Nyob rau hauv ib puas xyoo keeb kwm ntawm cov tshuaj ntsiav, gelatin yeej ib txwm khaws cov xwm txheej ntawm cov khoom siv tshuaj ntsiav vim nws qhov chaw dav, ruaj khov lub cev thiab tshuaj lom neeg thiab ua haujlwm zoo heev.Nrog rau kev nce ntawm cov neeg nyiam rau cov tshuaj ntsiav, hollow capsules tau siv ntau dua hauv cov khoom noj, tshuaj thiab khoom noj qab haus huv.
Txawm li cas los xij, qhov tshwm sim thiab kis tus kab mob nyuj vwm thiab kab mob ko taw thiab qhov ncauj ua rau tib neeg pib txhawj xeeb txog cov khoom siv tsiaj.Cov khoom siv raw ntawm gelatin feem ntau yog cov pob txha thiab tawv nqaij ntawm nyuj thiab npua, thiab nws txoj kev pheej hmoo tau maj mam nyiam cov neeg nyiam.Txhawm rau txo qhov kev pheej hmoo ntawm kev nyab xeeb ntawm hollow capsule raw cov ntaub ntawv, cov kws tshaj lij kev lag luam txuas ntxiv mus tshawb fawb thiab tsim cov ntaub ntawv cog qoob loo tsim nyog.
Tsis tas li ntawd, nrog kev nce ntau ntawm cov tshuaj ntsiav, ntau yam ntawm lawv cov ntsiab lus maj mam ua rau tib neeg paub tias muaj teeb meem sib xws ntawm gelatin hollow capsules thiab qee cov ntsiab lus nrog cov khoom tshwj xeeb.Piv txwv li, cov ntsiab lus uas muaj aldehyde pawg los yog reacting los tsim aldehyde pawg nyob rau hauv tej yam kev mob tej zaum yuav ua rau cross-linking ntawm gelatin;Cov ntsiab lus uas muaj zog txo qis yuav muaj Maillard cov tshuaj tiv thaiv nrog gelatin;Cov ntsiab lus uas muaj zog hygroscopicity yuav ua rau lub plhaub ntawm Ming capsule poob dej thiab poob nws qhov qub toughness.Kev ruaj ntseg ntawm gelatin hollow capsule ua rau txoj kev loj hlob ntawm cov ntaub ntawv tshiab capsule nyiam ntau xim.
Cov khoom siv cog qoob loo twg yog qhov tsim nyog rau kev tsim cov hollow hard capsules?Cov neeg tau sim ntau heev.Suav patent daim ntawv thov No.: 200810061238 X thov rau kev noj cellulose sodium sulfate ua cov khoom tseem ceeb capsule;200510013285.3 thov rau kev noj cov hmoov txhuv nplej siab los yog hmoov txhuv nplej siab ua cov khoom tseem ceeb ntawm cov tshuaj ntsiav;Wang GM [1] qhia tias hollow capsules yog tsim los ntawm chitosan capsules;Zhang Xu et al.[2] tshaj tawm cov khoom nrog Konjac soybean protein ua cov khoom tseem ceeb ntawm cov tshuaj ntsiav.Tau kawg, cov ntaub ntawv kawm feem ntau yog cov ntaub ntawv cellulose.Ntawm lawv, hollow capsules ua los ntawm hydroxypropyl methylcellulose (HPMC) tau tsim ntau lawm.
HPMC yog dav siv nyob rau hauv cov zaub mov thiab tshuaj.Nws yog ib qho kev siv tshuaj ntau ntxiv, uas suav nrog hauv Pharmacopoeia ntawm ntau lub teb chaws;FDA thiab EU pom zoo HPMC ua cov khoom noj ncaj qha lossis tsis ncaj;Gras yog ib yam khoom muaj kev nyab xeeb, No. GRN 000213;Raws li JECFA database, INS no.464, tsis muaj kev txwv rau qhov siab tshaj plaws txhua hnub koob tshuaj HPMC;Nyob rau hauv 1997, nws tau pom zoo los ntawm Ministry of Health ntawm Tuam Tshoj raws li ib tug khoom noj khoom haus additives thiab thickener (No. 20), uas muaj feem xyuam rau txhua yam khoom noj thiab ntxiv raws li qhov yuav tsum tau ntau lawm [2-9].Vim tias qhov sib txawv ntawm cov khoom ntawm HPMC thiab gelatin, cov tshuaj ntawm HPMC hollow capsule yog qhov nyuaj, thiab qee cov gelling yuav tsum tau ntxiv, xws li cov pos hniav Arabic, carrageenan (seaweed gum), starch, thiab lwm yam.
HPMC hollow capsule yog cov khoom lag luam nrog lub tswv yim ntuj.Nws cov khoom siv thiab cov tshuab tsim khoom tau lees paub los ntawm cov neeg Yudais, Islamic thiab cov koom haum neeg tsis noj nqaij.Nws tuaj yeem ua tau raws li cov kev xav tau ntawm cov neeg muaj ntau yam kev ntseeg thiab kev noj haus, thiab muaj kev lees paub siab.Tsis tas li ntawd, HPMC hollow capsules muaj cov yam ntxwv hauv qab no:
1. Cov ntsiab lus dej tsawg - txog 60% qis dua gelatin hollow capsule
Cov ntsiab lus dej ntawm gelatin hollow capsules feem ntau yog 12.5% - 17.5% [10].Qhov kub thiab av noo ntawm ib puag ncig yuav tsum tau tswj nyob rau hauv ib qho chaw tsim nyog thaum lub sij hawm tsim khoom, kev thauj mus los, kev siv thiab khaws cia ntawm hollow capsules.Qhov ntsuas kub uas tsim nyog yog 15-25 ℃ thiab qhov txheeb ze av noo yog 35% - 65%, yog li kev ua haujlwm ntawm cov khoom tuaj yeem tswj tau ntev.Cov dej ntsiab lus ntawm HPMC daim nyias nyias yog tsawg heev, feem ntau 4% - 5%, uas yog li 60% qis dua li ntawm gelatin hollow capsule (Fig. 1).Kev sib pauv dej nrog ib puag ncig thaum lub sijhawm khaws cia ntev yuav ua rau cov dej ntawm HPMC hollow capsule hauv cov ntim tau teev tseg, tab sis nws yuav tsis pub dhau 9% hauv 5 xyoos.
Fig1.LOD kev sib piv ntawm HMPC thiab Gelatin plhaub nyob rau hauv sib txawv RH
Cov yam ntxwv ntawm cov ntsiab lus dej tsawg ua rau HPMC hollow capsule haum rau sau hygroscopic lossis dej rhiab ntsiab lus kom ntev lub txee lub neej ntawm cov khoom.
2.High toughness, tsis muaj brittleness
Raws li tau hais los saum no, gelatin zaj duab xis muaj cov ntsiab lus noo noo.Yog tias nws qis dua qhov kev txwv no, gelatin zaj duab xis yuav ua rau nkig heev.Ordinary gelatin hollow capsules yam tsis muaj additives muaj kev pheej hmoo ntawm brittleness ntau tshaj 10% thaum cov dej noo yog 10%;Thaum cov ntsiab lus dej txuas ntxiv mus rau 5%, 100% brittleness yuav tshwm sim.Hauv qhov sib piv, qhov tawv ntawm HPMC hollow capsules yog qhov zoo dua, thiab lawv muaj kev ua tau zoo txawm tias ib puag ncig cov av qis (Daim duab 3).Tau kawg, tus nqi embrittlement ntawm HPMC hollow capsules nrog cov tshuaj sib txawv hauv cov av qis yuav qhia qhov sib txawv zoo.
Ntawm qhov tsis sib xws, gelatin hollow capsules muab tso rau hauv qhov chaw muaj av noo siab yuav muag, deform lossis txawm tias tawg tom qab nqus dej.HPMC hollow capsule tuaj yeem tswj tau cov duab zoo thiab kev ua haujlwm txawm tias nyob rau hauv cov av noo siab.Yog li ntawd, HPMC hollow capsule muaj zog adaptability rau ib puag ncig.Thaum qhov chaw muag khoom ntawm cov khoom lag luam npog ntau thaj chaw huab cua lossis cov chaw cia khoom tsis zoo, qhov zoo ntawm HMPC hollow capsule yog qhov tseem ceeb.
3. Muaj zog tshuaj stability
Cov tshuaj tiv thaiv crosslinking ntawm gelatin capsules yog ib qho teeb meem thorny ntsib los ntawm kev npaj tshuaj ntsiav.Vim hais tias pawg aldehyde ntawm cov ntsiab lus reacts nrog cov amino pawg ntawm cov amino acids nyob rau hauv gelatin los tsim ib tug network qauv, lub capsule plhaub yog ib qho nyuaj rau yaj nyob rau hauv lub dissolution nyob rau hauv vitro, uas cuam tshuam rau kev tso tawm ntawm cov tshuaj.Hydroxypropyl methylcellulose yog cellulose derivative, uas yog chemically inert thiab muaj zoo heev compatibility nrog rau feem ntau tshuaj.Yog li ntawd, HPMC hollow capsule tsis muaj kev pheej hmoo ntawm kev sib txuas cov tshuaj tiv thaiv thiab kev ruaj ntseg tshuaj
4.Cov txheej txheem zoo
Enteric coated capsules yog siv rau cov tshuaj uas yooj yim rau kev puas tsuaj los ntawm gastric acid, irritating gastric mucosa los yog xav tau kev tswj xyuas.Kev lees paub thoob ntiaj teb thev naus laus zis ntawm enteric coated capsules yog tag nrho cov txheej txheem ntawm enteric coated pellets thiab capsules.HPMC hollow capsule qhia tau hais tias muaj txiaj ntsig zoo hauv tag nrho cov txheej txheem ntawm cov tshuaj ntsiav.
Cov kev tshawb fawb qhia tau hais tias vim yog qhov ntxhib ntawm HPMC hollow capsule, qhov kev sib raug zoo nrog cov khoom siv txheej txheej feem ntau yog siab dua gelatin, thiab qhov adhesion ceev thiab uniformity ntawm cov ntaub ntawv txheej yog zoo dua li gelatin, tshwj xeeb tshaj yog cov txheej kev ntseeg siab ntawm lub cev hlws ris. yog kho tau zoo heev.Hauv vitro dissolution kuaj pom tias qhov permeability ntawm HPMC capsule hauv plab qis dua thiab muaj qhov tso tawm zoo hauv txoj hnyuv[
Xaus
Cov yam ntxwv ntawm HPMC hollow capsule tau nthuav dav nws daim ntawv thov teb.Los ntawm tag nrho cov khoom ntuj tsim los rau cov dej rhiab heev lossis hygroscopic cov ntsiab lus, nws kuj muaj cov ntawv thov tshwj xeeb hauv thaj chaw ntawm cov hmoov qhuav inhalants thiab enteric txheej.Nws yuav tsum raug sau tseg tias HPMC hollow capsules tam sim no nyob rau hauv kev ua lag luam hauv tsev thiab txawv teb chaws muaj cov pa oxygen permeability thiab qeeb qeeb qeeb dua li gelatin hollow capsules, tab sis lawv cov bioavailability hauv vivo zoo ib yam [11], uas yuav tsum tau xav txog hauv kev tshawb fawb thiab kev loj hlob.
Raws li peb txhua tus paub, muaj txoj hauv kev ntev mus los ntawm kev tshawb fawb hauv chav kuaj, kev sim loj, kev tsim khoom lag luam mus rau kev lag luam nce qib.Qhov no yog vim li cas, tom qab xyoo ntawm kev tshawb fawb thiab kev loj hlob, tsuas yog ob peb hollow capsule cov khoom ua los ntawm cov khoom siv cog qoob loo tau ua tiav tiav.Xyoo 1997, capsugel tau ua tus thawj coj hauv kev sau npe HPMC hollow capsule vcapstm hauv Tebchaws Meskas, muab kev xaiv tshiab rau qhov ncauj tshuaj ntsiav.Tam sim no, qhov muag txhua xyoo ntawm HPMC hollow capsules hauv ntiaj teb tau tshaj 20 billion, thiab tau loj hlob ntawm tus nqi ntawm 25% hauv ib xyoos.
Post lub sij hawm: May-06-2022