Capsule ndeimwe yemhando dzekare dzemushonga, dzakatangira kuEgypt yekare [1].De Pauli, wezvemishonga muVienna, akataura mubhuku rake rekufamba muna 1730 kuti Oval capsules akashandiswa kuvhara kunhuhwirira kwakashata kwemishonga kuderedza marwadzo evarwere [2].Makore anopfuura 100 gare gare, vemishonga Joseph Gerard Auguste dublanc naFrancois Achille Barnabe motors vakawana patent yenyika yekutanga gelatin capsule muna 1843 uye vakaramba vachiivandudza kuti ienderane nekugadzirwa kwemaindasitiri [3,4];Kubva ipapo, patents akawanda pahollow capsules akazvarwa.Muna 1931, Arthur Colton weParke Davis kambani akabudirira kugadzira nekugadzira otomatiki midziyo yekugadzira ye hollow capsule uye akagadzira yekutanga pasire-yakagadzirwa hollow capsule.Sezvineiwo, kusvika pari zvino, iyo hollow capsule yekugadzira mutsara yakangoramba ichivandudzwa pahwaro hwekugadzirwa kwaArthur kuvandudza kunaka kwechigadzirwa uye kugona kugadzira.
Parizvino, capsule yakaita hukuru uye nekukurumidza kukura mumunda wehutano hwehutano uye pharmacy, uye yave imwe yemhando huru yedoseji yemuromo yakasimba kugadzirira.Kubva 1982 kusvika 2000, pakati pemishonga mitsva yakatenderwa pasi rose, hard capsule dosage mafomu airatidza kukwira kumusoro.
Mufananidzo 1 Kubva 1982, mishonga mitsva yemamorekuru yakaenzaniswa pakati pemacapsules nemapiritsi
Nekuvandudzwa kwekugadzirwa kwemishonga uye indasitiri yeR & D, zvakanakira macapsules zvave kuzivikanwa zvakanyanya, kunyanya mune zvinotevera zvinhu:
1. Zvido zvemurwere
Kuenzaniswa nemamwe mafomu ekuyerwa, ma capsules akaoma anogona kunyatsovhara kunhuhwirira kwakashata kwezvinodhaka uye zviri nyore kumedza.Mavara akasiyana-siyana uye magadzirirwo ekudhinda anoita kuti zvinodhaka zvinyatsozivikanwa, kuitira kuti zvinyatso kuvandudza kutevedza kwemishonga.Muna 1983, tsvakurudzo yakaitwa nevakuru veEurope neAmerica yakaratidza kuti pakati pevarwere ve1000 vakasarudzwa, 54% yaifarira ma capsules akaoma, 29% yakasarudza shuga yakaputirwa pellets, 13% chete yakasarudza mapiritsi, uye imwe 4% haina kuita sarudzo yakajeka.
2. Yakakwirira R & D Kubudirira
Chirevo che2003 tufts chakaratidza kuti mutengo wekutsvagisa nekusimudzira zvinodhaka wakawedzera ne55% kubva 1995 kusvika 2000, uye avhareji mutengo wepasi rose wekutsvaga zvinodhaka nekusimudzira wasvika 897 mamirioni emadhora ekuAmerica.Sezvatinoziva tese, mishonga yekutanga yakanyorwa, iyo nguva yakareba yemusika yemishonga ine patent ichave, uye mitsva yemushonga yemabhizinesi emishonga ichawedzera zvakanyanya.Ivhareji yenhamba yezvinyorwa zvinoshandiswa mu capsules yaiva 4, iyo yakanyanya kuderedzwa kana ichienzaniswa ne8-9 mumapiritsi;Zvinhu zvekuyedzwa zvemacapsules zvakare zvakaderera, uye mutengo wekumisikidzwa kwenzira, kuongororwa uye kuongororwa ingangoita hafu yemapiritsi.Nokudaro, kana ichienzaniswa nemapiritsi, nguva yekuvandudza ye capsules inenge hafu yegore ipfupi pane yemapiritsi.
Kazhinji, 22% yezvitsva zvemubatanidzwa mukutsvaga zvinodhaka nekusimudzira zvinogona kupinda muchikamu I miyedzo yekiriniki, iyo isingasviki 1/4 inogona kupfuura chikamu chechitatu chekiriniki miedzo.Kuongororwa kwemishonga mitsva kunogona kudzikisa zvinobudirira mutengo wekutsvaga zvinodhaka zvitsva uye masangano ekusimudzira nekukurumidza.Naizvozvo, indasitiri yekugadzira kapisi yepasi rose yakagadzira preclinical capsules (pccaps) yakakodzera kuedzwa kwegonzo®）; Precision micro kuzadza midziyo (xcelodose) yakakodzera kugadzirwa kwemakiriniki capsule samples ®) , Uye kiriniki yakapetwa kaviri-mapofu capsules (dbcaps) yakakodzera. yezviyedzo zvakakura zvekiriniki ®) Uye huwandu hwakazara hwezvigadzirwa kutsigira Kuderedza R & D mutengo nekuvandudza R & D kushanda zvakanaka.
Uye zvakare, kune anopfuura 9 marudzi emakapisi muhukuru hwakasiyana, izvo zvinopa akawanda sarudzo dzekugadzirwa kwedoro rezvinodhaka.Iko kuvandudza tekinoroji yekugadzirira uye midziyo yakabatana inoitawo iyo capsule yakakodzera kune mamwe makomisheni ane akakosha zvivakwa, senge makomisheni isinganyungudika mumvura.Ongororo iyi inoratidza kuti 50% yezvikamu zvitsva zvemusanganiswa zvakawanikwa kuburikidza ne-high-throughput screening uye combinatorial chemistry hainyungudike mumvura (20%) μ G / ml), ese ari maviri emvura akazadzwa capsules uye akapfava capsules anogona kusangana nezvinodiwa zveiyi komputa gadziriro.
3. Mari yekugadzira yakaderera
Kuenzaniswa nemapiritsi, iyo GMP yekugadzira workshop yeakaoma capsules ine zvakanakira zvezvishoma process midziyo, yakakwirira nzvimbo kushandiswa, inonzwisisika marongerwo, nguva shoma yekuongorora mukugadzira maitiro, kushomeka kwemhando yekudzora paramita, vashoma vanoshanda, yakaderera njodzi yekusvibiswa kwemuchinjikwa, nyore. nzira yekugadzirira, maitiro mashoma ekugadzira, zviri nyore zvekubatsira zvinhu uye mutengo wakaderera.Maererano nekufungidzira kwevanyanzvi vane chiremera, mutengo wakakwana wemapulisi akaoma ndeye 25-30% yakaderera pane yemapiritsi [5].
Nekukura kwakasimba kwemakapisi, hollow capsules, seimwe yeanonyanya kubatsira, anewo kuita kwakanaka.Muna 2007, huwandu hwekutengesa huwandu hwehollow capsules munyika hwakapfuura 310 bhiriyoni, iyo 94% igelatin hollow capsules, nepo imwe 6% ichibva kune asiri mhuka akatorwa makapule, ayo epagore kukura kwehydroxypropyl methylcellulose (HPMC). ) hollow capsules inodarika 25%.
Kuwedzera kukuru kwekutengesa kwemakapisi asiri emhuka ega ega kunoratidza maitiro ekushandisa ekusimudzira zvigadzirwa zvechisikigo munyika.MuUnited States chete, semuenzaniso, kune vanhu vane mamiriyoni e70 "vasina kumbodya zvigadzirwa zvemhuka", uye 20% yehuwandu hwevanhu "vegetarians".Pamusoro peiyo pfungwa yechisikigo, asiri mhuka akatorwa hollow capsules anewo akasarudzika maitiro ehunyanzvi.Semuyenzaniso, HPMC hollow capsules ane yakaderera mvura zvirimo uye kunaka kuoma, uye akakodzera zviri mukati ane hygroscopicity uye mvura kunzwa;Pullulan hollow capsule inoparara nekukasira uye ine yakaderera kwazvo oksijeni permeability.Yakakodzera kune yakasimba kuderedza zvinhu.Hunhu hwakasiyana hunoita kuti akasiyana hollow capsule zvigadzirwa zvibudirire mumisika chaiyo uye mhando dzechigadzirwa.
REFERENCES
[1] La Wall, CH, 4000 makore emishonga, rondedzero nhoroondo yemishonga uye yakabatana sainzi, 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, Kuongorora Kuvandudza uye Mari Yekugadzira : Mahwendefa Versus Capsugels.Capsugel Library
Nguva yekutumira: Chivabvu-06-2022