Carboxymethylcellulose (CMC) yog ib qho tshuaj sib xyaw ua ke uas siv tau ntau yam hauv ntau yam lag luam, suav nrog zaub mov, tshuaj, tshuaj pleev ib ce, thiab kev tsim khoom. Nws cov yam ntxwv ua rau nws muaj txiaj ntsig zoo li tus neeg sawv cev thickening, stabilizer, emulsifier, thiab ntau ntxiv. Lub Koom Haum Saib Xyuas Khoom Noj thiab Tshuaj ntawm Tebchaws Meskas (FDA) ua lub luag haujlwm tseem ceeb hauv kev tswj hwm kev nyab xeeb thiab kev siv cov tshuaj no, kom ntseeg tau tias lawv ua tau raws li cov qauv nruj ua ntej lawv tau txais kev pom zoo rau kev siv hauv cov khoom lag luam rau cov neeg siv khoom.
Kev Nkag Siab Txog Carboxymethylcellulose (CMC)
Carboxymethylcellulose, feem ntau hu ua CMC, yog ib qho derivative ntawm cellulose. Cellulose yog cov organic compound ntau tshaj plaws hauv ntiaj teb thiab pom muaj nyob rau hauv cov phab ntsa cell ntawm cov nroj tsuag, muab kev txhawb nqa cov qauv. CMC yog muab los ntawm cellulose los ntawm cov txheej txheem hloov kho tshuaj uas cuam tshuam nrog kev qhia cov carboxymethyl pawg rau ntawm cellulose backbone. Qhov kev hloov kho no muab ntau yam khoom muaj txiaj ntsig rau CMC, suav nrog kev yaj dej, viscosity, thiab kev ruaj khov.
Cov Khoom ntawm Carboxymethylcellulose:
Kev Yaj Hauv Dej: CMC yaj tau hauv dej, ua rau nws muaj cov kua ntshiab thiab khov. Cov yam ntxwv no ua rau nws muaj txiaj ntsig zoo rau ntau yam kev siv uas xav tau tus neeg sawv cev ua kom tuab lossis ruaj khov.
Viscosity: CMC qhia txog tus cwj pwm pseudoplastic, txhais tau tias nws cov viscosity txo qis hauv qab kev ntxhov siab shear thiab nce ntxiv dua thaum 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.
Kev Ruaj Ntseg: CMC muab kev ruaj ntseg rau cov emulsions thiab cov suspensions, tiv thaiv cov khoom xyaw los ntawm kev sib cais lossis tawm mus raws sijhawm. Qhov kev ruaj ntseg no yog qhov tseem ceeb hauv cov khoom xws li cov kua zaub xas lav, cov tshuaj pleev ib ce, thiab cov suspensions tshuaj.
Kev Tsim Zaj Duab Xis: CMC tuaj yeem tsim cov zaj duab xis nyias, yoog tau thaum qhuav, ua rau nws muaj txiaj ntsig zoo rau cov ntawv thov xws li cov tshuaj pleev xim rau cov ntsiav tshuaj lossis tshuaj ntsiav, thiab hauv kev tsim cov zaj duab xis rau cov ntaub ntawv ntim khoom.
Cov ntawv thov ntawm Carboxymethylcellulose
CMC pom muaj kev siv dav dav thoob plaws ntau yam lag luam vim nws cov khoom siv tau ntau yam. Qee qhov kev siv dav suav nrog:
Kev Lag Luam Khoom Noj: CMC yog siv los ua cov khoom ua kom tuab, cov khoom ruaj khov, thiab cov khoom sib txuas hauv ntau yam khoom noj, suav nrog cov kua ntses, cov kua ntses, cov khoom qab zib, cov khoom ci, thiab cov dej haus. Nws pab txhim kho cov qauv, qhov ncauj zoo li cas, thiab kev ruaj khov ntawm lub txee.
Cov Tshuaj: Hauv cov tshuaj, CMC yog siv los ua cov khoom sib txuas hauv cov tshuaj ntsiav, ua cov khoom ua kom tuab hauv cov tshuaj ncua, thiab ua cov khoom ruaj khov hauv cov tshuaj emulsions. Nws ua kom muaj kev faib tshuaj sib npaug thiab ua kom cov neeg mob ua raws li qhov xav tau.
Cov Tshuaj Pleev Xim thiab Cov Khoom Siv Kho Mob Tus Kheej: CMC siv rau hauv cov tshuaj pleev xim thiab cov khoom siv kho mob tus kheej xws li tshuaj pleev, tshuaj pleev, tshuaj zawv plaub hau, thiab tshuaj txhuam hniav ua cov khoom ua kom tuab, emulsifier, thiab stabilizer. Nws pab tswj cov khoom kom sib xws thiab txhim kho kev ua haujlwm.
Kev Siv Hauv Kev Lag Luam: CMC siv rau ntau yam txheej txheem kev lag luam ua ib qho thickener, dej retention agent, thiab rheology modifier hauv cov khoom xws li detergents, xim, adhesives, thiab drilling fluids.
Cov Txheej Txheem Pom Zoo ntawm FDA
Hauv Tebchaws Meskas, FDA tswj kev siv cov khoom noj khoom haus ntxiv, suav nrog cov tshuaj xws li CMC, raws li Txoj Cai Khoom Noj Khoom Haus, Tshuaj, thiab Tshuaj Pleev Xim (FD&C Act) thiab Kev Hloov Kho Khoom Noj Khoom Haus ntxiv xyoo 1958. FDA qhov kev txhawj xeeb tseem ceeb yog xyuas kom meej tias cov tshuaj ntxiv rau hauv cov khoom noj muaj kev nyab xeeb rau kev noj thiab ua haujlwm tau zoo.
Cov txheej txheem kev pom zoo ntawm FDA rau cov khoom noj khoom haus feem ntau muaj cov kauj ruam hauv qab no:
Kev Ntsuam Xyuas Kev Nyab Xeeb: Tus neeg tsim khoom lossis tus neeg muag khoom ntawm cov khoom noj khoom haus muaj lub luag haujlwm los ua kev tshawb fawb txog kev nyab xeeb los qhia tias cov tshuaj no muaj kev nyab xeeb rau nws siv. Cov kev tshawb fawb no suav nrog kev ntsuam xyuas tshuaj lom, kev tshawb fawb txog kev ua haujlwm ntawm lub cev, thiab kev ua xua.
Kev Xa Daim Ntawv Thov Khoom Noj Khoom Haus: Tus neeg tsim khoom xa daim ntawv thov khoom noj khoom haus (FAP) mus rau FDA, muab cov ntaub ntawv qhia txog tus kheej, cov khoom sib xyaw, cov txheej txheem tsim khoom, kev siv, thiab cov ntaub ntawv kev nyab xeeb ntawm cov khoom noj khoom haus. Daim ntawv thov kuj tseem yuav tsum suav nrog cov kev cai sau npe.
Kev Tshuaj Xyuas FDA: FDA soj ntsuam cov ntaub ntawv kev nyab xeeb uas muab rau hauv FAP los txiav txim siab seb cov khoom ntxiv puas muaj kev nyab xeeb rau nws qhov kev siv raws li cov xwm txheej ntawm kev siv uas tus neeg thov tau teev tseg. Kev tshuaj xyuas no suav nrog kev ntsuam xyuas cov kev pheej hmoo rau tib neeg kev noj qab haus huv, suav nrog cov qib kev raug thiab txhua yam kev phiv uas paub.
Kev Tshaj Tawm Txog Cov Cai Tswjfwm Uas Tau Pom Zoo: Yog tias FDA txiav txim siab tias cov khoom ntxiv no muaj kev nyab xeeb, nws yuav tshaj tawm cov cai tswjfwm uas tau pom zoo hauv Federal Register, qhia meej txog cov xwm txheej uas cov khoom ntxiv no yuav siv tau rau hauv zaub mov. Daim ntawv tshaj tawm no tso cai rau pej xeem tawm tswv yim thiab cov tswv yim los ntawm cov neeg koom nrog.
Kev Tsim Cai Kawg: Tom qab xav txog cov lus tawm tswv yim ntawm pej xeem thiab cov ntaub ntawv ntxiv, FDA tshaj tawm txoj cai kawg pom zoo lossis tsis pom zoo siv cov khoom noj khoom haus ntxiv. Yog tias pom zoo, txoj cai kawg yuav tsim cov xwm txheej uas tso cai siv, suav nrog txhua qhov kev txwv, cov lus qhia tshwj xeeb, lossis cov kev cai ntawm daim ntawv lo.
Carboxymethylcellulose thiab FDA Kev Pom Zoo
Carboxymethylcellulose muaj keeb kwm ntev ntawm kev siv hauv kev lag luam zaub mov thiab lwm yam kev lag luam, thiab nws feem ntau lees paub tias muaj kev nyab xeeb (GRAS) rau nws cov kev siv thaum siv raws li cov kev coj ua zoo. FDA tau tshaj tawm cov cai thiab cov lus qhia tshwj xeeb tswj kev siv CMC hauv cov khoom noj thiab cov tshuaj.
FDA Kev Cai Tswjfwm ntawm Carboxymethylcellulose:
Xwm Txheej Khoom Noj Khoom Haus: Carboxymethylcellulose yog teev raws li cov khoom noj khoom haus uas raug tso cai hauv Title 21 ntawm Code of Federal Regulations (CFR) nyob rau hauv seem 172.Code 8672, nrog rau cov cai tshwj xeeb uas tau teev tseg rau nws siv rau hauv ntau pawg khoom noj. Cov cai no teev cov qib siab tshaj plaws uas tso cai ntawm CMC hauv cov khoom noj sib txawv thiab lwm yam kev cai.
Kev Siv Tshuaj: Hauv cov tshuaj, CMC yog siv ua cov khoom xyaw tsis muaj zog hauv cov tshuaj, thiab nws txoj kev siv yog tswj hwm los ntawm FDA's Center for Drug Evaluation and Research (CDER). Cov chaw tsim khoom yuav tsum xyuas kom meej tias CMC ua tau raws li cov lus qhia tshwj xeeb uas tau teev tseg hauv United States Pharmacopeia (USP) lossis lwm cov ntawv sau tseem ceeb.
Cov Kev Cai Sau Npe: Cov khoom 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 xyaw kom raug thiab cov ntawv sau npe rau txhua yam kev ua xua uas xav tau.
Carboxymethylcellulose (CMC) yog ib qho tshuaj siv dav dav uas muaj ntau yam kev siv hauv kev lag luam khoom noj, tshuaj, tshuaj pleev ib ce, thiab kev tsim khoom. Nws cov yam ntxwv tshwj xeeb ua rau nws muaj txiaj ntsig zoo li cov khoom ua kom tuab, cov khoom ruaj khov, cov khoom ua kom emulsifier, thiab cov khoom sib txuas 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, xyuas kom meej tias lawv ua tau raws li cov qauv kev nyab xeeb ua ntej lawv tau pom zoo rau kev siv hauv cov khoom siv rau cov neeg siv khoom. CMC tau teev tseg ua cov khoom noj ntxiv uas tau tso cai los ntawm FDA, thiab nws siv yog tswj hwm los ntawm cov cai thiab cov lus qhia tshwj xeeb uas tau teev tseg hauv Title 21 ntawm Code of Federal Regulations. Cov chaw tsim khoom thiab cov neeg muag khoom ntawm cov khoom uas muaj CMC yuav tsum ua raws li cov cai no, suav nrog kev ntsuam xyuas kev nyab xeeb, cov kev cai ntawm daim ntawv lo, thiab cov xwm txheej tshwj xeeb ntawm kev siv, kom ntseeg tau tias muaj kev nyab xeeb thiab zoo ntawm lawv cov khoom.
Lub sijhawm tshaj tawm: Lub Peb Hlis-22-2024