CarboxymethylcellSelcellse (CMC) Igicapo kikoreshwa cyane mu nganda zitandukanye, harimo ibiryo, imiti, kwisiga, no gukora. Umutungo wacyo wo mumicoma ukora agaciro nkumukozi wijimye, stabilizer, emalifier, nibindi byinshi. Ubuyobozi bw'ibiyobyabwenge n'ibiyobyabwenge (FDA) bigira uruhare runini mu gukoresha umutekano no gukoresha umutekano no gukoresha nk'ibyo bice, tubike bahura n'ibipimo ngenderwaho mbere yuko byemezwa ko bikoreshwa mu bicuruzwa by'abaguzi.
Gusobanukirwa CARBoxymethylcellsellse (CMC)
Carboxymethylcellse, akenshi ihwanye na CMC, ni ukomoka kuri selile. Cellulose nicyo kinyuranyo kinini ku isi kandi kiboneka mu rukuta rw'Akagari z'ibimera, bitanga inkunga y'imiterere. CMC ikomoka kuri Celeulose binyuze mu nzira yo guhindura imiti irimo gushyiraho amatsinda ya Carboxymethyl kuri selile. Iyi miterere itanga imitungo myinshi yingirakamaro kuri CMC, harimo no kwikebagura amazi, viccosity, no gutuza.
Imitungo ya Carboxymethylcellsells:
Amazi yonyine: CMC irashonje mumazi, ikora igisubizo kiboneye, viscous. Uyu mutungo utuma ari ingirakamaro muburyo butandukanye aho hakenewe umubyimba cyangwa guhagarara neza.
Viscosity: CMC yerekana imyitwarire ya pseudoplastique, bivuze ko viscosity yagabanutse munsi yo guhangayika kandi yongeye kwiyongera iyo imihangayiko ikuweho. Uyu mutungo wemerera gusaba byoroshye muburyo nko kuvoma, gutera, cyangwa kugenda.
Guhagarara: CMC itanga ituze kuri emulsions no guhagarikwa, gukumira ibikoresho byo gutandukanya cyangwa gutura mugihe. Uku gushikama ni ngombwa mubicuruzwa nka salade imyambarire, kwisiga, hamwe nibihagarikwa ya farumasi.
Ifishi ya Filime: CMC irashobora gukora film yoroheje, yoroshye iyo yumye, bigatuma ari ingirakamaro mubisabwa nkibikoresho biribwa kubinini cyangwa capsules, no mumusaruro wibikoresho byo gupakira.
Gusaba Carboxymethylcellsellse
CMC isanga ikoreshwa cyane mu nganda zitandukanye kubera imitungo yacyo itandukanye. Porogaramu zimwe na zimwe zirimo:
Inganda zibiribwa: CMC ikoreshwa nkuwabyimbye, stabilizer, na binder mubicuruzwa byinshi byibiribwa, harimo isosi, imyambarire, ice cream, n'ibinyobwa. Ifasha kunoza imiterere, umunwa, no gushikama.
Ibikoresho bya faruzi: Muri faruceuticals, CMC ikoreshwa nka bunder muri tablet igamije, ubunini mu guhagarikwa, hamwe nintangarugero mu mayoko. Iremeza ibiyobyabwenge kimwe no kuzamura umurwayi.
Amavuta yo kwisiga hamwe nibicuruzwa byita ku giti cye: CMC ikoreshwa mu kwisiga no kwita ku buryo bwita ku giti cye nko guhangayikishwa, amavuta, shampoos, emalsifiersPaner, na stabilizeri. Ifasha gukomeza guhuza ibicuruzwa kandi bitezimbere imikorere.
Gusaba inganda: CMC ikoreshwa muburyo butandukanye bwinganda nkumunyamaguru, abashinzwe kugumana amazi, hamwe nuburyo bwo guhindura ibintu mubicuruzwa nkibikoresho, amarangi, no gucukura, no gucukura, no gucukura.
Gahunda yo Kwemerera FDA
Muri Amerika, FDA igenga gukoresha inyongeramusaruro, harimo na CMC, munsi y'ibiryo bya federasiyo, ibiyobyabwenge, hamwe n'ibikorwa by'ibiryo (FD & C. PRO Carendike ni ukureba ko ibintu wongeyeho ibiryo bifite umutekano kugirango unywe kandi ukorere intego nziza.
Gahunda yo Kwemerera FDA yo kwishyiriraho ibiryo mubisanzwe bikubiyemo intambwe zikurikira:
Isuzuma ryumutekano: uwabikoze cyangwa utanga ibiryo byikunzwe ninshingano byo kuyobora ubushakashatsi bwumutekano kugirango yerekane ko ibintu bifite umutekano kubikoreshwa. Ubu bushakashatsi burimo isuzumabumenyi rya vaxicologiya, ubushakashatsi kuri metabolism, kandi bushobora kubaho allergenicity.
Gutanga ibiryo byongeweho: Uyu wabikoze ashyikiriza ibiryo (FAP) kuri FDA, gutanga amakuru arambuye kuri prongation, ibigize, imikorere, ikoreshwa, ikoreshwa ryumutekano. Icyifuzo kigomba kandi gushiramo ibisabwa bitangwa.
Gusubiramo FDA: FDA isuzuma amakuru yumutekano yatanzwe muri FAP kugirango umenye niba akomangoweho ufite umutekano kubijyanye no gukoreshwa mubihe bikoreshwa biteganijwe na penetioner. Iri suzuma ririmo gusuzuma ingaruka zishobora kubaho kubuzima bwabantu, harimo urwego rwo kwerekana hamwe ningaruka mbi zizwi.
Gutangaza amabwiriza asabwa: Niba FDA igena ko akorwa ari umutekano, bisohora amabwiriza yatanzwe mu gitabo cyatanzwe, kigaragaza ibihe byo kongeramo mu biryo. Iki gitabo cyemerera ibitekerezo rusange no kwinjiza abafatanyabikorwa.
Amabwiriza ya nyuma: Nyuma yo gusuzuma ibitekerezo bya leta hamwe namakuru yinyongera, ibibazo bya FDA ku itegeko rya nyuma ryemeza cyangwa guhakana ikoreshwa ryibiryo. Niba byemejwe, ubutegetsi bwa nyuma bushyiraho imiterere ifatika yo gukoresha, harimo imipaka, ibisobanuro, cyangwa ibisabwa bisabwa.
Carboxymethylcellsellse na FDA
Carboxymethylcellse ifite amateka maremare yo gukoresha munganda zibiribwa nizindi nzego, kandi muri rusange, kandi muri rusange izwiho umutekano (Gras) kubigenewe bikoreshwa mugukora ibikorwa byiza. FDA yatanze amabwiriza n'amabwiriza yihariye agenga imikoreshereze ya CMC mu biribwa n'ibicuruzwa.
Amabwiriza ya FDA ya Carboxymethylcellselcellse:
Imiterere yo kongeramo ibiryo: Carboxymethylcellses yashyizwe ku rutonde nk'ibiribwa byemewe mu ngingo ya 172.CAR) munsi y'ingingo ya 172.CE 8672, hamwe n'amabwiriza yihariye yagaragaye ko yakoresheje mu byiciro bitandukanye. Aya mabwiriza agaragaza urwego ntarengwa rwa CMC mubicuruzwa bitandukanye nibindi bisabwa.
Gukoresha imiti: Muri faruceticals, CMC ikoreshwa nkibikoresho bidakora mubiyobyabwenge, kandi imikoreshereze yayo igengwa nisuzuma ryibiyobyabwenge nubushakashatsi (Cder). Abakora bagomba kwemeza ko CMC yujuje ibisobanuro byavuzwe muri Pharmacoia zunze ubumwe za Amerika (USP) cyangwa izindi ngaruka zijyanye.
Ibisabwa bisabwa: Ibicuruzwa birimo CMC nkikintu kigomba kubahiriza Amabwiriza ya FDA yerekeranye na labeling, harimo urutonde rwose na allergen.
CarboxymethylcellSelcellse (CMC) ni ikigo gikoreshwa cyane hamwe n'ibisabwa bitandukanye mu biryo, imiti, kwisiga, kwisiga, no gukora inganda. Umutungo wacyo wihariye ukora agaciro nka Thuckener, Stabilizer, Emalifier, na Binder mubicuruzwa bitandukanye. FDA igira uruhare rukomeye mu kugenzura umutekano no gukoresha CMC hamwe n'izindi ngendo z'ibiribwa, kureba ko bahura n'ibipimo by'umutekano bidakomeye mbere yuko byemezwa gukoreshwa mu bicuruzwa by'abaguzi. CMC yerekana ibiryo byemewe na FDA, kandi imikoreshereze yayo igengwa namabwiriza yihariye namabwiriza avugwa mu mutwe wa 21 wubuyobozi bwamategeko ya federale. Abakora nibicuruzwa birimo CMC bagomba kubahiriza aya mabwiriza, harimo no gusuzuma umutekano, ibisabwa biranga, nibisabwa byihariye, kugirango umutekano wabo wibazwe.
Igihe cyohereza: Werurwe-22-2024