Capsule ni bumwe mu buryo bwa kera bw'ibiyobyabwenge, byatangiriye mu Misiri ya kera [1].De Pauli, umufarumasiye i Vienne, yavuze mu gitabo cye cy’urugendo mu 1730 ko capsules ya Oval yakoreshejwe mu gupfukirana impumuro mbi y’ibiyobyabwenge kugira ngo ububabare bw’abarwayi bugabanuke [2].Nyuma yimyaka irenga 100, abafarumasiye Joseph Gerard Auguste dublanc na moteri ya Francois Achille Barnabe babonye ipatanti ya capsule ya mbere ya gelatine ku isi mu 1843 kandi bakomeza kuyitezimbere kugirango ihuze n’inganda zikora inganda [3,4];Kuva icyo gihe, havutse patenti nyinshi kuri capsules zidafite akamaro.Mu 1931, Arthur Colton wo muri sosiyete ya Parke Davis yateguye neza kandi akora ibikoresho byikora byikora byikora capsule kandi akora capsule ya mbere yakozwe ku isi.Igishimishije, kugeza ubu, umurongo utanga umusaruro wa capsule wongeyeho gusa ubudahwema hashingiwe ku gishushanyo cya Arthur cyo kuzamura ibicuruzwa no gukora neza.
Kugeza ubu, capsule yagize iterambere rikomeye kandi ryihuse mubijyanye n'ubuvuzi na farumasi, kandi ibaye imwe mu miti nyamukuru yo gutegura umunwa.Kuva 1982 kugeza 2000, mumiti mishya yemejwe kwisi yose, dosiye ya capsule ikomeye yerekanaga kuzamuka.
Igishushanyo 1 Kuva 1982, imiti mishya ya molekile yagereranijwe hagati ya capsules na tableti
Hamwe niterambere ryinganda zikora imiti ninganda za R & D, ibyiza bya capsules byamenyekanye cyane cyane mubice bikurikira:
1. Ibyifuzo by'abarwayi
Ugereranije nubundi buryo bwa dosiye, capsules irashobora guhisha neza impumuro mbi yibiyobyabwenge kandi byoroshye kuyimira.Amabara atandukanye hamwe nigishushanyo mbonera bituma ibiyobyabwenge byamenyekana, kugirango bitezimbere neza iyubahirizwa ryibiyobyabwenge.Mu 1983, ubushakashatsi bwakozwe n'abayobozi b'Abanyaburayi n'Abanyamerika bwerekanye ko mu barwayi 1000 batoranijwe, 54% bahisemo capsules zikomeye, 29% bahitamo isukari isukuye isukari, 13% bonyine ni bo bahisemo ibinini, naho abandi 4% ntibahitamo neza.
2. Gukora neza R&D
Raporo ya tufts yo mu 2003 yerekanye ko ikiguzi cy’ubushakashatsi bw’ibiyobyabwenge n’iterambere cyiyongereyeho 55% kuva mu 1995 kugeza mu 2000, kandi impuzandengo y’ibiciro by’ubushakashatsi ku iterambere n’ibiyobyabwenge ku isi igera kuri miliyoni 897 z’amadolari y’Amerika.Nkuko twese tubizi, ibiyobyabwenge byashyizwe ku rutonde, igihe kirekire cyo kwiharira isoko ku biyobyabwenge byemewe, kandi inyungu nshya z’imiti y’imiti y’imiti iziyongera ku buryo bugaragara.Impuzandengo y'ibicuruzwa byakoreshejwe muri capsules byari 4, byagabanutse cyane ugereranije na 8-9 muri tableti;Ibikoresho byo gupima capsules nabyo ni bike, kandi ikiguzi cyo gushiraho uburyo, kugenzura no gusesengura hafi kimwe cya kabiri cyibinini.Kubwibyo, ugereranije na tableti, igihe cyiterambere cya capsules byibuze igice cyumwaka mugufi ugereranije nibinini.
Mubisanzwe, 22% byibintu bishya byubushakashatsi mubushakashatsi no guteza imbere ibiyobyabwenge bishobora kwinjira mu cyiciro cya mbere cy’amavuriro, aho munsi ya 1/4 gishobora gutsinda icyiciro cya gatatu cy’amavuriro.Kugenzura ibice bishya birashobora kugabanya neza igiciro cyibigo bishya byubushakashatsi bwibiyobyabwenge niterambere ryihuse.Kubwibyo, inganda zikora capsule ku isi zateje imbere capsules (pccaps) ikwiranye nigeragezwa ryimbeba ®） equipment Ibikoresho byuzuye bya mikorobe yuzuye (xcelodose) bikwiranye no gukora imiti ya capsule ivura ®） ， na capsules ya kabiri-impumyi (dbcaps) ibereye kubigeragezo binini byamavuriro ®） Kandi ibicuruzwa byuzuye kugirango dushyigikire kugabanya ibiciro bya R & D no kunoza imikorere ya R & D.
Mubyongeyeho, hari ubwoko burenga 9 bwa capsules mubunini butandukanye, butanga amahitamo menshi mugushushanya ibiyobyabwenge.Iterambere rya tekinoroji yo gutegura nibikoresho bifitanye isano nabyo bituma capsule ikwiranye nibindi byinshi bifite imiterere yihariye, nkibintu bitangirika mumazi.Isesengura ryerekana ko 50% byibintu bishya byabonetse byabonetse binyuze mugupima ibintu byinshi hamwe na chimie ya kombinatori idashobora gukama mumazi (20%) μ G / ml), capsules yuzuye amazi hamwe na capsules yoroshye birashobora guhaza ibikenewe muri iyi myiteguro.
3. Igiciro gito cy'umusaruro
Ugereranije na tableti, amahugurwa yumusaruro wa GMP ya capsules akomeye afite ibyiza byibikoresho bitunganijwe bike, gukoresha umwanya munini, imiterere ihamye, igihe gito cyo kugenzura mubikorwa, umusaruro muke wo kugenzura ubuziranenge, abadafite ubushobozi buke, ibyago bike byo kwanduza umusaraba, byoroshye inzira yo kwitegura, uburyo buke bwo gukora, ibikoresho byoroshye byingirakamaro hamwe nigiciro gito.Dukurikije igereranyo cy’inzobere zemewe, igiciro cyuzuye cya capsules kiri munsi ya 25-30% ugereranije n’ibinini [5].
Hamwe niterambere rikomeye rya capsules, capsules zidafite akamaro, nkimwe mubintu byingenzi bikurura, nabyo bifite imikorere myiza.Mu 2007, igiteranyo cyagurishijwe cyose cya capsules ku isi cyarenze miliyari 310, muri zo 94% ni capsules ya gelatin, mu gihe izindi 6% zikomoka kuri capsules zidakomoka ku nyamaswa, muri zo umuvuduko w’ubwiyongere bwa buri mwaka wa hydroxypropyl methylcellulose (HPMC) ) capsules yuzuye irenze 25%.
Ubwiyongere bukabije mu igurishwa ry’ibikomoka ku nyamaswa bitavuye mu mazi byerekana uburyo bwo gukoresha ibicuruzwa byunganira isi.Urugero, muri Amerika honyine, hari miliyoni 70 z'abantu “batigeze barya ibikomoka ku nyamaswa”, naho 20% by'abaturage bose ni “ibikomoka ku bimera”.Usibye igitekerezo gisanzwe, inyamaswa zidakomoka kuri capsules nazo zifite imiterere yihariye ya tekiniki.Kurugero, capsules ya HPMC ifite amazi make cyane hamwe nubukomezi bwiza, kandi irakwiriye kubirimo hamwe na hygroscopicity hamwe no kumva amazi;Pullulan hollow capsule isenyuka vuba kandi ifite umwuka wa ogisijeni muke cyane.Birakwiriye kugabanya ibintu bikomeye.Ibiranga ibintu bitandukanye bituma ibicuruzwa bitandukanye bya capsule bigenda neza mumasoko yihariye nibyiciro byibicuruzwa.
INGINGO
[1] La Wall, CH, imyaka 4000 ya farumasi, amateka yerekana farumasi nubumenyi bufatanije, 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, Gusuzuma Iterambere nigiciro cyumusaruro: Ibinini na Capsugels.Isomero rya Capsugel
Igihe cyo kohereza: Gicurasi-06-2022