Umutekano wa CMC

Sodium carboxymethyl selulose (CMC) muri rusange ifatwa nk’umutekano (GRAS) kugira ngo ikoreshwe n’inzego zibishinzwe nk’ubuyobozi bushinzwe ibiryo n’ibiyobyabwenge (FDA) muri Amerika ndetse n’ikigo cy’ibihugu by’Uburayi gishinzwe umutekano mu biribwa (EFSA) mu Burayi iyo gikoreshejwe neza. ibikorwa byo gukora (GMP) no gushyiraho umurongo ngenderwaho wumutekano. Dore incamake yibitekerezo byumutekano bijyana na CMC:

1. Kwemeza Amabwiriza: CMC yemerewe gukoreshwa nk'inyongeramusaruro mu bihugu byinshi ku isi, harimo Amerika, Umuryango w’ubumwe bw’ibihugu by’Uburayi, Kanada, Ositaraliya, n’Ubuyapani. Urutonde hamwe ninzego zinyuranye zishinzwe kugenzura nk'inyongeramusaruro yemewe yongerewe imipaka ikoreshwa neza.
2. Ubushakashatsi bwuburozi: Hakozwe ubushakashatsi bwimbitse bwuburozi kugirango harebwe umutekano wa CMC kubyo kurya byabantu. Ubu bushakashatsi burimo ibizamini bikaze, bitagaragara, na karande, hamwe na mutagenicity, genotoxicity, hamwe nisuzuma rya kanseri. Ukurikije amakuru aboneka, CMC ifatwa nkumutekano kubyo kurya byabantu murwego rwemewe.
3. Byemewe gufata buri munsi (ADI): Inzego zishinzwe kugenzura zashyizeho indangagaciro zemewe za buri munsi (ADI) kuri CMC zishingiye ku bushakashatsi bw’uburozi no gusuzuma umutekano. ADI yerekana umubare wa CMC ushobora gukoreshwa buri munsi mubuzima bwose nta ngaruka zishimishije kubuzima. Indangagaciro za ADI ziratandukanye mubigo bishinzwe kugenzura kandi bigaragazwa mubijyanye na miligarama kuri kilo yuburemere bwumubiri kumunsi (mg / kg bw / kumunsi).
4. Allergenicity: CMC ikomoka kuri selile, isanzwe ibaho polysaccharide iboneka murukuta rw'utugingo ngengabuzima. Ntabwo bizwi ko bitera allergie reaction mubaturage muri rusange. Nyamara, abantu bafite allergie izwi cyangwa bakangurira inkomoko ya selile bagomba kwitonda no kubaza inzobere mu buvuzi mbere yo kurya ibicuruzwa birimo CMC.
5. Umutekano w'ifunguro: CMC ntabwo yinjizwa na sisitemu y'ibiryo y'umuntu kandi inyura mu nzira ya gastrointestinal itiriwe ihindagurika. Bifatwa nk'uburozi kandi ntibitera umujinya wigifu. Nyamara, kunywa cyane CMC cyangwa ibindi bikomoka kuri selile birashobora gutera uburibwe bwa gastrointestinal, kubyimba, cyangwa impiswi kubantu bamwe.
6. Imikoranire n'imiti: CMC ntabwo izwiho gukorana n'imiti cyangwa kugira ingaruka ku iyinjira ryayo mu nzira ya gastrointestinal. Bifatwa nkibihuye nubuvuzi bwinshi bwa farumasi kandi bikunze gukoreshwa nkibisanzwe muburyo bwa dosiye yo mu kanwa nka tableti, capsules, hamwe no guhagarikwa.
7. Umutekano w’ibidukikije: CMC irashobora kwangirika kandi yangiza ibidukikije, kuko ikomoka ku masoko ashobora kuvugururwa nkibiti byimbuto cyangwa selile. Isenyuka bisanzwe mubidukikije binyuze mubikorwa bya mikorobe kandi ntabwo yegeranya mubutaka cyangwa mumazi.

Muri make, sodium carboxymethyl selulose (CMC) ifatwa nkumutekano mukoresha iyo ikoreshejwe ukurikije amabwiriza ngenderwaho hamwe nubuziranenge bwumutekano. Yakozweho ubushakashatsi bwimbitse kubera uburozi bwayo, allergique, umutekano wigifu, n’ingaruka ku bidukikije, kandi yemerewe gukoreshwa nk'inyongeramusaruro y'ibiribwa na farumasi mu bihugu byinshi ku isi. Kimwe nibindi bintu byose byongera ibiryo cyangwa inyongeramusaruro, abantu bagomba kurya ibicuruzwa birimo CMC mu rugero ruto mu rwego rwo kurya indyo yuzuye kandi bakabaza abahanga mu by'ubuzima niba bafite inzitizi z’imirire cyangwa ibibazo by’ubuvuzi.