Carboxymethylcellulose (CMC) yog cov khoom siv ntau yam siv dav hauv ntau yam lag luam, suav nrog zaub mov, tshuaj, tshuaj pleev ib ce, thiab kev tsim khoom.Nws cov khoom siv ntau yam ua rau nws muaj txiaj ntsig zoo li tus neeg sawv cev thickening, stabilizer, emulsifier, thiab lwm yam.Lub Tsev Haujlwm Saib Xyuas Kev Noj Qab Haus Huv thiab Tshuaj (FDA) tau ua lub luag haujlwm tseem ceeb hauv kev tswj hwm kev nyab xeeb thiab kev siv cov tshuaj no, ua kom lawv ua tau raws li cov qauv nruj ua ntej lawv raug pom zoo siv rau hauv cov khoom siv.
Nkag siab txog Carboxymethylcellulose (CMC)
Carboxymethylcellulose, feem ntau abbreviated li CMC, yog ib tug derivative ntawm cellulose.Cellulose yog cov organic ntau tshaj plaws nyob rau hauv lub ntiaj teb thiab pom nyob rau hauv lub cell phab ntsa ntawm cov nroj tsuag, muab kev pab txhawb nqa.CMC yog muab los ntawm cellulose los ntawm kev hloov tshuaj lom neeg cov txheej txheem uas muaj kev qhia txog carboxymethyl pawg mus rau hauv cov pob txha cellulose.Qhov kev hloov kho no qhia ntau yam khoom siv rau CMC, suav nrog cov dej solubility, viscosity, thiab stability.
Cov khoom ntawm Carboxymethylcellulose:
Dej Solubility: CMC yog soluble nyob rau hauv dej, tsim ib tug ntshiab, viscous tov.Cov cuab yeej no ua rau nws muaj txiaj ntsig zoo hauv ntau daim ntawv thov uas yuav tsum tau ua kom cov thickening lossis stabilizing tus neeg sawv cev.
Viscosity: CMC nthuav tawm tus cwj pwm pseudoplastic, txhais tau tias nws cov viscosity txo qis hauv kev ntxhov siab thiab nce ntxiv thaum qhov kev ntxhov siab raug tshem tawm.Cov cuab yeej no tso cai rau kev siv yooj yim hauv cov txheej txheem xws li twj tso kua mis, txau, lossis extrusion.
Stability: CMC imparts stability rau emulsions thiab suspensions, tiv thaiv cov khoom xyaw los ntawm kev sib cais los yog nyob rau hauv lub sij hawm.Qhov kev ruaj ntseg no yog qhov tseem ceeb hauv cov khoom lag luam xws li cov khaub ncaws hnav khaub ncaws, tshuaj pleev ib ce, thiab tshuaj tua kab mob.
Zaj duab xis-Forming: CMC tuaj yeem tsim cov yeeb yaj kiab nyias, hloov tau yooj yim thaum ziab, ua rau nws muaj txiaj ntsig zoo hauv cov ntawv thov xws li cov txheej txheem siv tau rau cov ntsiav tshuaj lossis tshuaj ntsiav, thiab hauv kev tsim cov yeeb yaj kiab rau cov khoom ntim.
Kev siv ntawm Carboxymethylcellulose
CMC pom dav siv thoob plaws ntau qhov kev lag luam vim nws cov khoom siv ntau yam.Qee cov ntawv thov siv xws li:
Kev lag luam khoom noj khoom haus: CMC yog siv los ua thickener, stabilizer, thiab binder nyob rau hauv ntau yam khoom noj khoom haus, nrog rau cov kua ntses, hnav khaub ncaws, ice cream, bakery khoom, thiab dej haus.Nws pab txhim kho kev ntxhib los mos, qhov ncauj qhov ntswg, thiab txee ruaj khov.
Pharmaceuticals: Hauv kev lag luam tshuaj, CMC yog siv los ua cov ntawv khi hauv cov ntsiav tshuaj, cov thickener hauv kev ncua, thiab cov stabilizer hauv emulsions.Nws ua kom muaj kev faib tshuaj zoo ib yam thiab txhim kho kev ua raws li tus neeg mob.
Cov Khoom Siv Tshuaj Txhuam Hniav thiab Kev Kho Tus Kheej: CMC yog ua haujlwm hauv cov tshuaj pleev ib ce thiab cov khoom tu tus kheej xws li tshuaj pleev, tshuaj pleev, tshuaj zawv plaub hau, thiab tshuaj txhuam hniav ua cov thickener, emulsifier, thiab stabilizer.Nws pab tswj cov khoom sib xws thiab txhim kho kev ua haujlwm.
Cov Ntawv Thov Kev Lag Luam: CMC yog siv rau hauv ntau cov txheej txheem kev lag luam ua cov thickener, dej tuav tus neeg sawv cev, thiab rheology hloov kho hauv cov khoom xws li tshuaj ntxuav tes, pleev xim, nplaum, thiab cov kua dej drilling.
FDA pom zoo txheej txheem
Hauv Tebchaws Meskas, FDA tswj kev siv cov khoom noj ntxiv, suav nrog cov khoom xws li CMC, raws li Tsoom Fwv Teb Chaws Khoom Noj, Tshuaj, thiab Tshuaj pleev ib ce (FD&C Act) thiab Food Additives Amendment of 1958. FDA qhov kev txhawj xeeb tseem ceeb yog los xyuas kom meej tias cov tshuaj Ntxiv rau cov zaub mov muaj kev nyab xeeb rau kev noj thiab ua haujlwm rau lub hom phiaj tseem ceeb.
Txoj kev pom zoo los ntawm FDA rau cov khoom noj ntxiv feem ntau suav nrog cov kauj ruam hauv qab no:
Kev Ntsuam Xyuas Kev Nyab Xeeb: Cov chaw tsim khoom lossis tus neeg muag khoom ntawm cov khoom noj ntxiv yog lub luag haujlwm rau kev tshawb fawb txog kev nyab xeeb kom pom tias cov khoom muaj kev nyab xeeb rau nws txoj kev npaj siv.Cov kev tshawb fawb no suav nrog kev ntsuam xyuas toxicological, kev tshawb fawb txog cov metabolism, thiab muaj peev xwm ua xua.
Kev Xa Daim Ntawv Thov Khoom Noj Ntxiv: Cov chaw tsim khoom xa daim ntawv thov zaub mov ntxiv (FAP) rau FDA, muab cov ncauj lus kom ntxaws txog tus kheej, muaj pes tsawg leeg, txheej txheem tsim khoom, npaj siv, thiab cov ntaub ntawv kev nyab xeeb ntawm cov khoom ntxiv.Daim ntawv thov yuav tsum suav nrog cov ntawv sau npe uas xav tau.
FDA Kev Ntsuam Xyuas: FDA ntsuas cov ntaub ntawv kev nyab xeeb uas tau muab hauv FAP los txiav txim siab seb cov tshuaj ntxiv puas muaj kev nyab xeeb rau nws txoj kev npaj siv raws li kev siv tau teev tseg los ntawm tus neeg thov.Qhov kev tshuaj xyuas no suav nrog kev ntsuam xyuas ntawm qhov muaj feem cuam tshuam rau tib neeg kev noj qab haus huv, suav nrog qib kis tau tus mob thiab paub txog qhov tsis zoo.
Kev Tshaj Tawm Txog Kev Cai Lij Choj: Yog tias FDA txiav txim siab tias cov tshuaj ntxiv muaj kev nyab xeeb, nws tshaj tawm cov cai tswj hwm hauv Tsoom Fwv Teb Chaws Register, qhia txog cov xwm txheej hauv qab uas cov additive yuav siv tau rau hauv cov zaub mov.Kev tshaj tawm no tso cai rau pej xeem tawm tswv yim thiab tawm tswv yim los ntawm cov neeg muaj feem.
Kev Txiav Txim Zaum Kawg: Tom qab txiav txim siab rau pej xeem cov lus pom thiab cov ntaub ntawv ntxiv, FDA tau tshaj tawm txoj cai zaum kawg yog pom zoo lossis tsis lees paub kev siv cov khoom ntxiv hauv cov zaub mov.Yog tias pom zoo, txoj cai kawg tsim cov kev tso cai ntawm kev siv, suav nrog cov kev txwv, kev qhia tshwj xeeb, lossis cov ntawv sau npe.
Carboxymethylcellulose thiab FDA pom zoo
Carboxymethylcellulose muaj keeb kwm ntev ntawm kev siv hauv kev lag luam khoom noj thiab lwm cov haujlwm, thiab nws feem ntau lees paub tias muaj kev nyab xeeb (GRAS) rau nws qhov kev npaj siv thaum siv raws li kev tsim khoom zoo.FDA tau tshaj tawm cov kev cai tshwj xeeb thiab cov lus qhia tswj kev siv CMC hauv cov khoom noj thiab tshuaj.
FDA Txoj Cai ntawm Carboxymethylcellulose:
Khoom noj khoom haus Additive Status: Carboxymethylcellulose yog teev raws li ib tug tso cai zaub mov additive nyob rau hauv Title 21 ntawm lub Code of the Federal Regulations (CFR) nyob rau hauv seem 172.Code 8672, nrog rau cov kev cai tshwj xeeb teev rau nws siv nyob rau hauv ntau yam zaub mov pawg.Cov kev cai no qhia txog qib siab tshaj plaws ntawm CMC hauv cov khoom noj sib txawv thiab lwm yam kev cai.
Kev Siv Tshuaj: Hauv kev siv tshuaj, CMC yog siv los ua cov khoom tsis muaj zog hauv cov tshuaj formulations, thiab nws siv yog tswj raws li FDA's Center for Drug Evaluation and Research (CDER).Cov neeg tsim khoom yuav tsum xyuas kom meej tias CMC ua tau raws li cov lus qhia tshwj xeeb uas tau teev tseg hauv Tebchaws Meskas Pharmacopeia (USP) lossis lwm yam cuam tshuam.
Kev Sau Npe: Cov khoom lag luam uas muaj CMC ua cov khoom xyaw yuav tsum ua raws li FDA cov cai hais txog kev sau npe, suav nrog cov npe khoom muaj tseeb thiab cov ntawv sau ua xua.
Carboxymethylcellulose (CMC) yog cov khoom siv dav siv nrog ntau hom kev siv hauv cov zaub mov, tshuaj, tshuaj pleev ib ce, thiab kev lag luam.Nws cov khoom tshwj xeeb ua rau nws muaj txiaj ntsig zoo li cov thickener, stabilizer, emulsifier, thiab binder hauv ntau yam khoom.FDA ua lub luag haujlwm tseem ceeb hauv kev tswj hwm kev nyab xeeb thiab kev siv CMC thiab lwm yam khoom noj ntxiv, kom ntseeg tau tias lawv ua tau raws li cov qauv kev nyab xeeb nruj ua ntej lawv raug pom zoo siv rau hauv cov khoom siv.CMC tau teev npe raws li kev tso cai noj zaub mov ntxiv los ntawm FDA, thiab nws txoj kev siv yog tswj hwm los ntawm cov cai tshwj xeeb thiab cov lus qhia tau teev tseg hauv Title 21 ntawm Txoj Cai Tswjfwm Ntiag Tug.Cov neeg tsim khoom thiab cov neeg muag khoom ntawm cov khoom uas muaj CMC yuav tsum ua raws li cov cai no, suav nrog kev soj ntsuam kev nyab xeeb, cov ntawv sau npe, thiab cov xwm txheej ntawm kev siv, kom ntseeg tau tias muaj kev nyab xeeb thiab zoo ntawm lawv cov khoom.
Post lub sij hawm: Mar-22-2024