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 the 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 translation of monographs of the Ph. Eur. Ed.7th and its 1st and the 2nd Supplements is at the present time prepared for publication.

 

The Czech Pharmacopoeia National parts include texts which are necessary for the Czech producers and pharmacies. PHARMACOPOEA BOHEMICA has now 37 monographs of active substances and excipients (decreasing tendency in order to be replaced by European monographs) and 95 monographs of preparations (increasing tendency due to unification of prescription) and 13 tables facilitate the work in local industry and pharmacies.

 

 

Contents of the National part of the Czech Pharmacopoeia:

·   General part (Determination of ethanol in liquid products by gas chromatography, Determination of methanol and propan-2-ol in liquid products by gas chromatography)

·   Reagents 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

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

·   Actives substances and excipients (Acidum peraceticum 4%, Acidum peraceticum 15%, Acidum peraceticum 35%, Adeps suillus, Aminophenazonum, Argenti diacetyltannas albuminatus, Aurantii pericarpium dulce, Bergamottae etheroleum, Butamirati citras, Cacao oleum, Calcii oxidum, Calcii sulfas hemihydricus, Cannabis sativae oleum, Carbethopendecinii bromidum, Cloroxinum, Ethanolum 60%, Ethanolum 85%, Ethanolum benzino denaturatum, Farfarae folium, Galla, Geranii etheroleum, Melissae herba, Menthae piperitae herba, Ornidazolum, Petroselini radix, Phenolum liquefactum, Pix fagi, Pix lithanthracis, Salviae herba, Sinapis etheroleum artificiale, Suxamethonii diiodidum, Trimecaini hydrochloridum, Veratri albi radix)

·   Medicinal products (Acaciae mucilago, Acidi borici aqua ophthalmica, Acidi borici oculoguttae, Acidi borici solutio 3%, Acidi borici unguentum 10%, Acidi salicylici solutio ethanolica, Acidi salicylici solutio ethanolica cum resorcinolo, Acidi salicylici unguentum 10%, Acidi salicylici unguentum 1% cum etheroleo lavandulae, 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 nitratis unguentum compositum, Atropini sulfatis oculoguttae, Bentoniti magma, Calcii chloridi solutio, Calcii hydroxidi solutio, Camphorae spiritus, Carbonis detergens tinctura, 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, Ethylmorphini hydrochloridi oculoguttae, Fluoresceini natrici oculoguttae, Formaldehydi Kutvirti gargarisma, Gallarum tinctura, Gelatum Holt, Glucosi infusio, Glyceroli suppositorium, Glyceroli unguentum, Hartmanni infusio, Homatropini hydrobromidi oculoguttae, 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, Mannitoli infusio, 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 cum trimecaino hydrochlorido, Natrii tetraboratis solutio glycerolica, Oculoguttae viscosae isotonicae, Paracetamoli suppositorium, Paracetamoli suppositorium pro infantibus, Pilocarpini hydrochloridi oculoguttae, Plantaginis extractum fluidum, Plantaginis sirupus, Ringeri infusio, Ringeri infusio cum glucoso, Ringeri infusio cum natrii lactate, Salia pro gargarismate pulvis, Sapo kalinus, Sirupus simplex, Solutio Castellani sine fuchsino, Solutio Fraeser, Solutio Galli-Valerio, Solutio Jarisch, Solutio phenoli camphorata, Spiritus ethereus, Spiritus saponatus, Spiritus saponis kalini, Sulfathiazoli globulus, Sulfuris pasta 50%, Sulfuris pasta composita, Sulfuris suspensio, Tetracaini hydrochloridi oculoguttae, Thymi extractum fluidum, Tinctura amara, Unguentum constituens pro antibioticis, Unguentum emulsificans anionicum, Unguentum emulsificans nonionicum, Unguentum molle, Unguentum ophthalmicum simplex, Unguentum simplex, Unguentum Whitfield, Zinci oxidi gelatina mollis, Zinci oxidi pasta, Zinci oxidi pasta 50%, Zinci oxidi pasta mollis, Zinci oxidi pasta salicylata, Zinci oxidi suspensio, Zinci oxidi unguentum, Zinci sulfatis oculoguttae)

·   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. RNDr. Jiří Portych, CSc.

Vicechairmen: PharmDr. Martin Beneš, prof. MVDr. Alfred Hera, CSc.

Members (heads of groups of experts, representatives of institutions - 22 persons)

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).

 

Secretariat (Ing. Hana Bízková, RNDr. Hana Jůzová, RNDr. Hana Lomská, Zdena Schifflerová)