Pharmacopoeia yog dab tsi? Yog tias koj pib los ntawm qhov deb, ces nws yuav tsum tau tshwm sim rau txhua tus neeg tsawg kawg ib zaug yuav ua li cas cov kws kho mob tswj kom nco txog ntau yam tshuaj, paub txog lawv cov tshuaj, tshuaj muaj pes tsawg leeg thiab cov txheej txheem ntawm kev ua. Hauv qhov no lawv tau pab los ntawm ntau phau ntawv siv thiab cov ntawv sau ua ke uas muaj cov ntaub ntawv tsim nyog. Thiab lawv cov kws sau ntawv, nyob rau hauv lem, kos kev tshoov siab los ntawm pharmacopoeia. Yog li ntawd yog dab tsi?
Definition
Pharmacopoeia yog ib phau ntawm cov ntaub ntawv tseem ceeb uas qhia cov qauv zoo ntawm cov khoom siv tshuaj, cov khoom siv, cov tshuaj tiav thiab lwm yam tshuaj siv hauv cov tshuaj.
txhawm rau tsim "tus qauv kub", cov kws tshaj lij hauv thaj chaw ntawm chemistry thiab tshuaj tshuaj ntsuam xyuas tau koom nrog, randomized thoob ntiaj teb ob qhov muag tsis pom kev tswj kev sim tau ua kom paub txog txhua yam ua tau ntawm cov khoom siv tshuaj thiab kev npaj los ntawm nws. Ua raws li tag nrho cov cai ua kom cov khoom lag luam zoo.
Lub Xeev Pharmocopoeia yog ib lub chaw muag tshuaj uas muaj kev cai lij choj thiab nyob rau hauv lub xeev saib xyuas. Cov kev cai thiab cov lus pom zoo tau teev tseg hauv nws yog kev khi rau txhua lub koom haum hauv lub tebchaws koom nrog hauv kev tsim, khaws cia, muag thiab siv tshuaj. Rau kev ua txhaum txoj cai nyob rau hauv cov ntaub ntawv, ib tug raug cai los yog ib tug neeg raug txim txhaum cai.
History of the International Pharmocopoeia
Kev xav txog kev tsim ib daim ntawv teev npe tshuaj uas qhia txog ntau npaum li cas thiab kev tsim cov npe no tau tshwm sim hauv zej zog kev kho mob tshawb fawb thaum kawg ntawm lub xyoo pua puv 19, xyoo 1874. Thawj lub rooj sib tham txog cov ntsiab lus no tau muaj nyob rau hauv Brussels xyoo 1092. Ntawm nws, cov kws tshaj lij tuaj yeem pom zoo rau cov npe ntawm cov tshuaj thiab daim ntawv ntawm lawv qhov tso tawm hauv cov tshuaj. Plaub xyoos tom qab, qhov kev pom zoo no tau pom zoo hauv nees nkaum lub tebchaws. Qhov kev vam meej no tau dhau los ua qhov pib rau kev txhim kho ntxiv ntawm cov tshuaj pharmacopoeia thiab nws cov ntawv tshaj tawm. Nees nkaum xyoo tom qab, lub rooj sib tham thib ob tau tshwm sim hauv Brussels, uas tau koom nrog cov neeg sawv cev ntawm plaub caug ib lub tebchaws hauv ntiaj teb.
Txij thaum ntawd los, kev saib xyuas ntawm kev tshaj tawm thiab kho cov tshuaj pharmacopoeia dhau mus rau Pab Koomtes ntawm Tebchaws. Thaum lub sijhawm pom zoo, daim ntawv cog lus suav nrog cov hauv paus ntsiab lus rau kev npaj tshuaj ntsuab npaj thiab koob tshuaj ntawm 77 tshuaj tshuaj. Kaum ob xyoos tom qab, nyob rau hauv 1937, ib tug commission ntawm cov kws txawj los ntawm Belgium, Denmark, Fabkis, Switzerland, lub teb chaws USA, lub Netherlands thiab Great Britain tau tsim, uas paub lawv tus kheej nrog tag nrho cov kev cai ntawm lub pharmacopoeia thiab txiav txim siab los nthuav nws mus rau ib tug thoob ntiaj teb cov ntaub ntawv..
Tsov Rog Ntiaj Teb Zaum Ob cuam tshuam kev ua haujlwm ntawm pawg thawj coj, tab sis twb dhau los lawmXyoo 1947, cov kws tshaj lij tau rov qab los ua lawv txoj haujlwm. Los ntawm 1959, lub commission tau raug hu ua Pawg Neeg Txawj Ntse ntawm Kev Qhia Tshwj Xeeb ntawm Kev Npaj Tshuaj. Ntawm ib qho ntawm WHO lub rooj sib tham, nws tau txiav txim siab los tsim ib txoj haujlwm ntawm International Generic Names los koom ua ke lub npe ntawm cov tshuaj.
Thawj Tsab
Pharmacopoeia yog ib daim ntawv thoob ntiaj teb uas twb muaj plaub tsab ntawv, thiab tom qab lawv txhua tus tau txais ib yam tshiab.
Thawj tsab tau pom zoo nyob rau hauv lub Ntiaj Teb Lub Rooj Sib Tham thib peb ntawm WHO. Ib lub chaw khaws ntaub ntawv ruaj khov ntawm International Pharmocopoeia tau tsim. Phau ntawv no tau luam tawm nyob rau hauv 1951, thiab plaub xyoos tom qab lub thib ob ntim tau luam tawm nrog ntxiv nyob rau hauv peb hom lus European: Lus Askiv, Fabkis thiab Spanish. Tom qab lub sijhawm luv luv, cov ntawv tshaj tawm tau tshwm sim hauv German thiab Japanese. Thawj cov tshuaj pharmacopoeia yog ib qho kev sau cov ntaub ntawv tswj hwm rau txhua yam tshuaj uas paub thaum lub sijhawm ntawd. Namely:
- 344 kab lus ntawm cov tshuaj tshuaj;
- 183 kab lus ntawm cov ntaub ntawv ntau npaum li cas (cov ntsiav tshuaj, tshuaj ntsiav, tinctures, kev daws hauv ampoules);
- 84 txoj hauv kev kuaj mob.
Cov nqe lus ntawm cov ntawv yog nyob rau hauv Latin, vim nws yog tib txoj kev xaiv rau txhua tus neeg ua haujlwm kho mob. Txhawm rau sau cov ntaub ntawv tsim nyog, cov kws tshaj lij hauv kev tsim cov txheej txheem lom neeg tau koom nrog, nrog rau cov kws tshwj xeeb nqaim hauv cov kab mob txaus ntshai tshaj plaws.
Cov ntawv tom ntej ntawm InternationalPharmacopoeia
thib ob tsab tshwm sim xyoo 1967. Nws tau mob siab rau kev tswj xyuas cov khoom siv tshuaj zoo. Tsis tas li ntawd, qhov yuam kev ntawm thawj tsab tau muab rau hauv tus account thiab 162 tshuaj ntxiv.
Daim ntawv thib peb ntawm cov tshuaj pharmacopoeia yog tsom rau cov tebchaws tsim. Nws tau nthuav tawm cov npe ntawm cov tshuaj uas tau siv dav hauv kev kho mob thiab tib lub sijhawm muaj tus nqi qis. Tsab ntawv no muaj tsib phau ntawv thiab tau tso tawm xyoo 1975. Kev hloov kho tshiab rau cov ntaub ntawv tsuas yog ua rau xyoo 2008. Lawv txhawj txog cov qauv tshuaj, cov txheej txheem ntawm lawv cov khoom tsim thiab kev faib tawm.
Tshuaj kho cov ntsiab lus
Pharmacopoeia yog ib phau ntawv uas tsis yog tsuas yog lub npe ntawm cov tshuaj, tab sis kuj cov lus qhia rau lawv siv, cia thiab lub hom phiaj. Phau ntawv no muaj cov lus piav qhia txog cov tshuaj chemical, lub cev thiab cov txheej txheem lom neeg ntawm kev tshuaj xyuas tshuaj. Tsis tas li ntawd, nws muaj cov ntaub ntawv hais txog cov tshuaj reagents thiab cov cim qhia, tshuaj yeeb tshuaj thiab kev npaj.
Pawg WHO tau sau cov npe tshuaj lom (daim A) thiab cov tshuaj muaj zog (npe B), nrog rau cov rooj ntawm cov tshuaj ntau tshaj ib zaug thiab txhua hnub.
YEuropean Pharmacopoeia
European Pharmacopoeia yog cov ntaub ntawv tswj hwm uas siv nyob rau hauv ntau lub tebchaws nyob sab Europe hauv kev tsim cov khoom lag luam ntawm kev sib koom nrog International Pharmacopoeia, ntxiv rau nws thiab tsom mus rau qhov peculiarities ntawm cov tshuaj hauv cheeb tsam no. Qhov noPhau ntawv no yog tsim los ntawm European Directorate for the Quality of Medicines, uas yog ib feem ntawm Council of Europe. Pharmacopoeia muaj qhov sib txawv raws li txoj cai los ntawm lwm cov ntaub ntawv zoo sib xws, uas tau muab rau nws los ntawm Pawg Thawj Kav Tebchaws. Cov lus tseem ceeb ntawm European Pharmacopoeia yog Fabkis. Qhov kawg, thib rau, rov tshaj tawm yog xyoo 2005.
National pharmacopoeias
Vim lub International Pharmacopoeia tsis muaj kev cai lij choj thiab yog qhov kev tawm tswv yim zoo, ib lub teb chaws tau tshaj tawm lub teb chaws cov tshuaj pharmacopoeias rau kev tswj hwm hauv tsev ntawm cov teeb meem tshuaj. Tam sim no, ntau lub teb chaws hauv ntiaj teb muaj cov phau ntawv tus kheej. Nyob rau hauv Russia, thawj pharmacopeia tau luam tawm nyob rau hauv 1778 nyob rau hauv Latin. Tsuas yog nees nkaum xyoo tom qab luam tawm ib hom lus Lavxias, dhau los ua thawj phau ntawv ntawm hom lus no hauv tebchaws.
Xyoo 1866, ib nrab xyoo tom qab ntawd, thawj thawj kws tshuaj Lavxias teb sab tau luam tawm. Lub 11th tsab, kawg thaum lub sij hawm lub hav zoov ntawm lub USSR, tshwm nyob rau hauv thaum ntxov nineties ntawm lub xeem caug xyoo. Kev npaj, ntxiv thiab rov muab cov ntaub ntawv siv los ua lub luag haujlwm ntawm Pawg Kws Tshuaj, tab sis tam sim no Ministry of He alth, Roszdravnadzor thiab General Medical Insurance Fund tau koom nrog qhov no nrog kev koom tes ntawm cov kws tshawb fawb hauv lub tebchaws.
State Pharmacopoeia ntawm Lavxias Federation 12th thiab 13th tsab
Nyob rau lub sijhawm uas lub xeev cov tshuaj pharmacopoeia raug hloov kho, cov tshuaj zoo tau tswj hwm los ntawm cov khoom muag tshuaj ntawm lub tuam txhab (FSP)thiab General Pharmopoeial Articles (GPM). Kaum ob tsab ntawm Lub Xeev Pharmacopoeia ntawm Lavxias Federation tau cuam tshuam los ntawm qhov tseeb tias cov kws tshaj lij Lavxias tau koom nrog hauv kev ua haujlwm ntawm Commission ntawm European Pharmacopoeia. Daim ntawv thib kaum ob muaj tsib ntu, txhua qhov suav nrog cov qauv tsim thiab cov kev cai rau kev tsim khoom, tshuaj lossis muag tshuaj. Phau ntawv no tau luam tawm xyoo 2009.
Rau xyoo tom qab, tsab ntawv kaum ob tau hloov kho. Thaum kawg ntawm 2015, Lub Xeev Pharmacopoeia, 13th tsab, tau tshwm sim ntawm lub vev xaib raug cai ntawm Ministry of He alth ntawm Lavxias Federation. Nws yog ib qho khoom siv hluav taws xob, txij li qhov kev tso tawm tau ua tiav ntawm kev siv nyiaj los ntawm kev muag khoom. Yog li ntawd, nyob rau theem kev cai lij choj, nws tau txiav txim siab tias txhua lub tsev muag tshuaj thiab cov muag khoom yuav tsum muaj lub xeev pharmacopoeia (13th tsab). Qhov no ua rau phau ntawv them nyiaj rau nws tus kheej.
Dab tsi yog monograph?
Muaj ob hom tshuaj kws tshuaj: rau cov tshuaj thiab rau daim ntawv noj tshuaj tiav. Txhua tsab xov xwm "ntawm cov khoom" muaj ib lub npe nyob rau hauv ob hom lus: Lavxias teb sab thiab Latin, thoob ntiaj teb tsis yog tswv cuab thiab tshuaj lub npe. Nws muaj cov qauv empirical thiab cov qauv, qhov hnyav molecular thiab tus nqi ntawm cov khoom tseem ceeb. Tsis tas li ntawd, muaj cov lus piav qhia ntxaws txog cov tsos mob ntawm cov tshuaj, cov txheej txheem tswj kom zoo, solubility hauv cov kua, thiab lwm yam khoom ntawm lub cev thiab tshuaj. Cov nqe lus ntawm kev ntim khoom, kev tsim khoom, kev cia khoom thiab kev thauj mus los tau raug teev tseg. TABSIShnub tas sij hawm.
Cov kab lus rau daim ntawv ua tiav, ntxiv rau tag nrho cov saum toj no, muaj cov txiaj ntsig ntawm kev kuaj mob thiab kev sim, kev tso cai sib txawv hauv pawg, ntim thiab qhov loj me ntawm cov tshuaj, nrog rau qhov siab tshaj plaws ib leeg. thiab noj txhua hnub rau cov menyuam yaus thiab cov neeg laus.
