Nrog rau qhov tob ntawm kev tshawb fawb txog kev xa tshuaj thiab cov kev cai nruj dua, cov tshuaj siv tshuaj tshiab tau tshwm sim, ntawm cov hydroxypropyl methylcellulose tau siv dav. Daim ntawv no tshuaj xyuas cov ntawv thov hauv tsev thiab txawv teb chaws ntawm hydroxypropyl methylcellulose. Cov txheej txheem ntau lawm thiab nws qhov zoo thiab qhov tsis zoo, cov cuab yeej siv thev naus laus zis thiab kev txhim kho hauv tsev, thiab nws daim ntawv thov hauv thaj chaw ntawm cov tshuaj excipients.
Ntsiab lus: tshuaj excipients; hydroxypropyl methylcellulose; ntau lawm; daim ntawv thov
1 Kev Taw Qhia
Pharmaceutical excipients hais txog lub ntsiab lus dav dav rau tag nrho lwm cov khoom siv tshuaj ntxiv rau kev npaj tshwj tsis yog cov tshuaj tseem ceeb txhawm rau daws cov formability, muaj thiab kev nyab xeeb ntawm kev npaj hauv cov txheej txheem ntawm kev tsim thiab tsim cov kev npaj. Pharmaceutical excipients tseem ceeb heev hauv kev npaj tshuaj. Muaj ntau ntau hom tshuaj excipients nyob rau hauv domestic thiab txawv teb chaws npaj, tab sis nyob rau hauv xyoo tas los no, cov kev xav tau ntawm purity, dissolution, stability, bioavailability nyob rau hauv vivo, kev txhim kho cov nyhuv kho thiab txo cov kev mob tshwm sim ntawm cov tshuaj yog nce thiab siab dua. , ua kom sai sai ntawm cov excipients tshiab thiab cov txheej txheem tshawb fawb txhawm rau txhim kho kev ua haujlwm ntawm kev npaj tshuaj thiab kev siv zoo. Ntau cov ntaub ntawv piv txwv qhia tau hais tias hydroxypropyl methylcellulose tuaj yeem ua tau raws li cov kev cai saum toj no raws li cov khoom siv tshuaj zoo. Qhov xwm txheej tam sim no ntawm kev tshawb fawb txawv teb chaws thiab kev tsim khoom thiab nws daim ntawv thov hauv kev npaj tshuaj kho mob tau sau tseg ntxiv.
2 Txheej txheem cej luam ntawm cov khoom ntawm HPMC
HPMC yog xim dawb lossis daj me ntsis, tsis muaj ntxhiab tsw, tsis muaj ntxhiab, tsis muaj tshuaj lom cov hmoov uas tau los ntawm etherification ntawm alkali cellulose, propylene oxide thiab alkyl chloride. Yooj yim soluble hauv dej hauv qab 60 ° C thiab 70% ethanol thiab acetone, isoacetone, thiab dichloromethane sib xyaw hnyav; HPMC muaj zog ruaj khov, feem ntau tshwm sim: ua ntej, nws cov kua aqueous tsis muaj nqi thiab tsis hnov mob nrog hlau ntsev los yog ionic organic tebchaw; thib ob, nws kuj yog resistant rau acids los yog bases. Tus txheeb ze ruaj khov. Nws yog cov yam ntxwv ruaj khov ntawm HPMC uas ua rau cov tshuaj zoo nrog HPMC raws li cov khoom siv ntxiv ruaj khov dua li cov khoom siv tshuaj ib txwm muaj. Hauv kev tshawb fawb toxicology ntawm HPMC raws li cov khoom siv ntxiv, nws tau pom tias HPMC yuav tsis raug metabolized hauv lub cev, thiab tsis koom nrog tib neeg lub cev metabolism. Cov khoom siv hluav taws xob, tsis muaj tshuaj lom thiab cov kev mob tshwm sim rau cov tshuaj, kev nyab xeeb tshuaj excipients.
3 Kev tshawb fawb txog kev tsim khoom hauv tsev thiab txawv teb chaws ntawm HPMC
3.1 Txheej txheem cej luam ntawm cov cuab yeej tsim khoom ntawm HPMC hauv tsev thiab txawv teb chaws
Txhawm rau kom tiv thaiv tau zoo dua nrog kev nthuav dav thiab nce cov kev xav tau ntawm kev npaj tshuaj nyob hauv tsev thiab txawv teb chaws, cov tshuab tsim khoom thiab cov txheej txheem ntawm HPMC tseem tab tom txhim kho ntawm txoj kev tortuous thiab ntev. Cov txheej txheem tsim khoom ntawm HPMC tuaj yeem muab faib ua batch txoj kev thiab txoj kev txuas mus ntxiv. Cov qeb loj. Cov txheej txheem txuas ntxiv yog feem ntau siv txawv teb chaws, thaum cov txheej txheem batch feem ntau yog siv hauv Suav teb. Kev npaj ntawm HPMC suav nrog cov kauj ruam ntawm kev npaj alkali cellulose, cov tshuaj tiv thaiv etherification, kev kho kom zoo, thiab kev kho cov khoom tiav. Ntawm lawv, muaj ob hom txheej txheem rau etherification cov tshuaj tiv thaiv. : Gas phase method thiab kua theem method. Hais txog kev hais lus, cov txheej txheem roj av muaj qhov zoo ntawm qhov muaj peev xwm ntau lawm, tsis tshua muaj qhov kub thiab txias, lub sij hawm luv luv, thiab kev tswj cov tshuaj tiv thaiv, tab sis cov tshuaj tiv thaiv siab yog loj, kev nqis peev yog loj, thiab thaum muaj teeb meem tshwm sim, nws yooj yim rau ua rau muaj xwm txheej loj. Cov txheej txheem ua kua feem ntau muaj qhov zoo ntawm cov tshuaj tiv thaiv tsis tshua muaj siab, tsis tshua muaj kev pheej hmoo, tus nqi qis peev, kev tswj tau yooj yim, thiab hloov tau yooj yim ntawm ntau yam; tab sis tib lub sijhawm, lub reactor xav tau los ntawm cov txheej txheem ua kua theem tsis tuaj yeem loj dhau, uas tseem txwv qhov muaj peev xwm ntawm cov tshuaj tiv thaiv. Piv nrog rau cov roj theem txoj kev, lub sij hawm cov tshuaj tiv thaiv yog ntev, lub peev xwm ntau lawm yog me me, cov khoom yuav tsum tau muaj ntau, kev khiav hauj lwm yog complex, thiab automation tswj thiab qhov tseeb yog qis dua cov roj theem txoj kev. Tam sim no, cov teb chaws tsim kho xws li Europe thiab Tebchaws Meskas feem ntau siv cov roj theem txheej txheem. Muaj cov kev xav tau siab ntawm kev siv tshuab thiab kev nqis peev. Kev txiav txim los ntawm qhov xwm txheej tiag tiag hauv peb lub tebchaws, cov txheej txheem ua kua theem yog ntau dua. Txawm li cas los xij, muaj ntau qhov chaw hauv Suav teb uas txuas ntxiv hloov kho thiab tsim kho thev naus laus zis, kawm los ntawm txawv teb chaws qib siab, thiab pib ua cov txheej txheem ib nrab. Los yog txoj kev ntawm kev qhia txawv teb chaws roj-theem txoj kev.
3.2 Kev tsim kho thev naus laus zis ntawm HPMC hauv tsev
HPMC hauv kuv lub tebchaws muaj peev xwm loj hlob. Raws li lub sijhawm zoo li no, nws yog lub hom phiaj ntawm txhua tus kws tshawb fawb los txuas ntxiv txhim kho cov cuab yeej tsim khoom ntawm HPMC thiab txo qhov sib txawv ntawm HPMC kev lag luam hauv tsev thiab txawv teb chaws qib siab. Cov txheej txheem HPMC Txhua qhov txuas hauv cov txheej txheem synthesis yog qhov tseem ceeb tshaj plaws rau cov khoom kawg, ntawm cov tshuaj alkalization thiab etherification [6] yog qhov tseem ceeb tshaj plaws. Yog li ntawd, cov cuab yeej siv HPMC hauv tsev uas twb muaj lawm tuaj yeem ua tau los ntawm ob qho kev qhia no. Kev hloov pauv. Ua ntej tshaj plaws, kev npaj ntawm alkali cellulose yuav tsum tau nqa tawm ntawm qhov kub thiab txias. Yog tias cov khoom uas tsis muaj viscosity tau npaj, qee cov oxidants tuaj yeem ntxiv; Yog tias cov khoom muaj viscosity siab tau npaj, yuav siv tau ib txoj kev tiv thaiv roj inert. Qhov thib ob, cov tshuaj tiv thaiv etherification yog nqa tawm ntawm qhov kub thiab txias. Muab cov toluene tso rau hauv cov khoom siv etherification ua ntej, xa cov alkali cellulose rau hauv cov khoom siv nrog lub twj tso kua mis, thiab ntxiv ib qho nyiaj ntawm isopropanol raws li qhov xav tau. Txo cov khoom-kua piv. Thiab siv lub khoos phis tawj tswj hwm, uas tuaj yeem tawm tswv yim sai sai, cov txheej txheem tsis xws li siab thiab pH raug hloov kho. Tau kawg, kev txhim kho ntawm HPMC cov cuab yeej tsim khoom kuj tuaj yeem txhim kho los ntawm cov txheej txheem, kev siv cov khoom siv raw, kev kho kom zoo thiab lwm yam.
4 Kev thov ntawm HPMC hauv kev kho mob
4.1 Kev siv HPMC hauv kev npaj cov ntsiav tshuaj uas tau tso tawm
Nyob rau hauv xyoo tas los no, nrog rau kev sib txuas ntxiv ntawm kev tshawb fawb txog kev xa tshuaj, kev txhim kho high-viscosity HPMC hauv daim ntawv thov kev npaj-tso tawm tau nyiam heev, thiab cov txiaj ntsig kev tso tawm tau zoo. Hauv kev sib piv, tseem muaj qhov sib txawv loj hauv daim ntawv thov ntawm cov ntsiav tshuaj matrix sustained-tso tawm. Piv txwv li, thaum muab piv rau hauv tsev thiab txawv teb chaws HPMC rau nifedipine sustained-tso ntsiav tshuaj thiab raws li ib tug matrix rau propranolol hydrochloride sustained-tso matrix ntsiav tshuaj, nws pom tau hais tias kev siv ntawm domestic HPMC nyob rau hauv sustained-tso npaj yuav tsum tau ntxiv kev txhim kho mus tas li txhim kho lub theem ntawm kev npaj hauv tsev.
4.2 Daim ntawv thov ntawm HPMC nyob rau hauv thickening ntawm kev kho mob lubricants
Vim tias qhov kev xav tau ntawm kev tshuaj xyuas lossis kev kho mob ntawm qee yam khoom siv kho mob niaj hnub no, thaum nkag los yog tawm hauv tib neeg lub cev thiab cov ntaub so ntswg, lub ntsej muag ntawm lub cuab yeej yuav tsum muaj qee yam lubricating zog, thiab HPMC muaj qee yam lubricating zog. Piv nrog rau lwm cov roj lubricants, HPMC tuaj yeem siv los ua cov khoom siv kho mob lubricating, uas tuaj yeem tsis tsuas yog txo cov khoom siv, tab sis kuj ua tau raws li cov kev xav tau ntawm kev kho mob lubrication thiab txo cov nqi.
4.3 Daim ntawv thov ntawm HPMC raws li ntuj antioxidant dej-soluble ntim zaj duab xis thiab zaj duab xis txheej khoom thiab zaj duab xis-tsim cov ntaub ntawv
Piv nrog rau lwm cov khoom siv tshuaj coated ntsiav tshuaj, HPMC muaj qhov pom tseeb zoo ntawm hardness, friability thiab noo noo nqus. HPMC ntawm cov qib viscosity sib txawv tuaj yeem siv los ua cov ntim dej-soluble rau cov ntsiav tshuaj thiab tshuaj. Nws kuj tseem tuaj yeem siv los ua cov yeeb yaj kiab ntim rau cov kuab tshuaj organic. Nws tuaj yeem hais tias HPMC yog cov khoom siv dav siv ntau tshaj plaws hauv kuv lub tebchaws. Tsis tas li ntawd, HPMC tseem tuaj yeem siv los ua cov khoom siv ua yeeb yaj kiab hauv cov neeg ua yeeb yaj kiab, thiab cov tshuaj tiv thaiv oxidative dej-soluble ntim zaj duab xis raws li HPMC tau siv dav hauv kev khaws cov zaub mov, tshwj xeeb tshaj yog cov txiv hmab txiv ntoo.
4.4 Daim ntawv thov ntawm HPMC ua cov khoom siv lub plhaub capsule
HPMC kuj tseem siv tau los ua cov khoom siv los npaj cov kaus mom plhaub. Qhov zoo ntawm HPMC capsules yog tias lawv kov yeej cov kev sib txuas ntawm cov tshuaj gelatin capsules, muaj kev sib raug zoo nrog cov tshuaj, muaj kev ruaj ntseg siab, tuaj yeem kho thiab tswj tus cwj pwm tso tawm ntawm cov tshuaj, txhim kho cov tshuaj zoo, Nws muaj qhov zoo ntawm kev tso tshuaj ruaj khov. txheej txheem. Ua haujlwm tau zoo, HPMC cov tshuaj ntsiav tuaj yeem hloov pauv cov gelatin capsules uas twb muaj lawm, sawv cev rau kev txhim kho yav tom ntej ntawm cov tshuaj ntsiav nyuaj.
4.5 Kev thov ntawm HPMC ua tus neeg sawv cev ncua
HPMC yog siv los ua tus neeg sawv cev ncua, thiab nws cov nyhuv ncua yog qhov zoo. Thiab cov kev sim qhia tau hais tias siv lwm cov ntaub ntawv polymer uas yog tus neeg sawv cev ncua los npaj lub ncua kev kawm qhuav yog piv nrog HPMC ua tus neeg sawv cev ncua los npaj cov kev ncua qhuav. Qhov kev ncua sij hawm qhuav yog ib qho yooj yim los npaj thiab muaj kev ruaj ntseg zoo, thiab kev tsim ncua kev kawm ntawv ua tau raws li qhov yuav tsum tau muaj ntawm ntau yam kev ntsuas zoo ntawm kev ncua kev kawm qhuav. Yog li ntawd, HPMC feem ntau yog siv los ua tus neeg sawv cev ncua rau kev npaj kho qhov muag.
4.6 Daim ntawv thov ntawm HPMC ua blocker, qeeb-tso tus neeg saib xyuas thiab porogen
HPMC tuaj yeem siv los ua tus neeg saib xyuas thaiv, tus neeg saib xyuas kev tso tawm thiab cov pore-forming tus neeg saib xyuas kom ncua thiab tswj cov tshuaj tso tawm. Niaj hnub no, HPMC kuj tau siv dav hauv kev npaj-tso tawm thiab kev npaj sib xyaw ntawm cov tshuaj suav tshuaj, xws li hauv Tianshan Snow Lotus sustained-tso cov ntsiav tshuaj matrix. Daim ntawv thov, nws cov txiaj ntsig tso tawm tau zoo yog qhov zoo, thiab cov txheej txheem kev npaj yog yooj yim thiab ruaj khov.
4.7 Daim ntawv thov ntawm HPMC ua cov kua nplaum thiab cov tshuaj tiv thaiv colloid
HPMC tuaj yeem siv los ua cov thickener [9] los tsim kev tiv thaiv colloids, thiab cov kev tshawb fawb txog kev sim tau pom tias siv HPMC ua cov thickener tuaj yeem txhim kho kev ruaj ntseg ntawm cov tshuaj activated carbon. Piv txwv li, nws yog feem ntau siv nyob rau hauv kev npaj ntawm pH-sensitive levofloxacin hydrochloride ophthalmic npaj-rau-siv gel. HPMC yog siv los ua thickener.
4.8 Kev siv HPMC ua bioadhesive
Cov adhesives siv nyob rau hauv bioadhesion technology yog macromolecular compounds nrog bioadhesive zog. Los ntawm kev ua raws li lub plab hnyuv mucosa, qhov ncauj mucosa thiab lwm qhov chaw, qhov txuas ntxiv thiab nruj ntawm kev sib cuag ntawm cov tshuaj thiab cov mucosa tau ntxiv dag zog kom ua tiav cov txiaj ntsig zoo dua. . Ntau tus piv txwv ntawm daim ntawv thov qhia tias HPMC tuaj yeem ua tau raws li qhov xav tau saum toj no raws li bioadhesive.
Tsis tas li ntawd, HPMC kuj tseem tuaj yeem siv los ua cov nag lossis daus rau cov tshuaj pleev ib ce thiab cov tshuab ua tus kheej microemulsifying, thiab hauv PVC kev lag luam, HPMC tuaj yeem siv los ua kev tiv thaiv kev tawg hauv VCM polymerization.
5 Kev xaus
Hauv ib lo lus, HPMC tau siv dav hauv kev npaj tshuaj thiab lwm yam vim nws qhov tshwj xeeb physicochemical thiab cov khoom siv roj ntsha. Txawm li cas los xij, HPMC tseem muaj ntau yam teeb meem hauv kev npaj tshuaj. Lub luag haujlwm tshwj xeeb ntawm HPMC yog dab tsi hauv daim ntawv thov; yuav ua li cas los txiav txim seb nws puas muaj cov nyhuv pharmacological; Nws muaj cov yam ntxwv zoo li cas hauv nws cov txheej txheem tso tawm, thiab lwm yam. Nws tuaj yeem pom tias thaum HPMC tau siv dav, ntau cov teeb meem yuav tsum tau daws sai. Thiab ntau thiab ntau tus kws tshawb fawb tau ua ntau txoj haujlwm rau kev siv HPMC zoo dua hauv cov tshuaj, yog li txuas ntxiv txhawb kev txhim kho ntawm HPMC hauv kev lag luam tshuaj excipients.
Post lub sij hawm: Nov-02-2022