I-Carboxymethylcelcellellulose (CMC) iyingxenye eguquguqukayo esetshenziswa kabanzi ezimbonini ezahlukahlukene, kubandakanya nokudla, amakhamishini, izimonyo kanye nokukhiqiza. Izakhiwo zayo ezisebenzayo zikwenza kubalulekile njenge-ejenti ekhuthele, i-Stabilizer, emulsifier, nokuningi. I-United States Food and Drug Administration (FDA) idlala indima ebalulekile ekulawuleni ukuphepha nokusetshenziswa kwalezi zinhlaka, ukuqinisekisa ukuthi zihlangabezana nezindinganiso ezinzima ngaphambi kokuvunywa ngemikhiqizo yabathengi.
Ukuqonda i-carboxymethylcelcellellulose (CMC)
I-Carboxymethylcelcellellulose, evame ukufushaniswa njenge-CMC, i-cellulose. I-Cellulose iyindawo ebanzi kakhulu ye-organic emhlabeni futhi itholakala ezindongeni zeseli zezitshalo, ukuhlinzeka ukwesekwa okuhlelekile. I-CMC isuselwa ku-cellulose ngenqubo yokuguqulwa kwamakhemikhali ehilela ukwethula amaqembu e-carboxymethyl e-cellulose backbone. Lokhu kuguqulwa kudlulisela izakhiwo eziningana eziwusizo ku-CMC, kufaka phakathi i-solubity yamanzi, ukubonakala nokuqina.
Izakhiwo ze-carboxymethylcellellulose:
I-Solubinity yamanzi: I-CMC incane emanzini, yakha isixazululo esicacile, esibonakalayo. Le mpahla yenza kube wusizo ezinhlelweni ezahlukahlukene lapho kudingeka khona i-ejenti yokuqina noma yokuzinza.
I-Viscosity: I-CMC ibonisa indlela yokuziphatha ye-Pseudoplastic, okusho ukuthi i-visposity yayo yehla ngaphansi kwengcindezi ye-shear futhi yandise futhi lapho kususwa ingcindezi. Le mpahla ivumela ukusetshenziswa okulula kwezinqubo ezifana nokupompa, ukufafaza, noma ukukhishwa.
Ukuqina: I-CMC inika ukuqina kuma-emulsion kanye nokumiswa, ukuvikela izithako ekuhlukaniseni noma ukuphuma ngokuhamba kwesikhathi. Lokhu kuzinza kubalulekile emikhiqizweni efana nokugqoka kwesaladi, izimonyo kanye nokumiswa kwemithi.
Ukukhamulwa ifilimu: I-CMC ingakha amafilimu amancanyana, aguqukayo lapho omisiwe, okwenza kube lusizo kuzinhlelo zokusebenza ezifana nezimbobo ezidliwayo zamathebulethi noma amakhompiyutha, kanye nokukhiqizwa kwamafilimu wezinto zokupakisha.
Izicelo ze-carboxymethylcellellulose
I-CMC ithola ukusetshenziswa okubanzi kuyo yonke imboni ehlukahlukene ngenxa yezindawo zayo eziguquguqukayo. Ezinye izinhlelo ezivamile zifaka:
Imboni yokudla: I-CMC isetshenziswa njengesikhulu, i-stabilizer, kanye ne-binger emikhiqizweni ehlukahlukene yokudla, kufaka phakathi amasoso, ukugqoka, u-ayisikhilimu, izinto zokubhaka, neziphuzo. Kuyasiza ukuthuthukisa ukuthungwa, umlomo nomlomo, nokuqina kweshalofu.
Ama-Pharmaceuticals: Emikhakheni, i-CMC isetshenziswa njenge-binder ekusungulweni kwethebhulethi, umkhulu ekunqumeni, kanye ne-stabilizer emulsions. Iqinisekisa ukuhanjiswa kwezidakamizwa okufanayo futhi kuthuthukisa ukuhambisana kweziguli.
Izimonyo kanye nemikhiqizo yokunakekelwa komuntu siqu: I-CMC iqashwa kwizimonyo kanye nemikhiqizo yokunakekelwa komuntu siqu efana nama-lotion, okhilimu, ama-shampoos, kanye nezinyo lamazinyo njengomuntu omkhulu, emulsifier, kanye ne-stabilizer. Kuyasiza ukugcina ukuvumelana komkhiqizo futhi kuthuthukise ukusebenza.
Izicelo zezimboni: I-CMC isetshenziswa ezinhlelweni ezahlukahlukene zezimboni njenge-Swerener, i-ejenti yokugcinwa kwamanzi, kanye nokushintsha kwe-Rheology emikhiqizweni enjengezihlanzi, amapende, anamathela, kanye nokumba uketshezi.
Inqubo yokuvunyelwa kwe-FDA
E-United States, i-FDA ilawula ukusetshenziswa kwezithasiselo zokudla, kufaka phakathi izinto ezinjenge-CMC, ngaphansi kokudla kwe-Federal, izidakamizwa, nesenzo sezimonyo (i-FDA CORT) kanye nokukhathalela okuyisisekelo kwe-FDA ukuqinisekisa ukuthi izinto Kungezwe ekudleni kuphephile ukuze kusetshenziswe futhi kusebenze injongo ewusizo.
Inqubo yokuvunyelwa kwe-FDA yezithasiselo zokudla zivame ukufaka izinyathelo ezilandelayo:
Ukuhlolwa Kwezokuphepha: Umkhiqizi noma umphakeli wezengezo zokudla unesibopho sokwenza izifundo zokuphepha ukukhombisa ukuthi into iphephile ngokusetshenziswa kwayo okuhlosiwe. Lezi zifundo zifaka ukuhlolwa kobuthi, izifundo ngemetabolism, kanye ne-allergenenicity.
Ukulethwa kwesicelo sesengezo sokudla: Umkhiqizi ufaka isicelo sesengezo sokudla (FAP) kwi-FDA, ukuhlinzeka ngemininingwane enemininingwane yobunikazi, ukwakheka, inqubo yokukhiqiza, idatha yokuphepha yesengezo. Isikhalazo kumele futhi sifake nezidingo zokulebula okuhlongozwayo.
Ukubuyekezwa kwe-FDA: I-FDA ihlola idatha yokuphepha enikezwe ku-fap ukuthola ukuthi isengezo siphephile yini ukusetshenziswa kwaso okuhlosiwe ngaphansi kwezimo ezichaziwe? Lokhu kubuyekezwa kufaka phakathi ukuhlolwa kwezingozi ezingaba khona empilweni yabantu, kubandakanya namazinga wokuvezwa kanye neminye imiphumela emibi.
Ukushicilelwa kwesimiso esiphakanyisiwe: Uma i-FDA inquma ukuthi isengezo siphephile, sishicilela umthetho ohlongozwayo kwirejista yombuso, echaza izimo lapho isengezo singasetshenziswa ekudleni. Le ncwadi ivumela ukuphawula komphakathi nokufakwa kwababambiqhaza.
Ukubonisana Kokugcina: Ngemuva kokubheka ukuphawula komphakathi kanye nemininingwane eyengeziwe, izingqinamba ze-FDA ziwumthetho wokugcina uvunywa noma ukuphika ukusetshenziswa kwesengezo ekudleni. Uma kuvunywa, umthetho wokugcina usungula izimo ezivumelekile zokusebenzisa, kufaka phakathi noma yimiphi imikhawulo, imininingwane, noma izidingo zokulebula.
I-Carboxymethylcelcelcellellose kanye ne-FDA imvume
I-Carboxymethylcellellulose inomlando omude wokusebenzisa embonini yokudla kanye neminye imikhakha, futhi ngokuvamile ibonwa njengephephile ukusetshenziswa kwayo okuhlosiwe lapho isetshenziswa ngokuhambisana nemikhuba emihle yokukhiqiza. I-FDA ikhiphe imithetho ethile kanye nemihlahlandlela elawula ukusetshenziswa kwe-CMC emikhiqizweni yokudla kanye nemithi.
Umthethonqubo we-FDA we-carboxymethylcellellulose:
Isimo Sokudla Ukudla: I-Carboxymethylcellellulose ifakwe kuhlu njengokungenisa ukudla okuvunyelwe ngesihloko 21 se-Code of Federal Regulations (CFR) ngaphansi kwesigaba 172.code 8672, nemigomo ethile echazwe ngokusetshenziswa kwayo ezigabeni ezahlukahlukene zokudla. Le mithethonqubo icacisa amazinga aphezulu avumelekile we-CMC emikhiqizweni ehlukene yokudla kanye nezinye izidingo ezifanele.
Ukusetshenziswa Kwemithi: Emikhakheni, i-CMC isetshenziswa njengesithako esingasebenzi ekusungulweni kwezidakamizwa, futhi ukusetshenziswa kwayo kulawulwa ngaphansi kwesikhungo se-FDA sokuhlolwa kwezidakamizwa nokucwaninga (cder). Abakhiqizi kumele baqinisekise ukuthi i-CMC ihlangana nezincazelo ezichazwe e-United States PharmaCopeia (USP) noma enye enye yezinto ezifanele.
Izidingo zelebuli
I-Carboxymethylcelcellellulose (CMC) iyindawo esetshenziswa kabanzi enezinhlelo zokusebenza ezahlukahlukene ekudleni, amakhambi, izimonyo kanye nezimboni zokukhiqiza. Izakhiwo zayo ezihlukile zikwenza kubalulekile njengomuntu omkhulu, i-stabilizer, emulsifier, kanye ne-binter emikhiqizweni ehlukahlukene. I-FDA idlala indima ebalulekile ekuhlinzekeni ukuphepha nokusetshenziswa kwe-CMC nezinye izithasiselo zokudla, ukuqinisekisa ukuthi zihlangabezana namazinga okuphepha anzima ngaphambi kokuba kuvunyelwe ukusetshenziswa kwimikhiqizo yabathengi. I-CMC ifakwe kuhlu njengokudla okuvunyelwe kwe-FDA, futhi ukusetshenziswa kwayo kulawulwa yimithetho ethile kanye nemihlahlandlela echazwe ngesihloko 21 seKhodi Yemithetho yeFederal. Abakhiqizi kanye nabaphakeli bemikhiqizo equkethe i-CMC kumele balandele le mithethonqubo, kufaka phakathi ukuhlolwa kokuphepha, izidingo zokulebula, kanye nemibandela ebekiwe yokusebenzisa, ukuqinisekisa ukuphepha kanye nekhwalithi yemikhiqizo yabo.
Isikhathi sePosi: Mar-22-2024