Mu igeragezwa no gutanga umusaruro mwinshi wa nifedipine ibinini bisohora-ibinini, ibinini byo kuboneza urubyaro, ibinini byangiza igifu, ibinini bya ferrous fumarate, ibinini bya hydrochloride ya buflomedil, nibindi, dukoreshahydroxypropyl methylcellulose (HPMC)amazi, Hydroxypropyl methylcellulose na aside polyacrylic acide resin, Opadry (itangwa na Colorcon, UK), nibindi nibindi bisukamo amafirime, yakoresheje neza tekinoroji yo gutwika firime, ariko yahuye nibibazo mubikorwa byo kugerageza no kuyikora. Nyuma yibibazo bimwe na bimwe bya tekiniki, ubu turimo kuvugana nabagenzi bacu kubibazo rusange nibisubizo muburyo bwo gutunganya film.
Mu myaka yashize, tekinoroji yo gutwika firime yakoreshejwe cyane mu myiteguro ihamye. Ipitingi ya firime irashobora kurinda ibiyobyabwenge urumuri, ubushuhe numwuka kugirango byongere umutekano wibiyobyabwenge; shyira uburyohe bubi bwibiyobyabwenge kandi byorohereze umurwayi kubifata; kugenzura aho barekura no kurekura umuvuduko wibiyobyabwenge; irinde ihinduka ryibiyobyabwenge; kunoza isura ya tablet Tegereza. Ifite kandi ibyiza byo gukora bike, igihe gito, gukoresha ingufu nke, no kongera ibiro bya tablet. Ubwiza bwibinini bikozwe muri firime biterwa ahanini nuburinganire nubwiza bwibikoresho bya tablet, kwandikirwa amazi ya coating, imiterere yimikorere, uburyo bwo gupakira no kubika, nibindi. Ibigize nubwiza bwibikoresho bya tablet bigaragarira cyane mubintu bifatika bigize ibinini bya tablet, ibintu bitandukanye nibigaragara, ubukana, ibice byacitse, hamwe na tableti yububiko bwa tablet. Gukora ibishishwa byamazi bisanzwe birimo polimeri nyinshi, plasitike, amarangi, ibishishwa, nibindi, kandi imikorere yimyenda ni impirimbanyi zingirakamaro zo gutera no gukama hamwe nibikoresho byo gutwikira.
1.Uruhande rumwe rwo gukuramo, kuruhande rwa firime gucamo no gukuramo
Ubukomere bwubuso bwo hejuru hejuru yibibaho bya tablet ni ntoya, kandi byoroshye guhura nubushyamirane bukomeye hamwe nihungabana mugihe cyo gutwikira, kandi ifu yuruhande rumwe cyangwa ibice bigwa, bikavamo pockmark cyangwa pore hejuru yubuso ibinini bya tablet, byambaye uruhande rumwe, cyane hamwe na firime yanditseho. Igice cyibasiwe cyane na firime muri tablet yubatswe na firime ni mfuruka. Iyo gufatira cyangwa imbaraga za firime bidahagije, guturika no gutobora impande za firime birashoboka. Ibi biterwa nuko guhindagurika kwa solve bitera firime kugabanuka, no kwaguka gukabije kwa firime ya coating hamwe nintangiriro byongera imihangayiko yimbere ya firime, irenze imbaraga zingana za firime.
1.1 Isesengura ryimpamvu nyamukuru
Kubijyanye na chip yibanze, impamvu nyamukuru nuko ubwiza bwa chip core butaba bwiza, kandi ubukana nubugome ni bito. Mugihe cyo gutwikira, intandaro ya tablet ikorerwa guterana gukomeye mugihe izunguruka mu isafuriya, kandi biragoye kwihanganira izo mbaraga zidafite ubukana buhagije, bujyanye nuburyo bwo gutegura no gutegura intangiriro ya tablet. Mugihe twapakiye ibinini bya nifedipine bikomeza-kurekura, kubera ubukana buke bwibikoresho bya tablet, ifu yagaragaye kuruhande rumwe, bivamo imyenge, kandi firime ya tablet yometseho firime ntiyari yoroshye kandi yari ifite isura mbi. Mubyongeyeho, iyi nenge yo gutwikira nayo ifitanye isano n'ubwoko bwa tablet. Niba firime itorohewe, cyane cyane iyo firime ifite ikirango ku ikamba, birashoboka cyane kwambara uruhande rumwe.
Mubikorwa byo gutwikira, umuvuduko mwinshi wa spray hamwe no gufata ikirere kinini cyangwa ubushyuhe bwinshi bwo mu kirere bizaganisha ku kwihuta byihuse, gukora firime gahoro gahoro yibikoresho bya tablet, igihe kirekire cyo kudakora cyibikoresho bya tablet mumasafuriya, hamwe nigihe kinini cyo kwambara. Icya kabiri, umuvuduko wa atomisation ni munini, ubwiza bwamazi yatwikiriye ni buke, ibitonyanga mu kigo cya atomisation byegeranye, kandi umusemburo uhindagurika nyuma yigitonyanga kimaze gukwirakwira, bikaviramo guhangayika cyane imbere; icyarimwe, ubushyamirane buri hagati yuruhande rumwe nabwo bwongera ibibazo byimbere muri firime kandi byihutisha film. Impande zacitse.
Byongeye kandi, niba umuvuduko wo kuzunguruka wipfundikizo yihuta cyane cyangwa igenamigambi rya baffle ridafite ishingiro, imbaraga zo guterana hejuru kuri tablet zizaba nini, kugirango amazi yo gutwikira adakwirakwira neza, kandi imiterere ya firime izatinda, ibyo bizatera kwambara kuruhande rumwe.
Uhereye kumazi yatwikiriye, biterwa cyane cyane no guhitamo polymer mugutegura hamwe nubukonje buke (concentration) bwamazi yo kwisiga, hamwe no kudahuza neza hagati ya firime ya coating hamwe na tablet ya tablet.
1.2 Igisubizo
Imwe muriyo ni uguhindura inyandiko cyangwa umusaruro wibikoresho bya tablet kugirango utezimbere ubukana bwibikoresho bya tablet. HPMC ni ibikoresho bisanzwe bikoreshwa. Gufatanya kw'ibikoresho bya tablet bifitanye isano n'amatsinda ya hydroxyl kuri molekile zidasanzwe, kandi amatsinda ya hydroxyl akora hydrogène ihuza amatsinda ahwanye na HPMC kugirango ibashe gukomera cyane; Gufatanya gucika intege, kandi uruhande rumwe na firime yo gutwika bikunda gutandukana. Umubare w'amatsinda ya hydroxyl kumurongo wa molekile ya selile ya microcrystalline ni mwinshi, kandi ifite imbaraga zifatika, kandi ibinini byateguwe na lactose hamwe nandi masukari bifite imbaraga zifatika. Gukoresha amavuta, cyane cyane amavuta ya hydrophobique nka acide stearic, magnesium stearate, na glyceryl stearate, bizagabanya guhuza hydrogène hagati ya tablet na polymer mugisubizo cyo gutwikira, bigatuma gufatira Imbaraga zigabanuka, hamwe no kwiyongera kwamavuta, imbaraga zifatika zigenda zigabanuka buhoro buhoro. Mubisanzwe, uko amavuta menshi, niko gufatana bigenda bigabanuka. Mubyongeyeho, muguhitamo ubwoko bwibinini, ubwoko bwa tablet ya biconvex bugomba gukoreshwa uko bishoboka kwose, bishobora kugabanya kugaragara kwinenge.
Iya kabiri ni uguhindura imiti yamazi yatwikiriye, kongera ibintu bikomeye mumazi yatwikiriye cyangwa ubwiza bwamazi yatwikiriye, no kunoza imbaraga no gufatira kumafirime, nuburyo bworoshye bwo gukemura ikibazo. Mubisanzwe, ibintu bikomeye muri sisitemu yo gutwikira amazi ni 12%, naho ibikomeye muri sisitemu yo gukemura ni 5% kugeza 8%.
Itandukaniro ryubwiza bwamazi yatwikiriye bigira ingaruka kumuvuduko no kurwego rwo kwinjira mumazi yatwikiriye muri tablet. Iyo habaye bike cyangwa bidafite aho bihurira, gufatira ni bike cyane. Ubukonje bwamazi yatwikiriye hamwe nibiranga firime ya coating bifitanye isano nuburemere buringaniye bwa molekile ya polymer muburyo bwo gukora. Iyo uburemere buringaniye buringaniye, niko gukomera kwa firime itwikiriye, kutoroha no kwihanganira kwambara. Kurugero, ubucuruzi buboneka HPMC ifite amanota atandukanye ya viscosity yo guhitamo kubera itandukaniro muburemere buringaniye. Usibye ingaruka za polymer, kongeramo plasitike cyangwa kongera ibirimo bya talc birashobora kugabanya ikibazo cyo guturika kwa firime, ariko kongeramo amabara ya okiside yicyuma na dioxyde de titanium bishobora no kugira ingaruka kumbaraga za firime, bityo rero igomba kuba ikoreshwa mu rugero.
Icya gatatu, mugikorwa cyo gutwikira, birakenewe kongera umuvuduko wo gutera, cyane cyane mugihe igifuniko cyatangiye bwa mbere, umuvuduko wo gutera ugomba kwihuta gato, kugirango intandaro ya tablet itwikiriwe nigice cya firime mugihe gito, ibyo ifite uruhare rwo kurinda ibinini bya tablet. Kongera igipimo cya spray birashobora kandi kugabanya ubushyuhe bwigitanda, igipimo cyuka nubushyuhe bwa firime, kugabanya imihangayiko yimbere, ndetse bikanagabanya ikibazo cyo gucika firime. Mugihe kimwe, hindura umuvuduko wo kuzenguruka kumasafuriya kugirango ugere kumurongo mwiza, hanyuma ushireho urujijo muburyo bwo kugabanya guterana no kwambara.
2.Guhuza no guhuha
Muburyo bwo gutwikira, mugihe guhuza kwimbere hagati yibice bibiri biruta imbaraga zo gutandukanya molekile, ibice byinshi (ibice byinshi) bizahuza mugihe gito hanyuma bitandukane. Iyo uburinganire buri hagati yo gutera no gukama butari bwiza, firime iba itose, firime izomeka kurukuta rwinkono cyangwa ifatanye, ariko kandi itera firime kumeneka aho ifatanye; Muri spray, mugihe ibitonyanga bitumye neza, ibitonyanga bitavunitse bizaguma muri firime yaho, hari udusimba duto, tugakora igipfundikizo cyinshi, kuburyo urupapuro rwitwikiriye rugaragara.
2.1 Isesengura ryimpamvu zingenzi
Ingano hamwe nindwara yiyi nenge iterwa ahanini nuburyo bwo gutwikira, ubusumbane buri hagati yo gutera no gukama. Umuvuduko wo gutera urihuta cyane cyangwa ingano ya gaze ya atome ni nini cyane. Umuvuduko wo kumisha uratinda cyane kubera ubwinshi bwumwuka winjira cyangwa ubushyuhe buke bwo mu kirere hamwe nubushyuhe buke bwigitanda cyurupapuro. Urupapuro ntabwo rwumishijwe kumurongo mugihe kandi gufatana cyangwa ibibyimba bibaho. Byongeye kandi, kubera spray idakwiye Inguni cyangwa intera, cone ikozwe na spray ni nto, kandi amazi yo gutwikira yibanda ahantu runaka, bikaviramo gutose kwaho, bikaviramo gufatana. Hariho umuvuduko wihuta wo gutwika inkono, imbaraga za centrifugal ni nto cyane, kuzunguruka firime ntabwo ari byiza nabyo bizatanga adhesion.
Gupfundikanya amazi yuzuye ni binini cyane, nimwe mumpamvu. Imyambarire yimyenda nini nini, byoroshye gukora ibicu binini binini, ubushobozi bwayo bwo kwinjira mumyanya mibi birakennye, guteranya uruhande rumwe hamwe no gufatira hamwe, icyarimwe, ubucucike bwa firime burakennye, bwinshi. Ariko ibi ntabwo bigira ingaruka nyinshi kumyanya yigihe gito.
Mubyongeyeho, ubwoko bwa firime idakwiye nayo izagaragara. Niba firime iringaniye mu gutwika inkono itari nziza, izuzuzanya hamwe, biroroshye gutera firime ebyiri cyangwa nyinshi. Mubigeragezo byacu byo gukora ibinini bya hydrochloride ya buflomedil, ibice byinshi byuzuzanya byagaragaye mumasafuriya asanzwe yometseho inkono kubera gutwikira.
2.2 Ibisubizo
Nibihindura cyane cyane spray no gukama kugirango ugere kuburinganire. Mugabanye umuvuduko wa spray, ongera ubwinshi bwumwuka winjira nubushyuhe bwikirere, ongera ubushyuhe bwigitanda n'umuvuduko wumye. Ongera ahantu ho gukwirakwiza spray, gabanya ingano yikigereranyo cyibipimo byibitonyanga bya spray cyangwa uhindure intera iri hagati yimbunda ya spray nigitanda cyurupapuro, kugirango ikibazo cyo gufatira mugihe gito kigabanuke hamwe noguhindura intera iri hagati yimbunda ya spray nigitanda.
Hindura ibisubizo byanditseho ibisubizo, ongera ibikubiye mubikomeye mugukemura, kugabanya ingano yumuti cyangwa kongera ingufu za Ethanol muburyo bukwiye; Anti-adhesive irashobora kandi kongerwamo muburyo bukwiye, nka poro ya talcum, magnesium stearate, ifu ya silika gel cyangwa peptide ya oxyde. Irashobora kunoza neza umuvuduko wikibindi, kongera imbaraga za centrifugal yigitanda.
Hitamo urupapuro rukwiye. Nyamara, kumpapuro ziringaniye, nkibinini bya buflomedil hydrochloride, igipfundikizo cyakozwe neza nyuma hifashishijwe isafuriya ikora neza cyangwa ushyiramo urufunzo mumasafuriya asanzwe kugirango utere imbere.
3.Uruhu rumwe rukabije kandi rukabije
Muburyo bwo gutwikira, kubera ko amazi yatwikiriye adakwirakwijwe neza, polymer yumye ntabwo itatanye, kubitsa bidasanzwe cyangwa gufatira hejuru ya firime, bikavamo ibara ribi nubuso butaringaniye. Uruhu rwijimye ni ubwoko bwubuso butagaragara, ni ibintu bigaragara cyane.
3.1 Isesengura ryimpamvu nyamukuru
Iya mbere ifitanye isano na chip core. Ninini yubuso bwambere bwubuso bwibanze, nubunini bwubuso bwibicuruzwa bisize bizaba.
Icya kabiri, ifitanye isano ikomeye na coating solution prescription. Mubisanzwe abantu bemeza ko uburemere bwa molekile, kwibanda hamwe ninyongeramusaruro za polymer mugisubizo cya coating bifitanye isano nubuso bwubuso bwa firime. Bakora muguhindura ubwiza bwigisubizo cyumuti, kandi ubukana bwamafirime ya firime burasa nkaho bujyanye nubwiza bwumuti wa coating, byiyongera hamwe no kwiyongera kwijimye. Ibintu byinshi bikomeye muburyo bwo gukemura birashobora gutera byoroshye uruhande rumwe.
Hanyuma, bifitanye isano nigikorwa cyo gutwikira. Umuvuduko wa atomisiyasi uri hasi cyane cyangwa muremure cyane (ingaruka ya atomisation ntabwo ari nziza), ibyo ntibihagije kugirango ukwirakwize ibitonyanga byigihu hanyuma ugire uruhu rwuruhande rumwe. Kandi ubwinshi bwumwuka wumuyaga (umwuka mwinshi ni munini cyane) cyangwa ubushyuhe burenze urugero, guhumeka vuba, cyane cyane umwuka uva mwinshi ni mwinshi, utanga amashanyarazi, kandi bigatuma igitonyanga gikwirakwira atari cyiza.
3.2 Ibisubizo
Icya mbere nukuzamura ireme ryibanze. Hashingiwe ku kwemeza ubwiza bwibanze, hindura ibisubizo byanditseho ibisubizo hanyuma ugabanye ubukonje (concentration) cyangwa ibikomeye bikemurwa. Inzoga-zishonga cyangwa inzoga-2-amazi yo gutwikira amazi arashobora gutoranywa. Noneho uhindure imikorere, utezimbere bikwiye umuvuduko wikibindi, kora firime iringaniye, wongere ubwumvikane buke, utezimbere ikwirakwizwa ryamazi. Niba ubushyuhe bwo kuryama buri hejuru, gabanya ubwinshi bwumwuka hamwe nubushyuhe bwikirere. Niba hari impamvu ziterwa na spray, igitutu cya atomisation kigomba kongerwa kugirango umuvuduko wihuse, kandi urugero rwa atomisation hamwe nubunini bwa spray bigomba kunozwa kugirango ibitonyanga byumwijima bikwirakwira ku gahato hejuru yurupapuro, kugirango bibe ibitonyanga byibicu bito. impuzandengo ya diametre kandi wirinde ko habaho ibicu binini bitonyanga, cyane cyane kubitwikiriye amazi hamwe nubwiza bwinshi. Intera iri hagati yimbunda ya spray nigitanda cyurupapuro nayo irashobora guhinduka. Imbunda ya spray ifite diameter ntoya ya nozzle (015 mm ~ 1,2 mm) hamwe n’umuvuduko mwinshi wa gaze ya gaze ya atome. Imiterere ya spray yahinduwe kumurongo mugari wa cone Ihanamye yibicu bitemba, kuburyo ibitonyanga bikwirakwizwa mugace kanini rwagati.
4.Garagaza ikiraro
4.1 Isesengura ryimpamvu nyamukuru
Ibi bibaho mugihe ubuso bwa firime bwashyizweho ikimenyetso cyangwa ikimenyetso. Kuberako imyenda yimyenda ikwiye ibipimo byubukanishi, nka coeffisiyeti yo hejuru ya elastique, imbaraga za firime zirakennye, kudafatana nabi, nibindi, mugihe cyo kumisha imyenda ya membrane yumisha itanga umusaruro mwinshi inyuma, uhereye kumyenda yimyenda yimbere, gukuramo membrane no kwikiraro bibaho, gukora icyerekezo kimwe cyabuze cyangwa ikirangantego ntigisobanutse neza, impamvu zibi bintu biri mubitabo byanditseho.
4.2 Igisubizo
Hindura ibyanditseho igisubizo. Koresha uburemere buke bwa polymers cyangwa ibikoresho byo hejuru bya firime; Ongera ubwinshi bwa solvent, gabanya ubwiza bwumuti utwikiriye; Ongera ubwinshi bwa plasitike, gabanya imihangayiko y'imbere. Ingaruka zitandukanye za plasitike ziratandukanye, polyethylene glycol 200 iruta propylene glycol, glycerine. Irashobora kandi kugabanya umuvuduko wa spray. Ongera ubushyuhe bwumwuka winjira, ongera ubushyuhe bwigitanda cyurupapuro, kugirango igifuniko cyakozwe kirakomeye, ariko kugirango wirinde kumeneka. Mubyongeyeho, mugushushanya ibimenyetso byapfuye, dukwiye kwitondera ubugari bwo gutema Inguni nizindi ngingo nziza, uko bishoboka kwose kugirango twirinde ko habaho ikiraro.
5.Kwambara membrane chromatism
5.1 Isesengura ryimpamvu nyamukuru
Mubisubizo byinshi byo gutwikira harimo pigment cyangwa amarangi bihagarikwa mugisubizo cyo gutwikira kandi kubera imikorere idahwitse, gukwirakwiza amabara ntabwo ari kimwe kandi itandukaniro ryamabara rikorwa hagati y'ibice cyangwa mubice bitandukanye. Impamvu nyamukuru nuko umuvuduko winkono yatwikiriye utinda cyane cyangwa kuvanga neza ni bibi, kandi ingaruka imwe yo gutwikira ntishobora kugerwaho hagati yibice mugihe gisanzwe cyo gutwikira; Ubwinshi bwa pigment cyangwa irangi mumazi yatwikiriye amabara ni menshi cyane cyangwa ibiyikomeye birakabije, cyangwa umuvuduko wo gutera amazi ya coating yihuta cyane, ubushyuhe bwigitanda buri hejuru cyane, kuburyo amazi atwikiriye amabara atazunguruka hanze igihe; Gufatanya kwa firime nabyo birashobora guterwa; Imiterere yikigice ntigikwiye, nkigice kirekire, capsule imeze nkigice, kubera kuzunguruka nkigice kizengurutse, nabyo bizatera itandukaniro ryibara.
5.2 Igisubizo
Ongera umuvuduko wikibiriti cyangwa umubare wa baffle, hindura kuri reta ikwiye, kugirango urupapuro mumasafuriya ruzunguruke. Mugabanye umuvuduko wa spray yihuta, gabanya ubushyuhe bwigitanda. Mu gishushanyo mbonera cyerekana igisubizo kibara amabara, dosiye cyangwa ibintu bikomeye bya pigment cyangwa irangi bigomba kugabanuka, kandi hagomba gutoranywa pigment ifite igifuniko gikomeye. Ibara cyangwa irangi bigomba kuba byoroshye kandi ibice bigomba kuba bito. Irangi ridashobora gushonga iruta irangi ryamazi, irangi ryamazi ntirimuka hamwe namazi byoroshye nkamabara asiga amazi, kandi igicucu, ituze kandi mukugabanya imyuka yamazi, okiside kumashanyarazi ya firime nayo iruta irangi ryamazi. Hitamo kandi ubwoko bukwiye. Mubikorwa byo gutwikisha firime, akenshi habaho ibibazo bitandukanye, ariko uko ibibazo byaba bimeze kose, ibintu nibyinshi, birashobora gukemurwa no kuzamura ireme ryibanze, ugahindura ibyanditswemo nibikorwa, kugirango ugere kubikorwa byoroshye n'imikorere y'imvugo. Hamwe nubuhanga bwa tekinoroji yo gutwikira, guteza imbere no gukoresha imashini nshya yo gutwikira hamwe nibikoresho byo gutwikira firime, tekinoroji yo gutwika izanozwa cyane, gutwika firime nabyo bizabona iterambere ryihuse mubikorwa byo kwitegura neza.
Igihe cyo kohereza: Apr-25-2024