Hydroxypropyl methylcellulose (HPMC)
Icyiciro: ibikoresho byo gutwikira;Ibikoresho bya Membrane;Ibikoresho byihuta byigikoresho cya polymer kubitegura-kurekura buhoro;Umukozi uhamye;Imfashanyo yo guhagarika, ibinini bifata;Umukozi ushimangira.
1. Kumenyekanisha ibicuruzwa
IYI PRODUCT NUBUNDI CELLULOSE NTIBISANZWE, igaragara hanze nkifu yifu, idafite impumuro nziza kandi itaryoshye, gushonga mumazi hamwe nudukoko twinshi twa polar organique, kubyimba mumazi akonje kugirango bisukure cyangwa bitoboye gato umuti wa colloidal.Igisubizo cyamazi gifite ibikorwa byubuso, gukorera mu mucyo no gukora neza.HPMC ifite umutungo wa gel ishyushye.Nyuma yo gushyushya, igisubizo cyamazi yo mumazi akora imvura ya gel, hanyuma igashonga nyuma yo gukonja.Ubushyuhe bwa gel bwibisobanuro bitandukanye buratandukanye.Guhinduka gukemuka hamwe nubwiza, viscosity zhao hasi, niko gukomera kwinshi, ibintu bitandukanye biranga imitungo ya HPMC bifite aho bitandukaniye, HPMC yashonga mumazi ntabwo ihindurwa nagaciro ka pH.
Ubushyuhe bwo gutwika bwihuse, ubwinshi bwubusa, ubwinshi bwukuri nubushyuhe bwikirahure byari 360 ℃, 0.341g / cm3, 1.326g / cm3 na 170 ~ 180 ℃.Nyuma yo gushyushya, ihinduka umukara kuri 190 ~ 200 ° C igashya kuri 225 ~ 230 ° C.
HPMC hafi ya yose idashonga muri chloroform, Ethanol (95%), na diethyl ether, hanyuma igashonga mu ruvange rwa Ethanol na methylene chloride, imvange ya methanol na chloride methylene, hamwe nuruvange rwamazi na Ethanol.Inzego zimwe na zimwe za HPMC zishonga mu mvange ya acetone, chloride methylene, na 2-propanol, ndetse no mubindi bimera.
Imbonerahamwe 1: Ibipimo bya tekiniki
umushinga
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
Ubushyuhe bwa 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
Kugabanya ibiro byumye%
5.0 cyangwa munsi yayo
Gutwika ibisigara%
1.5 cyangwa munsi yayo
pH
4.0-8.0
Icyuma kiremereye
20 cyangwa munsi yayo
arsenic
2.0 cyangwa munsi yayo
2. Ibiranga ibicuruzwa
2.1 Hydroxypropyl methylcellulose ishonga mumazi akonje kugirango ibe igisubizo cyiza cya colloidal.Igihe cyose yongewe kumazi akonje hanyuma ikabyutsa gato, irashobora gushonga mugisubizo kiboneye.Ibinyuranye, ahanini ntigishobora gushonga mumazi ashyushye hejuru ya 60 ℃ kandi irashobora kubyimba gusa.Mugutegura hydroxypropyl methicellulose yumuti wamazi, nibyiza ko wongeramo igice cya hydroxypropyl methicellulose mumazi runaka, ukabyutsa imbaraga, ugashyuha kugeza kuri 80 ~ 90 and, hanyuma ukongeramo hydroxypropyl methicellulose, hanyuma ukarangiza gukoresha amazi akonje kugirango wuzuze ku mubare usabwa.
2 umusaruro.
2.3 Hydroxypropyl methylcellulose ifite anti-sensitivite ikomeye, kandi hamwe no kwiyongera kurwego rwo gusimbuza imiterere ya molekile, anti-sensitivite nayo irakomera.Ibiyobyabwenge bifashisha HPMC nkibicuruzwa bifite ubuziranenge buhamye mugihe cyiza kuruta ibiyobyabwenge ukoresheje ibindi bintu gakondo (krahisi, dextrin, isukari y'ifu).
2.4 Hydroxypropyl methylcellulose ni inert metabolique.Nkimiti yimiti, ntabwo ihinduranya cyangwa ngo yinjizwe, ntabwo rero itanga ubushyuhe mumiti nibiryo.Ifite umwihariko udasanzwe ku gaciro gake, karimo umunyu, imiti itari allergiki n'ibiribwa kubarwayi ba diyabete.
2.5HPMC ihagaze neza kuri acide na base, ariko niba pH irenze 2 ~ 11 kandi ikagira ingaruka kubushyuhe bwo hejuru cyangwa igihe kinini cyo kubika, bizagabanya urwego rweze.
2.6 Hydroxypropyl methylcellulose igisubizo cyamazi gishobora gutanga ibikorwa byubuso, byerekana ubuso buringaniye hamwe nindangagaciro zimpagarara.Ifite emulisiyonike ikora muri sisitemu y'ibyiciro bibiri kandi irashobora gukoreshwa nka stabilisateur ikora neza kandi ikingira colloid.
2.7 Hydroxypropyl methylcellulose yumuti wamazi ufite imiterere myiza yo gukora firime, kandi nibikoresho byiza byo gutwikira ibinini n'ibinini.Ibibyimba byakozwe na byo ntabwo bifite ibara kandi birakomeye.Niba glycerol yongeyeho, plastike yayo irashobora kwiyongera.Nyuma yo kuvura hejuru, ibicuruzwa bikwirakwizwa mumazi akonje, kandi igipimo cyo kumeneka gishobora kugenzurwa no guhindura ibidukikije pH.Irakoreshwa mugutegura-kurekura imyiteguro no kwinjizamo enteric.
3. Gusaba ibicuruzwa
3.1.Byakoreshejwe nkibikoresho bifatika kandi bisenya
HPMC ikoreshwa mugutezimbere ibiyobyabwenge hamwe nurwego rwo kurekura, birashobora gushonga muburyo butaziguye kuko bifata neza, ubukonje buke bwa HPMC bwashonga mumazi kugirango bibe bisobanutse kumasenge yinzovu yumuti, ibinini, ibinini, granules kumuti no gusenyuka. umukozi, hamwe nubwiza buhanitse bwa kole, gusa ukoreshe bitewe nubwoko butandukanye nibisabwa bitandukanye, rusange ni 2% ~ 5%.
HPMC igisubizo cyamazi hamwe nubunini bwa Ethanol kugirango ikore hamwe;Urugero: 2% HPMC yumuti wamazi uvanze na 55% yumuti wa Ethanol wakoreshejwe muguhonda capsules ya amoxicillin, kuburyo impuzandengo yo gusesa capsules ya amoxicillin yavuye kuri 38% igera kuri 90% idafite HPMC.
HPMC irashobora gukorwa muburyo bufatika hamwe nubunini butandukanye bwa krahisi nyuma yo guseswa;Iseswa rya erythromycine ya enteric-yuzuye ibinini byiyongereye kuva kuri 38.26% bigera kuri 97.38% mugihe 2% HPMC na 8% bya krahisi byahujwe.
2.2.Kora ibikoresho byo gutwika firime nibikoresho byo gukora firime
HPMC nk'ibikoresho byo gutwikamo amazi bifata amazi bifite ibimenyetso bikurikira: ubukonje buringaniye;Igikorwa cyo gutwikira kiroroshye;Filime nziza ikora umutungo;Irashobora kugumana imiterere yikigice, kwandika;Irashobora kutagira amazi;Irashobora kurangi, uburyohe bwo gukosora.IYI PRODUCT YAKORESHEJWE NUKO AMAZI-SOLUBLE FILM YAKORESHEJWE KUBONA IMBONERAHAMWE N'INKINGI ZIFATANYIJE HASI, KANDI KUBURYO BUKORESHEJWE NA FILM ZIDASANZWE NA VISCOSITY, AMAFARANGA YAKORESHEJWE NI 2% -5%.
2.3, nkibikoresho byibyimbye hamwe na koleide yo gukingira
HPMC ikoreshwa nkibibyimba ni 0.45% ~ 1.0%, irashobora gukoreshwa nkigitonyanga cyamaso hamwe nubukorikori bwamarira;Ikoreshwa mu kongera ituze rya hydrophobe glue, irinde uduce duto duto, imvura, ibipimo bisanzwe ni 0.5% ~ 1.5%.
2.4, nkumuhagarika, ibikoresho byo kurekura buhoro, kugenzura kurekura hamwe na pore agent
Icyitegererezo cya HPMC cyakoreshejwe mugutegura ibibuza no kugenzura ibintu bisohora ibintu bivanze skeleton ikomeza kurekura hamwe na hydrophilic gel skeleton ikomeza kurekura ibinini.Icyitegererezo gike cyane ni igikoresho gikurura pore yo kurekura-kurekura cyangwa kugenzurwa-kurekura kugirango ibipimo byambere byo kuvura ibinini biboneka byihuse, bigakurikirwa no kurekurwa bikabije cyangwa kugenzurwa-kurekura kugirango bikomeze kwibanda mumaraso.
2.5.Gel na suppository matrix
Hydrogel suppositions hamwe nimyiteguro ya gastricike irashobora gutegurwa ukoresheje ibiranga imiterere ya hydrogel ikoreshwa na HPMC mumazi.
2.6 Ibikoresho bifata ibinyabuzima
Metronidazole yavanze na HPMC na polycarboxylethylene 934 muri mixer kugirango ikore ibinini byangiza bioadhesive birimo 250mg.Ikizamini cyo gusesa vitro cyerekanye ko imyiteguro yabyimbye mu mazi, kandi irekurwa ry'ibiyobyabwenge ryagenzuwe no gukwirakwiza no gukwirakwiza karubone.Ishyirwa mu bikorwa ry’inyamaswa ryerekanye ko uburyo bushya bwo kurekura ibiyobyabwenge bwari bufite imiterere ihambaye y’ibinyabuzima kuri bovine sublingual mucosa.
2.7, nk'imfashanyo yo guhagarika
HIGH viscosity yiki gicuruzwa nubufasha bwiza bwo guhagarika imyiteguro yo guhagarika amazi, dosiye isanzwe ni 0.5% ~ 1.5%.
4. Ingero zo gusaba
4.1 Igisubizo cya firime: HPMC 2kg, talc 2kg, amavuta ya castor 1000ml, Twain -80 1000ml, propylene glycol 1000ml, 95% Ethanol 53000ml, amazi 47000ml, pigment ingano ikwiye.Hariho inzira ebyiri zo kubikora.
4.1. .Kuvanga 80% yumuti (20% yo gusya) hamwe namafaranga yagenwe yamavuta ya castor, Tween-80, na propylene glycol.
4.1.2.20% yiki gisubizo cyafashwe kugirango gisukure, hanyuma 80% bisigaye hamwe na oxyde ya fer byateguwe hakoreshejwe uburyo bwo gusya amazi, hanyuma umubare w’ibindi bikoresho byongewemo hanyuma bivangwa neza kugirango bikoreshwe.Igikorwa cyo gutwikira amazi yo kwisiga: suka urupapuro rwintete mumasafuriya isukari, nyuma yo kuzunguruka, umwuka ushushe ushushe kuri 45 ℃, urashobora gutera igiti cyo kugaburira, kugenzura imigozi muri 10 ~ 15ml / min, nyuma yo gutera, komeza wumuke n'umwuka ushushe kuri 5 ~ 10min irashobora kuva mu nkono, ugashyiramo akuma kugirango wumuke kurenza 8h.
4.2.2Ibicuruzwa bikozwe mubikoresho bya firime.
4.3 Ibinini bya Cotrimoxazole (0.4g ± 0.08g) SMZ (mesh 80) 40kg, krahisi (mesh 120) 8kg, 3% HPMC igisubizo cyamazi 18-20kg, magnesium stearate 0.3kg, TMP (mesh 80) vanga SMZ na TMP, hanyuma wongeremo ibinyamisogwe hanyuma uvange 5min.Hamwe na 3% ya HPMC yumuti wamazi, ibikoresho byoroshye, hamwe na 16 mesh ya ecran ya granulation, yumisha, hanyuma hamwe na 14 mesh ya ecran ya mesh yose ingano, ongeramo magnesium stearate ivanze, hamwe na 12mm kuzengurutsa ijambo (SMZco) ibisate byanditseho kashe.Ibicuruzwa bikoreshwa cyane cyane nka binder.Iseswa ryibinini byari 96% / 20min.
4.Uburyo bwacyo bwo kubyaza umusaruro ni ukuvanga aside ya pipeoperic, krahisi, HPMC iringaniye, hamwe na 20% ya etanol yoroshye, 16 mesh ecran ya granule, yumye, hanyuma 14 mesh yerekana mesh yose ingano, hiyongereyeho na vector magnesium stearate, hamwe nijambo ryumukandara wa 100mm (PPA0.25 ) kashe.Hamwe na krahisi nkibintu bisenya, igipimo cyo gusesa iyi tablet ntikiri munsi ya 80% / 2min, iruta ibicuruzwa bisa nu Buyapani.
4.5 Amarira yubukorikori HPMC-4000, HPMC-4500 cyangwa HPMC-5000 0.3g, sodium chloride 0.45g, potasiyumu chloride 0.37g, borax 0.19g, 10% amonium chlorbenzylammonium 0.02ml, amazi yongewe kuri 100ml.Uburyo bwo kubyaza umusaruro ni HPMC ishyirwa mumazi 15ml, kuri 80 ~ 90 water amazi yuzuye fata a, ongeramo amazi 35ml, hanyuma ukubiyemo ibice bisigaye byumuti wamazi wa 40ml bivanze neza, ongeramo amazi kubwuzuye, hanyuma bivangwa neza, uhagarare ijoro ryose , witonze usukure muyungurura, uyungurure muri kontineri ifunze, ihindurwe kuri 98 ~ 100 ℃ kuri 30min, ni ukuvuga, pH iri hagati ya 8.4 ° C na 8,6 ° C. Iyi PRODUCT YAKORESHEJWE AMASO, NUBUNTU BWIZA KUBARA, IYO ikoreshwa kuri microscopi ya ANTERIOR chambre, irashobora GUSHYIRA MU BIKORWA BYINSHI BY'ICYICIRO, 0.7% ~ 1.5% BISHIMIYE.
4.6.Yateguwe nkibinini byuburyo busanzwe.Iki gicuruzwa gikoreshwa nkibikoresho bigenzurwa.
4.7 Kubisate bya avantomycine, 2149g avantomycine ⅳ monohydrate na 1000ml y'amazi ya isopropyl ivanze ya 15% (mass concentration) eudragitL-100 (9: 1) yarabyutswe, ivangwa, irasya, kandi yumishwa kuri 35 ℃.Granules zumye 575g na 62.5g hydroxypropylocellulose E-50 zaravanze neza, hanyuma aside 7.5g ya stearic na 3.25g ya magnesium stearate yongerwaho kubinini kugirango ibone irekurwa rya vanguard mycin ⅳ ibinini.Iki gicuruzwa gikoreshwa nkibikoresho byo gusohora buhoro.
4,8 buryo.Igipimo cyo kurekura ibiyobyabwenge bya granules ntabwo cyatewe n’imihindagurikire y’ibidukikije pH kandi cyatinze kurenza icya granules kiboneka mu bucuruzi.Nyuma yamasaha 12 yubuyobozi bwo mu kanwa, amaraso yabantu yari 12mg / ml, kandi nta tandukaniro ryihariye.
4.9 Hydrochloride ya Propranhaol ikomeza kurekura capsule Propranhaol hydrochloride 60kg, microcrystalline selulose 40kg, ukongeramo amazi 50L yo gukora granules.HPMC1kg na EC 9kg byavanze mumashanyarazi avanze (methylene chloride: methanol = 1: 1) 200L kugirango ikemure igisubizo, hamwe nigipimo cya 750ml / min cyo gutera uduce duto duto duto, uduce duto duto duto duto duto twa 1.4 mm ecran ibice byose, hanyuma yuzuza capsule yamabuye hamwe na mashini isanzwe yuzuza capsule.Buri capsule irimo 160mg ya propranolol hydrochloride spherical selile.
4.10 Ibinini bya skeleton ya Naprolol HCL byateguwe bivanga naprolol HCL: HPMC: CMC-NA ku kigereranyo cya 1: 0.25: 2.25.Igipimo cyo kurekura ibiyobyabwenge cyari hafi ya zeru mu masaha 12.
Indi miti irashobora kandi gukorwa mubikoresho bivanze bya skeleton, nka metoprolol: HPMC: CMC-NA ukurikije: 1: 1.25: 1.25;Allylprolol: HPMC ukurikije igipimo cya 1: 2.8: 2.92.Igipimo cyo kurekura ibiyobyabwenge cyari hafi ya zeru mu masaha 12.
4.11 Ibinini bya skeleton yibikoresho bivanze bya Ethylaminosine byateguwe muburyo busanzwe hakoreshejwe imvange ya micro powder silika gel: CMC-NA: HPMC 1: 0.7: 4.4.Umuti urashobora kurekurwa kuri 12h haba muri vitro ndetse no muri vivo, kandi uburyo bwo kurekura umurongo bwari bufitanye isano.Ibisubizo by'ibizamini byihuta byihuta ukurikije amabwiriza ya FDA bihanura ko ubuzima bwo kubika ibicuruzwa bugera ku myaka 2.
4.12 HPMC (50mPa ·) spray yumye.Iki gicuruzwa kirimo 80% yubuvuzi bukuru.
4.13 Ibinini bya Theophylline hydrophilic gel skeleton yabazwe ukurikije uburemere bwibinini byose, 18% -35% theophylline, 7.5% -22.5% HPMC, 0.5% lactose, hamwe nubunini bukwiye bwa hydrophobique lubricant byari bisanzwe byateguwe mubisate byarekuwe, byashoboraga gumana imbaraga zamaraso yumubiri wumuntu kuri 12h nyuma yo gutangwa kumanwa.
Igihe cyo kohereza: Nzeri-20-2022