Icyiciro: ibikoresho byo gusiga; Ibikoresho bya Membrane; Ibikoresho bya polymeri bigenzurwa n'umuvuduko kugira ngo bikoreshwe buhoro buhoro; Ibikoresho bihamye; Ibifasha gusimbuza, kole yo gufatisha; Ibikoresho bikomeza gufatana.
1. Intangiriro y'ibicuruzwa
Iki gicuruzwa ni ETHER YA SELULOSI ITARI IONIKI, igaragara inyuma nk'ifu yera, nta mpumuro kandi nta buryohe, ishongesha mu mazi no mu bintu byinshi biyungurura ibinyabuzima, ibyimba mu mazi akonje kugira ngo ibe isukuye cyangwa ifite turBId gato. Umuti w'amazi ufite imikorere yo hejuru, umucyo mwinshi kandi uhoraho. HPMC ifite imiterere ya gel ishyushye. Nyuma yo gushyushya, umuti w'amazi utanga gel iragwa, hanyuma irashonga nyuma yo gukonja. Ubushyuhe bwa gel butandukanye buratandukanye. Gushonga birahinduka bitewe n'ubushyuhe, ubushyuhe zhao buri hasi, uko gushonga kuba kunini, imiterere itandukanye ya HPMC igira itandukaniro, HPMC ishongesha mu mazi ntabwo ihinduka bitewe n'agaciro ka pH.
Ubushyuhe bwo gutwika butunguranye, ubucucike budafite aho buhuriye, ubucucike nyakuri n'ubushyuhe bwo guhindura ikirahure byari 360℃, 0.341g/cm3, 1.326g/cm3 na 170 ~ 180℃, uko bikurikirana. Nyuma yo gushyushya, ihinduka umukara kuri 190 ~ 200 ° C hanyuma igashya kuri 225 ~ 230 ° C.
HPMC ntabwo ishongera cyane muri chloroform, ethanol (95%), na diethyl ether, kandi ishongera mu ruvange rwa ethanol na methylene chloride, uruvange rwa methanol na methylene chloride, n'uruvange rw'amazi na ethanol. Ingano zimwe na zimwe za HPMC zishongera mu ruvange rwa acetone, methylene chloride, na 2-propanol, ndetse no mu bindi bintu bishongera ibinyabuzima.
Imbonerahamwe ya 1: Ibipimo bya tekiniki
umushinga
Igipimo,
60 gd (2910).
65GD (2906)
75GD (2208)
Methoxy %
28.0-32.0
27.0-30.0
19.0-24.0
% ya Hydroxypropoxy
7.0-12.0
4.0-7.5
4.0-12.0
Ubushyuhe bwa gel ℃
56-64.
62.0-68.0
70.0-90.0
Ubukana bwa mpa s.
3, 5, 6, 15, 50, 4000
50400 0
100400 0150 00100 000
Kugabanya ibiro byumye %
5.0 cyangwa munsi yayo
Ibisigazwa bitwikwa %
1.5 cyangwa munsi yayo
pH
4.0-8.0
Ibyuma bikomeye
20 cyangwa munsi yayo
arsenic
2.0 cyangwa munsi yayo
2. Ibiranga ibicuruzwa
2.1 Hydroxypropyl methylcellulose ishongeshwa mu mazi akonje kugira ngo ikore umuti wa colloidal urimo viscous. Igihe cyose wongewe mu mazi akonje kandi ukabyutswa gato, ushobora gushongeshwa mu muti ubonerana. Ahubwo, ntabwo ishongeshwa mu mazi ashyushye ari hejuru ya 60℃ kandi ishobora kubyimba gusa. Mu gutegura umuti w'amazi wa hydroxypropyl methicellulose, ni byiza kongeramo igice cya hydroxypropyl methicellulose mu mazi runaka, ukavanga cyane, ugashyushya kugeza kuri 80 ~ 90℃, hanyuma ukongeramo hydroxypropyl methicellulose isigaye, hanyuma ugakoresha amazi akonje kugira ngo wongere ingano ikenewe.
2.2 Hydroxypropyl methylcellulose ni eteri ya cellulose itari ionic, umuti wayo ntugira charge ya ionic, ntukorana n'umunyu w'icyuma cyangwa ibinyabutabire bya ionic, kugira ngo HPMC idakora n'ibindi bikoresho fatizo n'ibindi bikoresho byifashishwa mu gutegura.
2.3 Hydroxypropyl methylcellulose ifite ubushobozi bwo kurwanya indwara, kandi iyo imiterere ya molekile yiyongereye, ubushobozi bwo kurwanya indwara nabwo burushaho kwiyongera. Imiti ikoresha HPMC nk'ibikoresho by'inyongera ifite ubwiza buhamye mu gihe cy'imikorere kurusha imiti ikoresha ibindi bikoresho bisanzwe (starch, dextrin, isukari y'ifu).
2.4 Hydroxypropyl methylcellulose ntigira ingaruka mbi ku mikorere y'umubiri. Nk'umuti ufasha mu mikorere y'umubiri, ntabwo ihinduka cyangwa ngo inyurwe, bityo ntitanga ubushyuhe mu miti no mu biribwa. Ifite ubushobozi bwihariye bwo gukoresha mu miti ifite karori nke, idafite umunyu, imiti idatera allergie ndetse n'ibiryo by'abarwayi ba diyabete.
2.5HPMC irakomeye ku bijyanye na aside na base, ariko niba pH irenze 2 ~ 11 kandi ikagira ingaruka ku bushyuhe bwinshi cyangwa igihe kirekire cyo kubika, bizagabanya urugero rwo kwera.
2.6 Umuti w’amazi wa Hydroxypropyl methylcellulose ushobora gutanga imikorere y’ubuso, ukagaragaza agaciro k’ubuso n’ubuso bw’imbere. Ufite ubushobozi bwo gukurura neza mu buryo bw’ibyiciro bibiri kandi ushobora gukoreshwa nk’umuti urinda ibintu neza kandi urinda koloyide.
2.7 Umuti w’amazi wa Hydroxypropyl methylcellulose ufite ubushobozi bwiza bwo gukora filime, kandi ni ibikoresho byiza byo gusiga ibinini n’ibinini. Uruhu rukozwe na wo nta ibara rugira kandi rurakomeye. Iyo wongewemo glycerol, ubuziranenge bwayo bushobora kwiyongera. Nyuma yo gusukurwa ku buso, umuti ujugunywa mu mazi akonje, kandi igipimo cyo gushonga gishobora kugenzurwa hakoreshejwe guhindura imiterere ya pH. Ukoreshwa mu gutegura buhoro buhoro no mu gutegura hakoreshejwe enteric-coated.
3. Ikoreshwa ry'ibicuruzwa
3.1. Ikoreshwa nk'ikintu gifata kandi gisesagura
HPMC ikoreshwa mu guteza imbere ishonga ry'imiti n'urwego rwo kuyisohora, ishobora gushonga mu buryo butaziguye nk'umushongi, ubushyuhe buke bwa HPMC bushongeshejwe mu mazi kugira ngo bube umuti ubonerana ufatana n'indorerwamo, ibinini, ibinini, utunyangingo ku mushongi no ku mushongi usesagura, hamwe n'ubushyuhe bwinshi bwa kole, ikoreshwa gusa bitewe n'ubwoko butandukanye n'ibisabwa bitandukanye, rusange ni 2% ~ 5%.
Umuti w’amazi wa HPMC n’ingano runaka ya ethanol kugira ngo hakorwe igikoresho gihuza ibintu byinshi; Urugero: Umuti w’amazi wa 2% wa HPMC uvanze n’umuti wa ethanol wa 55% wakoreshejwe mu gusya capsule za amoxicillin, ku buryo impuzandengo y’imisemburo ya amoxicillin yavuye kuri 38% igera kuri 90% nta HPMC.
HPMC ishobora gukorwa muri kole ivanze ifite igipimo gitandukanye cy'ibinure by'ifu nyuma yo gushonga; Gushonga kw'ibinini bya erythromycin byasizwe na erithromycin byariyongereye kuva kuri 38.26% kugera kuri 97.38% ubwo 2% bya HPMC na 8% byashyirwaga hamwe.
2.2. Gukora ibikoresho byo gusiga firime n'ibikoresho byo gukora firime
HPMC nk'igikoresho gikingira amazi gifite ibi bikurikira: ubushyuhe buringaniye; Uburyo bwo gukingira ni bworoshye; Uburyo bwiza bwo gukora firime; Ishobora kugumana imiterere y'ikintu, ikandika; Ishobora kwirinda ubushuhe; Ishobora gusiga irangi, igakosora uburyohe. Iki gicuruzwa gikoreshwa nk'igikingira firime gishonga mu mazi ku binini n'ibinini bifite ubushyuhe buke, kandi ku gikingira firime kidashingiye ku mazi gifite ubushyuhe bwinshi, igipimo cy'ikoreshwa ni 2%-5%.
2.3, nk'ikintu gikomeza ubukonje n'uburinzi bwa kole
HPMC ikoreshwa nk'umuti wo gukurura ni 0.45% ~ 1.0%, ishobora gukoreshwa nk'ibitonyanga by'amaso n'umuti wo gukurura amarira y'ubukorano; Ikoreshwa mu kongera ubushobozi bwo guhagarara kw'umuti uterwa n'amazi, gukumira guhurirana kw'uduce duto, imvura igwa, igipimo gisanzwe ni 0.5% ~ 1.5%.
2.4, nk'ikintu kibuza ibintu gusohora buhoro buhoro, ikintu kigenzura irekurwa ry'ibintu n'ikintu kigabanya ubushyuhe
Uburyo bwa HPMC bwo kugabanya ubukana bw’amaraso bukoreshwa mu gutegura ibiziba n’ibinini bigabanya ubukana bw’amaraso bikoreshwa mu gusohora ibinini bivanze n’ibinini bigabanya ubukana bw’amaraso bikoreshwa mu gusohora ibinini. Uburyo bwa HPMC bwo kugabanya ubukana bw’amaraso ni uburyo butuma ibinini bigabanya ubukana bw’amaraso bigabanuka cyangwa bigashyirwa mu buryo bugenzurwa kugira ngo urugero rw’ibinini nk’ibyo bivurwe vuba, hagakurikiraho uburyo bwa HPMC bwo kugabanya ubukana bw’amaraso bukomeze kuba bwiza.
2.5. Jeli na matrix ya suppository
Ibikoresho bya Hydrogel n'ibikomoka ku gifu bishobora gutegurwa hakoreshejwe uburyo bwo gukora hydrogel bukunze gukoreshwa na HPMC mu mazi.
2.6 Ibikoresho by'ubukorano bw'ibinyabuzima
Metronidazole yavanzwe na HPMC na polycarboxylethylene 934 mu mvange kugira ngo hakorwe ibinini birekura bigenzurwa na biodive birimo 250mg. Isuzuma ryakozwe muri vitro ryagaragaje ko umuti wabyimbye vuba mu mazi, kandi ko umuti warekurwaga ugenzurwa no gukwirakwira kw'imiyoboro ya karuboni. Ishyirwa mu bikorwa ry'inyamaswa ryagaragaje ko uburyo bushya bwo kurekura umuti bufite ubushobozi bukomeye bwo gufatana n'umuyoboro w'inka mu gace k'inka.
2.7, nk'ubufasha bwo guhagarika
Uburemere bwinshi bw'iki gicuruzwa ni uburyo bwiza bwo kugikoresha mu gutegura amazi yo kugikoresha, igipimo cyacyo gisanzwe ni 0.5% ~ 1.5%.
4. Ingero z'ishyirwa mu bikorwa
4.1 Umuti wo gusiga filime: HPMC 2kg, talc 2kg, amavuta ya castor 1000ml, Twain -80 1000ml, propylene glycol 1000ml, 95% ethanol 53000ml, amazi 47000ml, irangi rikwiye. Hari uburyo bubiri bwo kubikora.
4.1.1 Gutegura amavuta atwikiriwe n'imyenda: Shyira ingano ya HPMC muri ethanoli ya 95%, uyinjize mu ijoro ryose, ushongeshe indi mvange y'amabara mu mazi (uyiyunguruze nibiba ngombwa), huza ibisubizo byombi hanyuma ubyuke neza kugira ngo bibe umuti ubonerana. Vanga 80% by'umuti (20% wo gusiga irangi) n'ingano yatanzwe y'amavuta ya castor, Tween-80, na propylene glycol.
4.1.2 Gutegura irangi ritashongesha (nk'icyuma gikingira okiside) HPMC yashyizwe muri ethanol 95% mu ijoro ryose, hanyuma hongerwamo amazi kugira ngo 2% HPMC iboneshe neza. 20% by'iki gisubizo byakuwemo kugira ngo bisukurwe, hanyuma 80% bisigaye bya 80% bya shimi na okiside y'icyuma byateguwe hakoreshejwe uburyo bwo gusya amazi, hanyuma ingano y'ibindi bice byatanzwe na muganga byongerwamo kandi bivanga neza kugira ngo bikoreshwe. Uburyo bwo gusiga irangi: suka urupapuro rw'ibinyampeke mu nkono itwikira isukari, nyuma yo kuzunguruka, umwuka ushyushye ushyuha kugeza kuri 45°C, ushobora gutera irangi ryo kugaburira, kugenzura amazi mu minota 10 ~ 15/min, nyuma yo gutera irangi, komeza wumishe n'umwuka ushyushye mu minota 5 ~ 10 ushobora kuva mu nkono, shyira mu cyuma cyumutsa kugira ngo cyume mu gihe kirenze amasaha 8.
Uruhu rw'amaso rwa 4.2α-interferon 50μg ya α-interferon yashongeshejwe muri 10ml0.01ml ya aside hydrochloric, ivanze na 90ml ya etanoli na 0.5GHPMC, iyungururwa, ipfundikirwa ku kirahuri kizenguruka, ishyirwamo umuti uvura ubushyuhe bwa 60℃ hanyuma yumishwa mu kirere. Iki gicuruzwa cyakozwemo firime.
Ibinini 4.3 bya Cotrimoxazole (0.4g ± 0.08g) SMZ (mesh 80) 40kg, sitashi (mesh 120) 8kg, 3% HPMC amazi 18-20kg, magnesium stearate 0.3kg, TMP (mesh 80) 8kg, uburyo bwo gutegura ni ukuvanga SMZ na TMP, hanyuma ukongeramo sitashi hanyuma ukavange mu gihe cy'iminota 5. Hamwe n'umuti w'amazi wa 3% HPMC wateguwe, ibikoresho byoroshye, hamwe n'udupira 16 twa mesh, byumutse, hanyuma hamwe n'udupira 14 twa mesh, ongeramo uruvange rwa magnesium stearate, hamwe na 12mm uruziga ruriho ibinini bya word (SMZco). Iki gicuruzwa gikoreshwa cyane nk'igifunga. Ibinini byashongeshejwe byari 96%/iminota 20.
4.4 Ibinini bya piperate (0.25g) piperate 80 mesh 25kg, starch (120 mesh) 2.1kg, magnesium stearate ingano ikwiye. Uburyo bwo gukora ni ukuvanga aside pipeoperic, starch, HPMC ku buryo bungana, hamwe n'ibikoresho byoroshye bya ethanol 20%, mesh screen granulate 16, byumye, hanyuma mesh screen 14 mesh whole grain, hamwe na vector magnesium stearate, hamwe na 100mm circular belt word (PPA0.25). Hamwe na starch nk'ikintu gisesagura, igipimo cyo gusenyuka kw'iki gipimo ntabwo kiri munsi ya 80%/2min, kiruta ibindi bisa mu Buyapani.
4.5 Ifu y'ubukorano HPMC-4000, HPMC-4500 cyangwa HPMC-5000 0.3g, sodium chloride 0.45g, potasiyumu chloride 0.37g, borax 0.19g, 10% ammonium chlorbenzylammonium solution 0.02ml, amazi yongewemo 100ml. Uburyo bwo gukora ni HPMC ishyirwa mu mazi ya mililitiro 15, ku bushyuhe bwa 80 ~ 90 ℃ yuzuye, fata, ongeramo mililitiro 35 z'amazi, hanyuma ushyiremo ibice bisigaye bya mililitiro 40 z'amazi bivanze neza, ongeramo amazi ku rugero rwuzuye, hanyuma uvange neza, uhagarare ijoro ryose, usukemo buhoro buhoro, usuke mu gikoresho gifunze, gisukuwe kuri 98 ~ 100 ℃ mu gihe cy'iminota 30, ni ukuvuga ko pH iri hagati ya 8.4 ° C na 8.6 ° C. Iki gicuruzwa gikoreshwa mu kubura amarira, ni ikintu cyiza gisimbura amarira, iyo gikoreshejwe kuri mikorosopi y'imbere y'icyumba, gishobora kongerwa neza. INGANO Y'IKI GIKORWA, 0.7% ~ 1.5% irakwiye.
Ibinini 4.6 bya Meththorphan bigenzurwa na resin umunyu wa meththorphan 187.5mg, lactose 40.0mg, PVP70.0mg, vapor silica 10mg, 40.0 mGHPMC-603, 40.0mg ~ microcrystalline cellulose phthalate-102 na magnesium stearate 2.5mg. Bitegurwa nk'ibinini mu buryo busanzwe. Iki gicuruzwa gikoreshwa nk'ibikoresho bigenzurwa na resin.
4.7 Ku binini bya avantomycin ⅳ, 2149g ya avantomycin ⅳ monohydrate n'amazi ya isopropyl ya 1000ml ya 15% (ubwinshi bw'ibinini) eudragitL-100 (9:1) byarakanzwe, bivangwa, bigashyirwamo uduce duto, hanyuma byumutswa kuri 35°C. Uduce twumye twa 575g na 62.5g ya hydroxypropylocellulose E-50 twavanzwe neza, hanyuma hongerwamo 7.5g ya aside stearic na 3.25g ya magnesium stearate kuri ibi binini kugira ngo ibinini bya vanguard mycin ⅳ bikomeze kurekurwa. Iki gicuruzwa gikoreshwa nk'ibikoresho byo kurekurwa buhoro buhoro.
4.8 Uduce twa Nifedipine dukomeza kurekurwa, igice kimwe cya nifedipine, ibice 3 bya hydroxypropyl methyl cellulose na ibice 3 bya ethyl cellulose byavanzwe n'umusemburo uvanze (ethanol: methylene chloride = 1:1), kandi hongewemo ibice 8 by'ifu y'ibigori kugira ngo hakorwe utwo duce hakoreshejwe uburyo bwo gushonga hagati. Igipimo cyo kurekurwa kw'uduce twa granules nticyagizweho ingaruka n'impinduka za pH y'ibidukikije kandi cyagabanutse ugereranyije n'utwo duce twagurishwaga. Nyuma y'amasaha 12 yo kunywa, ingano y'amaraso y'umuntu yari 12mg/ml, kandi nta tandukaniro ryagaragaye ku giti cye.
4.9 Kapsule ya Propranhaol hydrochloride irekura burundu Propranhaol hydrochloride 60kg, cellulose ya microcrystalline 40kg, bongeramo Litiro 50 z'amazi kugira ngo hakorwe utunyangingo. HPMC1kg na EC 9kg byavanzwe mu cyumyunyungugu kivanze (methylene chloride: methanol =1:1) 200L kugira ngo hakorwe umuti wo gusiga, hamwe n'umuvuduko wa 750ml/min ku duce tw'umubumbe duzunguruka, uduce dupfundikiye mu mwenge ungana na mm 1.4 z'uduce twuzuye, hanyuma byuzuzwa mu kapsule y'amabuye hakoreshejwe imashini isanzwe yo kuzuza kapsule. Buri kapsule irimo 160mg y'uduce tw'umubumbe twa propranolol hydrochloride.
Ibinini 4.10 bya Naprolol HCL byakozwe hakoreshejwe kuvanga naprolol HCL :HPMC: CMC-NA ku gipimo cya 1:0.25:2.25. Igipimo cyo gusohora imiti cyari hafi ya zeru mu masaha 12.
Indi miti ishobora kandi gukorwa mu bikoresho bivanze by'amagufwa, nka metoprolol: HPMC: CMC-NA hakurikijwe: 1:1.25:1.25; Allylprolol:HPMC hakurikijwe igipimo cya 1:2.8:2.92. Igipimo cyo gusohora imiti cyari hafi ya zeru mu masaha 12.
4.11 Ibinini by'amagufwa by'ibintu bivanze bya ethylaminosine byateguwe hakoreshejwe uburyo busanzwe hakoreshejwe uruvange rwa micro powder silica gel: CMC-NA :HPMC 1:0.7:4.4. Umuti washoboraga kurekurwa mu gihe cy'amasaha 12 haba muri vitro no muri vivo, kandi imiterere yo kurekurwa yari ifite isano nziza. Ibisubizo by'ikizamini cyihuse cyo kugumana ubuziranenge nk'uko amabwiriza ya FDA abiteganya bigaragaza ko igihe cyo kubika iki gicuruzwa gishobora kugera ku myaka 2.
4.12 HPMC (50mPa·s) (ibice 5), HPMC (4000 mPa·s) (ibice 3) na HPC1 byashongeshejwe mu bice 1000 by'amazi, ibice 60 bya acetaminophen na gel ya silica byongewemo, bivangwa hakoreshejwe homogenizer, hanyuma binashyirwa ku musemburo. Iki gicuruzwa kirimo 80% by'umuti w'ingenzi.
4.13 Ibinini bya gel ya Theophylline hydrophilic skeleton byabazwe hakurikijwe uburemere bw'ibinini byose, 18%-35% theophylline, 7.5%-22.5% HPMC, 0.5% lactose, n'ingano ikwiye y'amavuta yo mu mazi byateguwe mu binini birekurwa mu buryo bugenzurwa, bishobora kugumana ingano nziza y'amaraso mu mubiri w'umuntu mu gihe cy'amasaha 12 nyuma yo kunyobwa.
Igihe cyo kohereza: Gashyantare-05-2024