I-pharmacopoeia yintoni? I-Pharmacopeia: inkcazo, imbali, umxholo

Yintoni i-pharmopia? Ukuba uqala ukusuka kude, ngoko ngokuqinisekileyo umntu ngamnye ubuncinane wabuya ekhumbula ukuba oogqirha bakwazi ukukhumbula njani iziyobisi ezininzi, bazi i-dosage, i-chemical and mechanism of action. Kule nto bancedwa yiinkcukacha ezininzi kunye neenkomfa eziqulethe ulwazi oluyimfuneko. Kwaye ababhali babo, bafumana ukuphefumlelwa kwi-pharmacopoeia. Ngoko yintoni le?

Inkcazo

I-Pharmacopoeia yiqoqo leemibhalo ezisemthethweni ezibonisa imilinganiselo esemgangathweni yamachiza okuvelisa amayeza, i-excipients, amayeza alungiselelwe kunye namanye amayeza asetyenziswayo kwiyeza.

Ukuseka "umgangatho wegolide" ukhangela iingcali kwiinkcukacha zechemistry kunye nohlalutyo lwamachiza, ukuqhuba izifundo ezilawulwa ngokungaqhelekanga eziphindwe kabini ukufumana konke okusemandleni malunga nezinto zokwenza imichiza kunye namalungiselelo avela kuwo. Ukuthotyelwa kuyo yonke imigangatho kuqinisekisa umgangatho wemveliso yeyeza.

I-State Pharmacopoeia yi-pharmacopoeia enegunya lomthetho kwaye iphantsi kwe-supervision yelizwe. Iimfuno kunye neziphakamiso ezichazwe kuyo zibophezela yonke imibutho yelizwe isebenze ekuveliseni, ukugcinwa, ukuthengiswa nokusetyenziswa kwamachiza. Ngenxa yokwephulwa kwemithetho echanekileyo kumqulu, umntu osemthethweni okanye ngokomzimba ubhekene noxanduva lolwaphulo-mthetho.

Imbali ye-International Pharmacopoeia

Iingcamango zokudala uluhlu olulodwa lweziyobisi ngokubonakaliswa kwamanani kunye nokumiselwa kwemilinganiselo ye-nomenclature yabonakala kwizonyango zenzululwazi ngasekupheleni kwekhulu le-18, ngo-1874. Ingqungquthela yokuqala kulo mbandela ibanjelwe eBrussels ngo-1092. Kulo, iingcali zafika kwisivumelwano malunga namagama aqhelekileyo kwizilwanyana kunye nefom yokukhutshwa kwabo kwimimiselo. Kwiminyaka emine, le mvumelwano yavunyelwana kumazwe angamashumi amabini. Le mpu melelo yayiyindawo yokuqala yokuphuhliswa kwe-pharmacopeia kunye nokupapashwa kwayo. Iminyaka engamashumi amabini kamva, inkomfa yesibini yabanjelwa eBrussels, yabakholwa ngabameli bamazwe angama-40 ehlabathini.

Ukususela ngeli xesha, ukukhathazeka ngokupapashwa nokuhlaziywa kwe-pharmacopoeia kuye kwadlulela kwi-League of Nations. Ngexesha lesivumelwano, imigaqo yokulungiselela ama-galenic kunye nomthamo wamayeza angama-77 afakwe kwi-compendium. Kwiminyaka elishumi elinesibini kamva, ngowe-1937, ikhomishishini yecandelo laqulunqwa esuka eBelgium, eDenmark, eFransi, eSwitzerland, e-United States, e-Netherlands nase-United Kingdom, ezazifundela zonke izibonelelo ze-pharmacopoeia zaze zagqiba ekubeni zithunyelwe kwixwebhu lomhlaba jikelele.

Imfazwe Yehlabathi Yesibili yaphazamisa umsebenzi wekhomishini, kodwa sele sele ivele ngo-1947 iingcali zabuyela emsebenzini wazo. Ngomnyaka wamashumi amahlanu anesithoba, ikhomishoni yayibizwa ngokuba yikomiti yeengcali kwiinkcukacha zamalungiselelo amayeza. Kwisinye seentlanganiso ze-WHO, kwagqitywa ekubeni kuvelwe inkqubo yeeNkcukacha zamazwe angaphandle aMaxabiso aMaZiko okuNxulumanisa iSiNetywina seMida.

Uhlobo lo kuqala

I-pharmacopoeia ngumqulu wamazwe ngamazwe, owawunezinto ezine eziphindiweyo, kwaye emva kokuba ngamnye efumana into entsha.

Upapasho lokuqala luvunyiwe kwiNdibano yesithathu ye-WHO. Ubunobhala obunaphakade be-Pharmacopoeia yamazwe ngamazwe wasungulwa. Le ncwadi yanyatheliswa ngo-1951, kwaye emva kweminyaka emine umqulu wesibini wanyatheliswa ngezinye iilwimi ezithethiweyo ezintathu eYurophu: isiNgesi, isiFrentshi neSpanish. Emva kwexesha elifutshane kwakukho iimpapasho zesiJamani kunye nesiJapane. I-pharmacopeia yokuqala kukuqokelelwa kwamaxwebhu aqhelekileyo kuzo zonke iziyobisi ezaziwayo ngelo xesha. Ngalo:

• 344 amanqaku malunga neyeza;
• Amanqaku angama-183 kwiifom zeesayiti (iipilisi, iifomsile, izithambiso, izisombululo kwi-ampoules);
• Iindlela ezili-84 zokuxilongwa kwebhubhoratri.

Izihloko zala manqaku ziseLatini, njengoko kwakuyindlela efanayo ukuba bonke abasebenzi bezonyango bazikhethe. Ukuqokelela ulwazi oluyimfuneko, iingcali zibandakanyeke kwimigangatho yezinto eziphilayo, kunye neengcali ezincinci kwizifo eziphelileyo kunye neziyingozi.

Iingxelo ezilandelayo ze-International Pharmacopoeia

Inkqubo yesibini yabonakala ngo-1967. Yayizinikele ekulawuleni umgangatho weemveliso zonyango. Ukongezelela, iimpazamo zohlelo lokuqala zaqwalaselwa kwaye kwalungiselelwa amalungiselelo angu-162.

Uhlobo lwesithathu lwe-pharmacopoeia lujoliswe kumazwe asakhulayo. Kwakuqulethe uluhlu lwezinto ezisetyenziswa kakhulu kwiinkonzo zempilo kwaye ngelo xesha zineendleko eziphantsi. Olu hlobo luqulethe imiqulu emihlanu kwaye lukhutshwe ngo-1975. Ulungiso olutsha kumqulu lwenziwe kuphela ngo-2008. Baye bakhathalela ukusetyenziswa kwamachiza, iindlela zokuvelisa nokusabalalisa kwazo.

Okubhalwe kwi-pharmacopoeia

I-Pharmacopoeia yincwadi edibanisa kuphela isiqununu sezokwelapha, kodwa kunye nemiyalelo yokwenza kwabo, ukugcinwa kunye nokuphathwa. Le ncwadi iqulethe inkcazo yeekhemikhali, iindlela zokuzihlaziya iziyobisi. Ukongezelela, iqulethe ulwazi malunga nezigulane kunye nezikhombisi, izinto zokwelapha kunye namalungiselelo.

IKomidi ye-WHO iqulethe uluhlu lweetyhefu (uluhlu A) kunye nezinto ezinamandla (Uluhlu B), kwakunye neetafile zonyango oluqhelekileyo kunye nosuku lwezilwanyana.

I-European Pharmacopoeia

I-European Pharmacopoeia ngumqulu osemgangathweni osetyenziswa kumazwe amaninzi aseYurophu kwinkqubo yokuvelisa iimveliso zogcino kwi-International Pharmacopoeia, igqibezele kwaye igxile kwiinkalo ezithile zemichiza kule ndawo. Le ncwadi yasungulwa yiCandelo loMlawuli waseYurophu kwiMigangatho yeMithi, eyinxalenye yeBhunga laseYurophu. I-pharmacopeia ineemeko zomthetho ezahlukileyo kwamanye amaxwebhu afanayo, anikezelwa yiKhabhinethi yabaPhathiswa. Ulwimi olusemthethweni lwe-European pharmacopoeia yiFrentshi. Eyokugqibela, yesithandathu, ukuphindwa kwakhona kwaba ngowama-2005.

National Pharmacopoeias

Ekubeni i-Pharmacopoeia yamazwe ngamazwe ayibophezele ngokomthetho kwaye iyancomeka ngokubanzi, amazwe ngamazwe akhuphe i-pharmacopoeias kazwelonke ekulawuleni kwezinto ezinxulumene neziyobisi. Ngeli xesha amaninzi amazwe ehlabathini aneencwadi ezithile. ERashiya, i-pharmacopoeia yokuqala yakhishwa ngo-1778 ngesiLatini. Emva kweminyaka engamashumi amabini kwaphuma inguqulelo yesiRashiya, ibe yincwadi yokuqala yolu hlobo ngolwimi lwesizwe.

Ngo-1866, isiqingatha kwinkulungwane kamva, i-pharmopia yaseburusiya yokuqala yaseburusiya yapapashwa. Umqulu we-11, owokugqibela ngexesha lobukho be-USSR, wabonakala kwiminyaka emashumi asithoba ekhulwini lokugqibela. Ukuhlanganiswa, ukudibanisa kunye nokuphinda kukhishwe kwakhona kwiphepha ngaphambili kwanikwa iKomiti ye-Pharmacopoeia, kodwa ngoku uMphathiswa wezeMpilo, uRossznvnadzor kunye neNgxowa-mali yeNkxaso-mali ye-General Medical Fund baxhomekeke kule nto, ngokubandakanyeka koososayensi beli lizwe.

I-State Pharmacopoeia ye-Russian Federation 12 ne-13

Ngexesha apho i-pharmacopoeia yombuso ilungisiwe, umgangatho wamachiza wawulawulwa ngamacandelo e-pharmacopoeial ye-enterprise (FSP) kunye namaqumrhu e-pharmacopoeial (FBS) jikelele. Inkqubo yeshumi elinesibini ye-pharmacopoeia yaseburhulumenteni yaseRussia yayishukunyiswa kakhulu kukuba iingcali zeRashiya zabandakanyeka emsebenzini weKhomishoni yase-European Pharmacopoeia. Umqulu weshumi elinesibini unamalungu amahlanu, ngalinye elo libandakanya imigangatho ephantsi kunye nemigangatho emiselweyo yokuvelisa, injongo okanye ukuthengiswa kwamayeza. Le ncwadi yashicilelwa ngo-2009.

Kwiminyaka emithandathu kamva kwiphepha lelishumi elinesibini. Ekupheleni kuka-2015 kwiwebhusayithi esemthethweni yoLawulo loMphathiswa wezeMpilo yaseRussia kwakukho i-pharmacopeia yelizwe - ingu-13. Le ndlela yayiyikhompyutha, ekubeni ukukhululwa kwenziwa ngexabiso lemali ekuthengisweni. Ngoko ke, kwinqanaba lezomthetho, kwamkelwa ukuba yonke ishishini lokurhweba kunye ne-wholesale trade should have a pharmacopeia (state 13). Oku kwenza ukuba le ncwadi ihlawule ngokuzimela.

Iyiphi inqaku le-pharmacopoeial?

Kukho ezimbini iintlobo zamanqaku e- pharmopoeial: i-substance kunye nefom yefayili egqityiweyo. Inqaku ngalinye "kwizinto eziphathekayo" linalo ngeelwimi ezimbini: isiRashiya nesiLatini, igama elingazimeliyo kunye nekhempi. Ibonisa amafomula amacwecwe kunye nesakhiwo, ubunzima be-molecular kunye nesixa sezinto ezisetyenziswayo. Ukongezelela, kukho inkcazo ecacileyo yokubonakala kwento yeziyobisi, imilinganiselo yokulawula umgangatho, ukuchithwa kwamanzi kunye nezixhobo ezithile zomzimba kunye namachiza. Imiqathango yokupakisha, ukukhiqizwa, ukugcinwa kunye nokuthutha ichazwe. Kwakhona umhla wokuphela.

Ifom yefom yefayili egqityiweyo, ngaphezu kwayo yonke ingentla, iqulethe iziphumo zeemvavanyo zonyango kunye neelabhoratri, iimimiselo ezivumelekileyo zokuphuka komlinganiselo, umthamo kunye nobukhulu beengcambu zeziyobisi, kwakunye neyona mihla ephezulu kunye neyonke imihla ngemihla yabantwana kunye nabantu abadala.