Focus on Cellulose ethers

Ukhuseleko lweCMC

Ukhuseleko lweCMC

I-sodium carboxymethyl cellulose (CMC) ithathwa njengekhuselekile (GRAS) ukuba isetyenziswe ngabasemagunyeni abalawulayo njengoLawulo lokuTya kunye neDrugs (i-FDA) eUnited States kunye ne-European Food Safety Authority (EFSA) eYurophu xa isetyenziswa ngokuhambelana nokulungileyo. iindlela zokuvelisa (GMP) kunye nezikhokelo zokhuseleko ezisekiweyo. Nalu ushwankathelo lweengqwalasela zokhuseleko ezinxulumene ne-CMC:

  1. Ukwamkelwa okuLawulwayo: I-CMC yamkelwe ukuba isetyenziswe njengesongezo sokutya kumazwe amaninzi kwihlabathi liphela, kuquka i-United States, iManyano yaseYurophu, iKhanada, i-Australia, ne-Japan. Idweliswe kunye nee-arhente zolawulo ezahlukeneyo njengesongezo sokutya esivunyelweyo kunye nemida ethile yokusetyenziswa kunye neenkcukacha.
  2. Izifundo zobutyhefu: Uphononongo olubanzi lwetyhefu lwenziwe ukuvavanya ukhuseleko lweCMC ekusetyenzisweni kwabantu. Olu phononongo lubandakanya uvavanyo lwetyhefu olubukhali, olungaphantsi, kunye nolungapheliyo, kunye novavanyo lwe-mutagenicity, genotoxicity, kunye ne-carcinogenicity. Ngokusekelwe kwidatha ekhoyo, i-CMC ithathwa njengekhuselekile ukuba isetyenziswe ngabantu kumanqanaba avunyelweyo.
  3. I-Daily Intake eyamkelekileyo (ADI): Ii-arhente ezilawulayo ziseke amaxabiso amkelekileyo emihla ngemihla (ADI) ye-CMC ngokusekelwe kwizifundo ze-toxicological kunye novavanyo lokhuseleko. I-ADI imele isixa se-CMC esinokutyiwa yonke imihla kubomi bonke ngaphandle komngcipheko oxabisa impilo. Amaxabiso e-ADI ayahluka phakathi kwee-arhente ezilawulayo kwaye abonakaliswa ngokwemilligrams ngekhilogram yesisindo somzimba ngosuku (mg/kg bw/day).
  4. I-Allergenicity: I-CMC ithathwe kwi-cellulose, i-polysaccharide yendalo efumaneka kwiindonga zeeseli zezityalo. Ayaziwa ukuba ibangela ukuguquguquka komzimba kubantu ngokubanzi. Nangona kunjalo, abantu abane-allergies eyaziwayo okanye uvakalelo kwi-cellulose derivatives kufuneka balumke kwaye banxibelelane neengcali zezempilo ngaphambi kokuba batye iimveliso ezine-CMC.
  5. Ukhuseleko lokutya: I-CMC ayifuntshwa sisixokelelwano sokwetyisa komntu kwaye idlula kwiphecana lesisu ngaphandle kokuxutywa. Kuthathwa njengento engeyiyo inetyhefu kwaye ayicaphukisi i-mucosa yokugaya. Nangona kunjalo, ukusetyenziswa kakhulu kwe-CMC okanye ezinye izinto eziphuma kwi-cellulose kunokubangela ukuphazamiseka kwesisu, ukuqunjelwa, okanye isifo sohudo kwabanye abantu.
  6. Ukusebenzisana namayeza: I-CMC ayaziwa ukusebenzisana namayeza okanye ichaphazela ukufunxa kwabo kwindlela yesisu. Ithathwa njengehambelana nobuninzi bemixube yoxubo kwaye isetyenziswa ngokuqhelekileyo njenge-excipient kwiifom zedosi yomlomo ezifana neepilisi, iipilisi, kunye nokunqunyanyiswa.
  7. Ukhuseleko lokusiNgqongileyo: I-CMC iyabola kwaye inobuhlobo nokusingqongileyo, njengoko ithathwa kwimithombo ehlaziyekayo efana nentlaka yeenkuni okanye iseliulose yomqhaphu. Iqhekeza ngokwendalo kwindalo ngokusebenzisa isenzo se-microbial kwaye ayiqokeleli kumhlaba okanye kwiinkqubo zamanzi.

Isishwankathelo, i-sodium carboxymethyl cellulose (CMC) ithathwa njengekhuselekile ukuba isetyenziswe xa isetyenziswe ngokuhambelana nezikhokelo zokulawula kunye nemigangatho yokhuseleko olusekiweyo. Ifundwe ngokubanzi ngobutyhefu bayo, i-allergenicity, ukhuseleko lokugaya ukutya, kunye nefuthe lokusingqongileyo, kwaye ivunyiwe ukuba isetyenziswe njengesongezo sokutya kunye ne-excipient yamayeza kumazwe amaninzi kwihlabathi liphela. Njengaso nasiphi na isithako sokutya okanye isongezo, abantu kufuneka basebenzise iimveliso ezine-CMC ngokumodareyitha njengenxalenye yokutya okunesondlo kwaye badibane neengcali zezempilo ukuba banezithintelo ezithile zokutya okanye iinkxalabo zonyango.


Ixesha lokuposa: Mar-07-2024
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