Carboxymethylcellulose (CMC) ni uruganda rutandukanye rukoreshwa cyane mu nganda zitandukanye, harimo ibiryo, imiti, amavuta yo kwisiga, n’inganda.Imiterere yimikorere myinshi itanga agaciro nkigikoresho cyo kubyimba, stabilisateur, emulifier, nibindi byinshi.Ikigo cy’Amerika gishinzwe ibiryo n’ibiyobyabwenge (FDA) gifite uruhare runini mu kugenzura umutekano n’imikoreshereze y’ibi bikoresho, kureba ko byujuje ubuziranenge mbere yuko byemezwa gukoreshwa mu bicuruzwa by’umuguzi.
Gusobanukirwa Carboxymethylcellulose (CMC)
Carboxymethylcellulose, ikunze kwitwa CMC, ikomoka kuri selile.Cellulose ni uruganda rwinshi cyane ku isi kandi ruboneka mu rukuta rw'utugingo ngengabuzima, rutanga ubufasha bw'imiterere.CMC ikomoka kuri selile ikoresheje uburyo bwo guhindura imiti ikubiyemo kwinjiza amatsinda ya carboxymethyl kumugongo wa selile.Ihinduka ritanga ibintu byinshi byingirakamaro kuri CMC, harimo gukemura amazi, ubwiza, no gutuza.
Ibyiza bya Carboxymethylcellulose:
Amazi meza: CMC irashonga mumazi, ikora igisubizo gisobanutse neza.Uyu mutungo utuma ugira akamaro mubikorwa bitandukanye aho hasabwa umubyimba cyangwa gutuza.
Viscosity: CMC yerekana imyitwarire ya pseudoplastique, bivuze ko ububobere bwayo bugabanuka mugihe cyogosha kandi bikongera kwiyongera mugihe imihangayiko ikuweho.Uyu mutungo utuma porogaramu yoroshye mubikorwa nko kuvoma, gutera, cyangwa gukuramo.
Igihagararo: CMC itanga ituze kuri emulisiyo no guhagarikwa, ikabuza ibigize gutandukana cyangwa gutura mugihe runaka.Uku gushikama ningirakamaro mubicuruzwa nko kwambara salade, kwisiga, no guhagarika imiti.
Gukora firime: CMC irashobora gukora firime yoroheje, yoroheje iyo yumye, ikagira akamaro mubisabwa nko gutwika ibiryo bya tableti cyangwa capsules, no mugukora firime zo gupakira ibikoresho.
Porogaramu ya Carboxymethylcellulose
CMC isanga ikoreshwa cyane mu nganda zinyuranye bitewe nuburyo butandukanye.Porogaramu zimwe zisanzwe zirimo:
Inganda zikora ibiribwa: CMC ikoreshwa nkibibyimbye, stabilisateur, na binder mubicuruzwa byinshi byibiribwa, birimo isosi, imyambarire, ice cream, imigati, n'ibinyobwa.Ifasha kunoza imiterere, umunwa, hamwe no gutekana neza.
Imiti ya farumasi: Muri farumasi, CMC ikoreshwa nkumuhuza mugutegura ibinini, kubyimbye mubihagarikwa, hamwe na stabilisateur muri emulisiyo.Iremeza gukwirakwiza ibiyobyabwenge kimwe kandi byongera kubahiriza abarwayi.
Amavuta yo kwisiga hamwe n’ibicuruzwa byita ku muntu: CMC ikoreshwa mu kwisiga no mu bicuruzwa byita ku muntu nka amavuta yo kwisiga, amavuta, shampo, hamwe n’amenyo y’amenyo nkibyimbye, emulisiferi, na stabilisateur.Ifasha kugumya ibicuruzwa no kunoza imikorere.
Inganda zikoreshwa mu nganda: CMC ikoreshwa mubikorwa bitandukanye byinganda nkibibyimbye, bigumana amazi, hamwe na rheologiya ihindura ibicuruzwa nkibikoresho byo kwisiga, amarangi, ibifunga, hamwe namazi yo gucukura.
Inzira yo Kwemeza FDA
Muri Amerika, FDA igenga ikoreshwa ry'inyongeramusaruro y'ibiribwa, harimo ibintu nka CMC, hashingiwe ku itegeko ry’ibiribwa, ibiyobyabwenge, no kwisiga (FD&C Act) hamwe n'ivugururwa ry'ibiribwa byo mu 1958. Ikibazo cya FDA gihangayikishije ni ukureba niba ibintu wongeyeho ibiryo ni byiza kubikoresha kandi bitanga intego nziza.
Gahunda yo kwemeza FDA kubongerera ibiryo mubisanzwe ikubiyemo intambwe zikurikira:
Isuzuma ry'umutekano: Uwakoze cyangwa utanga ibiryo byongera ibiryo ashinzwe gukora ubushakashatsi bwumutekano kugirango yerekane ko ibintu bifite umutekano kubikoresha.Ubu bushakashatsi burimo gusuzuma uburozi, ubushakashatsi kuri metabolism, hamwe na allergique ishobora kuba.
Gutanga icyifuzo cyo kongeramo ibiryo: Uruganda rutanga ibyifuzo byongera ibiryo (FAP) muri FDA, bitanga amakuru arambuye kubiranga, ibiyigize, inzira yo gukora, kubikoresha, hamwe namakuru yumutekano yinyongera.Icyifuzo kigomba kandi kuba gikubiyemo ibisabwa byashyizweho ikimenyetso.
Isubiramo rya FDA: FDA isuzuma amakuru yumutekano yatanzwe muri FAP kugirango hamenyekane niba inyongeramusaruro itekanye kugirango ikoreshwe mugihe cyogukoresha cyagenwe nuwasabye.Iri suzuma ririmo gusuzuma ingaruka zishobora guhungabanya ubuzima bwabantu, harimo urwego rugaragaramo ningaruka zose zizwi.
Itangazwa ry'amabwiriza yatanzwe: Niba FDA yemeje ko inyongeramusaruro ifite umutekano, itangaza amabwiriza yatanzwe mu gitabo cya Leta, agaragaza imiterere ishobora gukoreshwa mu biribwa.Iki gitabo cyemerera ibitekerezo rusange no gutanga ibitekerezo kubafatanyabikorwa.
Gufata ibyemezo bya nyuma: Nyuma yo gusuzuma ibitekerezo rusange hamwe namakuru yinyongera, FDA itanga itegeko rya nyuma haba kwemeza cyangwa guhakana ikoreshwa ryinyongera mubiryo.Niba byemejwe, itegeko rya nyuma rishyiraho uburyo bwemewe bwo gukoresha, harimo imbogamizi zose, ibisobanuro, cyangwa ibimenyetso bisabwa.
Carboxymethylcellulose na FDA
Carboxymethylcellulose ifite amateka maremare yo gukoresha mu nganda z’ibiribwa no mu zindi nzego, kandi muri rusange izwi nk’umutekano (GRAS) kubyo igenewe iyo ikoreshejwe ikurikije uburyo bwiza bwo gukora.FDA yatanze amabwiriza n'amabwiriza yihariye agenga ikoreshwa rya CMC mu biribwa n'ibicuruzwa bya farumasi.
FDA Amabwiriza ya Carboxymethylcellulose:
Imiterere y'ibiribwa: Carboxymethylcellulose yashyizwe ku rutonde nk'inyongeramusaruro yemewe mu mutwe wa 21 w'igitabo cy'amategeko ngengamikorere (CFR) hakurikijwe ingingo ya 172.Kode 8672, hamwe n'amabwiriza yihariye agaragara kugira ngo akoreshwe mu byiciro bitandukanye by'ibiribwa.Aya mabwiriza agaragaza urwego ntarengwa rwemewe rwa CMC mubicuruzwa bitandukanye byibiribwa nibindi bisabwa byose.
Gukoresha imiti: Muri farumasi, CMC ikoreshwa nkibintu bidakora muburyo bwo gufata imiti, kandi imikoreshereze yayo igengwa n’ikigo cya FDA gishinzwe gusuzuma no gusuzuma ibiyobyabwenge (CDER).Ababikora bagomba kwemeza ko CMC yujuje ibisobanuro byavuzwe muri Reta zunzubumwe za Amerika Pharmacopeia (USP) cyangwa izindi compendia.
Ibisabwa Ibirango: Ibicuruzwa birimo CMC nkibigize bigomba kubahiriza amabwiriza ya FDA yerekeranye no gushyiramo ikimenyetso, harimo urutonde rwibintu nyabyo hamwe na label ya allerge isabwa.
Carboxymethylcellulose (CMC) ni uruganda rukoreshwa cyane hamwe nuburyo butandukanye mubiribwa, imiti, amavuta yo kwisiga, ninganda.Imiterere yihariye itanga agaciro nkibibyimbye, stabilisateur, emulifier, na binder mubicuruzwa bitandukanye.FDA igira uruhare runini mu kugenzura umutekano n’imikoreshereze ya CMC n’ibindi byongera ibiribwa, ikemeza ko byujuje ubuziranenge bw’umutekano mbere yuko byemezwa gukoreshwa mu bicuruzwa by’umuguzi.CMC yashyizwe ku rutonde nk'inyongeramusaruro yemewe na FDA, kandi imikoreshereze yayo igengwa n'amabwiriza n'amabwiriza yihariye agaragara mu mutwe wa 21 w'igitabo cy'amategeko ngengamikorere.Abakora ibicuruzwa nabatanga ibicuruzwa birimo CMC bagomba kubahiriza aya mabwiriza, harimo gusuzuma umutekano, ibisabwa byanditse, hamwe nuburyo bukoreshwa kugirango babungabunge umutekano nubuziranenge bwibicuruzwa byabo.
Igihe cyo kohereza: Werurwe-22-2024