Dab tsi yog cov teeb meem tseem ceeb rau kev nkag mus rau hauv kev lag luam cellulose ether hauv tsev?

(1) Cov teeb meem kev siv tshuab

Cov neeg siv khoom ntawm cov khoom lag luam hauv qab nocellulose ethermuaj cov kev xav tau siab dua ntawm qhov zoo thiab ruaj khov ntawm cellulose ether. Kev tswj hwm kev siv tshuab zoo yog qhov teeb meem tseem ceeb hauv kev lag luam cellulose ether. Cov chaw tsim khoom yuav tsum paub txog kev tsim qauv sib phim ntawm cov khoom siv tseem ceeb, kev tswj hwm qhov tseem ceeb ntawm cov txheej txheem tsim khoom, cov txheej txheem tsim khoom tseem ceeb, tsim cov qauv ua haujlwm, thiab tom qab lub sijhawm ntev ntawm kev debugging thiab kev txhim kho kev siv tshuab tas mus li, lawv tuaj yeem tsim cov cellulose ether ruaj khov thiab zoo; Tsuas yog tom qab lub sijhawm ntev ntawm kev nqis peev tshawb fawb peb tuaj yeem sau cov kev paub txaus hauv daim ntawv thov. Nws nyuaj rau cov tuam txhab 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 paub txog kev tsim khoom loj ntawm cov tshuaj thiab cov khoom noj khoom haus cellulose ethers nrog qhov ruaj khov zoo (tshwj xeeb tshaj yog cellulose ethers rau kev tso tawm qeeb thiab tswj tau), nws kuj xav tau qee qhov kev nqis peev tshawb fawb thiab kev txhim kho lossis lub sijhawm ntawm kev paub dhau los. Yog li ntawd, muaj qee qhov teeb meem kev siv tshuab hauv kev lag luam no.

(2) Cov teeb meem rau kev txawj ntse ua haujlwm

Hauv kev tsim khoom thiab kev siv cellulose ether, muaj cov kev cai siab rau qhov zoo thiab qib kev txawj ntawm cov kws tshaj lij, cov neeg ua haujlwm thiab cov thawj coj. Cov kws tshaj lij tseem ceeb thiab cov neeg ua haujlwm tseem ruaj khov. Nws nyuaj rau feem ntau cov neeg nkag tshiab 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 teeb meem kev txawj ntse.

(3) Cov teeb meem kev tsim nyog

Cov lag luam cellulose ether yuav tsum tau txais cov ntawv pov thawj tsim nyog los tsim thiab muag cov tshuaj cellulose ether thiab cov khoom noj khoom haus cellulose ether.

Ntawm lawv, cov tshuaj cellulose ether yog ib qho tshuaj tseem ceeb, thiab nws qhov zoo cuam tshuam ncaj qha rau kev nyab xeeb ntawm cov tshuaj. Txhawm rau kom ntseeg tau tias muaj kev nyab xeeb ntawm cov tshuaj, kuv lub tebchaws siv lub kaw lus tso cai rau kev tsim tshuaj. Txhawm rau txhawb kev saib xyuas ntawm kev lag luam tshuaj, lub xeev tau tsim ntau txoj cai thiab kev cai lij choj hais txog kev nkag mus rau kev lag luam, kev tsim khoom thiab kev ua haujlwm. Raws li "Tsab Ntawv Sau Txog Kev Luam Ntawv thiab Kev Faib Cov Kev Cai rau Kev Sau Npe thiab Daim Ntawv Thov Cov Tshuaj" uas tau muab los ntawm Lub Xeev Food and Drug Administration, kev tswj hwm daim ntawv tso cai tsim khoom ntawm cov tshuaj tau siv, thiab cov tshuaj tshiab thiab cov tshuaj txawv teb chaws raug pom zoo los ntawm Lub Chaw Haujlwm Hauv Tebchaws. Twb muaj cov tshuaj txheem hauv tebchaws uas tau pom zoo los ntawm lub chaw haujlwm hauv xeev. Lub xeev kev saib xyuas cov tshuaj ntxiv tau dhau los ua qhov nruj dua, thiab ntau lub xeev thiab nroog tau tsim cov kev ntsuas kev tswj hwm raws li "Kev Ntsuas Kev Tswj Xyuas rau Cov Tshuaj Ntxiv (Draft for Comment)" uas tau muab los ntawm lub xeev. Yav tom ntej, yog tias cov lag luam tsis tuaj yeem tsim cov tshuaj excipients raws li cov qauv hauv tebchaws, lawv yuav tsis tuaj yeem nkag mus rau hauv kev ua lag luam. Ua ntej xaiv lossis hloov ib hom lossis hom tshuaj cellulose ether, cov chaw tsim tshuaj yuav tsum dhau qhov kev tshuaj xyuas thiab xa mus rau cov tub ceev xwm ua ntej lawv tuaj yeem yuav thiab siv nws. Muaj qee qhov teeb meem hauv kev pom zoo ntawm cov chaw tsim tshuaj rau cov neeg muag khoom. . Tsuas yog tom qab lub tuam txhab tau txais "Daim Ntawv Tso Cai Tsim Khoom Siv Hauv Tebchaws" uas tau muab los ntawm Lub Chaw Haujlwm Saib Xyuas Kev Zoo thiab Kev Tshawb Fawb Hauv Xeev tuaj yeem pom zoo los tsim cov cellulose ether ua cov khoom noj khoom haus ntxiv.

Raws li cov cai lij choj cuam tshuam xws li "Cov Cai Cuam Tshuam Txog Kev Txhawb Nqa Kev Saib Xyuas thiab Kev Tswj Xyuas Cov Tshuaj Siv Tshuaj" uas tau muab los ntawm Lub Xeev Lub Chaw Haujlwm Saib Xyuas Khoom Noj thiab Tshuaj thaum Lub Yim Hli 1, 2012, cov tuam txhab lag luam yuav tsum tau txais "Daim Ntawv Tso Cai Tsim Tshuaj" los tsim cov tshuaj HPMC cog, thiab cov ntau yam yuav tsum tau txais daim ntawv tso cai sau npe los ntawm Lub Chaw Haujlwm Saib Xyuas Khoom Noj thiab Tshuaj hauv tebchaws.

(4) Cov teeb meem nyiaj txiag

Kev tsim cov cellulose ether muaj qhov cuam tshuam loj heev. Cov khoom siv me me uas siv tes ua muaj cov zis tsawg, tsis zoo, thiab tsis muaj kev nyab xeeb ntau. Lub cuab yeej tswj hwm tsis siv neeg loj yog qhov zoo rau kev ua kom ruaj khov ntawm cov khoom zoo thiab txhim kho kev nyab xeeb ntawm kev tsim khoom. Cov khoom siv automation loj loj xav tau nyiaj ntau. Txhawm rau txhim kho kev sib tw ntawm cov khoom, cov lag luam yuav tsum txuas ntxiv nqis peev rau kev nthuav dav peev xwm tsim khoom thiab nce kev nqis peev R & D. Cov neeg nkag tshiab yuav tsum muaj lub zog nyiaj txiag muaj zog kom thiaj li sib tw nrog cov tuam txhab uas twb muaj lawm thiab ntsib qee qhov teeb meem nyiaj txiag kom nkag mus rau hauv kev lag luam.

(5) Tej yam teeb meem ntawm ib puag ncig

Cov txheej txheem tsim khoom ntawmcellulose etheryuav tsim cov dej khib nyiab thiab cov pa roj khib nyiab, thiab cov khoom siv tiv thaiv ib puag ncig rau kev kho cov dej khib nyiab thiab cov pa roj khib nyiab muaj kev nqis peev loj, cov kev xav tau siab thiab cov nqi ua haujlwm siab. Tam sim no, txoj cai tiv thaiv ib puag ncig hauv tsev tab tom nruj zuj zus, uas tso cov kev cai nruj ntawm cov thev naus laus zis tiv thaiv ib puag ncig thiab kev nqis peev hauv kev tsim cov cellulose ether, uas ua rau cov nqi tsim khoom ntawm cov lag luam nce ntxiv thiab tsim cov teeb meem tiv thaiv ib puag ncig siab. Cov lag luam tsim khoom cellulose ether nrog cov thev naus laus zis tiv thaiv ib puag ncig rov qab thiab kev ua qias tuaj loj yuav ntsib qhov xwm txheej ntawm kev raug tshem tawm. Cov neeg siv khoom siab muaj cov kev xav tau tiv thaiv ib puag ncig siab dua rau cov tuam txhab tsim cellulose ether. Nws tab tom nyuaj dua rau cov lag luam uas tsis ua raws li cov qauv tiv thaiv ib puag ncig kom tau txais kev tsim nyog los muab cov neeg siv khoom siab.