Sehlopha: lisebelisoa tsa ho roala;Lisebelisoa tsa membrane;Lisebelisoa tsa polima tse laoloang ka lebelo bakeng sa litokisetso tsa ho lokolloa butle;Moemeli oa botsitso;Thuso ea ho emisa, sekhomaretsi sa letlapa;Moemeli oa ho khomarela o matlafalitsoeng.
1. Kenyelletso ea lihlahisoa
Sehlahisoa sena KE NON-IONIC CELLULOSE ETHER, e bonoa ka ntle e le phofo e tšoeu, e sa nkhang hamonate ebile e sa latsoehe, e qhibilihang ka metsing le li-solvents tse ngata tsa polar, ho ruruha ka metsing a batang ho hlakola kapa ho senya tharollo ea colloidal hanyenyane.Tharollo ea metsi e na le mosebetsi oa holim'a metsi, pepeneneng e phahameng le ts'ebetso e tsitsitseng.HPMC e na le thepa ea gel e chesang.Kamora ho futhumatsa, tharollo ea metsi a sehlahisoa e etsa pula ea li-gel, ebe e qhibiliha kamora ho pholile.Mocheso oa gel oa litlhaloso tse fapaneng o fapane.Solubility e fetoha ka viscosity, viscosity zhao e tlase, ho qhibiliha ho hoholo, litlhaloso tse fapaneng tsa thepa ea HPMC li na le phapang e itseng, HPMC e qhibilihisitsoeng ka metsing ha e amehe ke boleng ba pH.
Mocheso o tukang o itlelang feela, boima bo hlephileng, boima ba 'nete le mocheso oa phetoho ea khalase e ne e le 360℃, 0.341g/cm3, 1.326g/cm3 le 170 ~ 180℃, ka ho latellana.Kamora ho futhumatsa, e fetoha sootho ho 190 ~ 200 ° C ebe e chesa ho 225 ~ 230 ° C.
HPMC e batla e sa qhibilihe ka chloroform, ethanol (95%), le diethyl ether, 'me e qhibiliha ka motsoako oa ethanol le methylene chloride, motsoako oa methanol le methylene chloride, le motsoako oa metsi le ethanol.Maemo a mang a HPMC a qhibiliha ka har'a motsoako oa acetone, methylene chloride, le 2-propanol, hammoho le lihlahisoa tse ling tsa tlhaho.
Lethathamo la 1: Lipontšo tsa tekheniki
morero
Tekanyo,
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
Mocheso oa gel ℃
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
Ho fokotsa boima ba 'mele %
5.0 kapa ka tlase ho moo
Masala a tukang %
1.5 kapa ka tlase ho moo
pH
4.0-8.0
Tšepe e boima
20 kapa ka tlase ho moo
arsenic
2.0 kapa ka tlase ho moo
2. Likarolo tsa sehlahisoa
2.1 Hydroxypropyl methylcellulose e qhibiliha ka metsing a batang ho etsa tharollo ea viscous colloidal.Hafeela e kenngoa metsing a batang 'me e tsosoa hanyenyane, e ka qhibiliha ka tharollo e hlakileng.Ho fapana le hoo, ha e le hantle ha e qhibilihe metsing a chesang a ka holimo ho 60 ℃ 'me e ka ruruha feela.Ha ho lokisoa tharollo ea metsi a hydroxypropyl methiculose, ho molemo ho eketsa karolo ea hydroxypropyl methiccellulose ka metsi a mangata, ho hlohlelletsa ka matla, ho futhumala ho 80 ~ 90 ℃, ebe o eketsa hydroxypropyl methiculose e setseng, 'me qetellong u sebelise metsi a batang ho tlatsetsa. ho chelete e batloang.
2.2 Hydroxypropyl methylcellulose ke ether e seng ea ionic cellulose, tharollo ea eona ha e jare tefiso ea ionic, ha e sebelisane le letsoai la tšepe kapa metsoako ea ionic organic, e le ho etsa bonnete ba hore HPMC ha e sebetsane le lisebelisoa tse ling tse tala le li-excipients nakong ea ho lokisetsa. tlhahiso.
2.3 Hydroxypropyl methylcellulose e na le anti-sensitivity e matla, 'me ka ho eketseha ha tekanyo ea ho fetola sebopeho sa molek'hule, anti-sensitivity e boetse e ntlafatsoa.Lithethefatsi tse sebelisang HPMC e le li-excipients li na le boleng bo tsitsitseng nakong ea nako e sebetsang ho feta lithethefatsi tse sebelisang li-excipients tse ling tsa setso (starch, dextrin, tsoekere e phofshoana).
2.4 Hydroxypropyl methylcellulose ke inert metabolismally.Joaloka motsoako oa meriana, ha e na metabolized kapa ho kenngoa, kahoo ha e fane ka mocheso ka lithethefatsi le lijo.E na le ts'ebeliso e ikhethang ho boleng ba khalori e tlase, lithethefatsi tse se nang letsoai, tse seng allergenic le lijo tsa batho ba nang le lefu la tsoekere.
2.5HPMC e batla e tsitsitse ho acids le bases, empa haeba pH e feta 2 ~ 11 mme e angoa ke mocheso o phahameng kapa nako e telele ea polokelo, e tla fokotsa tekanyo ea ho butsoa.
2.6 Hydroxypropyl methylcellulose aqueous solution e ka fana ka ts'ebetso ea holim'a metsi, e bonts'a litekanyetso tse leka-lekaneng tsa holim'a sefahleho le sefahleho sa tsitsipano.E na le emulsification e sebetsang tsamaisong ea mekhahlelo e 'meli' me e ka sebelisoa e le stabilizer e sebetsang hantle le colloid e sireletsang.
2.7 Hydroxypropyl methylcellulose aqueous solution e na le thepa e babatsehang ea ho etsa filimi, 'me ke thepa e ntle ea ho roala matlapa le lipilisi.Lera le entsoeng ka eona ha le na 'mala ebile le thata.Haeba glycerol e eketsoa, polasetiki ea eona e ka eketseha.Ka mor'a phekolo ea holim'a metsi, sehlahisoa se qhalakanngoa metsing a batang, 'me sekhahla sa ho qhibiliha se ka laoloa ka ho fetola tikoloho ea pH.E sebelisoa ka litokisetso tsa ho lokolloa butle-butle le litokisetso tse entsoeng ka enteric.
3. Kopo ea sehlahisoa
3.1.E sebelisoa e le sekhomaretsi le se senyang
HPMC e sebelisetsoa ho ntšetsa pele ho qhala ha lithethefatsi le tekanyo ea likopo tsa tokollo, e ka qhibiliha ka ho toba ka solvent e le sekhomaretsi, viscosity e tlaase ea HPMC e qhibilihisitsoeng ka metsing ho etsa hore e be pepeneneng ho tharollo ea colloid ea lenaka la tlou, matlapa, lipilisi, granules holim'a sekhomaretsi le ho senya. le viscosity e phahameng ea sekhomaretsi, e sebelisoa feela ka lebaka la mefuta e fapaneng le litlhoko tse fapaneng, kakaretso ke 2% ~ 5%.
Tharollo ea metsi ea HPMC le motsoako o itseng oa ethanol ho etsa motsoako o kopanyang;Mohlala: 2% ea tharollo ea metsi ea HPMC e kopantsoeng le 55% ea tharollo ea ethanol e ile ea sebelisoa bakeng sa pelleting ea li-capsules tsa amoxicillin, e le hore karolelano ea ho qhibiliha ha li-capsules tsa amoxicillin e eketsehile ho tloha ho 38% ho ea ho 90% ntle le HPMC.
HPMC e ka etsoa ka sekhomaretsi se kopantsoeng se nang le mahloriso a fapaneng a starch slurry ka mor'a ho qhibiliha;Ho qhalloa ha matlapa a erythromycin a koahetsoeng ke enteric ho eketsehile ho tloha ho 38.26% ho ea ho 97.38% ha 2% HPMC le 8% ea starch li kopantsoe.
2.2.Etsa lisebelisoa tsa ho roala filimi le thepa ea ho etsa filimi
HPMC e le thepa ea ho roala ka metsi e na le litšobotsi tse latelang: viscosity ea tharollo e itekanetseng;Mokhoa oa ho roala o bonolo;Thepa e ntle ea ho etsa lifilimi;E ka boloka sebopeho sa sengoathoana, ho ngola;E ka ba mongobo;Na mmala, khalemelo tatso.Sehlahisoa sena se SEBELISOA JOALOKAHA FILMI E TLOHANG KA METSI BAKENG SA MATABLE LE LIPILISI TSE BONANG TLASE, LE BAKENG SA FILMI E SA THEOLENG EA METSI E NANG LE VISCOSITY E PHAHAMENG, TSEBETSI EA TŠEBELISO KE 2%-5%.
2.3, joalo ka sekhomaretsi se teteaneng le sekhomaretsi sa tšireletso ea colloidal
HPMC sebelisoa e le thickening moemeli ke 0.45% ~ 1.0%, e ka sebelisoa e le marotholi a mahlo le a maiketsetso a dikeledi thickening moemeli;E sebelisetsoa ho eketsa botsitso ba sekhomaretsi sa hydrophobic, ho thibela coalescence ea likaroloana, pula, tekanyo e tloaelehileng ke 0.5% ~ 1.5%.
2.4, joalo ka blocker, thepa ea ho lokolla butle, moemeli oa tokollo e laoloang le moemeli oa pore
HPMC mohlala o phahameng oa viscosity o sebelisoa ho lokisa li-blockers le lisebelisoa tse laoloang tsa tokollo ea matlapa a tokollo a skeleton le matlapa a hydrophilic gel skeleton.Mohlala o tlaase oa viscosity ke moemeli oa pore bakeng sa matlapa a tsoelang pele a lokolloa kapa a laoloang e le hore tekanyo ea pele ea phekolo ea matlapa a joalo e fumanoe ka potlako, e lateloa ke ho lokolloa ho tsitsitseng kapa ho laoloa ho boloka ho tsepamisa maikutlo ka katleho maling.
2.5.Gel le matrix a suppository
Li-suppositories tsa Hydrogel le litokisetso tsa sekhomaretsi sa gastric li ka lokisoa ka ho sebelisa sebopeho sa hydrogel se sebelisoang hangata ke HPMC metsing.
2.6 Lintho tse khomarelang tsa likokoana-hloko
Metronidazole e ne e kopantsoe le HPMC le polycarboxylethylene 934 ka motsoako ho etsa matlapa a lokolloang a laoloang ke bioadhesive a nang le 250mg.Teko ea in vitro dissolution e bonts'itse hore tokiso e ruruhile ka potlako ka metsing, mme ho lokolloa ha lithethefatsi ho ne ho laoloa ke ho pharalla le ho phomola ketane ea khabone.Ts'ebetsong ea liphoofolo e bontšitse hore mokhoa o mocha oa ho lokolla lithethefatsi o na le thepa ea bohlokoa ea ho khomarela likokoana-hloko ho mucosa ea sublingual ea bovine.
2.7, joalo ka thuso ea ho emisa
The viscosity HIGH ea sehlahisoa sena ke thuso e ntle ea ho emisa bakeng sa litokisetso tsa metsi a emisitsoeng, tekanyo ea eona e tloaelehileng ke 0.5% ~ 1.5%.
4. Mehlala ea tšebeliso
4.1 Film barbotage tharollo: HPMC 2kg, talc 2kg, castor oli 1000ml, Twain -80 1000ml, propylene glycol 1000ml, 95% ethanol 53000ml, metsi 47000ml, pigment palo e loketseng.Ho na le mekhoa e 'meli ea ho e etsa.
4.1.1 Ho lokisoa ha mokelikeli oa liaparo tse koahetsoeng ka pigment: Eketsa palo e behiloeng ea HPMC ho 95% ethanol, e inele bosiu bo le bong, qhala vector e 'ngoe ka metsing (filthara ha ho hlokahala), kopanya litharollo tsena tse peli ebe u hlohlelletsa ka ho lekana ho etsa tharollo e hlakileng. .Kopanya 80% ea tharollo (20% bakeng sa polishing) le palo e behiloeng ea oli ea castor, Tween-80, le propylene glycol.
4.1.2 Ho lokisoa ha pigment e sa qhibilihang (e kang iron oxide) ho roala mokelikeli HPMC e ne e kenngoa ka 95% ea ethanol ka bosiu bo le bong, 'me metsi a kenngoa ho etsa 2% HPMC tharollo e hlakileng.20% ea tharollo ena e ile ea ntšoa bakeng sa ho belisoa, 'me karolo e setseng ea 80% ea tharollo le oxide ea tšepe li lokiselitsoe ka mokhoa oa ho sila ka metsi,' me joale tekanyo ea lengolo la ngaka ea likarolo tse ling e ile ea eketsoa le ho tsoakoa ka mokhoa o ts'oanang.Mokhoa oa ho roala ha mokelikeli oa ho roala: tšela lesela la lijo-thollo ka pitseng ea ho roala tsoekere, ka mor'a ho potoloha, moea o chesang o chesa pele ho 45 ℃, o ka fafatsa seaparo sa ho fepa, taolo ea phallo ka 10 ~ 15ml / min, ka mor'a ho fafatsa, tsoela pele ho omella. ka moea o chesang bakeng sa 5 ~ 10min e ka ba ka ntle ho pitsa, kenya se omisang ho omella ho feta 8h.
Lera la mahlo la 4.2α-interferon 50μg ea α-interferon le ile la qhibiliha ka 10ml0.01ml hydrochloric acid, e kopantsoeng le 90ml ethanol le 0.5GHPMC, e hloekisitsoeng, e koahetsoe ka molamu oa khalase e potolohang, e hloekisitsoeng ka 60 ℃ 'me e omisitsoe moeeng.Sehlahisoa sena se entsoe ka thepa ea lifilimi.
4.3 matlapa a Cotrimoxazole (0.4g±0.08g) SMZ (80 mesh) 40kg, starch (120 mesh) 8kg, 3%HPMC aqueous solution 18-20kg, magnesium stearate 0.3kg, TMP (80 mesh) 8kg, mokhoa oa ho lokisa ke ho kopanya SMZ le TMP, ebe o eketsa starch ebe o kopanya 5min.Ka tharollo ea metsi ea 3% HPMC e entsoeng esale pele, lisebelisoa tse bonolo, tse nang le granulation ea 16 mesh skrineng, ho omisoa, 'me ka mor'a moo ka lijo-thollo tse 14 tsa marang-rang, eketsa motsoako oa magnesium stearate, o nang le matlapa a 12mm a pota-potileng ka lentsoe (SMZco).Sehlahisoa sena se sebelisoa haholo-holo e le binder.Ho qhibiliha ha matlapa e ne e le 96% / 20min.
4.4 Piperate tablets (0.25g) piperate 80 mesh 25kg, starch (120 mesh) 2.1kg, magnesium stearate chelete e nepahetseng.Mokhoa oa eona oa tlhahiso ke ho kopanya pipeoperic acid, starch, HPMC ka ho lekana, ka 20% ethanol soft material, 16 mesh screen granulate, e omeletseng, ebe 14 mesh screen whole grain, plus vector magnesium stearate, le 100mm circular belt word (PPA0.25) ) matlapa a stamping.Ka starch e le ntho e senyang, sekhahla sa ho qhibiliha ha letlapa lena ha se ka tlase ho 80% / 2min, e leng holimo ho feta lihlahisoa tse tšoanang Japane.
4.5 Meokho ea maiketsetso HPMC-4000, HPMC-4500 kapa HPMC-5000 0.3g, sodium chloride 0.45g, potasiamo chloride 0.37g, borax 0.19g, 10% ammonium chlorbenzylammonium tharollo 0ml2 ho metsi 0.02 ho metsi.Mokhoa oa eona oa tlhahiso ke HPMC e kenngoa ka metsing a 15ml, ho 80 ~ 90 ℃ metsi a tletseng a nka, eketsa metsi a 35ml, ebe o na le likarolo tse setseng tsa 40ml aqueous solution e kopantsoeng ka mokhoa o ts'oanang, eketsa metsi ho palo e feletseng, ebe e tsoakane ka ho lekana, ema bosiu bo le bong. , ka bonolo tšela filtration, filtre ka setshelo tiisitsoe, sterilized ka 98 ~ 100℃ bakeng sa 30min, ke hore, The pH ranges ho tloha 8.4 ° C ho 8.6 ° C. Sehlahisoa sena se sebelisoa BAKENG SA HO KHAETSOA MEOKHO, KE TŠENYETSO E MOLEMO EA MEKGO, HA E sebelisoa BAKENG SA maekrosekopo ea kamore e ka ntle, e ka EKETSWA KA HO TSHWANETSENG Tekanyetso YA SEHLAHISO ENA, 0.7% ~ 1.5% E NEpile.
4.6 Meththorphan e laoloang ho lokolloa matlapa a meththorphan resin letsoai 187.5mg, lactose 40.0mg, PVP70.0mg, silika silika 10mg, 40.0 mGHPMC-603, 40.0mg ~ microcrystalline cellulose phthalate-102 le magnesium stemga.2E lokiselitsoe e le matlapa ka mokhoa o tloaelehileng.Sehlahisoa sena se sebelisoa e le lisebelisoa tse laoloang tsa tokollo.
4.7 Bakeng sa matlapa a avantomycin ⅳ, 2149g avantomycin ⅳ monohydrate le 1000ml isopropyl metsi a motsoako oa 15% (mass concentration) eudragitL-100 (9:1) a ile a tsosoa, a tsoakoa, a granulated, 'me a omisoa ka 35 ℃.Li-granules tse omisitsoeng tsa 575g le 62.5g hydroxypropylocellulose E-50 li ile tsa tsoakoa ka botlalo, 'me joale 7.5g stearic acid le 3.25g magnesium stearate li ile tsa kenngoa matlapeng ho fumana tokollo e tsoelang pele ea matlapa a vanguard mycin ⅳ.Sehlahisoa sena se sebelisoa e le thepa ea ho lokolloa butle.
4.8 Nifedipine e tsoelang pele e lokolloa granules 1 karolo ea nifedipine, 3 likarolo hydroxypropyl methyl cellulose le 3 likarolo ethyl cellulose li ne li tsoakane le motsoako motsoako (ethanol: methylene chloride = 1: 1), le 8 likarolo poone starch ile a eketsoa ho hlahisa granules ka ho qhibiliha ha mahareng. mokhoa.Sekhahla sa ho lokolloa ha lithethefatsi tsa granules ha sea ka sa angoa ke phetoho ea pH ea tikoloho 'me e ne e le butle ho feta ea li-granules tse fumanehang khoebong.Ka mor'a lihora tsa 12 tsa tsamaiso ea molomo, khatello ea mali ea motho e ne e le 12mg / ml, 'me ho ne ho se na phapang ea motho ka mong.
4.9 Propranhaol hydrochloride e tsitsitseng e lokolloa capsule Propranhaol hydrochloride 60kg, microcrystalline cellulose 40kg, ho eketsa metsi a 50L ho etsa granules.HPMC1kg le EC 9kg li ne li tsoakane ka solvent e tsoakiloeng (methylene chloride: methanol = 1: 1) 200L ho etsa tharollo ea ho roala, ka tekanyo ea phallo ea 750ml / min spray holim'a likaroloana tse chitja, likaroloana tse koahetsoeng ka boholo ba pore ea 1.4 mm skrineng sa likaroloana tse felletseng, ebe o tlatsoa ka har'a capsule ea lejoe ka mochini o tloaelehileng oa ho tlatsa capsule.Capsule e 'ngoe le e' ngoe e na le 160mg ea propranolol hydrochloride spherical particles.
4.10 Matlapa a Naprolol HCL skeleton a ile a lokisoa ka ho kopanya naprolol HCL :HPMC: CMC-NA ka karolelano ea 1:0.25:2.25.Sekhahla sa ho lokolloa ha lithethefatsi se ne se le haufi le taelo ea zero nakong ea lihora tse 12.
Lithethefatsi tse ling li ka boela tsa etsoa ka lisebelisoa tse tsoakiloeng tsa skeleton, tse kang metoprolol: HPMC: CMC-NA ho latela: 1: 1.25: 1.25;Allylprolol: HPMC ho latela karo-karolelano ea 1:2.8:2.92.Sekhahla sa ho lokolloa ha lithethefatsi se ne se le haufi le taelo ea zero nakong ea lihora tse 12.
4.11 Matlapa a skeleton a lisebelisoa tse tsoakiloeng tsa lihlahisoa tsa ethylaminosine li ne li lokiselitsoe ka mokhoa o tloaelehileng ho sebelisa motsoako oa silika ea phofo e nyenyane ea silika: CMC-NA :HPMC 1: 0.7: 4.4.Setlhare se ne se ka lokolloa bakeng sa 12h ka bobeli in vitro le in vivo, 'me mokhoa oa ho lokolloa o ne o e-na le kamano e ntle.Liphetho tsa tlhahlobo e potlakileng ea botsitso ho latela melao ea FDA e bolela esale pele hore bophelo ba polokelo ea sehlahisoa sena bo fihla ho lilemo tse 2.
4.12 HPMC (50mPa·s) (likarolo tse 5), HPMC (4000 mPa·s) (likarolo tse 3) le HPC1 li ile tsa qhibiliha ka likarolo tse 1000 tsa metsi, likarolo tse 60 tsa acetaminophen le likarolo tse 6 tsa silika gel li ile tsa kenngoa, tsa tsosoa ka homogenizer, le fafatsa omisitsoe.Sehlahisoa sena se na le 80% ea meriana e ka sehloohong.
4.13 Theophylline hydrophilic gel skeleton matlapa a ne a baloa ho latela boima ba letlapa lohle, 18% -35% theophylline, 7.5% -22.5% HPMC, 0.5% lactose, le tekanyo e loketseng ea lubricant ea hydrophobic ka tloaelo e ne e lokiselitsoe matlapeng a laoloang, a neng a ka khona ho lokolloa. boloka matla a mangata a mali a 'mele oa motho bakeng sa 12h ka mor'a ho tsamaisoa ka molomo.
Nako ea poso: Feb-05-2024