Capsule ke e 'ngoe ea mefuta ea khale ea litekanyetso tsa lithethefatsi, e qalileng Egepeta ea boholo-holo [1].De Pauli, rakhemisi oa Vienna, o boletse bukeng ea hae ea maeto ka 1730 hore li-capsules tsa Oval li ne li sebelisetsoa ho koahela monko o mobe oa lithethefatsi ho fokotsa bohloko ba bakuli [2].Lilemo tse fetang 100 hamorao, bo-rakhemisi Joseph Gerard Auguste dublanc le Francois Achille Barnabe motors ba ile ba fumana patent ea "gelatin capsule" ea pele ea lefats'e ka 1843 'me ba tsoela pele ho e ntlafatsa ho ikamahanya le tlhahiso ea indasteri [3,4];Ho tloha ka nako eo, litokelo tse ngata tsa li-capsules tse se nang letho li hlahile.Ka 1931, Arthur Colton oa k'hamphani ea Parke Davis e atlehile ho rala le ho etsa thepa ea boiketsetso ea capsule e se nang letho 'me a hlahisa capsule ea pele e entsoeng ka mochini e entsoeng ka mochini.Hoa thahasellisa hore ho fihlela joale, mohala oa tlhahiso ea capsule o se nang letho o ntse o ntlafatsoa ka mokhoa o tsoelang pele motheong oa moralo oa Arthur oa ho ntlafatsa boleng ba sehlahisoa le katleho ea tlhahiso.
Hona joale, capsule e entse tsoelo-pele e kholo le e potlakileng tšimong ea tlhokomelo ea bophelo bo botle le k'hemisteng, 'me e fetohile e' ngoe ea mefuta e ka sehloohong ea litekanyetso tsa litokisetso tse tiileng tsa molomo.Ho tloha ka 1982 ho isa ho 2000, har'a litlhare tse ncha tse amohetsoeng lefatšeng ka bophara, mefuta ea litekanyetso tse thata tsa capsule e bonts'itse mokhoa o nyolohileng.
Setšoantšo sa 1 Ho tloha ka 1982, lithethefatsi tse ncha tsa molek'hule li 'nile tsa bapisoa pakeng tsa li-capsules le matlapa
Ka nts'etsopele ea tlhahiso ea meriana le indasteri ea R & D, melemo ea li-capsules e lemohuoe haholoanyane, haholo-holo likarolong tse latelang:
1. Likhetho tsa mokuli
Ha ho bapisoa le mefuta e meng ea litekanyetso, li-capsules tse thata li ka koahela monko o mobe oa lithethefatsi 'me li bonolo ho li metsa.Mebala e fapaneng le meralo ea khatiso e etsa hore lithethefatsi li bonahale haholoanyane, e le hore li ka ntlafatsa ho latela melao ea lithethefatsi.Ka 1983, phuputso e entsoeng ke ba boholong Europe le Amerika e bontšitse hore har'a bakuli ba 1000 ba khethiloeng, 54% ba khetha li-capsules tse thata, 29% ba khethile li-pellets tse koahetsoeng ka tsoekere, ke 13% feela ba khethileng matlapa, 'me ba bang ba 4% ha baa ka ba etsa khetho e hlakileng.
2. Tšebeliso e phahameng ea R & D
Tlaleho ea tufts ea 2003 e bontšitse hore litšenyehelo tsa lipatlisiso le nts'etsopele ea lithethefatsi li eketsehile ka 55% ho tloha 1995 ho ea 2000, 'me litšenyehelo tsa lefats'e tsa lipatlisiso le nts'etsopele ea lithethefatsi li fihlile ho liranta tse limilione tse 897 tsa US.Joalo ka ha bohle re tseba, litlhare tsa pejana li thathamisitsoe, nako e telele ea 'maraka oa lithethefatsi tse nang le tokelo ea molao e tla ba telele,' me phaello e ncha ea lithethefatsi ea likhoebo tsa meriana e tla eketseha haholo.Karolelano ea li-excipients tse sebelisoang ka li-capsules e ne e le 4, e neng e fokotsehile haholo ha e bapisoa le 8-9 matlapeng;Lintho tsa tlhahlobo ea li-capsules le tsona li tlase, 'me litšenyehelo tsa ho theha mokhoa, netefatso le tlhahlobo e batla e le halofo ea matlapa.Ka hona, ha ho bapisoa le matlapa, nako ea ntlafatso ea li-capsules bonyane halofo ea selemo e khuts'oane ho feta ea matlapa.
Ka kakaretso, 22% ea mekhatlo e mecha ea lipatlisiso le nts'etsopele ea lithethefatsi e ka kena litekong tsa tleliniki tsa mohato oa I, tseo ka tlase ho 1/4 e ka fetisang liteko tsa tleliniki tsa mohato oa III.Ho hlahlojoa ha metsoako e mecha ho ka fokotsa ka katleho litšenyehelo tsa lipatlisiso tse ncha tsa lithethefatsi le mekhatlo ea ntlafatso kapele kamoo ho ka khonehang.Ka hona, indasteri ea lefats'e ea ho etsa li-capsules e se nang letho e thehile li-capsules (pccaps) tse loketseng liteko tsa litoeba ®）； Precision micro filling equipment (xcelodose) e loketseng tlhahiso ea sampuli ea capsule ea kliniki ®）， Le li-capsules tse foufetseng habeli (dbcaps) tse loketseng. bakeng sa liteko tse kholo tsa kliniki ®) Le lihlahisoa tse felletseng tse tšehetsang Phokotso ea litšenyehelo tsa R&D le ho ntlafatsa ts'ebetso ea R&D.
Ho feta moo, ho na le mefuta e fetang 9 ea li-capsules ka boholo bo fapaneng, e fanang ka likhetho tse ngata bakeng sa moralo oa tekanyo ea lithethefatsi.Tsoelo-pele ea theknoloji ea ho itokisa le lisebelisoa tse amanang le tsona li boetse li etsa hore capsule e tšoanelehe bakeng sa metsoako e mengata e nang le thepa e khethehileng, e kang metsoako e ke keng ea qhibiliha ka metsing.Tlhahlobo e bonts'a hore 50% ea mekhatlo e mecha e fumanoeng ka tlhahlobo e phahameng ea tlhahlobo le k'hemistri e kopaneng ha e qhibilihe ka metsing (20%) μ G / ml), li-capsules tse tlatsitsoeng ka metsi le li-capsules tse bonolo li ka fihlela litlhoko tsa tokisetso ena ea motsoako.
3. Theko e tlaase ea tlhahiso
Ha ho bapisoa le matlapa, workshop ea tlhahiso ea GMP ea li-capsules tse thata li na le melemo ea lisebelisoa tse fokolang tsa ts'ebetso, tšebeliso ea sebaka se phahameng, mokhoa o utloahalang haholoanyane, linako tse fokolang tsa ho hlahloba ts'ebetsong ea tlhahiso, litekanyetso tse fokolang tsa taolo ea boleng, basebetsi ba fokolang, kotsi e tlaase ea tšilafalo ea sefapano, e bonolo. mokhoa oa ho lokisetsa, mekhoa e fokolang ea tlhahiso, lisebelisoa tse thusang tse bonolo le theko e tlaase.Ho ea ka khakanyo ea litsebi tse nang le matla a matla, litšenyehelo tse felletseng tsa li-capsules tse thata li tlase ho 25-30% ho feta tsa matlapa [5].
Ka nts'etsopele e matla ea li-capsules, li-capsules tse sekoti, e le e 'ngoe ea li-excipients tse ka sehloohong, le tsona li na le ts'ebetso e ntle.Ka 2007, kakaretso ea thekiso ea li-capsules tse se nang letho lefatšeng e fetile limilione tse likete tse 310, tseo 94% ea tsona e leng li-capsules tse nang le gelatin, ha tse ling tse 6% li tsoa ho li-capsules tse seng tsa liphoofolo, tseo sekhahla sa kholo ea selemo le selemo sa hydroxypropyl methylcellulose (HPMC). ) li-capsules tse sekoti li feta 25%.
Keketseho e kholo ea thekiso ea li-capsules tse sa hlahisoang ke liphoofolo li bonts'a mokhoa oa ho buella lihlahisoa tsa tlhaho lefatšeng.Ka mohlala, United States feela, ho na le batho ba limilione tse 70 “ba e-s’o ka ba ja lihlahisoa tse entsoeng ke liphoofolo”, ’me karolo ea 20 lekholong ea baahi bohle ke “ba sa jeng nama”.Ntle le mohopolo oa tlhaho, li-capsules tse se nang phoofolo tse se nang letho le tsona li na le litšobotsi tsa tsona tse ikhethang tsa tekheniki.Mohlala, li-capsules tse sekoti tsa HPMC li na le metsi a tlase haholo le boima bo botle, 'me li loketse litaba tse nang le hygroscopicity le kutloisiso ea metsi;Pullulan hollow capsule e qhalana ka potlako mme e na le ho kenella ha oksijene e tlase haholo.E loketse ho fokotsa lintho tse matla.Litšobotsi tse fapaneng li etsa hore lihlahisoa tse fapaneng tsa capsule li atlehe mebarakeng e itseng le ka mekhahlelo ea lihlahisoa.
LIEKETSENG
[1] La Wall, CH, lilemo tse 4000 tsa k'hemistri, nalane ea kemiso ea likhemisi le mahlale a kopaneng, 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, Ho Lekola Litšenyehelo tsa Tsoelo-pele le Tlhahiso: Matlapa a Bapisoa le Capsugels.Laebrari ea Capsugel
Nako ea poso: May-06-2022