HydroxyPropyyl methylcellulose (HPMC)
Qeb: Txheej ntaub ntawv; Membrane khoom; Cov khoom siv ceev polymer rau kev npaj qeeb; Stabilizing tus neeg sawv cev; Ncua kev pab, ntsiav tshuaj nplaum; Txhawb nqa adhesion tus neeg saib xyuas.
1. Cov Khoom Taw Qhia
Cov khoom no yog cov tshuaj uas tsis yog-ionic Cov tshuaj aqueous muaj cov haujlwm saum npoo av, siab transparency thiab ruaj khov ua tau zoo. HPMC muaj cov cuab yeej ntawm kub gel. Tom qab cua sov, cov khoom muaj aqueous daws teeb meem gel nag lossis daus, thiab tom qab ntawd yaj tom qab txias. Qhov kub thiab txias ntawm cov specifications sib txawv txawv. Solubility hloov nrog viscosity, viscosity zhao tsawg, ntau dua cov solubility muaj qee qhov sib txawv, HPMC yaj hauv dej tsis cuam tshuam los ntawm PH nqi.
Lub spontaneous combusttion kub, xoob ntom ntom thiab iav hloov chaw thiab tshuab hloov iav tau 360, 1.326g / cm3 thiab 170 ~ 180 ℃, feem. Tom qab cua sov, nws hloov xim av thaum 190 ~ 200 ° C thiab hlawv ntawm 225 ~ 230 ° C.
HPMC yuav luag tsis tau muaj tiag hauv chloroform, ethanol (95%), thiab diethil etharce, thiab yaj ntawm cov tshuaj methanol thiab methylene chloride, thiab kev sib xyaw ntawm dej thiab ethanol. Qee qib HPMC yog soluble hauv mixtines ntawm acetone, methylene chloride, thiab 2-propanol, zoo li nyob rau hauv lwm cov kuab organic.
Rooj 1: Qhov ntsuas kev ua haujlwm
yam haujlwm
Tagmee,
60 GD (2910).
65gd (2906)
75GD (2208)
Methoxy%
28.0-32.0
27.0-30.0
19.0-24.0
Hydroxyprropoxy%
7.0-12.0
4.0-7.5
4.0-12.0
Gel kub ℃
56-64.
62.0-68.0
70.0-90.0
Viscosity mpa s.
3,5,6,15,50,4000
50400 0
100400 0150 00100 000
Lub cev yuag qhuav phaus%
5.0 lossis tsawg dua
Hlawv Ntawm Cov Nqi
1.5 lossis tsawg dua
pH
4.0-8.0
Hnyav Hlau
20 lossis tsawg dua
khoom
2.0 lossis tsawg dua
2. Cov khoom nta
2.1 HydroxyPropyyl methylcellulose yog yaj nyob rau hauv dej txias kom tsim lub viscous colutide tov. Tsuav nws tau ntxiv rau dej txias thiab me ntsis nplawm, nws tuaj yeem ua rau muaj kev daws teeb meem pob tshab. On qhov tsis tooj, nws yog qhov tseem insoluble hauv dej kub saum 60 ℃ thiab tuaj yeem tsuas yog o. Nyob rau hauv kev npaj ntawm hydroxypropal aqueous ahouous kua tshuaj, nws yog qhov zoo tshaj plaws ntawm hydroxypropylulose, thiab thaum kawg siv cov dej txias los ntxiv rau qhov yuav tsum tau ua.
2.2 HydroxyPropyyl methylulose yog qhov tsis muaj ionic cellulose, yog li kom ntseeg tau tias Hionic cov khoom siv, yog li kom ntseeg tau tias muaj lwm cov ntaub ntawv raw thiab siv cov txheej txheem kev npaj ua haujlwm.
2.3 HydroxyPropyyl methylculose muaj zog tiv thaiv-rhiab, thiab nrog kev nce qib ua rau cov qauv molecular, cov tiv thaiv kev paub kuj yog txhim kho. Cov tshuaj siv HPMC kom zoo siab muaj cov khoom lag luam zoo nyob hauv kev siv tshuaj lom neeg (cov hmoov txhuv nplej siab, Dextrin, hmoov qab zib).
2.4 HydroxyPropyY methylcelleculose yog metabolically inert. Raws li kev khaws tshuaj kom zoo, nws tsis yog metabolized lossis nqus tau, yog li nws tsis muab cua sov hauv cov tshuaj thiab khoom noj. Nws muaj feem xyuam rau cov nqi qis dua calorific, ntsev-dawb, tsis muaj tshuaj thiab cov khoom noj rau cov neeg mob ntshav qab zib.
2.5hpmc yog qhov ruaj khov rau cov kua qaub thiab hauv paus, tab sis yog tias yuav cuam tshuam txog lub sijhawm ntev dua 2 ~ 11 thiab muaj kev cuam tshuam los ntawm cov sijhawm kub siab dua lossis sijhawm ntxiv, nws yuav txo cov kev tshem tawm.
2.6 HydroxyPropyyl methylulosequeous kua txiv tuaj yeem muab cov haujlwm saum npoo av, uas qhia txog qhov tseem ceeb thiab cuam tshuam txog kev sib tw. Nws muaj cov emulsification zoo nyob rau hauv ob-theem system thiab tuaj yeem siv los ua cov khoom siv khov kho thiab tiv thaiv kev tiv thaiv zoo.
2.7 HydroxyPropyyl methylulose aqueous kua aqueous muaj cov yeeb yaj kiab zoo heev, thiab yog cov khoom siv zoo rau cov ntsiav tshuaj thiab ntsiav tshuaj. Tus membrane tsim los ntawm nws yog tsis muaj kob thiab tawv. Yog tias glycerol yog ntxiv, nws cov yas tuaj yeem nce ntxiv. Tom qab kev kho deg, cov khoom yog dispersed nyob rau hauv dej txias, thiab kev sib cais tuaj yeem tswj tau los ntawm cov pH ib puag ncig. Nws yog siv hauv kev npaj qeeb thiab nkag rau hauv-coated npaj.
3. Cov Khoom Siv Khoom
3.1. Siv raws li adhesive thiab disintegrating tus neeg sawv cev
HPMC yog siv los txhawb cov tshuaj sib txawv thiab cov ntawv thov tso tawm hauv cov kua nplaum, thiab cov tshuaj tua kab mob siab, thiab cov tshuaj tua kab mob siab, thiab cov khoom siv sib txawv, qhov dav dav yog 2% ~ 5%.
HPMC aqueous daws thiab qee qhov kev xav ntawm ethanol los ua ib phau ntawv sib dhos; Piv txwv li: 2% HPMC aqueous daws nrog 55% ethanol daws tau siv rau Amoxicillin tsiav tshuaj, yog li qhov nruab nrab ntawm Amoxicenin tsiav tshuaj nce ntawm 38% mus rau 90% tsis muaj HPMC.
HPMC tuaj yeem ua los ntawm kev sib xyaw nrog cov nplaum sib txawv nrog cov hmoov txhuv nplej siab ntawm cov hmoov txhuv nplej siab tom qab kev xaus; Kev sib cais ntawm erythromycin interic-coated ntsiav tshuaj tau nce los ntawm 38.26% rau 97.38% HPMC thiab 8% Starch tau ua ke.
2.2. Ua yeeb yaj kiab txheej khoom thiab zaj duab xis ruaj ruaj khoom
HPMC raws li cov khoom siv dej-soluble Cov txheej txheem txheej txheej yog yooj yim; Zaj duab xis zoo tsim cov cuab yeej; Tuaj yeem ua kom cov duab ntawm daim, sau ntawv; Tuaj yeem ua kom noo noo; Tuaj yeem xim, kho cuav. Cov khoom no yog siv los ua dej-soluble zaj duab xis txheej rau cov ntsiav tshuaj thiab tsis muaj dej paug nrog cov viscosity heev, kev siv nyiaj yog 2%.
2.3, raws li tus neeg saib xyuas tuab thiab colloidal tiv thaiv kua nplaum
HPMC siv raws li thickening tus neeg sawv cev yog 0.45% ~ 1.0%, tuaj yeem siv los ua qhov muag thiab lub kua muag khoom muag zoo nkauj; Siv los ua kom muaj kev ruaj khov ntawm hydrophobic kua nplaum, tiv thaiv kom tsis txhob muaj pa cocalcle, nag lossis daus, ib txwm siv yog 0.5% ~ 1.5%.
2.4, raws li lub blocker, cov khoom tso tawm qeeb, tswj tso tawm cov neeg sawv cev thiab cov neeg sawv cev pore
HPMC siab viscosity qauv yog siv los npaj cov blockers thiab tswj kev tso tawm cov tshuab sib xyaw thiab hydrophilic gel skeleton pab tau cov ntsiav tshuaj. Tus qauv vos-viscosity yog ib tug pore-inducing tus neeg sawv cev ntawm cov ntsiav tshuaj sai tau, ua raws li kev tso tawm-tso tawm lossis tswj xyuas kom muaj cov ntshav kom zoo hauv cov ntshav.
2.5. Gel thiab suppository matrix
Hydrogel cov qhob thiab cov kua av nplaum nplaum npaj tau tuaj yeem npaj los ntawm kev siv tus yam ntxwv uas muaj cov yam ntxwv zoo ntawm HPMC hauv dej.
2.6 biological cov ntaub ntawv
Metronidazole tau tov nrog HPMC thiab Polycarboxylenethylene 934 hauv tov los ua bioaded tso tawm muaj 250mg. Nyob rau hauv cov vitro diseolution kev ntsuam xyuas pom tias qhov kev npaj sai sai hauv dej, thiab cov tshuaj tso tawm tau tswj los ntawm diffusion thiab roj saw so. Kev siv tsiaj ua kom pom tias cov tshuaj tso tawm Yeeb Tshuaj Tshiab muaj cov khoom siv roj ntsha ua kom muaj txiaj ntsig adhesion muaj txiaj ntsig rau bovine sublolingual mucosa.
2.7, raws li kev pab ncua
Lub viscosity siab ntawm cov khoom lag luam yog qhov kev zam txim zoo rau kev ncua kev ua kua npaj, nws li kev noj tshuaj pes tsawg yog 0.5% ~ 1.5%.
4. Thov piv txwv
4.1 Zaj duab xis txheej daws teeb meem: HPMC 2kg, Castor Roj 1000mL, Propylene Glycolles), Dej 47000mL, Xim Tsim Nyog Tus Nqi. Muaj ob txoj hauv kev los ua kom nws.
4.1.1 Kev npaj ntawm Soluble cov xim kua: Ntxiv cov nqi ntawm HPMC rau hauv 95% ethercharve tsaug zog rau hauv 95% ob qho tib si kev daws teeb meem. Sib tov 80% ntawm kev daws (20% rau polishing) nrog cov nqi ntawm cov roj Castor, Tween-80, thiab Propylene Glycol.
4.1.2 Kev npaj ntawm insoluble pigment (xws li hlau oxide) txheej ua kua HPMC tau soft hauv 95% ethanol thaum hmo ntuj, thiab dej ntxiv rau ua 2%. 20% ntawm cov kev daws teeb meem no tau raug coj tawm rau polishing, thiab seem seem tau npaj los ntawm cov qauv ua kua sib tsoo, thiab tom qab ntawd cov tshuaj sib tsoo ntawm lwm cov feem tau ntxiv thiab siv tusyees sib xyaw. Cov txheej txheem txheej txheej ntawm cov txheej txheej ua kua: Ncuav cov ntawv ntim rau hauv cov kua qab zib, koj tuaj yeem tso tshuaj lom rau hauv lub lauj kaub, koj tuaj yeem muab tso rau hauv lub lauj kaub kom qhuav rau ntau tshaj 8h.
4.2/ ntawm Interferon qhov muag membrane 50μg ntawm α-interferon tau yaj nyob rau hauv 10mlmc thiab 0.5glmc, filated ntawm lub iav tig, nplua nuj ntawm 60 ℃ thiab qhuav hauv huab cua. Cov khoom no yog tsim ua cov khoom siv zaj duab xis.
4.3 Cotrimoxazole ntsiav tshuaj (0.4g ± 0.0g) 40kg, Magnesium Stearate 0.3kg, thiab tom qab ntawd ntxiv cov hmoov txhuv nplej siab thiab sib tov rau 5min. Nrog prectricated 3 %% HPMC aqueous daws, muaj cov ntaub ntawv muag, nrog 16 mesh screen tag nrho, nrog 12mm round nrog lo lus (smzco) stamping ntsiav tshuaj. Cov khoom no yog tsuas yog siv los ua phau ntawv. Kev sib cais ntawm cov ntsiav tshuaj yog 96% / 20min.
4.4 Piperate ntsiav tshuaj (0.25g) Piperate 80 Mesh 25Kg, cov hmoov txhuv nplej siab (120 mesh (120 mesh (120 m1, magnesate stearate tsim nyog tus nqi. Nws txoj kev ntau lawm yog los ua cov yeeb nkab tsim ua kom xyaw, HPMC tusyees granesium, ntxiv rau 20 mesh exchatium steelate stearate, nrog 100mm voj voog siv tawv lo lus (PPA0.25) cov ntsiav tshuaj stamping. Nrog cov hmoov txhuv nplej siab xws li tus neeg sawv cev tsis sib xws, tus lej xaus ntawm cov ntsiav tshuaj no tsis tsawg dua 80% / 2min, uas yog siab dua cov khoom lag luam zoo sib xws hauv Nyij Pooj.
4.5 Actifiial BRIX-4000, HPMC-4500 lossis HPMC-5000 CLMC-5000 COLASLACY CLLORRYAMMONY daws 0.02ml, dej ntxiv rau 100ml. Nws txoj kev ntau lawm yog HPMC tso rau hauv 15ml dej, tom qab siv cov khoom seem, thiab tom qab ntawd muaj 30min, uas yog, lub xov tooj ntawm 8.4 ° C rau 8.6 ° C. Cov khoom no yog siv rau kev rhuav tshem cov kua muag, thaum siv rau lub anterior me me ntawm cov khoom no, 0.7% ~ 1.5% yog qhov tsim nyog.
4.6 Meththorphan tswj cov ntsiav tshuaj methtore resin ntsev 187.5mg, pvp70.0mg, pvocrystalline phthalate-102 thiab magnesium stearate 2.5mg. Nws tau npaj raws li cov ntsiav tshuaj los ntawm txoj kev qub. Cov khoom no yog siv los ua cov tshuaj tso tawm.
4.7 rau avantomycin ⅳ ntsiav tshuaj, 2149 greadantomycin ⅳ Monohydrate thiab 1000ml isopropyl roj sib tov sib xyaw ntawm 15% (9) tau starred, sib xyaw, granulated, thiab qhuav ntawm 35 ℃. Cov granules qhuav 575g thiab 62.5g hydroxellulose E-50 tau muab sib xyaw ua kom huv si ntxiv rau cov ntsiav tshuaj kom tau txais Vanguard MyCin ⅳ ntsiav tshuaj. Cov khoom no yog siv los ua cov khoom qeeb.
4.8 nifedipine txhawb nqa granules 1 ntu nifedipine, 3 ntu Etylrope Cellulose tau muab sib xyaw nrog cov granules los ntawm cov qauv granules los ntawm nruab nrab-soluble txujci. Cov tshuaj tso tawm ntawm cov granules tsis muaj kev cuam tshuam los ntawm kev hloov ntawm ib puag ncig p thiab tau qeeb qeeb tshaj li cov neeg lag luam muaj granules. Tom qab 12 teev ntawm kev tswj hwm qhov ncauj, tib neeg cov ntshav siab yog 12mg / ml, thiab tsis muaj ib tus neeg sib txawv.
4.9 profranhall hydrochloride sustained tso tawm tshuaj ntsiav hydrochloride 60kg, microcrystalline cellulose 40kg, ntxiv 50l, ntxiv rau 50l, ntxiv rau granules. HPMC1KG thiab EC 9KG tau sib xyaw hauv cov kuab tshuaj xyaw (metylen chloride) Txhua cov tshuaj ntsiav muaj 160mg ntawm propranolol hydrochloride sheralical hais.
4.10 naprolol hcl pob txha hniav tau npaj los ntawm kev sib tov Naprolol HCL: HPMC: CMC-NA ntawm qhov sib piv ntawm 1: 0.25: 2.25: 2.25: 2.25: 2.25: 2.25: 2.25: 2.25: 2.25: 2.25: 2.25: 2.25: 2.25: 2.25: 2.25: 2.25: 2.25: 2.25: 2.25: 2.25: 2.25: 2.25: 2.25: 2.25: 2.25: 2.25. Qhov ntsuas yeeb tshuaj tawm tau ze rau xoom kev txiav txim hauv 12 teev.
Other drugs can also be made of mixed skeleton materials, such as metoprolol: HPMC: CMC-NA according to: 1:1.25:1.25; AllyLPROLOLOL: HPMC raws li 1: 2.8: 2.92 piv. Qhov ntsuas yeeb tshuaj tawm tau ze rau xoom kev txiav txim hauv 12 teev.
4.11 Skeleton ntsiav tshuaj ntawm cov khoom xyaw sib xyaw tau npaj los ntawm cov qauv miclica siv cov hmoov sib xyaw: CMC-NA: HPMC 1: 0.4: 4.4. Cov tshuaj tuaj yeem tso tawm rau 12th ob qho tib si hauv vitro thiab hauv vivo, thiab cov kab tawm linear muaj kev sib txheeb zoo. Cov txiaj ntsig tau ntawm kev ntsuas kev ruaj ntseg nrawm raws li FDA cov kev cai twv kwv yees tias lub neej cia ntawm cov khoom no muaj txog 2 xyoos.
4.12 HPMC (50MPC (50MPC), HPMC (4000 MpAMOY) thiab 6 qhov chaw uas yog 6 feem Cov khoom no muaj 80% ntawm cov tshuaj tseem ceeb.
4.13 theophylline hydrots hydrotse cov ntsiav tshuaj tau raug suav raws li cov tshuaj tso tawm tau ib txwm muaj, thiab muaj txiaj ntsig zoo ntawm cov tshuaj lom neeg lub cev rau tib neeg lub cev rau 12th tom qab kev tswj hwm qhov ncauj.
Sijhawm Sijhawm: Sep-20-2022