I-Carboxymethylcellulose (CMC) iyinhlanganisela eguquguqukayo esetshenziswa kabanzi ezimbonini ezahlukahlukene, kufaka phakathi ukudla, ezemithi, izimonyo kanye nokukhiqiza.Izakhiwo zayo ezinemisebenzi eminingi ziyenza ibe yigugu njenge-ejenti yokuqina, i-stabilizer, i-emulsifier, nokunye.I-United States Food and Drug Administration (FDA) idlala indima ebalulekile ekulawuleni ukuphepha nokusetshenziswa kwezinhlanganisela ezinjalo, iqinisekisa ukuthi zihlangabezana nezindinganiso eziqinile ngaphambi kokuba zigunyazwe ukusetshenziswa emikhiqizweni yabathengi.
Ukuqonda i-Carboxymethylcellulose (CMC)
I-Carboxymethylcellulose, evame ukufushaniswa njenge-CMC, iphuma ku-cellulose.I-Cellulose iyinhlanganisela yezinto eziphilayo egcwele kakhulu eMhlabeni futhi itholakala ezindongeni zamangqamuzana ezitshalo, inikeza ukusekelwa kwesakhiwo.I-CMC isuselwa ku-cellulose ngenqubo yokuguqulwa kwamakhemikhali efaka ukwethulwa kwamaqembu e-carboxymethyl kumgogodla we-cellulose.Lokhu kuguqulwa kunikeza izici ezimbalwa eziwusizo ku-CMC, okuhlanganisa ukuncibilika kwamanzi, i-viscosity, nokuzinza.
Izici ze-Carboxymethylcellulose:
Ukunyibilika kwamanzi: I-CMC iyancibilika emanzini, yakha isixazululo esicacile, esibonakalayo.Lesi sakhiwo sikwenza kube usizo ezinhlelweni ezahlukahlukene lapho kudingeka khona i-ejenti yokuqina noma yokusimamisa.
I-Viscosity: I-CMC ibonisa ukuziphatha kwe-pseudoplastic, okusho ukuthi i-viscosity yayo iyancipha ngaphansi kwengcindezi ye-shear futhi iyanda futhi lapho ingcindezi isusiwe.Lesi sakhiwo sivumela ukusetshenziswa okulula ezinqubweni ezifana nokumpompa, ukufutha, noma ukukhipha.
Ukuzinza: I-CMC inika ukuzinza kuma-emulsion kanye nokumiswa, ukuvimbela izithako ukuthi zihlukanise noma zihlale ngokuhamba kwesikhathi.Lokhu kuzinza kubalulekile emikhiqizweni efana nezingubo zesaladi, izimonyo, nokumiswa okwesikhashana kwemithi.
Ukwakhiwa Kwefilimu: I-CMC ingakha amafilimu amancanyana, aguqukayo uma omisiwe, okuwenza abe wusizo ezinhlelweni ezifana nezingubo ezidliwayo zamaphilisi noma amaphilisi, nasekukhiqizeni amafilimu ezinto zokupakisha.
Ukusetshenziswa kweCarboxymethylcellulose
I-CMC ithola ukusetshenziswa okusabalele kuzo zonke izimboni ezahlukahlukene ngenxa yezakhiwo zayo eziguquguqukayo.Ezinye izinhlelo zokusebenza ezijwayelekile zifaka:
Imboni Yokudla: I-CMC isetshenziswa njenge-thickener, stabilizer, kanye ne-binder emikhiqizweni eminingi yokudla, okuhlanganisa amasoso, okokugqoka, u-ayisikhilimu, izinto zokubhaka, neziphuzo.Isiza ukuthuthukisa ukuthungwa, ukuzwakala komlomo, nokuzinza kweshalofu.
Ezemithi: Kwezemithi, i-CMC isetshenziswa njengesihlanganisi ekwakhiweni kwamathebulethi, i-thickener ekumisweni, kanye nesiqinisi kuma-emulsions.Iqinisekisa ukusatshalaliswa kwezidakamizwa okufanayo futhi ithuthukisa ukuthobela kwesiguli.
Izimonyo Nemikhiqizo Yokunakekelwa Komuntu Siqu: I-CMC iqashwe kuzimonyo nemikhiqizo yokunakekela umuntu siqu efana nezigcobo, okhilimu, ama-shampoos, nomuthi wokuxubha amazinyo njengento ejiyayo, i-emulsifier, ne-stabilizer.Isiza ukugcina ukungaguquguquki komkhiqizo futhi ithuthukisa ukusebenza.
Izicelo Zezimboni: I-CMC isetshenziswa ezinqubweni ezehlukene zezimboni njenge-thickener, i-ejenti yokugcinwa kwamanzi, nesilungisi se-rheology emikhiqizweni efana nezihlanzi, amapende, izinto ezinamathelayo, noketshezi lokumba.
Inqubo Yokugunyazwa kwe-FDA
E-United States, i-FDA ilawula ukusetshenziswa kwezithasiselo zokudla, okuhlanganisa izinto ezifana ne-CMC, ngaphansi kwe-Federal Food, Drug, and Cosmetic Act (FD&C Act) kanye ne-Food Additives Amendment yango-1958. Okukhathazayo okuyinhloko kwe-FDA ukuqinisekisa ukuthi izinto okwengezwe ekudleni kuphephile ukusetshenziswa futhi kufeza injongo ewusizo.
Inqubo yokugunyazwa kwe-FDA yezithasiselo zokudla ngokuvamile ibandakanya lezi zinyathelo ezilandelayo:
Ukuhlola Ukuphepha: Umkhiqizi noma umphakeli wesithasiselo sokudla unesibopho sokwenza izifundo zokuphepha ukuze abonise ukuthi into iphephile ekusetshenzisweni kwayo okuhlosiwe.Lezi zifundo zihlanganisa ukuhlolwa kwe-toxicological, izifundo ze-metabolism, kanye ne-allergenicity engaba khona.
Ukuhanjiswa Kwesicelo Sesengezo Sokudla: Umkhiqizi uhambisa isicelo sokwengeza ukudla (FAP) ku-FDA, ehlinzeka ngolwazi oluningiliziwe mayelana nobunikazi, ukwakheka, inqubo yokukhiqiza, ukusetshenziswa okuhlosiwe, kanye nedatha yokuphepha yesithasiselo.Uhlu lwezikhalazo kufanele lufake nezidingo zokulebula ezihlongozwayo.
Ukubuyekezwa kwe-FDA: I-FDA ihlola idatha yokuphepha enikezwe ku-FAP ukuze inqume ukuthi isithasiselo siphephile yini ekusetshenzisweni okuhlosiwe ngaphansi kwemibandela yokusetshenziswa eshiwo ngumfakisicelo.Lokhu kubuyekezwa kufaka phakathi ukuhlolwa kwezingozi ezingaba khona empilweni yomuntu, okuhlanganisa amazinga okuchayeka kanye nanoma yimiphi imiphumela emibi eyaziwayo.
Ukushicilelwa Komthethonqubo Ohlongozwayo: Uma i-FDA inquma ukuthi okungeziwe kuphephile, ishicilela umthethonqubo ohlongozwayo ku-Federal Register, ecacisa izimo lapho okungeziwe kungasetshenziswa khona ekudleni.Lolu shicilelo luvumela ukuphawula komphakathi kanye nemibono evela kubabambiqhaza.
Umthetho Wokugcina: Ngemva kokucabangela imibono yomphakathi nedatha eyengeziwe, i-FDA ikhipha umthetho wokugcina wokugunyaza noma ukwenqaba ukusetshenziswa kwesithasiselo ekudleni.Uma sivunyiwe, isimiso sokugcina sisungula izimo ezivumelekile zokusetshenziswa, okuhlanganisa noma yimiphi imikhawulo, ukucaciswa, noma izimfuneko zokulebula.
I-Carboxymethylcellulose kanye Nemvume ye-FDA
I-Carboxymethylcellulose inomlando omude wokusetshenziswa embonini yokudla nakweminye imikhakha, futhi ngokuvamile yaziwa njengephephile (i-GRAS) ngokusetshenziswa kwayo okuhlosiwe lapho isetshenziswa ngokuhambisana nezinqubo ezinhle zokukhiqiza.I-FDA ikhiphe imithethonqubo ethile nemihlahlandlela elawula ukusetshenziswa kwe-CMC ekudleni nasemikhiqizweni yezemithi.
Umthetho we-FDA weCarboxymethylcellulose:
Isimo Sokungezelela Ukudla: I-Carboxymethylcellulose isohlwini njengesengezo sokudla esivunyelwe esihlokweni sama-21 seKhodi Yezimiso Zombuso (CFR) ngaphansi kwesigaba 172.Ikhodi 8672, nemithethonqubo ethile echazwe ngokusetshenziswa kwayo ezigabeni ezihlukahlukene zokudla.Le mithetho icacisa amazinga aphezulu avumelekile e-CMC emikhiqizweni yokudla ehlukene kanye nanoma yiziphi ezinye izidingo ezifanele.
Ukusetshenziswa Kwemithi: Kwezemithi, i-CMC isetshenziswa njengesithako esingasebenzi ekwakhiweni kwezidakamizwa, futhi ukusetshenziswa kwayo kulawulwa ngaphansi kwe-FDA's Center for Drug Evaluation and Research (CDER).Abakhiqizi kufanele baqinisekise ukuthi i-CMC ihlangabezana nokucaciswa okuvezwe e-United States Pharmacopeia (USP) noma enye inhlanganisela efanele.
Izidingo Zokulebula: Imikhiqizo equkethe i-CMC njengesithako kufanele ithobelane nemithetho ye-FDA mayelana nokulebula, okuhlanganisa ukufakwa kuhlu okunembile kwezithako kanye nanoma yikuphi ukulebula okudingekile kwe-allergen.
I-Carboxymethylcellulose (CMC) iyinhlanganisela esetshenziswa kabanzi enezinhlelo zokusebenza ezahlukahlukene ezimbonini zokudla, ezemithi, zezimonyo nezokukhiqiza.Izici zayo eziyingqayizivele ziyenza ibe yigugu njenge-thickener, stabilizer, emulsifier, kanye ne-binder emikhiqizweni ehlukahlukene.I-FDA idlala indima ebalulekile ekulawuleni ukuphepha nokusetshenziswa kwe-CMC nezinye izithasiselo zokudla, iqinisekisa ukuthi ziyahlangabezana nezindinganiso eziqinile zokuphepha ngaphambi kokuba zigunyazwe ukusetshenziswa emikhiqizweni ethengwayo.I-CMC isohlwini njengesengezo sokudla esivunyelwe yi-FDA, futhi ukusetshenziswa kwayo kulawulwa yimithethonqubo ethile nemihlahlandlela eshiwo esihlokweni sama-21 seKhodi Yezimiso Zombuso.Abakhiqizi nabahlinzeki bemikhiqizo equkethe i-CMC kufanele bahambisane nale mithethonqubo, okuhlanganisa ukuhlolwa kokuphepha, izidingo zokulebula, nezimo ezithile zokusetshenziswa, ukuze baqinisekise ukuphepha kanye nekhwalithi yemikhiqizo yabo.
Isikhathi sokuthumela: Mar-22-2024