Carboxymethylcellulose (CMC) isanganiswa inogoneka inoshandiswa zvakanyanya mumaindasitiri akasiyana siyana, kusanganisira chikafu, mishonga, zvizorwa, uye kugadzira.Yayo yakawanda inoshanda zvinhu inoita kuti ive yakakosha seyakakora mumiriri, stabilizer, emulsifier, nezvimwe.United States Chikafu neDrug Administration (FDA) inoita basa rakakosha mukudzora kuchengetedzeka nekushandiswa kwemakomponi akadai, kuve nechokwadi kuti anosangana nemiyero yakaoma isati yatenderwa kushandiswa muzvigadzirwa zvevatengi.
Kunzwisisa Carboxymethylcellulose (CMC)
Carboxymethylcellulose, inowanzopfupikiswa seCMC, inotorwa kubva kune cellulose.Cellulose ndiyo yakanyanya kuwanda kwazvo paPasi uye inowanikwa musero madziro emiti, ichipa rutsigiro rwechimiro.CMC inotorwa kubva ku cellulose kuburikidza nemakemikari ekugadzirisa maitiro ayo anosanganisira kuunza mapoka ecarboxymethyl pamusana we cellulose.Iyi shanduko inopa akati wandei anobatsira zvivakwa kuCMC, kusanganisira kunyungudika kwemvura, viscosity, uye kugadzikana.
Zvinhu zveCarboxymethylcellulose:
Kunyungudika kweMvura: CMC inonyungudika mumvura, ichigadzira mhinduro yakajeka, ine viscous.Ichi chivakwa chinoita kuti chishande mune akasiyana maapplication uko kunoda kukora kana kudzikamisa mumiriri.
Viscosity: CMC inoratidza pseudoplastic maitiro, zvichireva kuti viscosity yayo inodzikira pasi pekunetseka kwekugera uye inowedzera zvakare kana kushushikana kwabviswa.Ichi chivakwa chinobvumira kushandiswa kuri nyore mumatanho akadai sekupomba, kupfapfaidza, kana extrusion.
Kugadzikana: CMC inopa kugadzikana kune emulsion uye kuturika, kudzivirira zvimisikidzo kubva pakuparadzanisa kana kugadzirisa nekufamba kwenguva.Uku kugadzikana kwakakosha muzvigadzirwa zvakaita semapfekero esaladhi, zvizorwa, uye kumiswa kwemishonga.
Firimu-Kugadzira: CMC inogona kuumba akatetepa, anochinjika mafirimu kana akaomeswa, zvichiita kuti abatsire mumashandisirwo akadai semachira anodyika emapiritsi kana makapisi, uye mukugadzirwa kwemafirimu ekurongedza zvinhu.
Kushandiswa kweCarboxymethylcellulose
CMC inowana kushandiswa kwakapararira mumaindasitiri akasiyana siyana nekuda kwezvivakwa zvayo zvakasiyana.Mamwe maapplication akajairika anosanganisira:
Indasitiri Yechikafu: CMC inoshandiswa seyakakora, inosimbisa, uye bhainda mune dzakasiyana siyana zvigadzirwa zvekudya, zvinosanganisira sosi, madhirezi, ice cream, bhekari zvinhu, uye zvinwiwa.Inobatsira kuvandudza kuumbwa, muromo, uye kugadzikana kwesherufu.
Pharmaceuticals: Mumishonga, CMC inoshandiswa sebhainda mumapiritsi ekugadzira, thickener mukumiswa, uye stabilizer mu emulsions.Inovimbisa kugoverwa kwezvinodhaka zvakafanana uye inowedzera kutevedza kwevarwere.
Cosmetics uye Personal Care Zvigadzirwa: CMC inoshandiswa muzvizoro uye zvigadzirwa zvekuchengeta zvega senge lotions, makirimu, shampoos, uye mushonga wemazino semukobvu, emulsifier, uye stabilizer.Inobatsira kuchengetedza chigadzirwa kuenderana uye inovandudza kushanda.
Maindasitiri Zvishandiso: CMC inoshandiswa mumhando dzakasiyana dzemaindasitiri seyakakora, mumiriri wekuchengetedza mvura, uye rheology modifier muzvigadzirwa zvakaita sedetergent, pendi, zvinonamira, uye zvinwiwa zvekuchera.
FDA Kubvumidza Maitiro
MuUnited States, FDA inoronga kushandiswa kwezvinowedzera zvekudya, zvinosanganisira zvinhu zvakaita seCMC, pasi peFederal Food, Drug, and Cosmetic Act (FD&C Act) neFood Additives Amendment ya1958. Chinetso chikuru cheFDA ndechekuona kuti zvinhu zvinowedzerwa pazvokudya hazvina ngozi kudyiwa uye zvinoshanda chinangwa chinobatsira.
Iyo FDA yekubvumidza maitiro ezvekuwedzera chikafu inowanzo sanganisira anotevera matanho:
Chengetedzo Yekuongorora: Mugadziri kana mutengesi wezvekuwedzera chikafu ane basa rekuita zvidzidzo zvekuchengetedza kuratidza kuti chinhu chacho chakachengeteka pakushandiswa kwacho.Zvidzidzo izvi zvinosanganisira toxicological assessments, zvidzidzo zvemetabolism, uye zvinogona allergenicity.
Kuendeswa kweChikafu Chekuwedzera Chikumbiro: Mugadziri anoendesa chikumbiro chekuwedzera chikafu (FAP) kuFDA, ichipa ruzivo rwakadzama pamusoro pekuzivikanwa, kuumbwa, maitiro ekugadzira, chinangwa chekushandiswa, uye kuchengetedza data rekuwedzera.Chikumbiro chinofanirwawo kusanganisira zvinodiwa zvekunyorwa mazita.
FDA Ongororo: Iyo FDA inoongorora iyo data yekuchengetedza yakapihwa muFAP kuona kana iyo yekuwedzera yakachengeteka kune yainoda kushandiswa pasi pemamiriro ekushandiswa anotsanangurwa nemumhan'ari.Ongororo iyi inosanganisira kuongororwa kwenjodzi dzinogona kuitika kuhutano hwevanhu, kusanganisira mazinga ekuratidzwa uye chero inozivikanwa yakaipa mhedzisiro.
Kushambadzirwa kweChirongwa Chemutemo: Kana iyo FDA ikaona kuti chinowedzera chakachengeteka, inoburitsa mutemo wakarongwa muFederal Register, ichitsanangura mamiriro ayo ekuwedzera angashandiswa muchikafu.Chinyorwa chino chinobvumira kuti veruzhinji vataure uye pfungwa dzavo kubva kune vane chekuita navo.
Final Rulemaking: Mushure mekutarisa zvakataurwa neveruzhinji uye mamwe data, iyo FDA inopa mutemo wekupedzisira kubvumidza kana kuramba kushandiswa kwekuwedzera mukudya.Kana ikabvumidzwa, mutemo wekupedzisira unogadza mamiriro anotenderwa ekushandiswa, kusanganisira chero zvipimo, zvakatemwa, kana zvinodikanwa zvekunyora.
Carboxymethylcellulose uye FDA Mvumo
Carboxymethylcellulose ine nhoroondo refu yekushandiswa muindasitiri yechikafu uye mamwe masekete, uye inowanzo zivikanwa seyakachengeteka (GRAS) kune yainoda kushandiswa kana ichishandiswa zvinoenderana nemaitiro akanaka ekugadzira.Iyo FDA yakapa yakananga mirau uye nhungamiro inotonga kushandiswa kweCMC muchikafu uye zvigadzirwa zvemishonga.
FDA Regulation yeCarboxymethylcellulose:
Chikafu Chinowedzera Mamiriro: Carboxymethylcellulose yakanyorwa sechinhu chinobvumirwa chikafu chekuwedzera muChinyorwa 21 cheCode of Federal Regulations (CFR) pasi pechikamu 172.Code 8672, ine mitemo yakananga yakarongedzerwa kushandiswa kwayo muzvikamu zvakasiyana-siyana zvekudya.Iyi mirau inotsanangura iyo yakanyanya kubvumidzwa mazinga eCMC mune zvakasiyana zvigadzirwa zvekudya uye chero zvimwe zvakakosha zvinodiwa.
Kushandisa Pharmaceutical: Mumishonga, CMC inoshandiswa sechinhu chisingashande mukugadzira zvinodhaka, uye kushandiswa kwayo kunodzorwa pasi peFDA's Center for Drug Evaluation and Research (CDER).Vagadziri vanofanirwa kuve nechokwadi chekuti CMC inosangana nezvakatsanangurwa muUnited States Pharmacopeia (USP) kana mamwe akakodzera compendia.
Zvinodiwa Pakunyora: Zvigadzirwa zvine CMC sechinhu chinofanirwa kutevedzera mirau yeFDA ine chekuita nemazita, kusanganisira yakaringana ingredient rondedzero uye chero inodiwa allergen labeling.
Carboxymethylcellulose (CMC) ikamu rinoshandiswa zvakanyanya rine akasiyana siyana mumaindasitiri ezvekudya, emishonga, zvekuzora, uye ekugadzira.Hunhu hwayo hwakasiyana hunoita kuti ive yakakosha seyakakora, inosimbisa, emulsifier, uye binder mune zvakasiyana zvigadzirwa.Iyo FDA inoita basa rakakosha mukudzora kuchengetedzwa uye kushandiswa kweCMC nezvimwe zvinowedzera zvekudya, kuve nechokwadi chekuti zvinosangana neyakaomarara mazinga asati atenderwa kushandiswa muzvigadzirwa zvevatengi.CMC yakanyorwa sechinhu chinobvumidzwa chekuwedzera chikafu neFDA, uye kushandiswa kwayo kunotongwa nemirau yakatarwa uye nhungamiro yakatsanangurwa muChinyorwa 21 cheCode of Federal Regulations.Vagadziri uye vatengesi vezvigadzirwa zvine CMC vanofanirwa kutevedzera iyi mirairo, inosanganisira kuongororwa kwekuchengetedza, zvinodikanwa zvekunyora, uye mamiriro akatsanangurwa ekushandiswa, kuve nechokwadi chekuchengetedza uye kunaka kwezvigadzirwa zvavo.
Nguva yekutumira: Mar-22-2024