Hydroxypropyl methylcellulose (HPMC)
Category: zokutira zipangizo;Zida za membrane;Zida za polima zoyendetsedwa mwachangu zokonzekera pang'onopang'ono kumasulidwa;Stabilizing wothandizira;Thandizo la kuyimitsidwa, zomatira piritsi;Wothandizira kumamatira.
1. Chidziwitso cha malonda
ZOCHITIKA ZONSE NDI ZONSE ZONSE ZONSE ETHER, zomwe zimawonedwa kunja ngati ufa woyera, wopanda fungo komanso wopanda kukoma, wosungunuka m'madzi ndi zosungunulira za polar organic, kutupa m'madzi ozizira kuti muchotse kapena kutsitsa pang'ono njira ya colloidal.Njira yothetsera madzi imakhala ndi zochitika zapamtunda, zowonekera kwambiri komanso zokhazikika.HPMC ili ndi katundu wa gel osakaniza.Pambuyo kutentha, mankhwala amadzimadzi njira kupanga gel osakaniza mpweya, ndiyeno amasungunuka pambuyo kuzirala.Kutentha kwa gel osakaniza ndi zosiyana.Solubility kusintha ndi mamasukidwe akayendedwe, mamasukidwe akayendedwe zhao otsika, wamkulu solubility, specifications HPMC katundu ndi zosiyana, HPMC kusungunuka m'madzi si anakhudzidwa ndi pH mtengo.
The mowiriza kuyaka kutentha, lotayirira kachulukidwe, kachulukidwe weniweni ndi galasi kusintha kutentha anali 360 ℃, 0.341g/cm3, 1.326g/cm3 ndi 170 ~ 180 ℃, motero.Ikatenthedwa, imasanduka bulauni pa 190 ~ 200 ° C ndikuyaka pa 225 ~ 230 ° C.
HPMC pafupifupi insoluble mu chloroform, Mowa (95%), ndi diethyl ether, ndi kusungunuka mu osakaniza Mowa ndi methylene kolorayidi, osakaniza methanol ndi methylene kolorayidi, ndi osakaniza madzi ndi Mowa.Milingo ina ya HPMC imasungunuka mu zosakaniza za acetone, methylene chloride, ndi 2-propanol, komanso muzosungunulira zina.
Gulu 1: Zizindikiro zaukadaulo
polojekiti
Gauge,
60 gd (2910).
65GD(2906)
75GD(2208)
Methoxy%
28.0-32.0
27.0-30.0
19.0-24.0
Hydroxypropoxy%
7.0-12.0
4.0-7.5
4.0-12.0
Kutentha kwa gel osakaniza ndi ℃
56-64.
62.0-68.0
70.0-90.0
Viscosity mpa s.
3,5,6,15,50,4000
504000
100400 0150 00100 000
Kutaya thupi %
5.0 kapena kuchepera
Kuwotcha zotsalira%
1.5 kapena kuchepera
pH
4.0-8.0
Chitsulo cholemera
20 kapena kuchepera
arsenic
2.0 kapena kuchepera
2. Zogulitsa
2.1 Hydroxypropyl methylcellulose imasungunuka m'madzi ozizira kuti apange viscous colloidal solution.Malingana ngati awonjezeredwa kumadzi ozizira ndikugwedezeka pang'ono, akhoza kusungunuka mu njira yowonekera.M'malo mwake, imakhala yosasungunuka m'madzi otentha kuposa 60 ℃ ndipo imatha kutupa.Pokonzekera hydroxypropyl methicellulose amadzimadzi njira, ndi bwino kuwonjezera mbali ya hydroxypropyl methiculose mu kuchuluka kwa madzi, chipwirikiti mwamphamvu, mkangano kwa 80 ~ 90 ℃, ndiyeno kuwonjezera otsala hydroxypropyl methiculose, ndipo potsiriza ntchito madzi ozizira kuwonjezera. pamtengo wofunikira.
2.2 Hydroxypropyl methylcellulose ndi non-ionic cellulose ether, yankho lake silimanyamula ndalama za ionic, silimagwirizanitsa ndi mchere wachitsulo kapena ma ionic organic compounds, kuti atsimikizire kuti HPMC sichitapo kanthu ndi zipangizo zina zopangira ndi zothandizira pokonzekera. kupanga.
2.3 Hydroxypropyl methylcellulose imakhala ndi anti-sensitivity, ndipo ndi kuwonjezeka kwa digiri ya m'malo mwa maselo, anti-sensitivity imakulitsidwanso.Mankhwala ogwiritsira ntchito HPMC monga othandizira amakhala ndi khalidwe lokhazikika mkati mwa nthawi yabwino kusiyana ndi mankhwala omwe amagwiritsa ntchito mankhwala ena achikhalidwe (wowuma, dextrin, shuga wa ufa).
2.4 Hydroxypropyl methylcellulose ndi metabolically inert.Monga chithandizo chamankhwala, sichimapangidwa ndi metabolized kapena kutengeka, kotero sichimapereka kutentha kwa mankhwala ndi chakudya.Imagwiritsidwa ntchito mwapadera pamtengo wotsika wa calorific, wopanda mchere, wopanda allergenic mankhwala komanso chakudya cha odwala matenda ashuga.
2.5HPMC imakhala yokhazikika ku ma acid ndi maziko, koma ngati pH idutsa 2 ~ 11 ndipo imakhudzidwa ndi kutentha kwakukulu kapena nthawi yayitali yosungira, idzachepetsa kukhwima.
2.6 Hydroxypropyl methylcellulose yankho lamadzimadzi limatha kupereka ntchito yapamtunda, kuwonetsa zolimbitsa thupi komanso zosagwirizana.Imakhala ndi emulsification yogwira ntchito mu dongosolo la magawo awiri ndipo ingagwiritsidwe ntchito ngati stabilizer yothandiza komanso yoteteza colloid.
2.7 Hydroxypropyl methylcellulose yankho lamadzimadzi lili ndi zinthu zabwino kwambiri zopangira filimu, ndipo ndi chinthu chabwino chokutira pamapiritsi ndi mapiritsi.Nembanemba yopangidwa ndi iyo imakhala yopanda mtundu komanso yolimba.Ngati glycerol iwonjezeredwa, pulasitiki yake imatha kuwonjezeka.Pambuyo pa chithandizo chapamwamba, mankhwalawa amamwazikana m'madzi ozizira, ndipo kuchuluka kwa kusungunuka kumatha kuwongoleredwa posintha chilengedwe cha pH.Amagwiritsidwa ntchito pokonzekera kumasulidwa pang'onopang'ono komanso kukonzekera kokhala ndi enteric.
3. Kugwiritsa ntchito mankhwala
3.1.Ntchito zomatira ndi disintegrating wothandizira
HPMC ntchito kulimbikitsa Kutha mankhwala ndi mlingo wa ntchito kumasulidwa, akhoza mwachindunji kusungunuka mu zosungunulira monga zomatira, otsika mamasukidwe akayendedwe a HPMC kusungunuka m'madzi kupanga mandala kwa minyanga pomata colloid njira, mapiritsi, mapiritsi, granules pa zomatira ndi disintegrating. wothandizira, komanso kukhuthala kwakukulu kwa guluu, amangogwiritsa ntchito chifukwa cha mitundu yosiyanasiyana ndi zofunikira zosiyanasiyana, ambiri ndi 2% ~ 5%.
HPMC amadzimadzi njira ndi ena ndende ya Mowa kupanga gulu binder;Chitsanzo: 2% HPMC yamadzimadzi yosakanikirana ndi 55% ya ethanol solution idagwiritsidwa ntchito popukutira makapisozi amoxicillin, kotero kuti kusungunuka kwa makapisozi amoxicillin kudakwera kuchokera 38% mpaka 90% popanda HPMC.
HPMC akhoza kupangidwa ndi gulu zomatira ndi ndende zosiyanasiyana wowuma slurry pambuyo kuvunda;Kusungunuka kwa mapiritsi okutidwa ndi erythromycin kunakwera kuchoka pa 38.26% kufika pa 97.38% pamene 2% HPMC ndi 8% wowuma zinaphatikizidwa.
2.2.Pangani zinthu zokutira filimu ndi kupanga filimu
HPMC monga madzi sungunuka ❖ kuyanika zakuthupi ali ndi makhalidwe awa: zolimbitsa njira mamasukidwe akayendedwe;Njira yokutira ndi yosavuta;Malo abwino opangira mafilimu;Akhoza kusunga mawonekedwe a chidutswa, kulemba;Ikhoza kukhala chinyezi;Akhoza mtundu, kukonza kununkhira.ZOCHITIKA ZIMAGWIRITSIDWA NTCHITO MONGA WOPHIRIRA MAFILAMU WOSAVUTA M'DZI PA MATABLETI NDI MAPIRITSI OKHALA WOCHEPA, KOMANSO POPITIRIRA MAFILAMU OSATI MWA MADZI NDI MTIMA KWAMBIRI, NTCHITO YOGWIRITSA NTCHITO NDI 2% -5%.
2.3, monga thickening wothandizira ndi colloidal chitetezo guluu
HPMC ntchito thickening wothandizila ndi 0,45% ~ 1.0%, angagwiritsidwe ntchito ngati diso madontho ndi yokumba misozi thickening wothandizila;Amagwiritsidwa ntchito kuonjezera bata la guluu hydrophobic, kupewa tinthu coalescence, mpweya, mwachizolowezi mlingo ndi 0.5% ~ 1.5%.
2.4, monga chotchinga, zinthu zotulutsa pang'onopang'ono, zowongolera zotulutsa ndi pore wothandizira
HPMC high viscosity model amagwiritsidwa ntchito pokonzekera ma blockers ndi owongolera kutulutsa mapiritsi osakanikirana a mafupa okhazikika ndi mapiritsi a hydrophilic gel omasulidwa.Chitsanzo chochepa cha viscosity ndi pore-inducing agent kuti atulutse-kumasulidwa kosalekeza kapena kuwongolera-kutulutsa mapiritsi kuti mlingo woyambirira wa mankhwala a mapiritsi oterowo upezeke mofulumira, kutsatiridwa ndi kumasulidwa kosalekeza kapena kumasulidwa-kumasulidwa kuti apitirizebe kukhazikika m'magazi.
2.5.Gel ndi suppository matrix
Ma suppositories a Hydrogel ndi zomatira zam'mimba zitha kukonzedwa pogwiritsa ntchito mawonekedwe a hydrogel omwe amagwiritsidwa ntchito ndi HPMC m'madzi.
2.6 Biological zomatira zida
Metronidazole inasakanizidwa ndi HPMC ndi polycarboxylethylene 934 mu chosakanizira kuti apange mapiritsi otulutsidwa ndi bioadhesive okhala ndi 250mg.Mayeso a in vitro dissolution adawonetsa kuti kukonzekera kudatupa mwachangu m'madzi, ndipo kutulutsidwa kwa mankhwalawa kumayendetsedwa ndi kufalikira komanso kupumula kwa kaboni.Kukhazikitsa kwa nyama kunawonetsa kuti njira yatsopano yotulutsira mankhwala inali ndi zinthu zophatikizira zamoyo ku bovine sublingual mucosa.
2.7, ngati chithandizo choyimitsidwa
Kukhuthala kwakukulu kwa mankhwalawa ndi chithandizo chabwino cha kuyimitsidwa kwa kuyimitsidwa kwamadzimadzi, mlingo wake wanthawi zonse ndi 0,5% ~ 1.5%.
4. Zitsanzo zogwiritsira ntchito
4.1 Film ❖ kuyanika njira: HPMC 2kg, talc 2kg, Kasitolo mafuta 1000ml, Twain -80 1000ml, propylene glycol 1000ml, 95% Mowa 53000ml, madzi 47000ml, pigment yoyenera kuchuluka.Pali njira ziwiri zopangira.
4.1.1 Kukonzekera kwamadzi osungunuka a pigment TACHIMATA zovala: Onjezani kuchuluka kwa HPMC mu 95% ethanol, zilowerereni usiku wonse, sungunulani vekitala ina ya pigment m'madzi (sefa ngati kuli kofunikira), phatikizani njira ziwirizi ndikugwedeza mofanana kuti mupange njira yowonekera. .Sakanizani 80% ya yankho (20% ya kupukuta) ndi kuchuluka kwa mafuta a castor, Tween-80, ndi propylene glycol.
4.1.2 Kukonzekera kwa insoluble pigment (monga chitsulo okusayidi) ❖ kuyanika madzi HPMC ankawaviika 95% Mowa usiku umodzi, ndi madzi anawonjezera kupanga 2% HPMC mandala njira.20% ya njira imeneyi anatengedwa kuti kupukuta, ndi otsala 80% yothetsera ndi okusayidi chitsulo anakonzedwa ndi madzi akupera njira, ndiyeno mankhwala kuchuluka kwa zigawo zina anawonjezera ndi kusakaniza wogawana ntchito.Njira yokutira yamadzimadzi yokutira: kutsanulira pepala lambewu mumphika wokutira shuga, mutatha kusinthasintha, mpweya wotentha umatenthetsa mpaka 45 ℃, mutha kupopera mbewu mankhwalawa, kuwongolera otaya mu 10 ~ 15ml/min, mutatha kupopera mbewu mankhwalawa, pitilizani kuumitsa. ndi mpweya wotentha kwa 5 ~ 10min ukhoza kutuluka mumphika, ikani mu chowumitsira kuti muume kwa nthawi yoposa 8h.
4.2α-interferon diso nembanemba 50μg wa α-interferon inasungunuka mu 10ml0.01ml hydrochloric acid, wothira 90ml Mowa ndi 0.5GHPMC, wosefedwa, TACHIMATA pa kasinthasintha galasi ndodo, chosawilitsidwa pa 60 ℃ ndi zouma mu mpweya.Izi zimapangidwa kukhala zinthu zamakanema.
4.3 mapiritsi a Cotrimoxazole (0.4g ± 0.08g) SMZ (80 mauna) 40kg, wowuma (120 mauna) 8kg, 3%HPMC amadzimadzi njira 18-20kg, magnesium stearate 0.3kg, TMP (80 mauna) 8kg, njira yokonzekera ndi sakanizani SMZ ndi TMP, ndiyeno yikani wowuma ndikusakaniza kwa 5min.Ndi 3% HPMC yankho lamadzi, zinthu zofewa, zokhala ndi 16 mesh screen granulation, kuyanika, kenako ndi 14 mesh screen njere yonse, onjezani kusakaniza kwa magnesium stearate, ndi mapiritsi osindikizira a 12mm ozungulira mawu (SMZco).Izi makamaka ntchito ngati binder.Kusungunuka kwa mapiritsi kunali 96%/20min.
4.4 Piperate mapiritsi (0.25g) piperate 80 mauna 25kg, wowuma (120 mauna) 2.1kg, magnesium stearate mlingo woyenera.njira yake yopanga ndi kusakaniza pipeoperic acid, wowuma, HPMC wogawana, ndi 20% Mowa zofewa zakuthupi, 16 mauna chophimba granulate, youma, ndiyeno 14 mauna chophimba mbewu zonse, kuphatikizapo vekitala magnesium stearate, ndi 100mm zozungulira lamba mawu (PPA0.25) ) mapiritsi osindikizira.Ndi wowuma ngati disintegrated wothandizira, kusungunuka kwa piritsi ili ndi osachepera 80%/2min, yomwe ndi yapamwamba kuposa mankhwala ofanana ku Japan.
4.5 Misozi Yopanga HPMC-4000, HPMC-4500 kapena HPMC-5000 0.3g, sodium kolorayidi 0.45g, potaziyamu kolorayidi 0.37g, borax 0.19g, 10% ammonium chlorbenzylammonium yankho 0.02 madzi owonjezera 0.02njira yake yopanga ndi HPMC anaikidwa 15ml madzi, pa 80 ~ 90 ℃ madzi zonse kutenga, kuwonjezera 35ml madzi, ndiyeno munali zigawo zotsala za 40ml amadzimadzi njira wosakanikirana wogawana, kuwonjezera madzi kuchuluka, ndiye kusakaniza wogawana, kuima usiku wonse. , tsitsani mofatsa kusefera, sefa mu chidebe chosindikizidwa, chosawilitsidwa pa 98 ~ 100 ℃ kwa 30min, ndiye kuti, pH imachokera ku 8.4 ° C mpaka 8.6 ° C. ZOTHANDIZA ZOKHUDZA ZOKHUDZA MISOZI, NDI MALOWA ABWINO MSOZI, IKAgwiritsidwa ntchito popanga maikulosikopu yakuchipinda cham'mbuyo, ikhoza KUWONJEZERA MMODZI MMODZI WA ZOKHUDZA ZIMENEZI, 0.7% ~ 1.5% NDI ZOYENERA.
4.6 Meththorphan ankalamulira kumasulidwa mapiritsi meththorphan utomoni mchere 187.5mg, lactose 40.0mg, PVP70.0mg, nthunzi silika 10mg, 40.0 mGHPMC-603, 40.0mg ~ microcrystalline mapadi phthalate-102 ndi magnesium stemga.2.Amakonzedwa ngati mapiritsi mwa njira yachibadwa.Izi zimagwiritsidwa ntchito ngati zinthu zotulutsidwa.
4.7 Pamapiritsi a avantomycin ⅳ, 2149g avantomycin ⅳ monohydrate ndi 1000ml isopropyl madzi osakaniza a 15% (mass concentration) eudragitL-100 (9:1) anagwedezeka, osakaniza, granulated, ndi zouma pa 35 ℃.Ma granules owuma a 575g ndi 62.5g hydroxypropylocellulose E-50 adasakanizidwa bwino, kenako 7.5g stearic acid ndi 3.25g magnesium stearate adawonjezedwa pamapiritsi kuti atulutsidwe mosalekeza mapiritsi a vanguard mycin ⅳ.Izi zimagwiritsidwa ntchito ngati zinthu zotulutsa pang'onopang'ono.
4.8 Nifedipine anakhalabe-kumasulidwa granules 1 mbali nifedipine, 3 mbali hydroxypropyl methyl cellulose ndi 3 mbali ethyl mapadi anali wothira zosungunulira wosanganiza (ethanol: methylene kolorayidi = 1: 1), ndi 8 mbali chimanga wowuma anawonjezera kubala granules ndi sing'anga sungunuka sungunuka. njira.Kutulutsa kwamankhwala kwa ma granules sikunakhudzidwe ndi kusintha kwa chilengedwe pH ndipo kunali kocheperako kuposa ma granules omwe amapezeka pamalonda.Pambuyo pa maola a 12 akuwongolera pakamwa, kuchuluka kwa magazi aumunthu kunali 12mg/ml, ndipo panalibe kusiyana kwapayekha.
4.9 Propranhaol hydrochloride yokhazikika yotulutsa kapisozi Propranhaol hydrochloride 60kg, cellulose microcrystalline 40kg, kuwonjezera madzi 50L kuti apange granules.HPMC1kg ndi EC 9kg anali wothira zosungunulira wosanganiza zosungunulira (methylene kolorayidi: methanol = 1: 1) 200L kuti ❖ kuyanika njira, ndi otaya mlingo wa 750ml/mphindi kutsitsi pa anagubuduza ozungulira particles, TACHIMATA particles mwa pore kukula 1.4 mm zenera lonse tinthu ting'onoting'ono, kenako ndikudzaza mu kapule yamwala ndi makina wamba odzaza kapisozi.Kapisozi iliyonse imakhala ndi 160mg ya propranolol hydrochloride particles spherical.
4.10 Naprolol HCL mafupa a mapiritsi anakonzedwa ndi kusakaniza naprolol HCL :HPMC: CMC-NA pa chiŵerengero cha 1:0.25:2.25.Kutulutsa kwamankhwala kunali pafupi ndi kuyitanitsa ziro mkati mwa maola 12.
Mankhwala ena amathanso kupangidwa ndi zinthu zosakanikirana za mafupa, monga metoprolol: HPMC: CMC-NA molingana ndi: 1:1.25:1.25;Allylprolol :HPMC molingana ndi 1:2.8:2.92 chiŵerengero.Kutulutsa kwamankhwala kunali pafupi ndi kuyitanitsa ziro mkati mwa maola 12.
4.11 Mapiritsi a mafupa a zinthu zosakanikirana za ethylaminosine zotumphukira anakonzedwa ndi njira yachibadwa pogwiritsa ntchito osakaniza ang'onoang'ono ufa silika gel osakaniza: CMC-NA :HPMC 1: 0.7: 4.4.Mankhwalawa amatha kutulutsidwa kwa 12h onse mu m'galasi ndi mu vivo, ndipo njira yotulutsira mzere inali ndi kulumikizana kwabwino.Zotsatira za mayeso okhazikika okhazikika malinga ndi malamulo a FDA amalosera kuti moyo wosungira wa mankhwalawa ndi zaka 2.
4.12 HPMC (50mPa·s) (magawo asanu), HPMC (4000 mPa·s) (gawo 3) ndi HPC1 zidasungunuka m'magawo 1000 amadzi, magawo 60 a acetaminophen ndi magawo 6 a silika gel anawonjezeredwa, kusonkhezeredwa ndi homogenizer, ndi utsi zouma.Mankhwalawa ali ndi 80% yamankhwala akuluakulu.
4.13 Theophylline hydrophilic gel skeleton mapiritsi anawerengedwa molingana ndi kulemera kwa piritsi, 18% -35% theophylline, 7.5% -22.5% HPMC, 0.5% lactose, ndi kuchuluka koyenera kwa hydrophobic lubricant nthawi zambiri amakonzedwa m'mapiritsi otulutsidwa, omwe amatha kumasulidwa. kusunga ogwira magazi ndende ya munthu kwa 12h pambuyo makonzedwe m`kamwa.
Nthawi yotumiza: Sep-20-2022