Hypromellose ni iki?

Hypromellose, izwi nka hydroxypropyl methylcellulose, HPMC. Inzira ya molekuline ni C8H15O8- (C10Hl8O6) n-C8Hl5O8, kandi uburemere bwa molekile ni hafi 86000. Hypromellose ni ibikoresho bya sintetike, igice cya methyl ndetse na polyhydroxypropyl ether ya selile. Irashobora kubyazwa uburyo bubiri: bumwe nuko urwego rukwiye rwa methyl selulose ruvurwa na NaOH, hanyuma rugakorwa na oxyde ya propylene munsi yubushyuhe bwinshi nigitutu. Ifishi ihujwe na anhydroglucose impeta ya selile, kandi irashobora kugera kurwego rwiza; ikindi ni ukuvura ipamba cyangwa fibre fibre hamwe na soda ya caustic, hanyuma ukitwara na methyl chloride na okiside ya propylene ikurikiranye kugirango uyibone, hanyuma ukarushaho kunonosorwa, kumenagura kugirango ukore ifu nziza cyangwa imwe. HPMC ni selile zitandukanye ziterwa na selile, kandi nigikoresho cyiza cya farumasi, gifite amasoko menshi. Kugeza ubu, ikoreshwa cyane mu gihugu ndetse no hanze yarwo, kandi ni kimwe mu bikoresho bikoresha imiti bifite umubare munini w’imiti ikoreshwa mu kanwa.

Hypromellose ni umweru kugeza amata yera mu ibara, adafite uburozi kandi ataryoshye, kandi ari muburyo bwa powder granular cyangwa fibrous itemba byoroshye. Irahagaze neza mugihe urumuri nubushuhe. Yabyimbye mumazi akonje kugirango ikore amata yera ya colloidal yumuti, afite urwego runaka rwubwiza, kandi ikibazo cyo guhuza sol-gel gishobora kubaho bitewe nihindagurika ryubushyuhe bwikigereranyo runaka cyumuti. Irashobora gushonga cyane muri 70% alcool cyangwa dimethyl ketone, kandi ntishobora gushonga muri alcool yuzuye, chloroform cyangwa ethoxyethane.

Iyo pH ya hypromellose iri hagati ya 4.0 na 8.0, iba ifite ituze ryiza, kandi irashobora kubaho neza mugihe pH iri hagati ya 3.0 na 11.0. Iyo ubushyuhe ari 20 ° C naho ubushuhe bugereranije ni 80%, bubikwa iminsi 10. Coefficente yo kwinjiza amazi ya HPMC ni 6.2%.

1. Ibintu byibanze bya Hypromellose HPMC

Bitewe nibintu bitandukanye bigize imikorerexy na hydroxypropyl muburyo bwa hypromellose, ubwoko bwibicuruzwa byagaragaye. Mubitekerezo byihariye, ubwoko bwibicuruzwa bitandukanye bifite ubukonje bwihariye nubushyuhe bwa Thermal gelation, kubwibyo, bifite ibintu bitandukanye kandi birashobora gukoreshwa mubikorwa bitandukanye. Imiti ya farumasi y'ibihugu bitandukanye ifite amabwiriza atandukanye kandi ahagarariwe ku ngero: Pharmacopoeia yu Burayi, ukurikije ibyiciro bitandukanye by’imitsi itandukanye hamwe n’impamyabumenyi yo gusimbuza ibicuruzwa byagurishijwe ku isoko, ihagarariwe n’amanota wongeyeho imibare, kandi igice ni mPa · S; muri Reta zunzubumwe za Amerika Pharmacopoeia, izina risanzwe Ongeraho imibare 4 kumpera kugirango werekane ibirimo nubwoko bwa buri kintu gisimbuza hypromellose, nka hypromellose 2208, imibare ibiri yambere igereranya ijanisha rigereranijwe rya mikorerexy, naho imibare ibiri yanyuma igereranya hydroxypropyl Ikigereranyo cya ijanisha rya.

2. Uburyo bwo gushonga Hypromellose HPMC mumazi

2.1 uburyo bwamazi ashyushye
Kubera ko hypromellose idashonga mumazi ashyushye, irashobora gukwirakwizwa kimwe mumazi ashyushye mugitangira, hanyuma igakonja. Uburyo bubiri busanzwe busobanurwa gutya:
. guswera, gukurura Cool the slurry down.
. amazi ashyushye ashyushye Muburyo bworoshye, imvange ikonjeshwa nyuma yo gukurura.

2.2 Uburyo bwo kuvanga ifu
Ifu ya poro ikwirakwizwa rwose no kuvanga byumye hamwe ningero zingana cyangwa nyinshi mubindi bikoresho byifu, hanyuma bigashonga mumazi. Muri iki gihe, hypromellose irashobora gushonga nta agglomeration.

3. Ibyiza bya Hypromellose HPMC

3.1 Amazi akonje
Gushonga mumazi akonje munsi ya 40 ° C cyangwa 70% Ethanol, ahanini ntigishobora gushonga mumazi ashyushye hejuru ya 60 ° C, ariko irashobora gushishwa.

3.2 Kutagira imiti
Hypromellose (HPMC) ni ubwoko bwa selile ya ionic selile. Igisubizo cyacyo ntikigira ionic kandi ntigikorana numunyu wicyuma cyangwa ibinyabuzima kama. Kubwibyo, ibindi bicuruzwa ntibabyitwaramo mugihe cyo kwitegura.

3.3 Guhagarara
Irahagaze neza kuri acide na alkali, kandi irashobora kubikwa igihe kirekire hagati ya pH 3 na 1l nta guhinduka kugaragara kwijimye. Igisubizo cyamazi ya hypromellose (HPMC) igira ingaruka zo kurwanya indwara kandi irashobora kugumya guhagarara neza mugihe cyo kubika igihe kirekire. Imiti ikoresha HPMC nkibisohoka ifite ireme ryiza kuruta abakoresha ibicuruzwa gakondo (nka dextrin, krahisi, nibindi).

3.4 Guhindura imiterere
Inkomoko zinyuranye zikomoka kuri HPMC zirashobora kuvangwa ukurikije ibipimo bitandukanye, kandi ububobere bwayo burashobora guhinduka ukurikije amategeko amwe, kandi bukagira umubano mwiza, bityo igipimo gishobora gutoranywa ukurikije ibisabwa.

3.5 Inertia ya metabolike
HPMC ntabwo yinjizwa cyangwa ngo ihindurwe mu mubiri, kandi ntabwo itanga ubushyuhe, bityo rero ni ibikoresho byiza byo gutegura imiti.

3.6 Umutekano
Muri rusange abantu bemeza ko HPMC ari ibintu bidafite uburozi kandi bidatera uburakari. Igipimo cyica hagati yimbeba ni 5g / kg, naho imiti yica imbeba ni 5.2g / kg. Ingano ya buri munsi ntacyo itwaye kubantu.

4. Gushyira mu bikorwa Hypromellose HPMC mugutegura

4.1 Nkibikoresho bya firime nibikoresho byo gukora film
Ukoresheje hypromellose (HPMC) nk'ibikoresho bisizwe na firime, ugereranije n'ibinini bisanzwe bisize nk'isukari isize isukari, ibinini bisize nta nyungu zigaragara bifite mu guhisha uburyohe bw'imiti no kugaragara, ariko ubukana bwabyo no gukaranga, kwinjiza amazi, gusenyuka, gutwikira ibiro kwiyongera nibindi bipimo byiza nibyiza. Urwego ruto-rwinshi rwibicuruzwa bikoreshwa nkibikoresho byo gukuramo amazi ya firime yifashisha ibinini n'ibinini, naho urwego rwo hejuru-rwinshi rukoreshwa nkibikoresho bifata firime kuri sisitemu yo gukemura ibibazo. Ubusanzwe kwibanda kuri 2.0% kugeza kuri 20%.

4.2 Nkuguhuza no gutandukana
Urwego ruto-rwinshi rwibicuruzwa rushobora gukoreshwa nkuguhuza no gutandukanya ibinini, ibinini, na granules, kandi urwego rwo hejuru rwinshi rushobora gukoreshwa gusa. Igipimo kiratandukanye nuburyo butandukanye nibisabwa. Mubisanzwe, ibipimo bya binder kubinini byumye byumye ni 5%, naho ibipimo bya binder kubinini bitose ni 2%.

4.3 Nkumukozi uhagarika
Umukozi uhagarika ibintu ni gel ya viscous gel ifite hydrophilicity, ishobora kugabanya umuvuduko wimitsi yibice iyo ikoreshejwe muguhagarika, kandi irashobora kwomekwa hejuru yibice kugirango ibuze guhurira hamwe no kugabanuka mumupira. . Guhagarika ibikorwa bigira uruhare runini muguhagarika. HPMC ni ubwoko buhebuje bwo guhagarika ibintu, kandi igisubizo cyacyo cya colloidal cyasheshwe kirashobora kugabanya ubukana bwimiterere yimiterere-yamazi nimbaraga zubusa kubice bito bito, bityo bikazamura ituze rya sisitemu yo gukwirakwiza heterogeneous. Urwego rwohejuru-rwinshi rwibicuruzwa bikoreshwa nkuburyo bwo guhagarika ubwoko bwamazi bwateguwe nkumukozi uhagarika. Ifite ingaruka nziza yo guhagarika, biroroshye gusubiramo, ntabwo ifatanye nurukuta, kandi ifite uduce duto duto. Igipimo gisanzwe ni 0.5% kugeza 1.5%.

4.4 Nkumuzitira, umukozi-urekura-urekura kandi utera pore
Urwego rwohejuru rwinshi rwibicuruzwa bikoreshwa mugutegura hydrophilique gel matrix ikomeza-kurekura ibinini, ibibuza hamwe nubugenzuzi-bwo kurekura ibikoresho bivanze na matrix ikomeza-kurekura, kandi bifite ingaruka zo gutinda kurekura ibiyobyabwenge. Ikoreshwa ryayo ni 10% ~ 80% (W / W). Amanota make-viscosity amanota akoreshwa nkibikoresho byo gukora pore kugirango irekure-irekure cyangwa igenzurwa-irekura. Igipimo cyambere gisabwa kugirango ingaruka zokuvura ubu bwoko bwibinini zirashobora kugerwaho vuba, hanyuma zikagira ingaruka zihoraho-zo kurekura cyangwa kugenzurwa-kurekura, kandi ibiyobyabwenge byamaraso bikomeza kugaragara mumubiri. Iyo hypromellose ihuye namazi, irayobora kugirango ikore geli. Uburyo bwo kurekura ibiyobyabwenge muri tablet ya matrix bikubiyemo cyane cyane ikwirakwizwa rya gel hamwe nisuri ya gel.

4.5 Gukingira kole nkibibyimbye na colloid
Iyo iki gicuruzwa gikoreshwa nkibibyimbye, ibisanzwe bikoreshwa ni 0.45% ~ 1.0%. Iki gicuruzwa nacyo gishobora kongera ituze rya hydrophobique glue, gukora colloide ikingira, ikabuza uduce duto guteranya no guteranya, bityo bikabuza kwibumbira mu myanda, kandi ubusanzwe ubusanzwe ni 0.5% ~ 1.5%.

4.6 Ibikoresho bya capsule kuri capsules
Mubisanzwe capsule shell capsule ibikoresho bya capsule bishingiye kuri gelatine. Igikorwa cyo gukora igikonoshwa cya gelatin capsule kiroroshye, ariko haribibazo bimwe na bimwe nko kurinda nabi imiti n’ibiyobyabwenge byangiza ogisijeni, umuvuduko muke w’ibiyobyabwenge, no gutinda gusenyuka kwa capsule mugihe cyo kubika. Kubwibyo, hypromellose, nkigisimbuza gelatine capsules, ikoreshwa mugutegura capsules, itezimbere imiterere nogukoresha capsules, kandi yazamuwe cyane mugihugu ndetse no mumahanga.

4.7 nka bioadhesive
Ikoranabuhanga rya Bioadhesion, gukoresha ibibyimba hamwe na polymeri ya bioadhesive, binyuze mu gufatira kuri mucosa biologique, byongera ubudahwema no gukomera kwimikoranire hagati yimyiteguro na mucosa, kuburyo imiti irekurwa buhoro buhoro kandi ikinjizwa na mucosa kugirango igere kubikorwa byo kuvura. Kugeza ubu irakoreshwa cyane Ikoreshwa mu kuvura indwara zifata izuru, mucosa yo mu kanwa nibindi bice. Ikoranabuhanga rya Gastrointestinal bioadhesion ni uburyo bushya bwo gutanga imiti bwakozwe mu myaka yashize. Ntabwo yongerera igihe cyo gutura imiti yimiti mungingo ya gastrointestinal, ahubwo inatezimbere imikorere yimikoranire hagati yibiyobyabwenge na selile ya selile aho yakira, ihindura amazi ya membrane selile, Kongera kwinjiza ibiyobyabwenge mumara. epithelial selile, bityo bitezimbere bioavailable yibiyobyabwenge.

4.8 Nka gele yibanze
Nukwifata neza kuruhu, gel ifite urukurikirane rwibyiza nkumutekano, ubwiza, isuku yoroshye, igiciro gito, inzira yoroshye yo gutegura, hamwe no guhuza neza nibiyobyabwenge. icyerekezo.

4.9 Nka inhibitori yimvura muri sisitemu ya emulisation