Cov Txheej Txheem Granulation hauv Kev Tsim Tshuaj
Granulation yog cov txheej txheem tseem ceeb ntawm kev tsim cov ntsiav tshuaj. Nws yog ntawm ob hom ntub thiab qhuav uas tau saws raws li ntawm API siv los hauv kev tsim khoom.
Granulation yog txheej txheem ntawm kev tsim cov granules feem ntau. Hauv kev tsim tshuaj, txheej txheem kev cog qoob loo cuam tshuam txog cov txheej txheem uas yog, siv los sib xyaw hmoov hmoov los tsim cov khoom loj dua hu ua granules. Txoj kev no yog siv rau kev lag luam tsim cov tshuaj.
Vim li cas Granulation Yuav Tsum Tau Txais?
Cov txheej txheem txheej txheem tso cai rau cov khoom me los lo sib xyaw ntau dua. Nws nce lub particle loj ntawm cov pov npav siv, uas feem ntau zoo hmoov ntau. Qhov ntau dua qhov me me ntawm qhov sib txuam, ntau dua nws yuav yog qhov nws muaj peev xwm compressive lossis khi.
Cov txheej txheem granulation rau cov txheej txheem tsim cov ntsiav tshuaj feem ntau yog ob hom:
1. ntub dej tshuab luam yeeb
2. Qhuav Granulation
1. ntub dej tshuab luam yeeb
Hauv cov txheej txheem ntub dej granulation, cov theem hauv qab no yog kev koom tes:
Sifting: Active Pharmaceutical Cov Khoom Siv (API) thiab cov xa tawm yog hloov pauv, feem ntau dhau los ntawm 40 pawg lossis 60 huab hwm coj sab. Thaum API thiab cov neeg tshem tawm yog hloov pauv lawv ua ke.
Kev sib xyaw: Yuav kom sib tov lawv ntau dua kom huv si, cov txheej txheem sib tov qhuav yog siv. Thaum cov kev sib xyaw ua tiav, cov kua dej granulating tau ntxiv rau sai sai cov khoom xyaw granulator lossis RMG.
Kev ziab kom qhuav: Cov ntaub ntawv no tom qab ziab hauv lub tshuab ziab khaub ncaws, feem ntau yog chav dej ua pa lossis lub tshuab ziab khaub ncaws. Thaum cov pov npav tau qhuav, lawv tom qab ntawd milled siv 16 loj lossis 20 pawg sieves.
Lubrication: Cov kauj ruam kawg yog lubrication nyob rau hauv thiaj li yuav ua rau cov lus hais kom nyob ruaj khov ua ke. Qhov no yog ua tiav nrog ntxiv ntawm tus neeg sawv cev lubricating. Kev siv cov roj nplua nyeem tshwj xeeb yog tshwj xeeb rau cov hom API thiab cov siv tsis tau. Feem ntau siv los ua tus nplawm lub cev yog magnesium stearate. Cov khoom tsim yog li npaj txhij rau ntxiv compression thiab kev tsim khoom.
2. Qhuav Granulation
Kev ziab khaub ncaws qhuav tsis koom nrog kev siv cov kua roj ua kom muaj zog. Qhov no vim tias cov cuab yeej cuab tam tau siv tshuaj xav nrog tus neeg sawv cev siv, yog li cov tshuab granulation qhuav txheej txheem siv.
Kev faib tawm: thawj kauj ruam hauv kev granulation qhuav yog faib ntawm API thiab cov neeg xa khoom siv, raws li cov nyiaj teev tseg.
Txoj Kev Sib Ntsuas Qhuav lossis Ua Si: Thaum ob qho tag nrho cov pov tseg tau faib tawm, API thiab intragranular excipients tau muab sib xyaw ua ke los ntawm kev sib tov qhuav.
Kev sib cais: Tom qab cov khoom sib xyaw qhuav, lawv dhau los ntawm cov menyuam cov hmoov pob zeb rau kev cog lus. Qhov no tshwm sim hauv kev tsim cov slugs. Slugs yog daim ntawv ntxhib ntawm cov ntsiav tshuaj, feem ntau muaj peev txheej loj hauv lub cev.
Sib tsoo los yog sib tsoo: Cov pob zeb yog tom qab ntawd zom los yog tsoo kom txog thaum uas xav tau cov granule loj. Ua raws li qhov xav tau ntawm cov khoom, sieves siv los muaj granules ntawm txoj cai loj. Nyob rau theem no, kev sib txuas ntxiv yog ua nrog kev ntxiv ntawm cov neeg sab nrauv.
Cov tshuaj tso tawm sab nraud tsis ua ntu ntawm cov sib xyaw tseem ceeb; hloov, lawv tau ntxiv tom qab kev granulation tau tshwm sim. Cov neeg xa tawm txawv txav suav nrog cov quav, cov khoom tawg yooj yim, thiab lwm tus. Cov ntaub ntawv tom qab ntawd npaj tiav los ntawm cov txheej txheem txheej txheem txheej granulation hauv kev lag luam kev tsim tshuaj rau kev nrawm dua.