxidi pasta 50%, Zinci oxidi pasta mollis, Zinci oxidi pasta salicylata, Zinci oxidi suspensio, Zinci oxidi suspensio cum levomentholo, Zinci oxidi unguentum, Zinci sulfatis oculoguttae, Zinci sulfatis solutio)

·   Lanae (Cellulosum ligni, Lana mixta depurata)   

      

 

CZECH PHARMACOPOEIA COMMISSION

 

 

The Czech Pharmacopoeia is drafted by the Czech Pharmacopoeia commission working on the base of the Groups of Experts (15 groups and 4 working parties).

Czech Pharmacopoeias are prepared according to the Act No 378/2007.

 

Chairman: doc. PharmDr. Ludmila Matysová, Ph.D.

Vicechairmen: Mgr. Irena Storová, MHA; MVDr. Jiří Bureš

Secretary: Ing. Hana Bízková

Deputy secretary:  RNDr. Hana Jůzová

Representative of Ministry of Health of the Czech Republic: PharmDr. Jana Milštainová

Representative of Ministry of Defense of the Czech RepublicPharmDr. Zdeněk Pečinka

Representative of SÚKL: Mgr. Lucie Kopecká

Members: prof. PharmDr. Martin Beránek, Ph.D.; MUDr. Jolana Schreiberová (Cermanová), Ph.D.; Ing. Milan Houska, CSc.; PharmDr. Michal Janů, Ph.D.; Ing. Ivana Kohoutová; PharmDr. Jaroslav Maxa, Ph.D.; RNDr. Dagmar Nová; RNDr. Helena Puffrová; doc. PharmDr. Zdeňka Šklubalová, Ph.D.; PharmDr. RNDr. Jiří Štěpán, Ph.D.; prof. RNDr. Jarmila Vinšová, CSc.; MUDr. Eva Vítková, CSc.

Groups of experts (Analytic chemistry, Inorganic chemistry, Dose of actives substances, Physicochemical methods, Gene and cell therapy, Homeopathy, Immunobiology, Blood and blood substances, Pharmaceutical, Microbiology, Organic chemistry, Radiopharmaceutical, Technology of dosage form, Terminology, Standard terms pharmaceutical dosage forms, routes of administrations and containers, Veterinary immunopreparations and medicaments, Medical supplies and packing techniques).