Mu mateka yimyaka ijana ya capsules, gelatin yamye igumana imiterere yibikoresho nyamukuru bya capsule kubera amasoko yagutse, ibintu bihamye byumubiri na chimique nibintu byiza byo gutunganya.Hamwe no kwiyongera kwabantu bakunda capsules, capsules yuzuye ikoreshwa cyane mubiribwa, ubuvuzi nibicuruzwa byubuzima.
Ariko, kubaho no gukwirakwizwa kwindwara zinka zasaze nindwara yamaguru-umunwa bituma abantu batangira guhangayikishwa nibikomoka ku nyamaswa.Ibikoresho fatizo bikoreshwa cyane muri gelatine ni igufwa nuruhu rwinka ningurube, kandi ingaruka zayo zagiye zikurura abantu buhoro buhoro.Mu rwego rwo kugabanya ingaruka z’umutekano w’ibikoresho fatizo bya capsule, impuguke mu nganda zikomeje gukora ubushakashatsi no guteza imbere ibikoresho bikomoka ku bimera bikomoka ku bimera.
Mubyongeyeho, hamwe no kwiyongera kwa capsules zitandukanye, ubwinshi bwibirimo burimo buhoro buhoro butuma abantu bamenya ko hariho ibibazo byo guhuza hagati ya gelatin hollow capsules nibintu bimwe na bimwe bifite ibintu byihariye.Kurugero, ibirimo birimo amatsinda ya aldehyde cyangwa reaction kubyara amatsinda ya aldehyde mubihe bimwe na bimwe bishobora gutuma habaho guhuza gelatine;Ibirimo bigabanutse cyane birashobora kugira Maillard reaction hamwe na gelatine;Ibirimo hamwe na hygroscopique ikomeye bizatuma igikonoshwa cya Ming capsule itakaza amazi ikabura ubukana bwumwimerere.Ihungabana rya gelatin hollow capsule ituma iterambere ryibikoresho bishya bya capsule bikurura abantu cyane.
Nibihe bikoresho bikomoka ku bimera bikwiranye no gukora capsules zidafite akamaro?Abantu bagerageje byinshi.Icyifuzo cy'ipatanti y'Ubushinwa No: 200810061238 X yasabye gufata selile sulfate ya selile nkibikoresho nyamukuru bya capsule;200510013285.3 wasabye gufata ibinyamisogwe cyangwa ibinyamisogwe nkibikoresho nyamukuru bya capsule;Wang GM [1] yatangaje ko capsules zuzuye zakozwe muri chitosan capsules;Zhang Xiaoju n'abandi.[2] yamenyesheje ibicuruzwa hamwe na poroteyine ya soya ya Konjac nkibikoresho nyamukuru bya capsule.Nibyo, ibikoresho byizwe cyane nibikoresho bya selile.Muri byo, capsules yuzuye ikozwe muri hydroxypropyl methylcellulose (HPMC) yakoze umusaruro munini.
HPMC ikoreshwa cyane mubiribwa nubuvuzi.Nibisanzwe bikoresha imiti, bikubiye muri Pharmacopoeia yibihugu bitandukanye;FDA na EU bemeza HPMC nk'inyongeramusaruro y'ibiryo itaziguye cyangwa itaziguye;Gras ni ikintu cyizewe, No GRN 000213;Dukurikije ububiko bwa JECFA, INS no.464, nta karimbi ku gipimo ntarengwa cya buri munsi cya HPMC;Mu 1997, byemejwe na Minisiteri y’ubuzima y’Ubushinwa nk'inyongeramusaruro kandi ikabyibuha (No 20), ikoreshwa ku biribwa by'ubwoko bwose kandi ikongerwaho hakurikijwe ibisabwa n'umusaruro [2-9].Bitewe no gutandukanya imitungo iri hagati ya HPMC na gelatine, imiti ya capsule ya HPMC iraruhije cyane, kandi hagomba kongerwamo ibintu bimwe na bimwe bya gelling, nka gum yicyarabu, karrageenan (amase yo mu nyanja), ibinyamisogwe, nibindi.
HPMC hollow capsule nigicuruzwa gifite imyumvire isanzwe.Ikoranabuhanga ryibikoresho n’umusaruro bizwi n’amashyirahamwe y'Abayahudi, Abayisilamu n’ibikomoka ku bimera.Irashobora guhaza ibyo abantu bafite amadini atandukanye hamwe nuburyo bwo kurya, kandi byemewe cyane.Mubyongeyeho, HPMC hollow capsules ifite ibintu byihariye bikurikira:
1.Gabanya amazi - hafi 60% munsi ya gelatin hollow capsule
Amazi arimo capsules ya gelatin muri rusange ni 12.5% - 17.5% [10].Ubushyuhe nubushuhe bwibidukikije bigomba kugenzurwa mugihe gikwiye mugihe cyo gukora, gutwara, gukoresha no kubungabunga capsules zidafite akamaro.Ubushyuhe bukwiye ni 15-25 ℃ naho ubushuhe bugereranije ni 35% - 65%, kugirango imikorere yibicuruzwa ishobora kugumaho igihe kirekire.Amazi arimo membrane ya HPMC ni make cyane, muri rusange 4% - 5%, ibyo bikaba biri munsi ya 60% ugereranije na capsule ya gelatine (Ishusho 1).Guhana amazi hamwe nibidukikije mugihe cyo kubika igihe kirekire bizongera amazi ya HPMC hollow capsule mubipfunyika byagenwe, ariko ntibizarenga 9% mugihe cyimyaka 5.
Igishushanyo1.LOD igereranya ibishishwa bya HMPC na Gelatin munsi ya RH itandukanye
Ibiranga amazi make bituma HPMC yuzuye capsule ikwiranye no kuzuza hygroscopique cyangwa amazi yoroheje kugirango yongere ubuzima bwibicuruzwa.
2.Ubukomere bukabije, nta buryarya
Nkuko byavuzwe haruguru, firime ya gelatine ifite ibinyabuzima byihariye.Niba ari munsi yiyi mipaka, firime ya gelatin izaba yoroheje cyane.Ubusanzwe gelatin hollow capsules nta nyongeramusaruro zifite ibyago byo gukomera kurenza 10% mugihe ubuhehere buri 10%;Iyo amazi akomeje kugabanuka kugera kuri 5%, ubupfura buzabaho 100%.Ibinyuranye, ubukana bwa capsules ya HPMC ni nziza cyane, kandi bugumana imikorere myiza nubwo ubushuhe bwibidukikije buri hasi (Ishusho 3).Birumvikana ko igipimo cyo kwinjiza HPMC cyuzuye capsules hamwe na progaramu zitandukanye munsi yubushyuhe buke bizerekana itandukaniro rinini.
Ibinyuranye, capsules ya gelatin yashyizwe ahantu hafite ubuhehere bwinshi bizoroha, bihinduke cyangwa bisenyuke nyuma yo gufata amazi.HPMC hollow capsule irashobora kugumana imiterere nimikorere myiza nubwo haba hari ubushyuhe bwinshi.Kubwibyo, HPMC hollow capsule ifite imbaraga zo guhuza ibidukikije.Iyo agace kagurishirizwamo ibicuruzwa karimo uturere dutandukanye twikirere cyangwa ibihe byo guhunika bikennye, iyi nyungu ya capsule ya HMPC igaragara cyane.
3.Imiti ihamye
Kwisubiraho kwa gelatin capsules nikibazo cyamahwa gihura nimyiteguro ya capsule.Kuberako itsinda rya aldehyde yibirimo ryifata hamwe nitsinda rya amino ya aside amine acide muri gelatine kugirango habeho imiterere y'urusobe, igikonoshwa cya capsule kiragoye gushonga mugihe cyo gusenyuka muri vitro, bigira ingaruka kumurekura.Hydroxypropyl methylcellulose ni selile ikomoka kuri selile, ikaba idafite imiti kandi ikaba ihuza neza nibintu byinshi.Kubwibyo, HPMC hollow capsule ntabwo ifite ibyago byo guhuza reaction no gukomera kwimiti
4.Imikorere myiza yo gutwikira
Enteric coated capsules ikoreshwa kumiti yoroshye kwangizwa na acide gastric, irakaza mucosa gastric cyangwa ikeneye ubuyobozi bugenewe.Ikoranabuhanga ryemewe ku rwego mpuzamahanga rwa enteric coated capsules ni igifuniko rusange cya pellet na capsules.HPMC hollow capsule yerekana ibyiza byihariye muburyo rusange bwa capsule.
Ubushakashatsi bwerekana ko bitewe nubuso bukabije bwa capsule ya HPMC, isano iri hamwe nibikoresho byinshi byo gutwika byinjira cyane biri hejuru ya gelatine, kandi umuvuduko wo gufatana hamwe nuburinganire bwibikoresho byo gutwikira ni byiza cyane kuruta gelatine, cyane cyane kwizerwa kwizerwa ryumubiri. ni Byateye imbere.Ikizamini cyo gusesa vitro cyerekanye ko ubushobozi bwa capsule ya HPMC mu gifu bwari hasi kandi hakaba harekuwe neza mu mara [
Umwanzuro
Ibiranga HPMC hollow capsule yaguye umurima wabyo.Kuva ku bicuruzwa karemano byose kugeza kubushuhe bworoshye cyangwa ibirimo hygroscopique, bifite kandi uburyo bwihariye mubijyanye no guhumeka ifu yumye hamwe na enteric.Twabibutsa ko HPMC hollow capsules kuri ubu iri ku isoko mu gihugu ndetse no hanze yacyo ifite umuvuduko mwinshi wa ogisijeni kandi ugabanuka gahoro gahoro ugereranije na gelatin hollow capsules, ariko bioavailable yabo muri vivo irasa [11], igomba kwitabwaho mubushakashatsi niterambere.
Nkuko twese tubizi, hari inzira ndende yo kuva mubushakashatsi bwa laboratoire, ubushakashatsi bunini, umusaruro winganda ukazamura isoko.Niyo mpamvu, nyuma yimyaka yubushakashatsi niterambere, gusa ibicuruzwa bike bya capsule bikozwe mubikoresho bikomoka ku bimera byashyizwe ku rutonde neza.Mu 1997, capsugel yafashe iyambere mugutondekanya HPMC hollow capsule vcapstm muri Amerika, itanga amahitamo mashya kuri capsule yo mu kanwa.Kugeza ubu, igurishwa rya buri mwaka rya HPMC hollow capsules ku isi ryarenze miliyari 20, kandi rikaba ryiyongera ku gipimo cya 25% ku mwaka.
Igihe cyo kohereza: Gicurasi-06-2022