ICarboxymethylcellulose (CMC) yikhompawundi eguquguqukayo esetyenziswa ngokubanzi kumashishini ahlukeneyo, kubandakanya ukutya, amayeza, izinto zokuthambisa, kunye nokuvelisa. Iimpawu zayo ezinomsebenzi omninzi zenza ukuba zixabiseke njenge-ejenti yokuqina, i-stabilizer, i-emulsifier, kunye nokunye. I-United States Food and Drug Administration (FDA) idlala indima ebalulekileyo ekulawuleni ukhuseleko kunye nokusetyenziswa kwekhompawundi ezinjalo, iqinisekisa ukuba ziyahlangabezana nemigangatho engqongqo phambi kokuba zivunywe ukuba zisetyenziswe kwiimveliso zabathengi.
Ukuqonda iCarboxymethylcellulose (CMC)
I-Carboxymethylcellulose, ehlala ishunqulwa njenge-CMC, iphuma kwi-cellulose. I-Cellulose iyona nto ininzi kakhulu emhlabeni kwaye ifumaneka kwiindonga zeeseli zezityalo, ezibonelela ngenkxaso yesakhiwo. I-CMC ithathwe kwi-cellulose ngenkqubo yokuguqulwa kweekhemikhali ebandakanya ukwazisa amaqela e-carboxymethyl kumqolo we-cellulose. Olu hlengahlengiso lunika iipropati ezininzi eziluncedo kwi-CMC, kuquka ukunyibilika kwamanzi, i-viscosity, kunye nozinzo.
Iimpawu zeCarboxymethylcellulose:
Ukunyibilika kwamanzi: I-CMC iyanyibilika emanzini, yenza isisombululo esicacileyo, esibonakalayo. Le propati yenza kube luncedo kwizicelo ezahlukeneyo apho kufuneka i-agent yokuqina okanye ukuzinzisa.
I-Viscosity: I-CMC ibonisa ukuziphatha kwe-pseudoplastic, oku kuthetha ukuba i-viscosity yayo iyancipha phantsi koxinzelelo lwe-chear kwaye inyuke kwakhona xa uxinzelelo lususiwe. Le propati ivumela ukusetyenziswa okulula kwiinkqubo ezifana nokumpompa, ukutshiza, okanye ukukhupha.
Ukuzinza: I-CMC inika uzinzo kwi-emulsions kunye nokumiswa, ukuthintela izithako ekwahluleni okanye ukuzinza ngokuhamba kwexesha. Olu uzinzo lubalulekile kwiimveliso ezifana nokunxitywa kwesaladi, izithambiso, kunye nokunqunyanyiswa kwamayeza.
Ukwenziwa kweFilimu: I-CMC inokwenza iifilimu ezibhityileyo, eziguquguqukayo xa zomisiwe, ziyenza ibe luncedo kwizicelo ezinje ngeengubo ezityiwayo zeetafile okanye iicapsules, kunye nokuveliswa kweefilimu kwizinto zokupakisha.
Ukusetyenziswa kweCarboxymethylcellulose
I-CMC ifumana ukusetyenziswa okuxhaphakileyo kuwo wonke amashishini ahlukeneyo ngenxa yeepropathi zayo eziguquguqukayo. Ezinye izicelo eziqhelekileyo ziquka:
Ishishini lokutya: I-CMC isetyenziswa njenge-thickener, i-stabilizer, kunye ne-binder kuluhlu olubanzi lweemveliso zokutya, ezibandakanya iisosi, iilokhwe, i-ayisikrimu, izinto zokubhaka, kunye neziselo. Inceda ukuphucula ukuthungwa, umlomo, kunye nokuzinza kweshelufu.
Amachiza: Kumachiza, i-CMC isetyenziswa njenge-binder kwi-tablet formulations, i-thickener in suspensions, kunye ne-stabilizer kwi-emulsions. Iqinisekisa ukuhanjiswa kwamachiza okufanayo kwaye iphucula ukuthotyelwa kwezigulane.
Izithambiso kunye neeMveliso zoKhathalelo loBuqu: I-CMC iqeshwe kwizinto zokuthambisa kunye neemveliso zokhathalelo lomntu ezifana nezithambiso, iikhrimu, iishampu, kunye nentlama yamazinyo njenge-thickener, emulsifier, kunye ne-stabilizer. Inceda ukugcina ukuhambelana kwemveliso kunye nokuphucula ukusebenza.
Usetyenziso lwezoShishino: I-CMC isetyenziswa kwiinkqubo zoshishino ezahlukeneyo njenge-thickener, i-arhente yokugcina amanzi, kunye ne-rheology modifier kwiimveliso ezifana nezicoci, iipeyinti, izinto zokuncamathelisa, kunye nolwelo lokomba.
Inkqubo yokuVunywa kwe-FDA
EUnited States, i-FDA ilawula ukusetyenziswa kwezongezo zokutya, kubandakanywa izinto ezifana ne-CMC, phantsi koMthetho we-Federal Food, Drug, and Cosmetic Act (FD & C Act) kunye noLungiso lwezoTyelo lokutya lwe-1958. Inkxalabo ephambili ye-FDA kukuqinisekisa ukuba izinto kongezwe ekutyeni kukhuselekile ukutyiwa kwaye kufeza injongo eluncedo.
Inkqubo yokuvunywa kwe-FDA yezongezo zokutya ibandakanya la manyathelo alandelayo:
UVavanyo loKhuseleko: Umenzi okanye umthengisi wezongezo zokutya unoxanduva lokuqhuba izifundo zokhuseleko ukubonisa ukuba into ikhuselekile ekusetyenzisweni kwayo. Ezi zifundo ziquka uvavanyo lwe-toxicological, izifundo kwi-metabolism, kunye ne-allergenicity enokubakho.
Ukungeniswa kweSicelo soKutya okongeziweyo: Umenzi ungenisa isicelo sokongeza ukutya (FAP) kwi-FDA, enikezela ngolwazi oluthe kratya malunga nesazisi, ukubunjwa, inkqubo yokuvelisa, ukusetyenziswa okujoliswe kuko, kunye nedatha yokhuseleko yesongezo. Uxwebhu lwezikhalazo kufuneka lubandakanye iimfuno zokuleyibhela ezicetywayo.
Uphononongo lwe-FDA: I-FDA ivavanya idatha yokhuseleko enikezelweyo kwi-FAP ukuze inqume ukuba i-additive ikhuselekile ukusetyenziswa kwayo ekujoliswe kuyo phantsi kweemeko zokusetyenziswa ezichazwe ngumfaki-sicelo. Olu hlaziyo lubandakanya uvavanyo lweengozi ezinokubakho kwimpilo yabantu, kubandakanywa amanqanaba okuvezwa kunye nayo nayiphi na imiphumo emibi eyaziwayo.
Ukupapashwa koMgaqo ocetywayo: Ukuba i-FDA inquma ukuba i-additive ikhuselekile, ipapasha ummiselo ocetywayo kwiRejista ye-Federal, ichaza iimeko apho isongezo singasetyenziselwa ukutya. Olu papasho luvumela uluntu ukuba luhlomle kunye negalelo elivela kwabachaphazelekayo.
Umthetho wokugqibela: Emva kokuqwalasela izimvo zoluntu kunye nedatha eyongezelelweyo, i-FDA ikhupha umgaqo wokugqibela okanye ukuvuma okanye ukukhanyela ukusetyenziswa kwesongezo ekudleni. Ukuba uvunyiwe, umgaqo wokugqibela umisela imiqathango evumelekileyo yokusetyenziswa, kubandakanywa naziphi na izithintelo, iinkcukacha, okanye iimfuno zokuleyibheli.
I-Carboxymethylcellulose kunye nokuVunywa kwe-FDA
ICarboxymethylcellulose inembali ende yokusetyenziswa kwishishini lokutya kunye namanye amacandelo, kwaye yaziwa ngokubanzi njengekhuselekile (GRAS) kusetyenziso olucetywayo xa isetyenziswa ngokuhambelana neendlela ezilungileyo zokuvelisa. I-FDA ikhuphe imigaqo ethile kunye nezikhokelo ezilawula ukusetyenziswa kwe-CMC ekutyeni nakwimveliso yamayeza.
Ulawulo lwe-FDA lweCarboxymethylcellulose:
ISimo Sokongeza ukutya: I-Carboxymethylcellulose idweliswe njengezongezo zokutya ezivunyelweyo kwiSihlokwana 21 seKhowudi yeMithetho ye-Federal (CFR) phantsi kwecandelo 172.Code 8672, kunye nemimiselo ethile echazwe ukusetyenziswa kwayo kwiindidi zokutya ezahlukeneyo. Le mimiselo ichaza amanqanaba aphezulu avumelekileyo e-CMC kwiimveliso zokutya ezahlukeneyo kunye naziphi na ezinye iimfuno ezifanelekileyo.
Ukusetyenziswa kwamachiza: Kumayeza, i-CMC isetyenziswa njengesithako esingasebenziyo ekuqulunqweni kweziyobisi, kwaye ukusetyenziswa kwayo kulawulwa phantsi kweZiko le-FDA loVavanyo lweZiyobisi kunye noPhando (CDER). Abavelisi kufuneka baqinisekise ukuba i-CMC ihlangabezana neenkcukacha ezichazwe e-United States Pharmacopeia (USP) okanye enye i-comendia efanelekileyo.
IiMfuno zokuFakwa kwelebhile: Iimveliso eziqulathe i-CMC njengesithako kufuneka zihambelane nemigaqo ye-FDA malunga nokuleyibhelishwa, kubandakanywa noluhlu lwezithako ezichanekileyo kunye naluphi na uhlobo olufunekayo lokuleyibhile.
ICarboxymethylcellulose (CMC) yikhompawundi esetyenziswa ngokubanzi enezicelo ezahlukeneyo kukutya, kumayeza, kwizinto zokuthambisa, nakwimizi mveliso. Iimpawu zayo ezizodwa ziyenza ixabiseke njenge-thickener, stabilizer, emulsifier, kunye ne-binder kwiimveliso ezahlukeneyo. I-FDA idlala indima ebalulekileyo ekulawuleni ukhuseleko kunye nokusetyenziswa kwe-CMC kunye nezinye izongezo zokutya, iqinisekisa ukuba ziyahlangabezana nemigangatho engqongqo yokhuseleko phambi kokuba zamkelwe ukuba zisetyenziswe kwiimveliso zabathengi. I-CMC idweliswe njengesongezo sokutya esivumelekileyo yi-FDA, kwaye ukusetyenziswa kwayo kulawulwa yimimiselo ethile kunye nezikhokelo ezichazwe kwiSihloko 21 seKhowudi yeMithetho ye-Federal. Abavelisi kunye nabanikezeli beemveliso eziqulethe i-CMC kufuneka babambelele kule mimiselo, kubandakanywa uvandlakanyo lokhuseleko, iimfuno zokuleyibhela, kunye neemeko ezichaziweyo zokusetyenziswa, ukuqinisekisa ukhuseleko kunye nomgangatho weemveliso zabo.
Ixesha lokuposa: Mar-22-2024