Muzana remakore renhoroondo yemacapsules, gelatin yakagara yakachengetedza chimiro chezvakanyanya capsule zvinhu nekuda kwehupamhi hwayo, yakagadzikana yemuviri uye makemikari zvimiro uye yakanakisa kugadzirisa zvivakwa.Nekuwedzera kwekuda kwevanhu macapsules, hollow capsules anoshandiswa zvakanyanya muminda yezvekudya, mishonga uye hutano zvigadzirwa.
Zvisinei, kuitika uye kupararira kwechirwere chemombe dzinopenga uye chirwere chetsoka-ne-muromo chinoita kuti vanhu vatange kunetseka pamusoro pezvigadzirwa zvemhuka.Izvo zvinowanzo shandiswa zvegelatin ibhonzo nedehwe remombe nenguruve, uye njodzi yaro yakwezva vanhu zvishoma nezvishoma.Kuti uderedze njodzi yekuchengetedza yehollow capsule raw materials, nyanzvi dzeindasitiri dzinoramba dzichitsvaga nekugadzira yakakodzera chirimwa-yakatorwa capsule zvinhu.
Mukuwedzera, nekuwedzera kwezvakasiyana-siyana zve capsules, kusiyana-siyana kwezviri mukati zvishoma nezvishoma kunoita kuti vanhu vaone kuti kune matambudziko ekuenderana pakati pegelatin hollow capsules uye zvimwe zviri mukati zvine zvakakosha.Semuenzaniso, zvinyorwa zvine mapoka e-aldehyde kana kuita kuti zvibudise mapoka e-aldehyde pasi pemamwe mamiriro ezvinhu zvinogona kutungamirira kuyambuka-kubatanidzwa kwegelatin;Izvo zviri mukati zvine simba reducibility zvinogona kunge zvine Maillard reaction negelatin;Izvo zvirimo zvine yakasimba hygroscopicity ichaita kuti goko reMing capsule irasikirwe nemvura uye kurasikirwa nekuoma kwayo kwepakutanga.Iko kugadzikana kwegelatin hollow capsule kunoita kuti kuvandudzwa kwezvinhu zvitsva zvecapsule kukwezve kutarisisa.
Ndeapi chirimwa chakatorwa zvinhu akakodzera kugadzirwa kwehollow hard capsules?Vanhu vakaedza zvakawanda.Chinese patent document application Nha.: 200810061238 X yakanyorera kutora cellulose sodium sulfate sechinhu chikuru capsule material;200510013285.3 yakashandiswa kutora starch kana starch kuumbwa sechinhu chikuru che capsule;Wang GM [1] yakashuma kuti magomba capsules akagadzirwa kubva ku chitosan capsules;Zhang Xiaoju et al.[2] yakashuma zvigadzirwa neKonjac soyabean protein seyakanyanya capsule zvinhu.Ehe, iyo inonyanya kudzidzwa zvinhu ndeye cellulose zvinhu.Pakati pavo, magomba makapu akagadzirwa nehydroxypropyl methylcellulose (HPMC) akagadzira kugadzirwa kwakakura.
HPMC inoshandiswa zvakanyanya mumunda wekudya nemishonga.Iyo inowanzoshandiswa mishonga yemishonga, iyo inosanganiswa muPharmacopoeia yenyika dzakasiyana-siyana;FDA uye EU inobvumira HPMC sechikafu chakananga kana chisina kunanga chekuwedzera;Gras chinhu chakachengeteka, Kwete GRN 000213;Maererano neJECFA database, INS no.464, hapana muganho wepamusoro wezuva nezuva weHPMC;Muna 1997, yakagamuchirwa neHurumende yehutano yeChina sechikafu chekuwedzera uye thickener (No. 20), iyo inoshandiswa kune marudzi ose ezvokudya uye yakawedzerwa maererano nezvinodiwa zvekugadzira [2-9].Nekuda kwemusiyano wezvivakwa pakati peHPMC negelatin, kunyorerwa kweHPMC hollow capsule yakanyanya kuoma, uye mamwe majelling agents anofanirwa kuwedzerwa, akadai seArabic gum, carrageenan (seaweed gum), starch, nezvimwe.
HPMC hollow capsule chigadzirwa chine pfungwa yechisikigo.Yayo tekinoroji uye tekinoroji yekugadzira inozivikanwa nevechiJudha, Islamic uye masangano ezvinomera.Inogona kuzadzisa zvinodiwa nevanhu vane zvitendero zvakasiyana-siyana uye madyiro, uye ine kugamuchirwa kwepamusoro.Mukuwedzera, HPMC hollow capsules ine zvinotevera zvakasarudzika zvivakwa:
1.Mvura yakadzika - inenge 60% yakaderera pane gelatin hollow capsule
Mvura yemvura yegelatin hollow capsules inowanzoita 12.5% - 17.5% [10].Tembiricha uye hunyoro kwezvakatipoteredza zvinofanirwa kudzorwa mukati mechikamu chakakodzera panguva yekugadzira, yekufambisa, kushandiswa nekuchengetedza mahollow capsules.Iyo tembiricha yakakodzera ndeye 15-25 ℃ uye hunyoro hunyoro ndeye 35% - 65%, kuitira kuti kuita kwechigadzirwa kuchengetedzwe kwenguva yakareba.Mvura yeHPMC membrane yakaderera zvikuru, kazhinji 4% - 5%, iyo inenge 60% yakaderera pane iyo yegelatin hollow capsule (Fig. 1).Kutsinhana kwemvura nemhoteredzo panguva yekuchengetera kwenguva refu kuchawedzera mvura yeHPMC hollow capsule mune yakatsanangurwa kurongedza, asi haizopfuure 9% mukati memakore mashanu.
Fig1.LOD kuenzanisa kweHMPC neGelatin magomba ari pasi peRH yakasiyana
Hunhu hwehuwandu hwemvura hunoita kuti HPMC hollow capsule ikwane kuzadza hygroscopic kana mvura inonzwa zvirimo kuti uwedzere hupenyu hwesherufu yechigadzirwa.
2.Kuoma kwepamusoro, hapana brittleness
Sezvambotaurwa pamusoro, iyo gelatin firimu ine yakatsanangurwa mwando.Kana yakaderera pane iyi muganhu, iyo gelatin firimu ichave yakanyanya brittle.Ordinary gelatin hollow capsules pasina chero zvinowedzera zvine njodzi yebrittleness inopfuura 10% kana mwando uri 10%;Kana mvura yemukati ichiramba ichidzikira kusvika pa5%, 100% brittleness ichaitika.Kusiyana neizvi, kuoma kweHPMC hollow capsules kuri nani zvikuru, uye vanochengetedza kushanda kwakanaka kunyange kana hunyoro hwezvakatipoteredza huri pasi (Fig. 3).Ehe, iyo embrittlement mwero weHPMC hollow capsules ane akasiyana madhiri pasi pehunyoro hunyoro hunoratidza misiyano mikuru.
Kusiyana neizvi, gelatin hollow capsules akaiswa munzvimbo ine hunyoro hwepamusoro anopfava, akanganisa kana kudonha mushure mekutora mvura.HPMC hollow capsule inogona kuchengetedza chimiro chakanaka uye kuita kunyangwe pasi pemamiriro ehunyoro hwepamusoro.Naizvozvo, HPMC hollow capsule ine yakasimba kuchinjika kune nharaunda.Kana nzvimbo yekutengesa yechigadzirwa ichivhara nzvimbo dzakasiyana dzemamiriro ekunze kana mamiriro ekuchengetedza ari mashoma, mukana uyu weHMPC hollow capsule inonyanya kukosha.
3.Kugadzikana kwakasimba kwemakemikari
Iyo crosslinking reaction yegelatin capsules idambudziko rine minzwa rinosangana ne capsule kugadzirira.Nokuti boka re aldehyde rezvinyorwa rinopindirana neboka reamino yeamino acids mugelatin kuti iite network network, iyo capsule shell yakaoma kuparara pasi pemamiriro ekuparara in vitro, iyo inokanganisa kusunungurwa kwemishonga.Hydroxypropyl methylcellulose inobuda mu cellulose, ine makemikari inert uye inonyatso enderana nezvinhu zvakawanda.Naizvozvo, HPMC hollow capsule haina njodzi yekuyambuka-inobatanidza kuita uye yakanyanya kugadzikana kwemakemikari
4.Good coating performance
Enteric coated capsules inoshandiswa kune zvinodhaka zviri nyore kukuvadzwa negastric acid, inogumbura kune gastric mucosa kana inoda kutungamirirwa kwakananga.Iyo tekinoroji inogamuchirwa pasi rose yeenteric yakavharwa kapisi ndiyo yakazara yakanamwa ye enteric yakavharwa pellets uye capsules.HPMC hollow capsule inoratidza yakasarudzika mabhenefiti mune yakazara coating yekapisi.
Tsvagiridzo iyi inoratidza kuti nekuda kwekushata kwepamusoro peHPMC hollow capsule, kuwirirana neakawanda enteric coating zvinhu kwakakwira zvakanyanya kupfuura gelatin, uye kumhanya kwekunamatira uye kufanana kwezvinhu zvekupfeka zviri nani zvakanyanya kupfuura gelatin, kunyanya kuvimbika kwekupfeka kwemuviri cap junction. inovandudzwa zvakanyanya.In vitro dissolution test yakaratidza kuti kupera kweHPMC capsule mudumbu kwaive kwakaderera uye kwaive nekusunungurwa kwakanaka muura.
Mhedziso
Hunhu hweHPMC hollow capsule yakawedzera nzvimbo yayo yekushandisa.Kubva kune zvese zvigadzirwa zvechisikigo kusvika kune hunyoro hunonzwa kana hygroscopic zvirimo, ine zvakare yakasarudzika mashandisirwo mumunda wehupfu hwakaoma inhalants uye enteric coating.Zvinofanira kucherechedzwa kuti HPMC hollow capsules parizvino ari pamusika kumba nekune dzimwe nyika ane yakakwira oksijeni permeability uye zvishoma zvishoma kuparara pane gelatin hollow capsules, asi bioavailability yavo mu vivo yakafanana [11], iyo inofanirwa kutariswa mukutsvaga nekusimudzira.
Sezvatinoziva tese, kune nzira refu yekuenda kubva pakutsvaga murabhoritari, kuyedza kwakakura, kugadzirwa kwemaindasitiri kuenda kukusimudzira musika.Ichi ndicho chikonzero, mushure memakore ekutsvagisa uye kusimudzira, mashoma mashoma maburi macapsule zvigadzirwa zvakagadzirwa nechirimwa-zvakagadzirwa zvinhu zvakabudirira kunyorwa.Muna 1997, capsugel yakatungamira mukunyora HPMC hollow capsule vcapstm muUnited States, ichipa sarudzo nyowani yemuromo capsule.Parizvino, huwandu hwekutengesa hwepagore hweHPMC hollow capsules munyika hwakapfuura bhiriyoni makumi maviri, uye huri kukura pamwero we25% pagore.
Nguva yekutumira: Chivabvu-06-2022