Ibintu bisanzwe byamafranga akomeye ya dosiye

Imyiteguro ihamye nubu ikwirakwizwa cyane kandi ikoreshwa cyane kumasoko, kandi mubisanzwe bigizwe nibintu bibiri byingenzi nibisohoka.Ibicuruzwa, bizwi kandi nkibicuruzwa, bivuga ijambo rusange kubikoresho byose byongeweho mugutegura gukomeye usibye ibiyobyabwenge nyamukuru.Ukurikije imitungo n'imikorere itandukanye yabatumije, ibicuruzwa byimyiteguro ihamye akenshi bigabanyijemo: ibyuzuza, binders, disintegrants, lubricants, abashinzwe kurekura, kandi rimwe na rimwe ibintu bisiga amabara hamwe nuburyohe bwo guhumura nabyo birashobora kongerwaho ukurikije ibisabwa byateguwe. kunoza Cyangwa guhindura isura nuburyohe bwa formulaire.
Ibicuruzwa byimyiteguro ihamye bigomba kuba byujuje ibisabwa kugirango bikoreshwe mu miti, kandi bifite ibimenyetso bikurikira: tBigomba kugira imiti ihamye y’imiti kandi ntibigire ingaruka zifatika n’imiti n’ibiyobyabwenge;TNtibigomba kugira ingaruka zo kuvura no kugena ibiyigize imiti nyamukuru;ONtabwo byangiza umubiri wumuntu Byangiza, uburozi butanu, nta reaction mbi.
1. Uzuza (yoroheje)
Bitewe numubare muke wibiyobyabwenge nyamukuru, ikinini cyibiyobyabwenge rimwe na rimwe ni miligarama nkeya cyangwa munsi yacyo, ibyo bikaba bidakorwa muburyo bwo gukora ibinini cyangwa mubuvuzi.Kubwibyo, mugihe ibiyobyabwenge byingenzi bitarenze 50mg, ikinini cyuzuza, kizwi kandi nka diluent, kigomba kongerwaho.
Icyuzuzo cyiza kigomba kuba inert physiologique na chimique kandi ntigire ingaruka kuri bioavailable yibintu bikora byibiyobyabwenge.Ibyuzuzwa bikoreshwa cyane cyane birimo: arch Ibinyamisogwe, harimo ibinyamisogwe by ingano, ibinyamisogwe by ibigori, hamwe n ibirayi byibirayi, muri byo ibinyamisogwe ni byo bikoreshwa cyane;itajegajega muri kamere, hasi muri hygroscopicity, ariko ikennye muri compressible;② Lactose, nziza cyane mumiterere kandi igabanuka, itemba neza;③ sucrose, ifite hygroscopicity ikomeye;Arch pregelatinized krah, izwi kandi nka compressible krah, ifite compressible nziza, fluidity and self-lubricity;⑤ microcrystalline selulose, yitwa MCC, ifite ubushobozi bukomeye bwo guhuza no kwikuramo neza;bizwi nka “binder yumye”;AnnMannitol, ugereranije niyuzuza hejuru, ihenze gato, kandi ikoreshwa kenshi mubinini byononekaye, nayo ifite uburyohe bworoshye;Sunyunyu ngugu, cyane cyane harimo calcium sulfate, calcium fosifate, calcium karubone, nibindi, bifite imiterere ihamye yumubiri nubumara.
2. Umuti woza no gufatira hamwe
Ibikoresho byo guhanagura hamwe na binders ni ibicuruzwa byongewe mugihe cyo guhunika.Igikoresho cyo guhanagura ubwacyo nticyoroshye, ahubwo ni amazi atera ubwiza bwibintu mu guhanagura ibikoresho.Ibikoresho bikunze gukoreshwa cyane birimo amazi yatoboye na Ethanol, muri byo amazi yatoboye niyo mahitamo ya mbere.
Ibifatika bivuga ibikoresho bifasha bishingiye ku bwenge bwabo bwite kugirango bitange ibikoresho bitagaragara neza cyangwa bidahagije hamwe nubukonje bukwiye.Ibikoreshwa bisanzwe bifata cyane cyane harimo: arch Ibinyamisogwe, ni kimwe mu bifata cyane, bihendutse, kandi bifite imikorere myiza, kandi kwibanda cyane ni 8% -15%;EtMethylcellulose, yitwa MC, ifite amazi meza;③Hydroxypropylcellulose, yitwa HPC, irashobora gukoreshwa nkifu ya pisine itaziguye;YHydroxypropylmethylcellulose, yitwa HPMC, ibikoresho bishonga mumazi akonje;SodiumCarboxymethylcellulose sodium, yitwa CMC-Na, ibereye ibiyobyabwenge bifite compression nke;⑥Ethylcellulose, byitwa EC, ibikoresho ntibishobora gushonga mumazi, ariko bigashonga muri Ethanol;⑦Povidone, yitwa PVP, ibikoresho ni hygroscopique cyane, bigashonga mumazi na Ethanol;⑧ Mubyongeyeho, hariho polyethylene glycol (bita PEG), Ibikoresho nka gelatine.
3. Gutandukana
Disintegrants bivuga ibintu bitera imbaraga gusenyuka byihuse ibinini mubice byiza mumazi ya gastrointestinal.Usibye ibinini byo munwa hamwe nibisabwa byihariye nkibisohoka-bisohora ibinini, ibiyobora-bisohora ibinini, hamwe na tableti yahekenya, ibidakenewe muri rusange bigomba kongerwaho.Ibisanzwe bikoreshwa ni: arch ibinyamisogwe byumye, bikwiriye imiti idashobora gushonga cyangwa ibishishwa bike;② carboxymethyl krahisi sodium, yitwa CMS-Na, ibi bikoresho ni imikorere idahwitse;Hyd hydroxypropyl selulose isimbuwe nkeya, bita L -HPC, ishobora kubyimba vuba nyuma yo gufata amazi;SodiumCode ihuza methyl selulose sodium, yitwa CCMC-Na;ibikoresho byabyimbye mbere mumazi hanyuma bigashonga, kandi ntibishobora gushonga muri Ethanol;Ikibi ni uko ifite hygroscopique ikomeye kandi ikoreshwa cyane mugusya ibinini bya effevercent cyangwa ibinini byoroshye;⑥Imikorere idahwitse irimo cyane cyane ivangwa rya sodium bicarbonate na aside citric, na aside citric, aside fumaric, na sodium karubone nayo irashobora gukoreshwa, Potasiyumu Carbonate na Potasiyumu Bicarbonate nibindi.
4. Amavuta
Amavuta yo kwisiga arashobora kugabanwa mubice bitatu, harimo glidants, anti-sticking, na lubricants muburyo buke.Id Glidant: umurimo wacyo nyamukuru ni ukugabanya ubushyamirane buri hagati y’ibice, kunoza amazi ya poro, no gufasha kugabanya itandukaniro ryibiro byibinini;Ant anti-sticking agent: umurimo wingenzi wacyo ni ukurinda kwizirika mugihe cyo kwikuramo ibinini, Kugirango habeho imikorere myiza yo kwikuramo ibinini, birashobora kandi kunoza isura yibinini;Uv chivalrous lubricant: gabanya ubushyamirane buri hagati yibikoresho nurukuta rwubatswe, kugirango umenye neza imikorere ya compression yo gusunika no gusunika.Amavuta akoreshwa cyane (muburyo bwagutse) harimo ifu ya talc, magnesium stearate (MS), silika gel ya micronize, polyethylene glycols, sodium lauryl sulfate, amavuta yimboga ya hydrogenated, nibindi.
5. Kurekura modulator
Abashinzwe kurekura ibinini byo mu kanwa birakwiriye kugenzura umuvuduko n’urwego rwo gusohora ibiyobyabwenge mu myiteguro ikomeza-kurekura mu kanwa, kugirango harebwe niba imiti igezwa ku barwayi ku muvuduko runaka kandi igakomeza kwibanda cyane mu ngingo cyangwa mu mubiri. , bityo Kubona ingaruka ziteganijwe zo kuvura no kugabanya uburozi ningaruka.Ibisanzwe bikoreshwa mugusohora bigabanijwe cyane mubwoko bwa matrix, firime-yashizwemo buhoro-gusohora polymer no kubyimba.
(1) Moderi yo kurekura moderi
MaterialHydrophilic gel skeleton material: irabyimba iyo ihuye namazi kugirango ibe inzitizi ya geli yo kugenzura irekurwa ryibiyobyabwenge, bikunze gukoreshwa ni methyl selulose, carboxymethyl selulose, hydroxypropyl selulose, povidone, karbomer, aside alginic Umunyu, chitosan, nibindi.
Material Ibikoresho bya skeleton idashobora gushonga: Ibikoresho bya skeleton bitangirika bivuga polymer muremure cyane idashobora gushonga mumazi cyangwa ifite amazi make.Bikunze gukoreshwa cyane cyane ni Ethyl selulose, polyethylene, polyethylene yuburozi butanu, aside polymethacrylic, Ethylene-vinyl acetate copolymer, reberi ya silicone, nibindi.
Materials Ibikoresho bya bioerodible: Ibikoresho bisanzwe bikoreshwa bioerodible harimo ibinure byinyamanswa, amavuta y’ibimera ya hydrogène, ibishashara, inzoga ya stearyl, ibishashara bya karnauba, monostearate ya glyceryl, nibindi.
(2) Impinduka irekuwe
Ibikoresho bya polymer bidashobora gukemuka: ibikoresho bya skeleton bisanzwe bitangirika nka EC.
Material Ibikoresho bya polymeriki: ibikoresho bya enterineti bisanzwe byinjizwamo ahanini birimo resin ya acrylic, L-na S-S, hydroxypropylmethylcellulose acetate succinate (HPMCAS), selulose acetate phthalate (CAP), hydroxypropylmethylcellulose phthalate (HPMCP), nibindi. hejuru ibikoresho mumitobe y amara, kandi bigashonga mubice byihariye kugirango bigire uruhare.
6. Ibindi bikoresho
Usibye ibicuruzwa byavuzwe haruguru bikunze gukoreshwa, ibindi byongeweho rimwe na rimwe byongerwaho kugirango bigerweho neza nubuyobozi bwibiyobyabwenge, kunoza ibiyobyabwenge cyangwa kunoza kubahiriza.Kurugero, amabara, uburyohe no kuryoshya ibintu.
Agent Amabara: Intego nyamukuru yo kongeramo ibi bikoresho nukuzamura isura ya tablet kandi byoroshye kumenya no gutandukanya.Ibicuruzwa bisanzwe bikoreshwa bigomba kuba byujuje ibya farumasi, kandi amafaranga yongeweho ntagomba kurenza 0.05%.
RomAromatike n'ibijumba: Intego nyamukuru ya aromatique hamwe nibisosa ni ukunoza uburyohe bwimiti, nkibinini byinyoye hamwe nibinini byangiza.Impumuro nziza ikoreshwa cyane harimo essence, amavuta atandukanye ya aromatiya, nibindi.;ibisanzwe bikoreshwa muburyohe cyane harimo sucrose, aspartame, nibindi