Pharmacopoeia - dab tsi yog qhov no? Pharmacopoeia: hauj lwm, keeb kwm, cov ntsiab lus

Yuav ua li cas yog lub pharmacopoeia? Yog hais tias koj pib los ntawm deb deb, ces muaj tseeb txhua tus txiv neej tsawg kawg ib zaug tshwm sim rau cov kws kho mob tswj kom nco ntsoov li ntawd, muaj ntau yam tshuaj, paub lawv ntau npaum, tshuaj muaj pes tsawg leeg thiab mechanism ntawm qhov kev txiav txim. Nyob rau hauv no lawv yog pab los ntawm cov heev heev manuals thiab compendiums, muaj cov kev tsim nyog ntxiv. Tab sis tus sau phau ntawv, nyob rau hauv lem, yog tshwm sim los ntawm lub pharmacopoeia. Yog li ntawd yog dab tsi?

txhais

Pharmacopeia - ib tug sau ntawm cov ntaub ntawv, uas teev tawm tus qauv zoo ntawm medicinal raw cov ntaub ntawv, koom haum pab cov ntaub ntawv, tiav lawm cov kws tshuaj thiab lwm yam tshuaj siv nyob rau hauv cov tshuaj.

Yuav kom tsim ib tug "kub txheej txheem" nyiam cov kws txawj nyob rau hauv lub tshav pob ntawm Science News for KIDS thiab kws tsom xam, ua nyob rau hauv cia li thoob ntiaj teb ob-dig muag tswj tau raug mus nrhiav txhua yam tau txog lub lam raw cov ntaub ntawv thiab cov tshuaj noj tawm ntawm nws. Yuav ua raws li tag nrho cov qauv kuas qhov zoo tshaj ntawm cov kws tshuaj.

State Pharmacopoeia - ib tug pharmacopoeia yam raug cai losis tswvyim dabtsi thiab uas yog nyob rau hauv lub xeev saib xyuas. Cov uas yuav tsum tau thiab cov tswv yim muab tawm nyob rau ntawd, yog losis tswvyim dabtsi rau tag nrho cov tsev kawm ntawv hauv lub teb chaws, koom nyob rau hauv qhov siv thiab ua, cia, muag thiab siv cov tshuaj. Rau kev ua txhaum ntawm cov kev cai teem tseg nyob rau hauv cov ntaub ntawv, raws li txoj cai los yog tej yam ntuj tso tus neeg txojkev txhaum kev lav.

Lub keeb kwm ntawm thoob ntiaj teb pharmacopoeia

Xav nyob rau hauv lub tsev lag luam ntawm ib tug ntau daim ntawv teev cov tshuaj nrog ib tug hais txog ntawm ntau npaum li cas cov kev nomenclature nyob rau hauv lub scientific kev kho mob hauv zej zog nyob rau hauv lub lig thib kaum cuaj xyoo pua, hauv 1874. Tus thawj lub rooj sib tham rau hauv kev kawm tau nyob rau hauv Brussels nyob rau hauv 1092. Nyob rau nws, cov kws txawj tau tuaj mus rau ib tug pom zoo rau kev ntau npe rau cov tshuaj, thiab qhov zoo ntawm lawv cov nqe lus nyob rau hauv cov zaub mov txawv. Tsis pub dhau plaub lub xyoos, qhov no daim ntawv cog lus tau ratified los ntawm nees nkaum lub teb chaws. Qhov no kev vam meej yog starting taw tes rau ntxiv txoj kev loj hlob ntawm lub pharmacopeia thiab nws cov ntawv. Nees nkaum xyoo tom qab, ib tug thib ob lub rooj sib tham nyob rau hauv Brussels, uas twb tau mus kawm los ntawm cov neeg sawv cev ntawm plaub caug-ib lub teb chaws ntawm lub ntiaj teb no.

Los ntawm lub sij hawm ntawd tu txog qhov ntawv thiab kho nqi lus ntawm lub pharmacopoeia tau tsiv mus rau League of Nations. Thaum lub sij hawm ntawm daim ntawv cog lus ntsiab cai galenic npaj thiab koob tshuaj 77 ntawm cov tshuaj muaj nyob rau hauv lub Compendium. Tom qab lwm kaum ob xyoos, nyob rau hauv 1937, nws tau tsim los ntawm lub pawg neeg ntawm cov kws txawj los ntawm Belgium, Denmark, Fabkis, Switzerland, lub teb chaws USA, lub Netherlands thiab cov UK uas tau familiarized nrog tag nrho cov kev cai ntawm lub pharmacopoeia thiab txiav txim siab los cuag nws mus rau lub thoob ntiaj teb kev ntsuas.

Lub ob ntiaj teb rog tu ncua rau hauv lub chaw ua hauj lwm ntawm lub commission, tab sis nyob rau hauv 1947, cov kws txawj rov qab mus rau nws cov hauj lwm. Rau tsib caug-cuaj xyoo lub Commission twb hu ua cov kws muaj txuj Committee on Specifications rau Kws Npaj. Nyob rau ib lub ntawm cov LEEJ TWG lub rooj sib tham, nws tau txiav txim siab los ua ib tug pab cuam ntawm International Nonproprietary npe rau lub unification ntawm lub ntau yam ntawm cov tshuaj.

thawj tsab

Pharmacopoeia - ib tug thoob ntiaj teb daim ntawv, uas muaj twb muaj plaub reprints, thiab tom qab txhua ib tug nws muab rau ib yam dab tsi tshiab.

Tus thawj tsab tau pom zoo nyob rau lub thib peb ntiaj teb los ua ke ntawm LEEJ TWG. Cob phum Secretariat ntawm lub International Pharmacopoeia tau tsim muaj. Cov phau ntawv twb luam tawm nyob rau hauv 1951, thiab plaub lub xyoos tom qab twb luam tawm lub thib ob ntim nrog ntxiv mus rau peb ntau European lus: Lus Askiv, Fabkis thiab lus Spanish. Tom qab ib tug luv luv lub sij hawm ntawm lub sij hawm muaj ntaub ntawv nyob rau hauv German thiab Japanese. Tus thawj pharmacopoeia - ib tug sau ntawm normative cov ntaub ntawv rau tag nrho cov paub thaum lub sij hawm npaj. Namely:

• 344 cov khoom nyob rau yeeb tshuaj tshuaj;
• 183 khoom ntau npaum ntaub ntawv (cov ntsiav tshuaj, tsiav tshuaj, tinctures, kev daws teeb meem nyob rau hauv ampoule);
• 84 laboratory txoj kev kuaj mob.

Headlines twb nyob rau hauv Latin, vim nws yog tib yam rau tag nrho cov kev kho mob txoj kev uas yuav xa mus rau neeg ua hauj lwm. Yuav kom sau tus tsim nyog cov ntaub ntawv rau lom standardization kws txawj twb muab kev koom tes, raws li zoo raws li nqaim tshwj xeeb nyob rau hauv lub feem ntau tuaj teb thiab txaus ntshai kab mob.

Tom ntej tshooj ntawm lub International Pharmacopoeia

Qhov thib ob tsab nyob rau hauv 1967. Nws twb muaj nplooj siab mus rau qhov zoo tswj ntawm cov kws tshuaj. Nyob rau hauv tas li ntawd, nws tau raug suav hais tias yog thawj tsab ntawm kab thiab ntxiv 162 tshuaj.

Qhov thib peb ib tsab ntawm tus pharmacopoeia tau teem rau tej teb chaws. Nws twb muab xa mus rau daim ntawv teev cov tshuaj, uas yog dav siv nyob rau hauv kev kho mob thiab nyob rau tib lub sij hawm muaj ib tug kuj tsis tshua muaj nqi. Qhov no tsab muaj tsib tagnrho thiab tau tso tawm nyob rau hauv 1975. Tsis ntev los no kev pauv hloov mus rau lub daim ntawv tau ua nyob rau hauv 2008 nyob ib leeg. Cov hais txog standardization ntawm cov tshuaj, dab rau lawv siv, thiab muab faib rau.

Tus txheem ntawm lub pharmacopoeia

Pharmacopeia - ib phau ntawv uas combines tsis tau tsuas yog ib tug ntau yam ntawm cov tshuaj, tab sis kuj raws li kev cai rau lawv cov siv thiab ua, cia thiab lwm yam hom phiaj. Phau ntawv no muaj ib tug piav qhia ntawm cov tshuaj, lub cev thiab lom txoj kev rau lub tsom xam ntawm cov tshuaj. Nyob rau hauv tas li ntawd, nws muaj cov lus qhia rau cov reagents thiab indicators, As, tshuaj tshuaj thiab npaj.

LEEJ TWG Committee tau kos mus txog cov npe ntawm cov tshuaj lom (Sau A) thiab nyuaj tshuaj (Sau B), raws li zoo raws li ib lub rooj nyob ntawm ntau ib thiab txhua hnub koob tshuaj ntawm cov tshuaj.

European Pharmacopoeia

European Pharmacopoeia - ib tug normative daim ntawv, uas yog siv nyob rau hauv feem ntau lub teb chaws nyob sab Europe nyob rau hauv cov txheej txheem ntawm cov kws tshuaj rau ib tug par nrog lub International Pharmacopoeia, nws pab thiab kev pab rau cov kev tshuaj nyob rau hauv lub cheeb tsam. Phau ntawv no yog tsim los ntawm cov European Directorate rau lub zoo ntawm tshuaj, uas yog ib feem ntawm lub Council ntawm teb chaws Europe. Pharmacopeia muaj sib txawv los ntawm lwm yam uas zoo sib xws raws li txoj cai raws li txoj cai ntawm cov ntaub ntawv uas tau muab rau nws txee. Cov hauj lwm hom lus ntawm cov European Pharmacopoeia - Fabkis. Lub Xeem, Lub lub thib rau, yog tus re-tso tawm nyob rau hauv 2005.

lub teb chaws pharmacopoeia

Txij li thaum lub International Pharmacopoeia twb tsis muaj kev cai lij choj kev quab yuam thiab yog ntau tshaj ntawm ib tug recommendatory xwm, tej lub teb chaws muab ib lub teb chaws pharmacopoeia rau hauv kev cai ntawm tej teeb meem muaj feem xyuam rau cov tshuaj. Thaum lub caij, ntau lub teb chaws muaj ib tug neeg phau ntawv. Nyob rau hauv Russia thawj pharmacopoeia twb tso tawm nyob rau hauv 1778 nyob rau hauv Latin. Lavxias teb sab version cia li tuaj tawm, ua thawj phau ntawv ntawm no zoo nyob rau hauv lub teb chaws cov lus nyob rau hauv nees nkaum xyoo.

Nyob rau hauv 1866, ib nrab xyoo tom qab, tuaj cov thawj nom Lavxias teb sab Pharmacopoeia. 11 tsab, kawg thaum lub sij hawm lub hav zoov ntawm cov Soviet Union, nyob rau hauv thaum ntxov nineties ntawm lub xeem caug xyoo. Yog nqus tau li, Nkij los txuam rau thiab re-tso cov ntaub ntawv ua ntej lub Committee twb entrusted rau lub pharmacopoeia, tab sis tam sim no yog koom nyob rau hauv lub Ministry of Health, Roszdravnadzor thiab noj qab haus huv kev tuav pov hwm cov nyiaj nrog kev koom tes ntawm lub teb chaws txoj kev tshawb fawb.

RF State Pharmacopeia 12 thiab 13 tshooj

Nyob rau hauv lub nruab nrab, thaum twg lub xeev pharmacopoeia kawm rau cov kev hloov kho, qhov zoo ntawm kev kho mob cov khoom tswj los ntawm pharmacopoeia khoom Enterprise (SAF) thiab cov pharmacopoeia cov khoom (CFC). Nyob rau hauv kaum ob tsab ntawm lub State Pharmacopoeia ntawm lub RF ho los ntawm lub fact tias kev koom tes ntawm Lavxias teb sab kws txawj nyob rau hauv lub chaw ua hauj lwm ntawm lub Commission ntawm cov European Pharmacopoeia. Kaum ob tsab muaj tsib qhov chaw, txhua tus uas muaj normalizing qhov yooj yim qauv thiab cov kev tswj rau qhov siv thiab ua, muag los sis txoj hauj lwm ntawm medicaments. Phau ntawv no tau luam tawm nyob rau hauv kev nyob rau hauv 2009.

Rau xyoo tom qab ntawd, kaum ob tsab tau edited. Qhov kawg ntawm 2015 nyob rau hauv cov nom lub website ntawm Lavxias teb sab Federation Ministry of Health nyob State Pharmacopoeia - 13th tsab. Nws yog ib qho hluav taws xob version raws li qhov kev tso tawm tau nqa tawm nrog cov nyiaj los ntawm qhov muag. Yog li ntawd, nws tau txiav txim siab nyob rau hauv cov PatientsÕ theem, nyob rau hauv txhua txhua lub khw muag tshuaj thiab lag luam wholesale lub tuam txhab yuav tsum tau xeev Pharmacopoeia (13th tsab). Qhov no enabled hauv phau ntawv samookupitsya.

Yuav ua li cas yog lub pharmacopoeial tsab xov xwm?

Nws muaj ob hom ntawm pharmacopoeia cov khoom: nyob rau hauv tshuaj thiab lub tiav lawm ntau npaum daim ntawv. Txhua tsab xov xwm "nyob rau lub substance" muaj ib lub npe nyob rau hauv ob yam lus: Lavxias teb sab thiab Latin, lub thoob ntiaj teb generic tshuaj lub npe. Nws pib ua ib qho empirical thiab yam ntxwv mis, molecular nyhav thiab ntau npaum li cas ntawm cov yooj yim acting substance. Tsis tas li ntawd, muaj ib tug paub piav qhia txog ntawm cov tsos ntawm cov tshuaj zoo tswj kev uas lub solubility nyob rau hauv lub cev, thiab lwm yam lub cev thiab tshuaj zog. Tej yam kev mob rau lub ntim, manufacturing, cia thiab kev thauj mus los. Raws li zoo raws li lub hnub tas sij hawm.

Tsab xov xwm rau hauv lub tiav lawm ntau npaum daim ntawv no, nyob rau hauv tas li ntawd rau tag nrho cov saum toj no, muaj cov kev tshwm sim ntawm kev soj ntsuam thiab kuaj ntsuam xyuas, cov permissible txwv ntawm hloov los ntawm hnyav, ntim tau thiab luaj li cas ntawm cov tshuaj yeeb tshuaj, raws li zoo raws li ib tug-lub sij hawm thiab nyiaj pab ntau tshaj txhua hnub noj tshuaj npaum cas rau cov me nyuam thiab cov neeg laus.