(1)Technical barriers
Cov neeg siv khoom hauv qab ntawm cellulose ether muaj qhov xav tau siab dua ntawm qhov zoo thiab ruaj khov ntawm cellulose ether.Kev tswj xyuas tshuab zoo yog ib qho kev cuam tshuam tseem ceeb hauv kev lag luam cellulose ether.Cov neeg tsim khoom yuav tsum tau ua tus qauv tsim kev ua tau zoo ntawm cov cuab yeej tseem ceeb, qhov tseem ceeb ntawm kev tswj cov txheej txheem ntau lawm, cov txheej txheem tseem ceeb, tsim cov qauv kev ua haujlwm, thiab tom qab lub sijhawm ntev ntawm kev debugging thiab kev txhim kho txuas ntxiv, lawv tuaj yeem tsim cov cellulose ether ruaj khov thiab zoo;Tsuas yog tom qab lub sijhawm ntev ntawm kev tshawb fawb kev nqis peev tuaj yeem peb tau txais kev paub txaus hauv daim ntawv thov.Nws yog qhov nyuaj rau cov lag luam tshiab nkag mus rau hauv kev lag luam kom paub txog cov thev naus laus zis tseem ceeb hauv lub sijhawm luv luv.Txhawm rau kom paub qhov loj ntawm kev tsim tshuaj thiab zaub mov-qib cellulose ethers nrog kev ruaj khov zoo (tshwj xeeb tshaj yog cellulose ethers rau qeeb thiab tswj kev tso tawm), nws kuj yuav tsum muaj qee qhov kev tshawb fawb thiab kev loj hlob peev lossis lub sijhawm ntawm kev ua tiav.Yog li ntawd, muaj qee yam kev teeb meem hauv kev lag luam no.
(2)Kev cuam tshuam rau kev txawj ntse
Hauv kev tsim khoom thiab kev siv ntawm cellulose ether, muaj cov kev xav tau siab rau kev ua tau zoo thiab qib ntawm cov kws tshaj lij, cov neeg ua haujlwm thiab cov thawj coj.Cov kws tshaj lij thiab cov neeg ua haujlwm tseem ceeb tseem nyob ruaj khov.Nws yog qhov nyuaj rau cov neeg tuaj tshiab feem ntau kom tau txais cov txuj ci tshaj lij nrog R & D thiab cov thev naus laus zis tseem ceeb hauv lub sijhawm luv luv, thiab muaj cov txuj ci kev tshaj lij.
(3)Txuj ci teeb meem
Cellulose ether cov tuam txhab yuav tsum tau txais cov kev tsim nyog tsim nyog los tsim thiab muag tshuaj qib cellulose ether thiab zaub mov qib cellulose ether.
Ntawm lawv, cov tshuaj qib cellulose ether yog ib qho tseem ceeb ntawm cov tshuaj excipient, thiab nws qhov zoo cuam tshuam ncaj qha rau kev nyab xeeb ntawm cov tshuaj.Txhawm rau kom muaj kev nyab xeeb ntawm cov tshuaj, kuv lub tebchaws siv cov ntawv tso cai rau kev tsim tshuaj.Txhawm rau ntxiv dag zog rau kev saib xyuas ntawm kev lag luam tshuaj, lub xeev tau tsim cov kev cai lij choj thiab kev tswj hwm kev lag luam hauv kev lag luam, kev tsim khoom thiab kev ua haujlwm.Raws li "Tsab Ntawv Tshaj Tawm thiab Tshaj Tawm Cov Kev Xav Tau rau Kev Sau Npe thiab Kev Thov Cov Khoom Siv Tshuaj" muab los ntawm Lub Xeev Food and Drug Administration, kev tswj xyuas daim ntawv tso cai tsim khoom ntawm cov tshuaj excipients yog siv, thiab cov tshuaj tshiab thiab cov khoom siv tshuaj tuaj txawv teb chaws yog raug rau kev pom zoo los ntawm National Bureau.Muaj twb muaj lub teb chaws tus qauv tshuaj excipients Pom zoo los ntawm lub xeev bureau.Lub xeev txoj kev saib xyuas ntawm cov tshuaj excipients yog nruj zuj zus, thiab ntau lub xeev thiab lub nroog tau tsim cov kev tswj xyuas zoo raws li "Kev Tswj Xyuas Kev Tswj Xyuas Tshuaj rau Cov Khoom Siv Tshuaj (Draft for Comment)" los ntawm lub xeev.Nyob rau hauv lub neej yav tom ntej, yog tias cov lag luam tsis tuaj yeem tsim cov tshuaj excipients nruj me ntsis raws li lub teb chaws tus qauv, lawv yuav tsis tuaj yeem nkag mus rau hauv kev ua lag luam.Ua ntej xaiv lossis hloov qee yam lossis hom tshuaj qib cellulose ether, cov chaw tsim tshuaj yuav tsum dhau qhov kev tshuaj xyuas thiab ua ntaub ntawv nrog cov neeg muaj peev xwm ua ntej lawv tuaj yeem yuav thiab siv tau.Muaj qee yam teeb meem hauv kev pom zoo ntawm cov kws tsim tshuaj rau cov neeg muag khoom..Tsuas yog tom qab lub tuam txhab tau txais daim ntawv tso cai "National Industrial Product Production License" uas tau muab los ntawm Lub Tsev Haujlwm Saib Xyuas Kev Noj Qab Haus Huv thiab Kev Saib Xyuas Kev Ua Haujlwm hauv Xeev tuaj yeem pom zoo los tsim cov cellulose ether ua cov khoom noj ntxiv.
Raws li cov kev cai muaj feem xyuam xws li "Txoj Cai Hais Txog Kev Txhim Kho Kev Saib Xyuas thiab Kev Tswj Xyuas Tshuaj" uas tau tshaj tawm los ntawm Lub Xeev Food and Drug Administration thaum Lub Yim Hli 1, 2012, cov tuam txhab yuav tsum tau txais daim ntawv tso cai "Drug Production License" los tsim HPMC cov tshuaj ntsiav tshuaj, thiab ntau yam yuav tsum tau txais kev saib xyuas zaub mov hauv tebchaws thiab tshuaj.daim ntawv tso npe tso tawm los ntawm Bureau.
(4)Nyiaj txiag teeb meem
Kev tsim cov cellulose ether muaj cov txiaj ntsig pom tseeb.Cov khoom siv me me uas siv tau manually muaj cov zis tsawg, tsis muaj kev ruaj ntseg zoo, thiab tsis tshua muaj kev ruaj ntseg zoo.Qhov loj-scale tsis siv neeg tswj ntaus ntawv yog qhov tsim nyog los ua kom muaj kev ruaj ntseg ntawm cov khoom zoo thiab txhim kho kev nyab xeeb ntawm kev tsim khoom.Loj-scale ua tiav cov khoom siv automation yuav tsum tau txais nyiaj ntau.Txhawm rau txhim kho cov khoom sib tw, cov tuam txhab yuav tsum tau nqis peev ntxiv rau kev nthuav dav cov peev txheej tsim khoom thiab nce R & D peev.Cov neeg tuaj tshiab yuav tsum muaj lub zog nyiaj txiag muaj zog txhawm rau sib tw nrog cov tuam txhab uas twb muaj lawm thiab ntsib qee yam teeb meem nyiaj txiag nkag mus rau hauv kev lag luam.
(5)Environmental barriers
Cov txheej txheem tsim khoom ntawm cellulose ether yuav tsim cov dej khib nyiab thiab cov roj pov tseg, thiab cov khoom siv tiv thaiv ib puag ncig rau kev kho cov dej khib nyiab thiab cov roj khib nyiab muaj peev txheej loj, cov kev xav tau siab thiab cov nqi khiav lag luam.Tam sim no, txoj cai tswjfwm kev tiv thaiv ib puag ncig hauv tebchaws tau dhau los ua nruj zuj zus, uas ua rau cov kev cai nruj ntawm kev tiv thaiv ib puag ncig thiab kev nqis peev hauv kev tsim cov cellulose ether, uas ua rau cov nqi tsim khoom lag luam thiab tsim cov kev tiv thaiv ib puag ncig.Cellulose ether cov tuam txhab tsim khoom nrog rov qab ib puag ncig kev tiv thaiv thev naus laus zis thiab cov pa phem loj yuav ntsib qhov teeb meem ntawm kev tshem tawm.Cov neeg siv khoom siab kawg muaj kev tiv thaiv ib puag ncig siab dua rau cov tuam txhab cellulose ether.Nws tau dhau los ua nyuaj rau cov lag luam uas tsis ua raws li cov qauv kev tiv thaiv ib puag ncig kom tau txais kev tsim nyog los muab cov neeg siv khoom siab.
Lub sij hawm xa tuaj: Plaub Hlis-10-2023