Capsule yog ib qho ntawm cov tshuaj siv thaum ub, uas tau tshwm sim hauv tebchaws Iziv thaum ub [1].De Pauli, tus kws muag tshuaj hauv Vienna, tau hais hauv nws daim ntawv teev npe mus ncig hauv xyoo 1730 tias Oval capsules tau siv los npog cov ntxhiab tsw phem ntawm cov tshuaj los txo qhov mob ntawm cov neeg mob [2].Ntau tshaj 100 xyoo tom qab, cov kws muag tshuaj Joseph Gerard Auguste dublanc thiab Francois Achille Barnabe motors tau txais patent ntawm lub ntiaj teb thawj gelatin capsule nyob rau hauv 1843 thiab txuas ntxiv txhim kho nws kom haum rau kev lag luam ntau lawm [3,4];Txij thaum ntawd los, ntau patents ntawm hollow capsules tau yug los.Xyoo 1931, Arthur Colton ntawm Parke Davis lub tuam txhab tau ua tiav thiab tsim cov khoom siv tsis siv neeg ntau lawm ntawm hollow capsule thiab tsim lub ntiaj teb thawj lub tshuab ua hollow capsule.Interestingly, mus txog rau tam sim no, hollow capsule ntau lawm kab tsuas yog tau txuas ntxiv txhim kho nyob rau hauv lub hauv paus ntawm Arthur tus tsim los txhim kho cov khoom zoo thiab ntau lawm efficiency.
Tam sim no, tshuaj ntsiav tau ua kom muaj kev loj hlob zoo thiab ceev ceev hauv kev kho mob thiab chaw muag tshuaj, thiab tau dhau los ua ib qho ntawm cov tshuaj tseem ceeb ntawm cov khoom noj hauv qhov ncauj.Txij xyoo 1982 txog xyoo 2000, ntawm cov tshuaj tshiab tau pom zoo thoob ntiaj teb, cov ntawv siv tshuaj ntsiav nyuaj tau pom muaj kev nce siab.
Daim duab 1 Txij li xyoo 1982, cov tshuaj molecular tshiab tau muab piv nrog cov tshuaj ntsiav thiab cov ntsiav tshuaj
Nrog rau txoj kev loj hlob ntawm kev tsim tshuaj thiab R & D kev lag luam, qhov zoo ntawm cov tshuaj ntsiav tau raug lees paub ntau dua, feem ntau hauv cov hauv qab no:
1. Cov neeg mob nyiam
Piv nrog rau lwm hom tshuaj, cov tshuaj ntsiav nyuaj tuaj yeem npog cov ntxhiab tsw phem ntawm cov tshuaj thiab yooj yim rau nqos.Ntau yam xim thiab cov qauv luam tawm ua rau cov tshuaj paub ntau dua, txhawm rau txhim kho kev ua raws li cov tshuaj.Xyoo 1983, kev tshawb fawb los ntawm European thiab Asmeskas cov tub ceev xwm tau pom tias ntawm 1000 tus neeg mob xaiv, 54% nyiam cov tshuaj ntsiav nyuaj, 29% xaiv cov qab zib coated pellets, tsuas yog 13% xaiv cov ntsiav tshuaj, thiab lwm 4% tsis xaiv qhov tseeb.
2. Siab R & D Efficiency
Daim ntawv tshaj tawm xyoo 2003 tau taw qhia tias tus nqi ntawm kev tshawb fawb tshuaj thiab kev loj hlob tau nce 55% txij li xyoo 1995 txog 2000, thiab qhov nruab nrab tus nqi thoob ntiaj teb ntawm kev tshawb fawb tshuaj thiab kev loj hlob tau mus txog 897 lab US dollars.Raws li peb txhua tus paub, cov tshuaj ua ntej tau teev tseg, lub sijhawm ntev ntawm kev lag luam monopoly ntawm cov tshuaj patented yuav yog, thiab cov tshuaj tshiab cov txiaj ntsig ntawm cov lag luam tshuaj yuav nce ntxiv.Qhov nruab nrab tus naj npawb ntawm excipients siv nyob rau hauv capsules yog 4, uas tau txo qis piv nrog 8-9 hauv ntsiav tshuaj;Cov khoom kuaj ntawm cov tshuaj ntsiav kuj tsawg dua, thiab tus nqi ntawm txoj kev tsim, kev tshuaj xyuas thiab kev tshuaj xyuas yog yuav luag ib nrab ntawm cov ntsiav tshuaj.Yog li ntawd, piv nrog cov ntsiav tshuaj, lub sijhawm txhim kho ntawm cov tshuaj ntsiav yog tsawg kawg ib nrab xyoo luv dua li cov ntsiav tshuaj.
Feem ntau, 22% ntawm cov koom haum tshiab hauv kev tshawb fawb tshuaj thiab kev txhim kho tuaj yeem nkag mus rau theem I kev sim tshuaj ntsuam xyuas, uas tsawg dua 1 / 4 tuaj yeem dhau theem III kev sim tshuaj.Kev tshuaj xyuas cov tshuaj tshiab tuaj yeem txo tus nqi ntawm kev tshawb fawb tshuaj tshiab thiab kev txhim kho cov tsev kho mob kom sai li sai tau.Yog li ntawd, lub ntiaj teb hollow capsule manufacturing kev lag luam tau tsim preclinical capsules (pccaps) haum rau nas sim ® ) ； Precision micro filling khoom (xcelodose) haum rau zus tau tej cov tshuaj capsule kuaj ® ), Thiab kho ob-dig muag tshuaj ntsiav (dbcaps) haum rau kev soj ntsuam loj loj ®) Thiab ntau yam khoom siv los txhawb txo R & D nqi thiab txhim kho R & D efficiency.
Tsis tas li ntawd, muaj ntau dua 9 hom tshuaj ntsiav nyob rau hauv ntau qhov sib txawv, uas muab ntau txoj kev xaiv rau kev tsim cov tshuaj noj.Txoj kev loj hlob ntawm kev npaj technology thiab lwm yam khoom siv kuj ua rau lub capsule haum rau ntau cov tebchaw nrog tshwj xeeb cov khoom, xws li cov tebchaw insoluble nyob rau hauv dej.Kev tshuaj xyuas qhia tau hais tias 50% ntawm cov khoom sib xyaw tshiab tau txais los ntawm kev tshuaj ntsuam xyuas siab thiab kev sib xyaw ua ke yog insoluble hauv dej (20%) μ G / ml), ob qho tib si cov kua ntim tshuaj thiab cov tshuaj ntsiav mos tuaj yeem ua tau raws li qhov xav tau ntawm qhov kev npaj sib xyaw no.
3. Tsawg tus nqi tsim khoom
Piv nrog rau cov ntsiav tshuaj, GMP kev cob qhia ntawm cov tshuaj ntsiav nyuaj muaj qhov zoo ntawm cov txheej txheem tsawg dua, kev siv qhov chaw siab, ntau qhov tsim nyog, tsawg lub sijhawm tshuaj xyuas hauv cov txheej txheem ntau lawm, tsis muaj kev tswj tsis zoo, tsis tshua muaj neeg ua haujlwm, tsis tshua muaj kev pheej hmoo ntawm cov pa phem, yooj yim. txheej txheem kev npaj, kev tsim khoom tsawg dua, cov khoom siv yooj yim thiab cov nqi qis.Raws li kev kwv yees ntawm cov kws tshaj lij, cov nqi ntawm cov tshuaj ntsiav nyuaj yog 25-30% qis dua li cov ntsiav tshuaj [5].
Nrog rau kev loj hlob ntawm cov tshuaj ntsiav, hollow capsules, ua ib qho ntawm cov khoom tseem ceeb, kuj muaj kev ua tau zoo.Nyob rau hauv 2007, tag nrho cov muag ntim ntawm hollow capsules nyob rau hauv lub ntiaj teb no tau tshaj 310 billion, ntawm cov uas 94% yog gelatin hollow capsules, thaum lwm yam 6% yog los ntawm cov tsiaj tsis yog muab los capsules, ntawm uas txhua xyoo kev loj hlob tus nqi ntawm hydroxypropyl methylcellulose (HPMC). ) hollow capsules yog ntau tshaj 25%.
Kev nce ntau hauv kev muag khoom ntawm cov tsiaj tsis yog los ntawm cov tshuaj ntsiav hollow qhia txog kev noj haus ntawm kev tawm tsam cov khoom ntuj hauv ntiaj teb.Hauv Tebchaws Meskas ib leeg, piv txwv li, muaj 70 lab tus tib neeg uas "tsis tau noj cov khoom noj tsiaj", thiab 20% ntawm tag nrho cov pejxeem yog "neeg tsis noj nqaij".Ntxiv nrog rau lub tswv yim ntuj, tsis yog tsiaj los ntawm hollow capsules kuj muaj lawv tus kheej cov yam ntxwv tshwj xeeb.Piv txwv li, HPMC hollow capsules muaj cov ntsiab lus dej tsawg heev thiab zoo toughness, thiab haum rau cov ntsiab lus nrog hygroscopicity thiab dej rhiab heev;Pullulan hollow capsule disintegrates sai thiab muaj oxygen permeability tsawg heev.Nws yog tsim rau muaj zog txo cov tshuaj.Cov yam ntxwv sib txawv ua rau ntau yam hollow capsule cov khoom lag luam ua tiav hauv cov khw tshwj xeeb thiab cov khoom lag luam.
REFERENCES
[1] La Wall, CH, 4000 xyoo ntawm lub tsev muag tshuaj, keeb kwm ntawm lub tsev muag tshuaj thiab cov kev tshawb fawb sib koom, JB Lippincott Comp., Philadelphia/London/Montreal, 1940
[2] Feldhaus, FM: Zur Geschichte der Arzneikapsel.Dtsch.Apoth.-Ztg, 94 (16), 321 (1954)
[3] Französisches Patent Nr.5648, Erteilt am 25. März 1834
[4] Planche und Gueneau de Mussy, Bulletin de I'Académie Royale de Médecine, 442-443 (1837)
[5] Graham Cole, Kev Ntsuam Xyuas Kev Txhim Kho thiab Kev Tsim Nyog Tus Nqi: Cov ntsiav tshuaj Versus Capsugels.Capsugel Library
Post lub sij hawm: May-06-2022