Hauv kev lag luam kws tshuaj thiab nutraceutical, cov tshuaj ntsiav tshuaj tau siv dav vim lawv qhov yooj yim ntawm kev txav mus los thiab muaj peev xwm los npog cov ntxhiab tsw tsw. Ntawm lawv, enteric-cov tshuaj ntsiav coated, raws li cov khoom siv tshuaj tshwj xeeb, ua lub luag haujlwm tseem ceeb. Thaum lub sijhawm kev yuav khoom lossis R&D txheej txheem, ntau lub tuam txhab tshuaj tsom mus rau qhov ntsuas tseem ceeb: Lub sijhawm tawg ntawm enteric -coated capsules yog dab tsi? Kab lus no yuav txheeb xyuas qhov teeb meem no kom ntxaws los pab koj nkag siab tob txog cov yam ntxwv ntawm kev tawg thiab qhov tseem ceeb ntawm enteric-coated capsules.
I. Standard Disintegration Time of Enteric-Coated Capsules
Raws li Suav Pharmacopoeia thiab cov qauv tseem ceeb hauv lub tebchaws, lub sijhawm tawg ntawm enteric-coated nyuaj capsules raug txiav txim siab. Cias muab tso, nws cov txheej txheem disintegration yog muab faib ua ob theem, coj mus rau qhov chaw ntawm lub digestive kabmob sib txawv nyob rau hauv tib neeg lub cev:
Gastric Fluid Ib puag ncig (Acid-Resistant Stage):
Enteric capsules yuav tsum nyob ruaj khov hauv cov kua dej hauv plab yam tsis muaj kev tawg lossis tawg. Tus qauv feem ntau xav kom nyob rau hauv 2 teev ntawm oscillation los yog immersion nyob rau hauv cov khoom siv gastric kua (pH 1.2 hydrochloric acid tov), cov tshuaj ntsiav yuav tsum tsis muaj cov cim qhia ntawm kab nrib pleb, disintegration, los yog to ntawm cov ntsiab lus. Qhov no yog los xyuas kom meej tias cov tshuaj muaj kev nyab xeeb dhau los ntawm lub plab, tiv thaiv gastric acid los ntawm degrading cov tshuaj Cheebtsam los yog cov tshuaj los ntawm irritating gastric mucosa.
Lub plab hnyuv ib puag ncig (Disintegration Stage):
Thaum cov tshuaj ntsiav nkag mus rau hauv txoj hnyuv ib puag ncig, nws yuav tsum tso cov tshuaj sai sai. Tus txheej txheem yuav tsum tau hloov cov tshuaj ntsiav tshuaj hauv cov kua hauv plab mus rau hauv cov kua hauv plab hnyuv (pH 6.8 phosphate tsis), qhov uas nws lub sij hawm tawg feem ntau yuav tsum tsis pub dhau 60 feeb (qee cov qauv siab xav tau lub sijhawm luv, xws li hauv 30 feeb). Lub sijhawm tshwj xeeb sib txawv me ntsis nyob ntawm tus neeg tsim khoom cov txheej txheem thiab cov qauv, tab sis lub hauv paus ntsiab lus tseem ceeb yog "tshem tawm thaum ncav cuag txoj hnyuv".
Yog li ntawd, lub sij hawm disintegration ntawm enteric-coated capsules tsis yog ib daim duab, tab sis ib qho kev nthuav qhia ntawm "tsis muaj kev sib cais hauv cov kua hauv plab (Ntau dua lossis sib npaug li 2 teev)" thiab "kev tawg sai hauv cov hnyuv (tsawg dua lossis sib npaug li 60 feeb)".
II. Vim li cas Lub Sij Hawm Disintegration tseem ceeb heev?
Lub hom phiaj tsim qauv ntawm enteric-cov tshuaj ntsiav coated yog "site-kev tso tawm tshwj xeeb". Yog hais tias lub sij hawm disintegration yog substandard, nws tuaj yeem muaj qhov tshwm sim loj:
Kev puas tsuaj ntxov ntxov (hauv plab): Qhov no tuaj yeem ua rau cov tshuaj degradation los ntawm gastric acid, txo cov nyhuv; los yog cov tshuaj yuav ua rau mob plab, ua rau muaj kev phiv xws li xeev siab thiab ntuav.
Kev ncua qeeb (hauv txoj hnyuv): Yog tias cov tshuaj ntsiav disintegrates qeeb heev hauv txoj hnyuv, cov tshuaj tsis tuaj yeem tso tawm ntawm qhov chaw nqus tau zoo tshaj plaws hauv cov hnyuv, ua rau txo qis kev nqus lossis txawm tias raug tso tawm ntawm lub cev ua ntej tso tawm.
Yog li ntawd, nruj me ntsis tswj lub sij hawm disintegration yog qhov tseem ceeb los xyuas kom meej lub bioavailability thiab kho cov nyhuv ntawm cov tshuaj.
III. Tej yam cuam tshuam rau lub sij hawm tawg
Txawm hais tias lub teb chaws cov qauv muaj cov kev cai sib koom ua ke, hauv kev siv tswv yim, lub sij hawm tawg tuaj yeem cuam tshuam los ntawm ntau yam:
Raw Material Composition: High -zoo enteric capsules feem ntau siv gelatin coated nrog enteric txheej ntaub ntawv (xws li Cellulose Acetate Phthalate CAP, Acrylic resin, thiab lwm yam). Lub thickness thiab uniformity ntawm txheej txheej ncaj qha txiav txim siab lub sij hawm acid kuj thiab disintegration ceev.
Cia Lub Sijhawm: Cov av noo thiab qhov kub thiab txias cuam tshuam rau lub plhaub capsule. Cov av noo ntau dhau tuaj yeem ua rau lub plhaub capsule soften, hloov nws lub cev thiab yog li cuam tshuam rau lub sijhawm tawg.
Cov Ntsiab Lus: Yog tias cov tshuaj ntim cov hmoov lossis cov granules muaj hygroscopicity lossis pH tshwj xeeb, lawv tuaj yeem cuam tshuam nrog cov khoom siv tshuaj ntsiav, cuam tshuam nrog cov txheej txheem tsis sib xws.
IV. Xaus
Piv txwv li, lub sij hawm disintegration yog dab tsienteric{0}}coated capsules? Cov lus teb yog: tsis muaj kev sib cais hauv 2 teev hauv cov kua hauv plab, thiab feem ntau disintegration hauv 1 teev hauv cov kua hauv plab hnyuv. Rau cov tuam txhab tshuaj, xaiv tus neeg muab khoom ntawm enteric- cov tshuaj ntsiav uas ua tau raws li cov qauv tshuaj pharmacopoeia thiab muaj qhov zoo ruaj khov yog qhov yuav tsum tau ua ua ntej kom ntseeg tau tias cov tshuaj muaj kev nyab xeeb thiab ua tau zoo. Thaum lub sij hawm kev yuav khoom, nco ntsoov thov cov qauv rau lub sij hawm disintegration kuaj kom paub tseeb tias cov khoom ua tau raws li koj cov txheej txheem tshwj xeeb. Yog tias muaj lus nug txog cov tshuaj ntsiav khoob, txais tos hu rau KornnacCaps.
