Kev Nkag Siab Txog Kev Txheej Txheem Enteric Hauv Cov Tshuaj
Txheej enteric yog ib daim yas tshwj xeeb, ua los ntawm polymer uas siv rau cov tshuaj noj - feem ntau yog cov tshuaj hauv cov ntsiav tshuaj, tshuaj capsule, lossis cov ntsiav tshuaj. Nws ua haujlwm los tiv thaiv cov tshuaj ntawm qhov chaw acidic ntawm lub plab (pH 1–3), ua kom cov tshuaj tso tawm tsuas yog hauv cov xwm txheej nruab nrab lossis alkaline uas pom muaj nyob rau hauv cov hnyuv (pH ≥ 5.5–7). Qhov kev thaiv no yog qhov tseem ceeb rau kev tiv thaiv cov tshuaj uas ua rau mob acid, txo qis kev khaus plab, thiab coj cov tshuaj mus rau cov cheeb tsam plab.
Txheej Enteric Yog Dab Tsi?
- Kev Txhais LusCov tshuaj txheej enteric siv ib txheej tiv thaiv uas tsis yaj hauv dej uas tiv taus cov kua qaub hauv plab tab sis sai sai yaj lossis nkag tau thaum lub plab pH.
- Cov Khoom Siv Sib XwsCov txheej no feem ntau siv methacrylic acid copolymers, hydroxypropyl methylcellulose (HPMC), cellulose acetate, polyvinyl acetate, lossis kev sib xyaw ntawm cov polymers ntuj xws li alginate thiab pectin.
- Kev tiv thaiv ntawm AcidityNtau yam tshuaj tsis ruaj khov thaum muaj kua qaub. Cov txheej txheej enteric txo qhov hydrolysis ua ntej lub sijhawm, oxidation, lossis crystallization ntawm cov khoom xyaw nquag thaum hla lub plab.
- Kev Xa Khoom Raws Li Lub Hom PhiajLos ntawm kev nyob twj ywm kom txog thaum mus txog duodenum lossis deb dua ntawm txoj hnyuv plab, cov ntsiav tshuaj enteric coated ua kom cov tshuaj nqus tau ntawm qhov chaw zoo tshaj plaws, txhim kho ob qho tib si kev ua haujlwm zoo thiab bioavailability.
Lub Hom Phiaj: Tiv Thaiv Kev Ncaj Ncees ntawm Tshuaj thiab Kev Tso Tawm Raws Lub Hom Phiaj
Cov Tshuaj Ntsuas thiab Tshuaj Capsules Uas Muaj Enteric Coated Rau Kev Xa Tshuaj Zoo Dua
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Cov Qauv Tshuaj: Cov Tshuaj Pleev Uas Muaj Txheej Enteric, Cov Tshuaj Ntsuas, thiab Cov Tshuaj Capsules
- Cov Qauv MonolithicCov no suav nrog cov tshuab ib chav xws li cov tshuaj ntsiav uas muaj txheej enteric, cov ntsiav tshuaj, thiab cov tshuaj ntsiav. Cov tshuaj methacrylic acid copolymers feem ntau yog cov kev xaiv zoo tshaj plaws rau cov ntawv thov no vim tias nws tau ua pov thawj tias tiv taus cov kua qaub.
- Cov Txheej Txheem Ntau Yam: Kev txheej enteric kuj tseem siv rau cov pellets, granules, lossis microcapsules. Txoj hauv kev no tuaj yeem ua rau cov tshuaj tso tawm zoo ib yam thiab txo qhov sib txawv ntawm cov tshuaj, uas yog qhov tseem ceeb rau cov tshuaj generic thiab cov khoom tshwj xeeb.
- Piv txwv:
- Cov Tshuaj Pantoprazole: Txheej enteric rau kev tso tawm qeeb, tiv thaiv cov proton twj tso kua mis inhibitor los ntawm kev puas tsuaj hauv plab.
- Cov Txheej Txheem Protein Cog Qoob Loo Microencapsulated: Txheej rau kev tiv thaiv thiab kev xa khoom noj khoom haus raws li lub hom phiaj.
Kev Tiv Thaiv Kev Tso Tshuaj Ua Ntej Hauv Cov Chaw Acidic
Cov txheej txheem enteric vam khom cov txheej txheem pH-triggered rau kev tiv thaiv tshuaj:
- Polymer Insolubility ntawm Qis pHCov polymer matrix no tau tsim los kom nyob ruaj khov hauv cov kua qaub hauv plab. Piv txwv li, methacrylic acid copolymers tsuas yaj thaum pH nce siab tshaj 5.5 - qhov pH ib txwm muaj ntawm txoj hnyuv sab saud.
- Kev Sib Tw Lub Cev thiab Cov Txheej Txheem NtseCov khoom siv siab heev siv cov mesoporous silica lossis 3D-printed shells los tiv thaiv kev tso tawm kom txog thaum ua tiav cov pH thresholds tshwj xeeb.
- Cov Khoom Siv Yas thiab Cov Khoom NtxivCov tshuaj xws li Polysorbate 80 ua rau muaj kev ywj pheej ntau dua thiab ua kom cov qauv tso tawm zoo dua, ua kom cov txheej txheem tseem ua haujlwm tau zoo thiab sib xws thaum lub sijhawm tsim khoom thiab khaws cia.
Kev Sib Xws thiab Kev Ntsuas Txheej Txheem
Kev sib npaug ntawm cov txheej yog qhov tseem ceeb heev. Kev tsis sib xws tuaj yeem ua rau yaj ua ntej lub sijhawm, poob qhov ua tau zoo ntawm cov tshuaj, lossis muaj cov kev mob tshwm sim ntxiv. Kev lag luam siv cov txheej txheem ntsuas viscosity inline rau cov tshuaj kom tswj tau qhov sib xwskev nplaum ntawm txheej—ib qho tseem ceeb ntawm cov txheej txheem uas tau saib xyuas los ntawm kev ntsuas viscosity tas mus li thiab kev saib xyuas inline viscosity rau cov txheej. Qhov zoo tshaj plaws ntawm cov txheej viscosity rau cov ntsiav tshuaj enteric yog qhov tseem ceeb rau qhov pom tseeb ntawm zaj duab xis, kev nplaum, thiab kev ua haujlwm zoo.
Hauv kev xaus lus, txheej enteric coating txhawb nqa kev ruaj khov ntawm cov tshuaj thiab kev tswj hwm kev tso tawm, siv ob qho tib si kev tshawb fawb txog cov ntaub ntawv thiab kev ua haujlwm raug. Cov txiaj ntsig ntawm txheej enteric coating txhawb nqa kev ruaj khov ntawm cov tshuaj, kev nqus tau zoo, thiab kev kho mob hauv qhov ncauj muaj kev nyab xeeb dua.
Cov Khoom Tseem Ceeb Uas Yuav Tsum Muaj Rau Kev Txheej Txheem Enteric Zoo
Kev Tiv Thaiv Acid thiab Kev Tiv Thaiv Qhov Ntsuas
Yuav kom tiv thaiv tau cov khoom xyaw tshuaj uas ua haujlwm los ntawm cov kua qaub hauv plab, cov ntsiav tshuaj uas muaj txheej enteric yuav tsum tsim ib daim thaiv uas ruaj khov thiab tiv taus kua qaub. Daim thaiv no tiv thaiv kev tso tawm tshuaj sai sai thiab kev puas tsuaj hauv cov mob plab. Cov polymers ua haujlwm hauv cov txheej txheej tseem tsis yaj thaum pH qis (1-3), yaj lossis tawg tsuas yog thaum raug rau pH siab dua ntawm txoj hnyuv (feem ntau pH ≥ 5.5-7). Piv txwv li, cov sib xyaw xws li alginate thiab pectin—tshwj xeeb tshaj yog thaum ua ke nrog glycerol monostearate (GMS)—tau pom tias khaws lawv qhov kev ua tiav thiab tiv thaiv kev tso tawm tshuaj txog li 2 teev hauv cov kua qaub hauv plab, teb sai sai thaum pH hauv plab raug ncav cuag. Cov txiaj ntsig zoo li no yog sib xws nrog Tebchaws Meskas Pharmacopeia (USP) cov kev cai tso tawm qeeb, ua kom ntseeg tau tias kev xa tshuaj raug thiab txo qis cov kev mob tshwm sim hauv plab.
Qhov Tuab Txheej Txheem Yam Tsawg Kawg Nkaus rau Kev Ua Haujlwm Zoo
Qhov ua tau zoo ntawm cov tshuaj pleev plab hnyuv yog txuas ncaj qha rau qhov tuab ntawm cov zaj duab xis uas siv. Kev pleev tsis txaus ua rau cov kua qaub nkag mus, ua rau kev tiv thaiv tsis zoo. Cov txheej txheem thaij duab siab heev xws li optical coherence tomography (OCT) tau tsim kom muaj qhov tseem ceeb - kwv yees li 27.4 µm - rau kev tiv thaiv kua qaub ntawm cov tshuaj pleev plab hnyuv. Cov polymers lag luam feem ntau xav tau qhov tuab tsawg kawg nkaus: Acryl-Eze® (68 µm), Aquarius™ ENA (69 µm), thiab Nutrateric® (65 µm). Hauv qab cov nqi no, qhov kev pheej hmoo ntawm cov kua qaub nkag mus thiab kev tso tawm tshuaj ua ntej lub sijhawm yog qhov tseem ceeb. OCT ua rau tsis muaj kev puas tsuaj, kev ntsuam xyuas lub sijhawm tiag tiag ntawm kev tsim cov txheej txheem thaum lub sijhawm txheej txheem pleev plab hnyuv, txhawb nqa kev rov ua dua thiab kev ua raws li txoj cai.
Qhov Tseem Ceeb ntawm Kev Sib Xws thiab Kev Ceev ntawm Txheej
Kev sib npaug ntawm cov txheej tuab, ob qho tib si sab hauv thiab ntawm cov ntsiav tshuaj, yog qhov tseem ceeb rau kev ua tau zoo ntawm cov ntsiav tshuaj thiab cov qauv tso tawm tshuaj. Qhov sib txawv ntawm cov tuab tuaj yeem ua rau qee cov chav tsev ua tsis tau zoo rau kev tiv thaiv plab (yog tias tsis tau coated) lossis ncua kev tso tawm ntau dhau (yog tias over-coated). Cov txheej tuab ua kom tiav cov tuab los ntawm kev cuam tshuam rau qhov permeability thiab kev yaj ntawm zaj duab xis. Cov txheej tuab dua - feem ntau yog los ntawm cov khoom siv xaiv zoo tshaj plaws thiab kev tswj viscosity - ua rau porosity txo qis thiab kev tiv thaiv acid muaj zog dua. Kev tsim kho tshiab xws likev soj ntsuam viscosity hauv kabrau kev txheej thiab kev ntsuas viscosity tas mus li hauv kev tsim tshuaj tam sim no ua rau muaj kev tswj hwm cov txheej txheem nruj dua, txo qis kev hloov pauv ntawm intra- thiab inter-batch.
Cov Khoom Siv Pab Txhawb thiab Cov Neeg Ua Yeeb Yam Siv Hauv Cov Tshuaj Pleev Enteric
Cov Polymers Tsim Zaj Duab Xis
Cov polymer uas tsim cov zaj duab xis yog lub hauv paus ntawm txhua lub txheej enteric, uas yog lub luag haujlwm rau pH-selective solubility:
- Cov Khoom Siv Methacrylate(piv txwv li, Eudragit® L100, S100): Yaj ntawm pH siab dua 6.0/7.0, siv dav vim yog qhov ntsuas pH meej thiab tiv taus kua qaub.
- Polyvinyl Acetate Phthalate (PVAP):Muab kev tiv thaiv lub plab zoo, tshwj xeeb tshaj yog rau cov khoom tso tawm qeeb.
- Cov Khoom Siv Polymer Ntuj:Alginate, pectin, shellac, thiab carboxymethyl starch (CMS) yog lwm txoj hauv kev "ntsuab" uas tau ua pov thawj tias tiv taus kua qaub. Kev nce qib hauv cov khoom xyaw ntuj tsim teb raug hais txog kev ruaj khov thiab kev nyab xeeb ntawm tus neeg mob.
Cov Plasticizers thiab Cov Khoom Ntxiv
Cov tshuaj yas xws li glycerol, sorbitol, PEG 3350, thiab triacetin hloov kho qhov yooj ywm ntawm zaj duab xis, tiv thaiv kev tawg, thiab txhawb nqa kev ua haujlwm:
- PEG 3350:Tswj kev ruaj khov ntawm cov tshuaj, tiv thaiv kev tawm, thiab txhim kho kev ruaj khov ntawm cov tshuaj amorphous.
- Triacetin:Ua rau cov zaj duab xis yooj ywm dua tab sis tuaj yeem nkag mus rau hauv lub plawv ntsiav tshuaj, qee zaum ua rau cov khoom siv rhiab heev tsis ruaj khov.
- Glycerol/Sorbitol:Zoo tshwj xeeb hauv cov txheej txheem polymer ntuj los txhim kho elasticity thiab workability.
- Glycerol Monostearate (GMS):Txhim kho hydrophobicity, txhim kho qhov tsis kam ntawm cov kua qaub hauv cov txheej txheem polymer-raws li ntuj.
- Lwm Cov Khoom Ntxiv:Cov tshuaj xim, cov tshuaj tiv thaiv kev nplaum, thiab cov tshuaj ua kom cov qhov hws (piv txwv li, talc, titanium dioxide, polysorbates) muab cov txiaj ntsig zoo rau kev ua haujlwm thiab kev ua haujlwm.
Cov Tshuaj Txhim Kho Kev Tiv Thaiv Acid thiab Cov Khoom Siv Ua Haujlwm
Cov Teeb Meem Hauv Kev Ua Kom Tau Qhov Sib Xws Thiab Kev Ua Haujlwm Zoo Tshaj Plaws
Kev Hloov Pauv ntawm Cov Tshuaj Pleev Xim Sab Hauv thiab Sab Hauv Cov Tshuaj Pleev Xim
Kev ua kom cov ntsiav tshuaj uas muaj txheej txheej sib xws yog qhov tseem ceeb heev. Kev hloov pauv ntawm cov ntsiav tshuaj hauv ib lub ntsiav tshuaj qhia txog qhov sib txawv ntawm cov tuab ntawm ib lub ntsiav tshuaj, thaum kev hloov pauv ntawm cov ntsiav tshuaj ntsuas qhov sib txawv ntawm cov ntsiav tshuaj hauv ib pawg. Ob qho tib si pab txhawb rau kev ua haujlwm ntawm cov khoom kawg.
Kev Cuam Tshuam ntawm Cov Txheej Txheem Tsis Sib Xws rau Kev Tso Tshuaj thiab Kev Ua Haujlwm Zoo
Cov txheej txheej enteric uas tsis sib xws ncaj qha cuam tshuam rau cov qauv tso tshuaj. Kev hloov pauv ntawm qhov tuab tuaj yeem ua rau cov kua qaub tsis kam, ua rau cov tshuaj tso tawm ntxov ntxov. Piv txwv li, txheej txheej enteric ntawm abiraterone acetate ua rau muaj kev cuam tshuam rau lub cev ntau dua 2.6 npaug piv rau cov qauv tsis muaj txheej, txuas nrog kev tiv thaiv lub plab zoo dua. Ntawm qhov tod tes, cov txheej txheej tsis sib xws hauv cov ntsiav tshuaj pantoprazole ua rau muaj kev ua haujlwm tsis sib xws thiab bioavailability, tshwj xeeb tshaj yog ntawm cov khoom lag luam dav dav thiab cov khoom lag luam muaj npe.
Cov tshuaj tso tawm ntawm cov pellets uas tau coated yog rhiab heev rau qhov tuab thiab cov khoom sib xyaw ntawm cov polymer zaj duab xis. Lub sijhawm txheej ntev dua thiab kev nias atomizing siab dua tuaj yeem ua rau cov zaj duab xis tuab dua, tab sis kev siv tsis sib xws ua rau muaj kev tso tawm tsis paub tseeb.
Cov Txheej Txheem Ib puag ncig: Av noo, Kub, thiab Kev Qhuav
Cov yam ntxwv ib puag ncig thaum lub sijhawm thiab tom qab txheej txheem txheej txheem enteric muaj kev cuam tshuam loj heev rau kev sib npaug thiab kev ua tiav ntawm txheej. Qhov kub thiab txias siab thiab qhov av noo qis ua rau kom qhuav sai dua tab sis ua rau muaj kev pheej hmoo ntawm kev tawg thiab kev sib xyaw ntawm qhov chaw. Kev qhuav sai feem ntau ua rau muaj qhov tsis zoo ntawm cov qauv, suav nrog kev tawg lossis kev ntsws, tshwj xeeb tshaj yog hauv cov tshuaj ntsuab thiab cov yeeb yaj kiab protein.
Cov xwm txheej khaws cia tom qab txheej txheej kuj tseem ceeb. Cov chaw muaj av noo ntau ntawm qhov kub qis ua rau muaj kev tawg yooj yim, thaum cov av noo ntau ntawm qhov kub siab tuaj yeem ua rau cov txheej txheej sib xyaw thiab lo. Cov txheej txheem xws li scanning electron microscopy (SEM) thiab X-ray computed tomography (CT) qhia tau hais tias cov kab nrib pleb me me lossis kev sib xyaw ncaj qha txhais tau tias ua rau muaj kev cuam tshuam tsis zoo rau kev ua haujlwm ntawm cov tshuaj thiab hloov pauv cov qauv tso tawm tshuaj.
Lub Luag Haujlwm ntawm Cov Qauv Txheej Txheem (Hom Polymer, Plasticizer, Solvent)
Cov txheej txheem txheej txheem enteric txiav txim siab ob qho tib si kev ua tau zoo ntawm lub cev thiab cov yam ntxwv ntawm kev tso tshuaj. Kev xaiv cov qauv polymer - cellulosic, acrylic-based, lossis cov hom hluavtaws zoo li PLGA - cuam tshuam rau kev tiv thaiv acid thiab kev ua haujlwm ntawm lub cev. Cov yas ua kom muaj kev ywj pheej thiab txo qhov kev pheej hmoo ntawm kev tawg. Cov yas ua kom hydrophilic (PEG 400, PEG 6000) ua rau muaj kev nkag tau zoo dua tab sis yuav ua rau muaj kev tiv thaiv acid los ntawm kev ua haujlwm ua cov pore-formers, qeeb qeeb tso tshuaj. Cov yas ua kom hydrophobic (piv txwv li, dibutyl sebacate, acetyl tributyl citrate) zoo dua tswj cov zaj duab xis coherence thiab cov khoom thaiv.
Cov tshuaj yaj muaj feem cuam tshuam rau kev siv thiab kev ziab ntawm cov tshuaj. Cov tshuaj Isopropyl cawv thiab dej sib xyaw ua ke txhawb kev tsim cov zaj duab xis zoo sib xws nrog cov txheej txheem ethylcellulose-hypromellose matrix. Qhov sib piv thiab hom tshuaj yaj yuav tsum sib phim nrog cov kev xaiv polymer thiab plasticizer kom ua kom cov txheej txheem sib xws, tswj kev nkag mus, thiab khaws cia kev tiv thaiv kua qaub.
Kev sib phim ntawm cov polymer, plasticizer, thiab cov solvent systems yog qhov tseem ceeb heev rau kev ua kom zoo dua cov txiaj ntsig ntawm enteric coating. Kev lag luam tshuaj siv cov formulations uas sib npaug zoo kom paub tseeb tias muaj kev ua tau zoo ntawm ntau yam tshuaj ntsiav, tshuaj ntsiav, thiab cov tshuaj noj uas muaj cov tshuaj sib xyaw.Kev ntsuas viscosity hauv lub sijhawm tiag tiagthiab kev saib xyuas ntxiv ua rau muaj kev tswj hwm qhov tseeb ntawm cov txheej viscosity, xyuas kom meej tias cov txheej viscosity zoo tagnrho rau cov ntsiav tshuaj enteric thiab pab txhawb kev sim sib xws ntawm cov txheej hauv cov tshuaj.
Cov Txheej Txheem Txheej Txheem Enteric
Cov Kauj Ruam Ib Kauj Ruam Txheej Txheem Txheej Txheem Enteric
Kev Npaj Cov Tshuaj Txheej
Kev tsim cov ntsiav tshuaj enteric coated, cov tshuaj ntsiav, thiab cov tshuaj multiparticulate pib nrog kev xaiv cov polymers thiab plasticizers zoo. Cov polymers enteric feem ntau suav nrog cellulose derivatives thiab methacrylate-based cov ntaub ntawv xws li DRUGCOAT® L 100-55. Cov plasticizers xws li triethyl citrate (TEC), polyethylene glycol (PEG 400, 6000), diethyl phthalate, thiab triacetin tau koom ua ke los txhim kho cov zaj duab xis yooj ywm thiab lub zog kho tshuab. Lubkev daws teeb meemKev npaj suav nrog kev yaj lossis kev faib cov polymer thiab plasticizer hauv dej lossis cov kuab tshuaj organic, nrog rau kev sib xyaw kom huv si kom ua tiav qhov viscosity zoo tagnrho rau cov ntsiav tshuaj enteric, feem ntau ntawm 50–100 cP nyob ntawm cov txheej txheem txau thiab cov kev xav tau atomization. Kev ntsuas viscosity tas mus li hauv kev tsim tshuaj - siv cov txheej txheem ntsuas viscosity inline rau cov tshuaj - ua kom muaj kev sib xws ntawm cov khoom thiab kev ua tau zoo tshaj plaws ntawm zaj duab xis. Kev saib xyuas viscosity inline rau cov txheej txheem txo qis kev pheej hmoo ntawm kev tsis sib xws thiab tiv thaiv cov teeb meem lo.
Cov Txheej Txheem Siv: Kev Txheej Txheem Pan thiab Kev Txheej Txheem Fluidized Bed
Kev txheej txheem yog siv los ntawm kev txheej lauj kaub lossis cov txheej txheem txaj fluidized, xaiv raws li hom khoom thiab cov yam ntxwv ntawm zaj duab xis xav tau.
Txheej Txheej: Cov ntsiav tshuaj raug muab tso rau hauv lub lauj kaub uas muaj qhov lossis lub lauj kaub tiaj tiaj uas tig thaum cov tshuaj pleev xim raug txau ua ntu zus. Cua kub raug tshuab kom qhuav sai. Lub lauj kaub txheej yog qhov tsim nyog rau cov ntsiav tshuaj thiab cov tshuaj ntsiav uas muaj txheej enteric tab sis tuaj yeem ua rau cov txheej tuab sib txawv thiab tsis zoo rau cov kab ke ntau yam. Kev sib xws yog nyob ntawm qhov ceev ntawm lub lauj kaub, qhov nrawm ntawm kev txau, thiab kev tswj qhov kub.
Txheej Txheem Fluidized Bed: Cov ntsiav tshuaj lossis cov pellets raug dai rau hauv cov cua sov thaum cov tshuaj atomized coating raug txau. Kev teeb tsa suav nrog kev txau sab saud, kev txau hauv qab (Wurster txheej txheem), lossis kev txau tangential. Kev txheej fluidized txaj tso cai rau kev tswj hwm zoo dua ntawm cov zaj duab xis tuab thiab kev sib xws, ua rau nws zoo dua rau cov tshuaj enteric coating uas xav tau cov qauv tso tawm meej. Cov kev tsim kho tshiab xws li rotary fluidized txaj (RFB) systems txhim kho kev tswj hwm ntawm cov pellet formulations nyuaj. Kev sim kev sib xws ntawm cov txheej hauv cov tshuaj yog ua tas li thaum lub sijhawm thiab tom qab siv kom paub tseeb tias kev faib tawm sib npaug thiab kev npog txaus.
Kev Qhuav thiab Kho: Cov Nyhuv ntawm Kev Sib Xws, Qhov Ceev, thiab Kev Tiv Thaiv Acid
Thaum cov txheej txheej raug siv lawm, cov ntsiav tshuaj yuav qhuav thiab kho kom ruaj khov kom daim zaj duab xis ruaj khov. Cov txheej txheem ziab - kub, av noo, cua ntsawj - yog qhov tseem ceeb rau kev tsim cov zaj duab xis thiab yuav tsum tau tswj hwm kom zoo. Kev kho kom zoo suav nrog kev muab cov ntsiav tshuaj uas tau coated rau qhov kub thiab / lossis av noo rau lub sijhawm teev tseg (static: txog li 24 teev, dynamic: 3-4 teev). Cov txheej txheem no txhim kho cov saw polymer coalescence, ua rau lub zog tensile nce ntxiv, thiab ua rau cov kua qaub tiv taus ntawm cov txheej enteric.
Lub sijhawm ziab thiab kho kom zoo yuav cuam tshuam rau qhov tuab thiab kev sib xws ntawm cov txheej. Kev kho tsis tiav yuav ua rau tsis muaj kev tiv thaiv zoo tiv thaiv cov kua qaub hauv plab, ua rau cov tshuaj tsis zoo. Ntawm qhov tod tes, kev kho ntev tuaj yeem txo qhov dej ntws los ntawm zaj duab xis, ua rau kev tiv thaiv kua qaub zoo dua. Ntawm cov theem txheej nruab nrab (tuab ≈ 7.5%), lub sijhawm kho muaj qhov cuam tshuam me me, thaum cov theem qis lossis siab xav tau kev tswj hwm meej. Kev saib xyuas tsis tu ncua ntawm cov tuab thiab cov khoom sib xyaw ua kom ntseeg tau tias cov txheej ua tau raws li cov lus qhia tshwj xeeb.
Cov Txheej Txheem Tswj Xyuas Tseem Ceeb (CPK)
Kev tswj cov txheej txheem hauv kev txheej txheem enteric tsom mus rau ntau yam txheej txheem tseem ceeb uas cuam tshuam rau qhov zoo ntawm cov khoom kawg:
- Cov cua nkag: Tswj kev ziab thiab kev tsim zaj duab xis.
- Kev ceev ntawm lub lauj kaub(hauv txheej txheej lauj kaub): Cuam tshuam rau qhov sib xws ntawm txheej thiab kev raug cov khoom siv.
- Kub ntawm huab cua: Ncaj qha cuam tshuam rau cov kuab tshuaj evaporation thiab polymer coalescence.
- Lub sijhawm txheej: Txheeb xyuas tag nrho cov zaj duab xis tso tawm thiab tuab.
- Kev kub siab ntawm kev ua kom lub cev muaj zogTswj qhov loj ntawm cov tee dej thiab qhov sib kis ntawm txheej txheej—qhov tseem ceeb tshaj plaws rau kev sib npaug ntawm cov ntsiab lus.
- Lub kiv cua siab: Cuam tshuam rau kev ncua ntawm cov ntsiav tshuaj hauv cov txheej txheem txaj fluidized.
Cov cuab yeej tswj cov txheej txheem suav xws li Plackett-Burman tsim txheeb xyuas cov yam ntxwv tseem ceeb tshaj plaws. Kev ntsuas cov khoom siv niaj hnub thiab kev ntsuas viscosity tas mus li ua kom muaj kev sib xws. Piv txwv li, kev sib xws ntawm cov tshuaj hauv cov tshuaj ntsiav enteric coated yog nyob ntawm qhov ceev ntawm lub lauj kaub ruaj khov thiab kev tswj hwm cov nqi tsuag zoo. Kev tswj cov viscosity ntawm cov txheej txheem ntawm kev ntsuas inline tiv thaiv kev hloov pauv thaum lub sijhawm tsim khoom.
Kev Ua Kom Ruaj Ntseg thiab Kev Tiv Thaiv Lub Sijhawm Txee Khoom
Kev ruaj khov mus sij hawm ntev ntawm cov tshuaj enteric coating yog qhov tseem ceeb rau kev tswj hwm kev ua haujlwm qeeb. Kev tswj xyuas zoo suav nrog cov txheej txheem tshuaj xyuas xws li:
- Kev sim yaj: Xyuas kom meej tias nws tiv taus cov kua qaub thiab lees paub tias cov tshuaj tso tawm ntawm lub plab hnyuv pH uas tau teem tseg.
- Kev ntsuas tuab: Xyuas kom tseeb tias daim ntawv thov ntawm zaj duab xis enteric txaus thiab sib xws.
- Kev saib xyuas ib puag ncig: Tswj cov av noo thiab qhov kub kom haum thaum lub sijhawm khaws cia thiab tsim khoom.
- Kev Ntsuas Calorimetry / Thermogravimetric Sib Txawv: Soj ntsuam cov kev hloov pauv ntawm cov qauv zaj duab xis raws sijhawm.
Yuav tsum ua raws li cov lus qhia ntawm txoj cai (GMP, FDA, ICH Q8/Q9) thoob plaws kev lees paub, kev tsim khoom, thiab kev saib xyuas zoo. Cov ntaub ntawv ntawm cov txheej txheem tswj hwm tseem ceeb thiab kev tshuaj xyuas tsis tu ncua tiv thaiv kev ncaj ncees ntawm cov khoom. Piv txwv li: Hauv kev tshawb fawb txog kev ruaj khov ntawm cov ntsiav tshuaj enteric coated, cov qauv yaj thiab kev ncaj ncees ntawm lub txheej raug saib xyuas txog li 24 lub hlis kom paub tseeb tias cov kev cai ntawm lub sijhawm khaws cia tau ua tiav.
Kev ua kom zoo dua cov txheej txheem, kev kho cov khoom siv kom zoo, thiab kev saib xyuas viscosity tas mus li ua rau muaj kev tsim khoom tas mus li thiab cov txiaj ntsig zoo ntawm cov tshuaj enteric coating rau cov tshuaj noj.
Kawm Txog Ntau Cov Ntsuas Qhov Ceev
Ntau Cov Txheej Txheem Online
Qhov Tseem Ceeb ntawm Kev Txheej Txheem Viscosity hauv Cov Txheej Txheem Enteric Coating
Qhov viscosity ntawm cov txheej yog qhov ntsuas ntawm qhov tsis kam ntawm cov kua dej rau kev ntws, thiab nws yog lub hauv paus tseem ceeb hauv cov tshuaj txheej enteric thiab lawv txoj kev tiv thaiv sib xws. Kev tswj hwm viscosity ua kom muaj kev npog zaj duab xis rov ua dua, tuab, thiab tiv taus kua qaub rau cov ntsiav tshuaj txheej enteric thiab cov tshuaj ntsiav. Qhov viscosity zoo tagnrho rau cov ntsiav tshuaj enteric tso cai rau kev siv tas li yam tsis muaj sagging, kev faib tawm tsis sib xws, lossis kev cuam tshuam cov txheej txheem, ncaj qha cuam tshuam rau qhov sib xws ntawm cov txheej thiab kev ua tau zoo.
Kev cuam tshuam ntawm Kev Txheej Viscosity ntawm Kev Txheej Txheem Sib Xws
Qhov viscosity kom zoo yog qhov tseem ceeb rau kev ua kom muaj kev sib npaug hauv cov txheej txheem txheej enteric. Cov txheej txheem txheej sib npaug tso cai rau kev tswj hwm cov tshuaj tso tawm thiab kev tiv thaiv acid zoo - cov txiaj ntsig tseem ceeb ntawm txheej enteric. Thaum viscosity qis dhau, cov kua txheej yuav khiav lossis sag, ua rau muaj cov pob nyias nyias lossis tsis npog tag; siab dhau, thiab nws tuaj yeem txhaws cov atomizers lossis tiv thaiv kev nthuav dav, tsim cov qhov tsis zoo ntawm txheej lossis cov zaj duab xis ntxhib. Cov txheej txheem xws li terahertz pulsed imaging (TPI) thiab Raman mapping ntsuas thiab ntsuas qhov sib npaug ntawm txheej, nrhiav pom cov teeb meem cuam tshuam nrog viscosity tsis zoo xws li qhov tuab thiab qhov ceev ntawm cov ntsiav tshuaj. Cov kev tshawb fawb lees paub tias cov tshuaj viscosity siab dua, tshwj xeeb tshaj yog cov uas muaj cov polymers hnyav dua, tsim cov zaj duab xis nrog qhov tuab sib xws ntau dua thiab txo cov nqi tsis zoo, txhim kho kev tiv thaiv acid thiab qeeb qeeb kev ua haujlwm ntawm cov tshuaj tso tawm.
Kev sib raug zoo ntawm cov xim pleev xim thiab cov khoom siv zaj duab xis
Qhov viscosity ntawm cov txheej txheem ncaj qha ua rau cov yam ntxwv ntawm cov zaj duab xis xws li qhov ceev, tuab, kev sib xws, lub zog tensile, thiab permeability. Cov zaj duab xis tuab, zoo tsim los ntawm cov qauv viscous zoo tshaj plaws, uas tiv thaiv kev o, kev yaig, lossis kev ua tsis tiav hauv cov kua dej hauv plab hnyuv. Qhov viscosity qis dhau tuaj yeem ua rau cov khoom siv kho tshuab tsis zoo thiab tsis muaj zog acid, thaum cov zaj duab xis pov rau qhov viscosity siab qhia txog kev txhim kho kev ruaj khov thiab kev ua haujlwm thaiv. Cov ntsiab lus plasticizer thiab qib polymer hais txog rheology ntawm cov txheej txheem - lawv qhov sib npaug cuam tshuam rau qhov kawg ntawm zaj duab xis. Piv txwv li:
- Cov ntsiav tshuaj Pantoprazole:Viscosity cuam tshuam rau qhov tuab thiab qhov ceev, yog li cuam tshuam rau cov yam ntxwv tso tawm qeeb thiab cov qauv yaj.
- Chitosan/zein zaj duab xis:Cov plasticizer uas nce ntxiv yuav txo cov viscosity thiab modulus, ua rau muaj kev ywj pheej ntau dua tab sis txo cov khoom thaiv.
Kev ntsuam xyuas kev sib xws hauv cov tshuaj feem ntau siv cov duab thaij duab (TPI, SEM) thiab Raman mapping los xyuas qhov sib txuas ntawm viscosity, cov khoom ntawm zaj duab xis, thiab kev ua haujlwm ntawm txoj hnyuv.
Cov Yam Cuam Tshuam Rau Qhov Viscosity Ntawm Cov Txheej Txheem
Kev tsim cov qauv
Kev tsim cov tshuaj yog qhov tseem ceeb tshaj plaws ntawm viscosity. Cov polymer concentration siab dua ua rau cov kua viscosity nce ntxiv, ua rau cov zaj duab xis muaj zog thiab sib xws. Cov yas ua kom zoo nkauj—xws li glycerol, PEG-400, thiab sorbitol—hloov cov viscosity los ntawm kev ua kom cov molecular txav mus los thiab txhim kho kev ywj pheej, txawm hais tias cov ntau dhau yuav ua rau muaj kev cuam tshuam rau kev ua haujlwm ntawm cov khoom thaiv.
- Piv txwv li: Hauv cov txheej txheem sodium alginate, feem pua ntawm glycerol lossis PEG-400 hloov pauv viscosity, yog li kho qhov wettability, stability, thiab qhov tuab kawg ntawm cov txheej txheem.
Kub
Qhov kub thiab txias tswj tau qhov viscosity. Qhov kub thiab txias nce feem ntau yuav txo qhov viscosity, txhim kho kev ntws thiab atomization hauv cov khoom siv txheej. Cov qauv viscosity yaj (Carreau thiab Arrhenius equations) piav qhia txog kev sib xyaw tshuaj txheej teb rau qhov kub thiab txias hloov pauv li cas, cuam tshuam rau cov txheej txheem tsim zaj duab xis. Txawm li cas los xij, qhov kub thiab txias ntau dhau yuav ua rau cov tshuaj nyias dhau, ua rau cov txheej tsis sib xws lossis ua rau cov tshuaj rhiab heev puas tsuaj.
- Piv txwv li: Eudragit L 100-55 txheej qhia tau tias cov viscosity qis dua thiab kev tsim cov zaj duab xis zoo dua ntawm qhov kub siab dua, yog tias cov qib plasticizer raug tswj tau zoo.
Kev Hloov Pauv Ua Ib Pawg
Kev hloov pauv ntawm pawg mus rau pawg cuam tshuam rau qhov viscosity, thiab yog li ntawd qhov sib xws ntawm cov txheej txheem enteric. Qhov sib txawv ntawm cov khoom siv raw (qhov loj me ntawm cov khoom me me, qib polymer) thiab cov xwm txheej txheej txheem tuaj yeem hloov cov kua lossis cov viscosity yaj ntawm cov txheej txheem ntau lawm, ua rau muaj kev hem thawj rau kev rov ua dua. Kev saib xyuas viscosity inline rau cov txheej txheem - siv cov txheej txheem analytical technology (PAT) - pab taug qab thiab kho cov txheej txheem sib txawv hauv lub sijhawm tiag tiag, txhawb kev ntsuas viscosity tas mus li hauv kev tsim tshuaj.
- Piv txwv li: Cov ntsiav tshuaj Sodium alginate los ntawm ntau pawg sib txawv tuaj yeem sib txawv ntawm qhov o thiab qhov nrawm ntawm kev tawg vim qhov kev hloov pauv ntawm qib viscosity, cuam tshuam rau kev tso tawm tshuaj tag nrho.
Kev tswj cov viscosity ntawm cov txheej txheem pleev xim—xws li kev tsim cov tshuaj, qhov kub, thiab kev tswj hwm ntau ntau—yog qhov tseem ceeb rau cov ntsiav tshuaj uas pleev xim rau hauv plab uas rov ua dua tau, ua haujlwm tau zoo thiab cov txheej txheem pleev xim rau hauv plab uas ua haujlwm tau zoo.
Kev Lag Luam Inline thiab Continuous Viscosity Measurement Systems rau Enteric Coating
Qhov Xav Tau Rau Kev Soj Ntsuam Viscosity Tiag Tiag
Kev tswj kom muaj qhov sib xws thoob plaws hauv cov txheej txheem txheej enteric yog qhov tseem ceeb rau kev sib xws ntawm cov tshuaj xws li cov ntsiav tshuaj thiab cov tshuaj ntsiav. Kev hloov pauv ntawm qhov viscosity feem ntau ua rau muaj qhov tsis zoo xws li qhov tuab ntawm txheej tsis sib xws, npuas, thiab qhov ntxhib ntawm qhov chaw, uas cuam tshuam ncaj qha rau cov khoom siv tau zoo thiab qhov zoo nkauj.
Kev saib xyuas viscosity tiag tiag muab cov lus teb tam sim ntawd, tso cai rau cov neeg teb xov tooj kom tswj tau qhov viscosity ntawm cov tshuaj enteric ntau ntau tom qab ntau ntau. Qhov no txo qhov kev pheej hmoo ntawm kev ua tsis tiav ntawm kev sim ua kom zoo ib yam hauv cov tshuaj, thaum txhawb nqa kev txhim kho cov txheej txheem tas mus li thiab txo cov khib nyiab kim lossis kev rov ua dua tshiab ntawm cov khoom. Raws li cov tshuaj pleev xim tuaj yeem hloov pauv hauv viscosity vim qhov kub hloov pauv, cov kuab tshuaj evaporation, lossis cov khoom siv raw hloov pauv, kev saib xyuas viscosity inline rau cov tshuaj pleev xim ua rau muaj kev hloov pauv dynamic, tiv thaiv kev hloov pauv tseem ceeb hauv txhua pawg thiab txhawb nqa cov kev cai lij choj rau cov tshuaj enteric coated tiav lawm.
Muaj Cov Tshuab Ntsuas Viscosity Inline Lag Luam
Cov txheej txheem txheej txheem tshuaj niaj hnub no tau tsav txoj kev hloov pauv ntawm cov txheej txheem ntsuas viscosity hauv kev lag luam. Cov txheej txheem no siv ntau yam ntsiab cai ua haujlwm thiab muaj cov yam ntxwv tshwj xeeb tsim rau kev tsim tshuaj zoo.
Cov Ntsiab Cai Ua Haujlwm:
- Cov Viscometers Tig:Ntsuas lub zog uas xav tau los tig ib yam khoom hauv cov kua txheej, txhais cov kev tiv thaiv tshuab mus rau hauv cov nqi viscosity. Txawm hais tias muaj zog, cov kev xaiv tshiab dua tuaj yeem muab kev tu cev zoo dua thiab kev koom ua ke ntawm automation.
- Cov Sensors Vibrational:Cov khoom siv xws li covLonnmeter Pharma Viscometersiv kev tshuaj xyuas kev co los txiav txim siab qhov viscosity thiab qhov ceev ntawm cov kua dej tib lub sijhawm. Cov no muab kev nyeem ntawv tam sim ntawd, tsis tas yuav saib xyuas ntau, thiab tsim los rau kev ua haujlwm tas mus li hauv cov kab ke kaw, huv si.
- Cov ntsuas ultrasonic thiab cov khoom siv viscometer khov kho:Cov txheej txheem zoo li BiODE's solid-state viscometers siv cov nthwv dej ultrasonic lossis cov khoom siv lub cev khov kho, ua rau lawv tiv taus cov xwm txheej ib puag ncig nyuaj thiab zoo tagnrho rau kev ntsuas viscosity tas mus li hauv kev tsim tshuaj.
- Cov ntsuas capillary thiab microfluidic:Cov tshuab ntsuas kinematic capillary viscometers thiab microfluidic rheology systems yog qhov tsim nyog rau kev sim viscosity me me nrog qhov tseeb siab, muaj txiaj ntsig zoo thaum ua haujlwm nrog cov kua tshuaj kim lossis tsawg.
- Cov Txheej Txheem Spectroscopic:Cov txheej txheem inline vibrational (piv txwv li, Raman, IR) thiab fluorescence spectroscopic tuaj yeem koom ua ke, feem ntau siv chemometric modeling rau kev tshuaj xyuas cov txheej txheem siab heev.
Cov Txheej Txheem Lag Luam Tseem Ceeb:
- LonnmeterCov Viscometers online:Tsim los rau kev tsim tshuaj txuas ntxiv mus, muab ntau yam viscosity, kev saib xyuas qis, thiab kev koom ua ke nrog cov kab txheej tsis siv neeg.
Cov Qauv Xaiv Rau Kev Siv Tshuaj:
Thaum xaiv lub tshuab ntsuas viscosity inline rau kev lag luam rau kev tshuaj enteric coating, tsom mus rau cov qauv no:
- Kev Tseeb Tiag Tiag:Qhov tseem ceeb rau kev tswj cov txheej txheem thiab cov khoom zoo.
- Kev Sib Haum Xeeb:Cov cuab yeej yuav tsum haum rau hom txheej txheem txheej txheem tshwj xeeb (gelatin, polymer-based, aqueous, sustained-release).
- Kev Hloov Kho thiab Kev Koom Ua Ke:Kev tsim qauv modular thiab kev sib raug zoo nrog cov tshuab tswj tsis siv neeg thiab Kev Lag Luam 4.0 cov qauv.
- Kev Txij Nkawm thiab Kev Ntsuas:Nyiam cov khoom siv uas tsis tas yuav saib xyuas ntau, thiab nws tus kheej kho tau uas tuaj yeem tiv taus cov chaw tsim tshuaj.
- Kev Ruaj Ntseg Ib puag ncig:Muaj peev xwm tswj tau qhov tseeb nyob rau hauv ntau yam kub, av noo, thiab cov dej ua haujlwm.
Cov txiaj ntsig ntawm kev ntsuas viscosity tas mus li rau kev tswj cov txheej txheem enteric coating
Kev ntsuas viscosity tas mus li hloov pauv cov txheej txheem enteric coating nrog ntau qhov txiaj ntsig ntsuas tau:
- Kev Sib Xws ntawm Txheej Txheem thiab Kev Tiv Thaiv Qhov Tsis Zoo:Cov lus teb rov qab tam sim ntawd ua kom ntseeg tau tias kev siv cov txheej txheej enteric sib xws. Qhov no txo qhov tsis zoo xws li kev sib xyaw ua ke, kev npuas, thiab kev ua haujlwm tsis zoo, txhawb nqa kev cai lij choj thiab kev cia siab ntawm kev ua lag luam rau cov tshuaj ntsiav thiab cov ntsiav tshuaj enteric coated.
- Kev Ua Haujlwm Zoo:Kev tswj hwm tsis siv neeg txo lub sijhawm tsis ua haujlwm rau kev kuaj thiab kho kom raug, ua kom muaj txiaj ntsig zoo tshaj plaws thiab siv cov khoom siv pleev xim tau zoo dua.
- Kev Txuag Khoom Siv thiab Kev Cuam Tshuam Rau Ib Puag Ncig:Los ntawm kev kho qhov viscosity kom zoo, cov txheej txheem yuav txo cov khoom pov tseg thiab zam kev siv cov kuab tshuaj tsis tsim nyog. Qhov no txhawb nqa kev ruaj khov ntawm ib puag ncig thiab kev siv cov peev txheej zoo tshaj plaws.
- Kev Tswj Xyuas Zoo thiab Kev Ua Raws Cai:Cov ntaub ntawv tsis tu ncua, uas tau teev tseg muab cov ntaub ntawv pov thawj rau txhua pawg txheej enteric, ua kom yooj yim tswj xyuas qhov zoo thiab kev tshaj tawm txog kev cai lij choj.
- Rov Qab Los Ntawm Kev Nqis Peev:Cov chaw tsim khoom pom tias cov khoom tsim tau zoo dua, cov khoom zoo sib xws, thiab txo cov haujlwm rov ua dua lossis cov khoom tsis lees txais tom qab kev siv cov kev soj ntsuam viscosity hauv kab rau cov txheej. Cov txiaj ntsig no tau sau tseg hauv cov kev tshawb fawb tsis ntev los no thiab kev tshawb fawb los ntawm cov phooj ywg.
Hauv kev xaus, cov txheej txheem ntsuas viscosity inline lag luam - rotational, vibrational, ultrasonic, capillary, microfluidic, thiab spectroscopic - tsim lub hauv paus ntawm kev tswj hwm viscosity niaj hnub. Lawv qhov kev xaiv thiab kev koom ua ke ua rau muaj cov qauv siab tshaj plaws ntawm kev tswj cov txheej txheem, qhov zoo, thiab kev ua haujlwm zoo rau cov ntawv thov tshuaj enteric.
Cov Tswv Yim Tswj Xyuas Zoo rau Kev Txheej Txheem Sib Xws hauv Kev Tsim Tshuaj
Kev txheej txheej sib xws yog qhov tseem ceeb heev rau kev tsim cov ntsiav tshuaj enteric coated, cov ntsiav tshuaj enteric coated, thiab lwm yam tshuaj noj. Kev tswj xyuas zoo yog tsom mus rau kev tswj kom cov txheej txheej sib xws los ntawm kev koom ua ke kev saib xyuas cov txheej txheem tiag tiag, kev kuaj xyuas zoo, thiab kev daws teeb meem sai - txhua yam tau txhawb nqa los ntawm kev siv tshuab thiab cov thev naus laus zis digital.
Kev Soj Ntsuam Hauv Kab: Viscosity, Thickness, thiab Uniformity
Kev saib xyuas tas mus li hauv kab yog lub hauv paus ntawm kev sib npaug ntawm cov txheej txheem.
- Qhov nplaum:Cov tshuab ntsuas viscosity hauv kab lag luam, zoo li cov viscometers hauv kab tsis siv neeg, xa cov lus teb tam sim ntawd, txuas ntxiv mus rau qhov viscosity ntawm txheej. Qhov no tseem ceeb heev rau cov tshuaj pleev enteric, vim tias qhov viscosity tsis raug cuam tshuam rau kev tsim cov zaj duab xis, ua rau muaj qhov tsis zoo lossis tsis sib npaug ntawm cov txheej. Cov viscometers tsis siv neeg muab qhov tseeb nrog kev saib xyuas tsawg kawg nkaus, ua kom ntseeg tau tias cov tshuaj pleev tseem nyob hauv qhov ntau ntawm viscosity zoo tshaj plaws rau cov ntsiav tshuaj enteric thiab txo qis kev cuam tshuam ntawm tus neeg teb xov tooj.
- Qhov tuab:Kev Siv Optical Coherence Tomography (OCT) ua rau kev ntsuas qhov tuab ntawm txheej txheej tsis muaj kev puas tsuaj, hauv kab. Nws tsim cov ntaub ntawv tiag tiag ntawm qhov tuab ntawm zaj duab xis, kev sib xws, thiab txawm tias qhov roughness ntawm qhov chaw. Cov thev naus laus zis OCT sib raug zoo nrog kev sim porosity thiab hardness offline, txhawb kev tswj cov txheej txheem thiab kev txhim kho sai ntawm cov kauj ruam tshiab ntawm cov txheej txheem txheej txheem enteric.
- Kev sib xws:Kev thaij duab ntawm qhov chaw thiab kev tshuaj xyuas spectrophotometric muab kev saib xyuas ntxiv rau xim, ci ntsa iab, thiab kev sib xws, txhua yam qhia txog kev ua tiav ntawm cov txheej txheem tshuaj enteric coating.
Cov txheej txheem sib xyaw ua ke feem ntau muab cov sensors no tso rau hauv IoT-npaj, kaw-lub voj voog tawm tswv yim, txhawb nqa Cov Kev Pib Zoo-los ntawm-Tsim (QbD) thiab kev ua raws li txoj cai.
Cov Txheej Txheem Kuaj Xyuas Rau Kev Ntsuam Xyuas Hauv Pawg Thiab Hauv Pawg
Kev kuaj xyuas cov ntaub ntawv ua kom ntseeg tau tias cov txheej txheem sib xws hauv thiab ntawm cov pawg:
- Kev Sampling Hauv Pawg:Kos tsawg kawg yog peb daim ntawv theej los ntawm kaum qhov chaw tshwj xeeb hauv lub nruas txheej lossis lub tshuab sib tov thaum lub sijhawm tsim khoom ntau ntau. Qhov no ua kom ntseeg tau tias muaj cov txiaj ntsig sawv cev thoob plaws qhov sib txawv ntawm cov txheej txheem.
- Kev Sampling Interbatch:Cov lus qhia ntawm txoj cai lij choj pom zoo kom tshuaj xyuas tsawg kawg yog peb pawg sib cais, nrog tsawg kawg yog rau tus qauv hauv ib pawg thaum qhov sib txawv ntawm cov qauv me me tsawg. Txoj hauv kev no lees paub qhov rov ua dua ntawm pawg mus rau pawg hauv kev sim kev sib xws ntawm cov txheej txheem hauv cov tshuaj.
- Feem ntau cov kev ntsuam xyuas siv cov kev ntsuas tuab, kev tshuaj xyuas pom, thiab cov txheej txheem spectroscopic los xyuas kom meej tias muaj kev sib npaug. Cov qauv lees txais tsom mus rau qhov kev hloov pauv tus qauv thiab cov coefficient ntawm kev hloov pauv, nrog rau cov qauv ntsuas dhau sijhawm los txheeb xyuas cov teeb meem uas tseem muaj lossis cov txheej txheem tsis sib xws.
Kev daws teeb meem thiab kev kho kom raug rau cov teeb meem ntawm cov txheej txheem
Cov teeb meem ntawm cov txheej txheej—xws li kev sib tw, kev sib xyaw, thiab kev tawg—tuaj yeem ua rau cov ntsiav tshuaj uas muaj txheej txheej enteric tsis ua haujlwm zoo thiab zoo li cas. Kev daws teeb meem yuav tsum tau ua raws li cov kauj ruam:
- Kev sib tw:Feem ntau yog vim cov duab ntawm lub ntsiav tshuaj lossis qhov ceev ntawm lub lauj kaub. Cov kev kho mob suav nrog kev kho qhov tig ntawm lub lauj kaub, kev ua kom lub hauv paus ntawm lub ntsiav tshuaj zoo dua, thiab kev tswj hwm kev thauj khoom ntau ntau.
- Mottling:Cov txiaj ntsig los ntawm kev sib tov tsis txaus lossis kev sib cais cov xim. Txhim kho los ntawm kev ua kom zoo dua cov txheej txheem sib tov, kho qhov nrawm ntawm kev txau, lossis rov ua dua cov xim sib xyaw.
- Kev txiav:Txuas nrog rau cov txheej txheej tawg lossis kev ntxhov siab ntawm lub tshuab. Kho kom raug los ntawm kev kho cov qauv txheej - nce cov qib plasticizer lossis hloov kho qhov ceev ntawm kev ziab - kom txhim kho kev ua kom zoo thiab kev ywj pheej ntawm zaj duab xis.
Kev siv cov txheej txheem Kho thiab Tiv Thaiv (CAPA) ua kom yooj yim rau kev daws teeb meem. Kev tshuaj xyuas cov hauv paus ua rau pom qhov txawv ntawm cov txheej txheem lossis cov khoom siv, thaum cov kev tiv thaiv ua kom zoo dua cov zaub mov txawv thiab cov chaw teeb tsa kom tsis txhob rov tshwm sim.
Cov Lus Teb Rov Qab Tam Sim No thiab Kev Ua Haujlwm Tsis Siv Neeg hauv Cov Txheej Txheem Txheej Txheem
Kev siv tshuab thiab kev tawm tswv yim tiag tiag ua rau muaj kev ua haujlwm zoo thiab zoo hauv cov txheej txheem txheej txheem enteric:
- Cov Txheej Txheem Tswj Xyuas Siab Tshaj Plaws:Cov platform uas siv IoT thiab cov thev naus laus zis txheeb xyuas cov txheej txheem (PAT) sau cov ntaub ntawv txheej txheem tas mus li. Cov txheej txheem xws li cov qauv digital thiab cov chaw siv AI DataFactory txheeb xyuas cov qauv, ua rau muaj kev teb hloov pauv hauv qhov nrawm ntawm kev tsuag, qhov kub thiab txias kom qhuav, thiab qhov viscosity ntawm txheej.
- Kev Kho Kom Zoo Tam Sim Ntawd:Cov txheej txheem tsis siv neeg teb rau cov kev ntsuas hauv kab los ntawm kev hloov kho cov kev ntsuas tseem ceeb tam sim ntawd, txo cov feem pua ntawm qhov tsis zoo thiab cov khoom pov tseg.
- Kev Txheeb Xyuas Txuas Ntxiv Mus:Cov platforms no txhawb nqa cov kev cai rau kev txheeb xyuas cov txheej txheem txuas ntxiv (CPV) raws li tau teev tseg hauv cov lus qhia kev cai lij choj, pab cov chaw tsim khoom tswj hwm kev sib xws thiab zoo ntawm cov txheej txheem thoob plaws hauv cov voj voog tsim khoom.
Los ntawm kev koom ua ke kev tshuaj xyuas viscosity hauv kev lag luam rau cov txheej txheem, kev tshuaj xyuas tuab uas tsis ua rau puas tsuaj, thiab kev tswj hwm kev kho kom zoo, cov chaw tsim tshuaj ua tiav cov txiaj ntsig enteric coating sib xws thaum ua tau raws li qhov xav tau ntawm kev ua raws li niaj hnub thiab kev ua haujlwm zoo.
Cov Ntsiab Lus Tseem Ceeb rau Kev Sib Xws ntawm Cov Txheej Txheem thiab Kev Ua Haujlwm ntawm Cov Tshuaj
Qhov Txheej Txheem Tseem Ceeb: Yuav kom tiv thaiv tau cov kua qaub, yuav tsum muaj qhov tuab ntawm cov tshuaj enteric uas tsawg kawg yog 27.4 µm. Qhov tuab nruab nrab ntawm ≥ 63.4 µm ua kom txhua lub tshuaj enteric coated ua tau raws li cov qauv kev yaj thiab ua rau cov txiaj ntsig kho mob zoo ib yam. Yuav tsum paub tseeb tias qhov tuab ntawm cov tshuaj enteric coated siv cov txheej txheem siab xws li optical coherence tomography (OCT), uas ua rau muaj kev ntsuam xyuas tiag tiag, tsis sib cuag ntawm cov tshuaj thaum lub sijhawm tsim khoom.
Kev Ntsuam Xyuas Kev Sib XwsSiv cov kev faib tawm ntawm kev tshuaj xyuas thiab cov kev ntsuas suav xws li qhov sib txawv ntawm tus qauv (RSD) los ntsuas qhov sib npaug ntawm cov txheej txheem thoob plaws. Cov kab ke OCT hauv kab tau ua pov thawj tias muaj peev xwm ua lag luam tau zoo, sib phim thiab feem ntau dhau qhov tseeb ntawm cov txheej txheem ib txwm muaj los ntawm kev xa cov SDs tuab ntawm cov ntsiav tshuaj qis li 9 µm (kwv yees li 13% RSD).
Kev Txhim Kho Cov Txheej TxheemSaib xyuas thiab ua kom zoo dua cov txheej txheem tseem ceeb - qhov ceev ntawm lub lauj kaub, qhov nrawm ntawm kev tsuag, cov cua nkag, qhov kub ntawm cov pa tawm, qhov deb ntawm rab phom mus rau txaj, thiab lub zog cua atomization.
Kev Xaiv Polymer thiab PlasticizerXaiv cov polymers siab heev rau cov zaj duab xis uas yoog tau yooj yim, nyias dua thiab txo lub sijhawm ua tiav. Xav txog cov kev xaiv uas ruaj khov xws li PVAP, methacrylic acid copolymers (Eudragit L/S), polyethylene glycol (PEG) ua cov yas ua kom yas, lossis shellac ntuj rau cov kev siv tshiab. Kev xaiv zoo cuam tshuam rau kev tsim zaj duab xis, kev tso tshuaj, thiab tuaj yeem ua rau kev tswj hwm cov txheej txheem yooj yim dua.
Kev Koom Tes Ua Ke Cov Txheej Txheem Ntsuas Viscosity Txuas Ntxiv Mus Rau Kev Tswj Xyuas Cov Txheej Txheem Ruaj Khob
Kev Saib Xyuas Viscosity Hauv KabSiv cov tshuab ntsuas viscosity inline rau cov tshuaj lag luam kom tswj tau qhov viscosity ntawm cov tshuaj ntsiav enteric. Kev ntsuas thiab kev tswj hwm lub sijhawm tiag tiag yog qhov tseem ceeb rau kev tswj qhov viscosity ntawm cov tshuaj pleev, tiv thaiv qhov tsis zoo los ntawm cov qauv tsis txaus lossis dhau viscous.
Cov txiaj ntsig ntawm cov txheej txheem:
- Xyuas kom meej tias ntsuas qhov viscosity tas mus li hauv kev tsim tshuaj, muab cov lus teb tam sim ntawd thiab kev hloov kho rau cov kauj ruam txheej txheem enteric coating.
- Txo qhov sib txawv ntawm ib pawg mus rau ib pawg thaum txhawb nqa kev sim sib xws ntawm cov txheej txheem hauv cov tshuaj.
- Txhim kho cov lus teb rau kev cuam tshuam xws li kev hloov pauv cov mis lossis cov khoom siv tsis sib xws, ua rau lub sijhawm voj voog sai dua thiab txo cov khib nyiab.
Cov kev coj ua zoo tshaj plaws no, txhawb nqa los ntawm cov cuab yeej siv niaj hnub thiab kev tswj cov txheej txheem, txhais cov txheej txheem zoo tshaj plaws rau kev tsim cov ntsiav tshuaj thiab cov tshuaj ntsiav zoo, sib xws.
Cov Lus Nug Feem Ntau
1. Cov tshuaj pleev plab yog dab tsi thiab vim li cas nws thiaj tseem ceeb rau cov tshuaj noj?
Txheej enteric yog ib daim yas polymer tshwj xeeb uas siv rau cov tshuaj noj xws li cov ntsiav tshuaj thiab cov tshuaj capsules. Nws lub hom phiaj tseem ceeb yog los tiv thaiv cov tshuaj kom tsis txhob lwj hauv lub plab qhov chaw acidic, ua rau cov khoom xyaw nquag tsuas yog tso tawm thaum nws mus txog qhov chaw alkaline lossis alkaline ntawm txoj hnyuv. Qhov no tiv thaiv cov tshuaj uas tsis haum acid, xws li qee cov enzymes lossis cov tshuaj proton pump inhibitors, kom tsis txhob lwj ua ntej nqus. Nws kuj tiv thaiv cov ntaub so plab ntawm kev khaus los ntawm cov tshuaj uas yuav ua rau muaj kev phom sij, xws li cov tshuaj nonsteroidal anti-inflammatory drugs (NSAIDs). Piv txwv li, abiraterone acetate uas muaj txheej enteric tseem zoo li qub thaum lub sijhawm hla mus rau hauv plab, ua rau nqus tau qhov chaw uas nws ua tau zoo tshaj plaws. Cov txheej txheem txheej enteric yog qhov tseem ceeb hauv cov txheej txheem txheej enteric tshuaj thiab pab txhawb rau kev siv tshuaj zoo tshaj plaws, ua rau nws yog qhov txiaj ntsig tseem ceeb hauv kev xa tshuaj noj.
2. Qhov viscosity ntawm cov tshuaj pleev xim cuam tshuam li cas rau qhov zoo ntawm cov ntsiav tshuaj enteric coated?
Qhov viscosity ntawm cov tshuaj pleev ib ce—uas cov tshuaj pleev ib ce tuab npaum li cas los yog kua npaum li cas—ua lub luag haujlwm tseem ceeb hauv cov txheej txheem pleev ib ce enteric. Qhov viscosity ntawm cov tshuaj pleev ib ce tswj cov dej ntws, kev nthuav dav, thiab kev nplaum ntawm cov zaj duab xis polymer ntawm txhua lub tshuaj. Yog tias qhov viscosity ntawm cov tshuaj pleev ib ce qis dhau, cov zaj duab xis yuav tsis sib npaug, nrog rau cov cheeb tsam nyias uas tsis tiv thaiv cov tshuaj hauv plab. Yog tias nws siab dhau, cov khoom sib sau ua ke thiab cov qhov tsis zoo xws li tawg lossis "txiv kab ntxwv tev" tuaj yeem tshwm sim. Kev tswj qhov viscosity ntawm cov tshuaj pleev ib ce zoo tagnrho rau cov tshuaj pleev ib ce enteric yog qhov tseem ceeb kom ua tiav qhov sib xws, seamless barrier uas muab kev tiv thaiv acid thiab tswj cov tshuaj tso tawm. Kev tswj viscosity kom zoo kuj tiv thaiv cov teeb meem tsim khoom xws li delamination thiab ua kom muaj kev ua tau zoo hauv txhua pawg.
3. Cov txheej txheem ntsuas viscosity inline lag luam yog dab tsi thiab vim li cas ho siv lawv rau kev txheej enteric?
Cov tshuab ntsuas viscosity inline rau cov tshuaj yog cov sensors lossis cov khoom siv tiag tiag uas tau teeb tsa ncaj qha rau hauv cov kab txheej. Cov kab ke no saib xyuas thiab tswj cov viscosity ntawm cov tshuaj txheej thoob plaws hauv kev tsim khoom. Kev saib xyuas viscosity inline rau cov txheej pab tswj cov viscosity lub hom phiaj, txo cov qauv tes, thiab sai sai ntes tau cov txheej txheem sib txawv. Cov viscometers hauv kab tsis siv neeg thiab cov tshuab siab heev xws li kinematic capillary lossis microfluidic viscometers txhawb nqa kev tswj cov viscosity txheej los ntawm kev xa cov txheej txheem ruaj khov, rov ua dua tshiab. Qhov no txo qhov sib txawv ntawm cov tsos thiab kev ua haujlwm ntawm cov ntsiav tshuaj, ruaj ntseg zoo, thiab pab ua raws li cov qauv kev coj ua zoo (GMP). Kev ntsuas viscosity tas mus li hauv kev tsim tshuaj, tshwj xeeb tshaj yog rau cov tshuaj txheej enteric, ua rau muaj qhov tsis zoo ntawm cov txheej txheem tsawg dua, cov nqi tsis lees paub qis dua, thiab kev ua haujlwm zoo ib yam.
4. Vim li cas qhov sib npaug ntawm cov tshuaj ntsiav uas muaj txheej txheej thiaj li tseem ceeb rau cov tshuaj ntsiav uas muaj txheej txheej enteric?
Kev sib npaug ntawm cov txheej txheej enteric txhais tau tias qhov tuab thiab kev npog sib xws ntawm txhua lub tshuaj hauv ib pawg. Cov txheej txheej tsis sib xws yuav ua rau muaj kev tiv thaiv ib nrab, ua rau cov tshuaj tso tawm thaum ntxov hauv plab lossis ua tsis tau raws li xav tau hauv plab hnyuv. Qhov no tuaj yeem ua rau muaj kev cuam tshuam rau kev ua haujlwm zoo, kev nyab xeeb, thiab kev ua raws li txoj cai, thiab yuav ua rau muaj kev pheej hmoo ntawm kev puas tsuaj ntawm cov tshuaj lossis cov kev mob tshwm sim ntawm tus neeg mob. Qhov sib txawv me me ntawm qhov tuab ntawm cov txheej txheej ncaj qha cuam tshuam rau qhov kev tso tawm tshuaj thiab cov txiaj ntsig kho mob. Kev sim sib npaug ntawm cov txheej txheej hauv cov tshuaj feem ntau vam khom cov txheej txheem tshuaj ntsuam xyuas tsis ua puas tsuaj kom ntseeg tau tias txhua lub tshuaj enteric coated muab kev tiv thaiv thiab tswj kev tso tawm.
