I-HPMC esetshenziswe kwi-film coating kanye nezixazululo

Ekukhiqizweni kwecala nokukhiqizwa kwesisindo samathebulethi okukhishwa kwezinsizakusebenza, amaphilisi okuvimbela inzalo, amaphilisi we-stomachicaciang, amaphilisi we-fumbarate fumbarate, amaphilisi we-pumpledil hydrochloride, njll., SisebenzisaI-Hydroxypropyl methylcellulose (HPMC)I-Liquid, i-Hydroxypropyl Methylcellulose kanye ne-polyacrylic acid resin, opadry (enikezwe yi-Colorscon, e-UK), njll. Ngemuva kwezinkinga ezithile zobuchwepheshe, manje sesixhumana nozakwethu ngezinkinga ezivamile nezixazululo ezisezinhlotsheni ze-film coating.

Eminyakeni yamuva nje, ubuchwepheshe be-Film Coating busetshenziswe kabanzi emalungiseleleni aqinile. I-coating yefilimu ingavikela umuthi kusuka ekukhanyeni, umswakama nomoya ukukhulisa ukuqina kwesidakamizwa; Maka ukunambitheka okubi kwesidakamizwa futhi kusiza isiguli ukusithatha; Lawula indawo yokukhishwa nendawo yokukhipha isivinini somuthi; vimbela ukuguqulwa kokuhambisana kwesidakamizwa; Thuthukisa ukubukeka kwethebhulethi linda. Iphinde ibe nezinzuzo zezinqubo ezimbalwa, isikhathi esifushane, ukusetshenziswa kwamandla okuphansi, nokuzuza kwesisindo sethebhulethi esincane. Izinga lamathebulethi ahlanganiswe amafilimu lincike ekwakhiweni kanye nekhwalithi ye-tablet core, imigomo yokusebenza okusebenzayo, izimo zokufaka kanye nezindawo zokugcina, njll. Ukwakheka kanye nekhwalithi ye-tablet core kuboniswa ikakhulukazi Ezithandweni ezisebenzayo ze-The Tablet Core, ama-Excipients ahlukahlukene kanye nokubukeka, ubunzima, izingcezu ze-brittle, kanye nokwakheka kwethebhulethi. Ukwakhiwa koketshezi we-coating kuvame ukuqukethe ama-polymers aphezulu ama-polymers, amapulasitiki, amadayi, izixazululo, njll.

I-abrasion eyi-1.one-limited, Film Edge Cracking and Peleng

Ubulukhuni bobuso bendawo ephezulu yethebhulethi buncane kakhulu, futhi lubhekwa kalula ekucindezelweni okuqinile kanye nengcindezi ngesikhathi senqubo yokuhlanganisa, futhi izinhlayiya noma izinhlayiya noma izinhlayiya ezingaphezulu Umgogodla wethebhulethi, okungukugqoka okunecala elilodwa, ikakhulukazi ngefilimu ebhalwe okuqoshiwe. Ingxenye esengozini enkulu yefilimu ethebhulethi ehlanganiswe ngefilimu yikhona. Lapho ukunamathela noma amandla efilimu akwanele, ukuqhekeka kanye nokukhonkotha kwemiphetho yefilimu kungenzeka kwenzeke. Lokhu kungenxa yokuthi ukuguquguquka kwe-solvent kudala ukuthi ifilimu linciphe, futhi ukwanda ngokweqile kwefilimu yokuhlanganisa kanye nokwenza umnyombo kukhulisa ukucindezela kwangaphakathi kwefilimu, okudlula amandla ashubile efilimu yokuhlanganisa.

1.1 Ukuhlaziywa kwezizathu eziphambili

Ngokuqondene ne-Chip Core ethintekayo, isizathu esiyinhloko ukuthi ikhwalithi ye-chip core ayilungile, futhi ubulukhuni kanye nobunzima buncane. Ngesikhathi senqubo yokuhlanganisa, umnyombo wethebhulethi ufakwa ngaphansi kokuxabana okuqinile lapho ugingqa epanini lokuhlanganisa, futhi kunzima ukubekezelela amandla anjalo ngaphandle kobulukhuni obanele, okuhlobene nendlela yokulungiswa kwethebhulethi. Lapho sihlanganisa amaphilisi we-nifedipine asetshenziselwa ukukhishwa, ngenxa yobulukhuni obuncane be-tablet core, kuvela uhlangothi olulodwa, okuholela kuma-pores, futhi ifilimu lethebhulethi elihlanganisiwe lalingabushelelezi futhi lalinokubukeka kabi. Ngaphezu kwalokho, lesi sici sokuhlanganisa sihlobene nohlobo lwethebhulethi. Uma ifilimu ingakhululekile, ikakhulukazi uma ifilimu ine-logo emqheleni, ithambekele ekugqokeni uhlangothi olulodwa.

Ekusebenzeni kwe-coating, isivinini esikhulu kakhulu sokufafaza kanye nokudla komoya omkhulu noma okushisa okuphezulu komoya kuzoholela kwijubane lokumisa ngokushesha, ukwakheka kwamafilimu okusheshayo kwamathebhulethi, isikhathi eside sethebhulethi, isikhathi eside sokugqoka. Okwesibili, ingcindezi ye-avocation inkulu, ukubonwa koketshezi we-coating kuphansi, amaconsi esikhungweni se-atomization agxile, futhi i-solvent inamathela ngemuva kokuthi amaconsi asabalale, okuholela ekucindezelekeni okukhulu kwangaphakathi; Ngasikhathi sinye, ukungqubuzana phakathi kwezindawo ezinamacala elilodwa nakho kukhulisa ukucindezelwa kwangaphakathi kwefilimu futhi kusheshisa ifilimu. Imiphetho ephukile.

Ngaphezu kwalokho, uma ijubane lokujikeleza kwephaneli le-coating lishesha kakhulu noma ukuhlelwa okuxakile akunangqondo, amandla okuphambana kuthebulethi azoba mkhulu, ukuze kusetshenziswe uketshezi lwefilimu ngeke kuthambeke, okuyinto kuzodala ukugqokwa okunecala elilodwa.

Kusuka ku-coating liquid, ikakhulukazi ngenxa yokukhethwa kwe-polymer ekwakhekeni kanye nokubonakaliswa okuphansi (okuhlushwa) koketshezi lwe-coating, kanye nokunamathela okumpofu phakathi kwefilimu yokuhlanganisa kanye ne-tablet core.

1.2 Isixazululo

Eyokuqala ukulungisa i-Rectory noma inqubo yokukhiqiza yethebhulethi ukuthuthukisa ubunzima be-tablet core. I-HPMC iyinto esetshenziswayo esetshenziswa kakhulu. Ukunamatheliwa kwamathebhulethi e-Execustients kuhlobene namaqembu e-hydroxyl kuma-molecule ase-exydroxy, futhi amaqembu e-hydroxyl akha ama-hydrogen bond ngamaqembu ahambisanayo anamaqembu ahambisanayo we-HPMC ukukhiqiza akesion aphezulu; Ukunamathelisa kubuthakathaka, futhi okukodwa kanye nefilimu yokuhlanganisa kuvame ukuhlukana. Inani lamaqembu ama-hydroxyl ku-chain moleklar ye-microcrystalline celtulose liphezulu, futhi linamandla anamathela aphezulu, futhi amaphilisi alungiselelwe kusuka kushukela we-lactose nolunye banamandla alinganiselwe anamathela. Ukusetshenziswa kwama-lubrances, ikakhulukazi ama-lubricants hydrophobic afana ne-stearic acid, i-magnesium stearate, futhi i-glyceryl, izonciphisa isibopho se-hydrogen phakathi kwesixazululo sethebhulethi, nokwenza ukunamathela amandla kuncipha, amabutho anama-adhesion abuthaka kancane kancane. Ngokuvamile, inani elithe xaxa lokuthambisa, lapho ukunamathela kubuthakathaka kakhulu. Ngaphezu kwalokho, ekukhetheni uhlobo lwethebhulethi, uhlobo lwethebhulethi ye-viconvex oluyindilinga kufanele lusetshenziswe ngangokunokwenzeka ukuze uthole ukunamathela, okunganciphisa ukwenzeka kwezici ezinhlamba.

Okwesibili ukuguqula ukunikezwa kuka-Unitiwolwoti, ukukhulisa okuqukethwe okuqinile ku-coatium liquid noma i-viscosity yoketshezi lwe-coating, futhi uthuthukise amandla nokunamathela kwefilimu ehambisanayo, okuyindlela elula yokuxazulula inkinga. Ngokuvamile, okuqukethwe okuqinile ohlelweni lwama-aquoud aquaing system kungu-12%, futhi okuqukethwe okuqinile ohlelweni lwe-organic solvent kungu-5% kuya ku-8%.

Umehluko ekuboneni uketshezi lwe-coating luthinta ijubane kanye ne-degree yokungena koketshezi lwe-coating lube yi-tablet core. Lapho kunokungena kancane noma akukho ukungena, ukunamathela kuphansi kakhulu. I-viscosity yoketshezi lwe-coating kanye nezindawo zefilimu yokuhlanganisa zihlobene nesisindo samangqamuzana esivamile se-polymer ekwakhekeni. Lapho kukhuphuka isisindo samangqamuzana aphakathi, kulapho kukhulisa ubunzima befilimu yokuhlanganisa, ukuqina okuncane kanye nokumelana nokugqoka. Isibonelo, i-HPMC etholakala kwezentengiso ine-visuosity ehlukile yokukhethwa ngenxa yomehluko isisindo esiyisilinganiso se-molecular. Ngaphezu kwethonya le-polymer, engeza amapulasitiki noma ukwandisa okuqukethwe kwe-talc kunganciphisa izehlakalo zokuqhekeka kwamanga wefilimu, kepha ukwengeza ama-colorants iron oxide kanye ne-titanium dioxide kungathinta namandla wefilimu yokuhlanganisa, ngakho-ke kufanele kube isetshenziswe ngokulinganisela.

Okwesithathu, ekusebenzeni kwe-coating, kuyadingeka ukwandisa ijubane lokufafaza, ikakhulukazi lapho ukuhlanganiswa kuqala kuqalwa, ijubane lokufafaza kufanele lisheshe, ukuze umnyombo wethebhulethi embozwe ungqimba lwefilimu esikhathini esifushane, okuyinto Idlala indima yokuvikela umnyombo wethebhulethi. Ukwandisa izinga lokufafaza kunganciphisa futhi izinga lokushisa kombhede, izinga lokuhwamuka kwamazinga wefilimu, ukunciphisa ukucindezela kwangaphakathi, futhi kunciphise izehlakalo zokuqhekeka kwefilimu. Ngasikhathi sinye, lungisa ijubane lokujikeleza kwepani le-coating esimweni esihle kakhulu, bese usetha i-baffle kahle ukunciphisa ukungqubuzana nokugqoka.

I-2.Adhesion ne-blaitering

Enqubweni yokuhlangana, lapho ukuhlangana kwesimo esibonakalayo phakathi kwezingcezu ezimbili kukhulu kunombuso wama-molecular ukwehlukana, izingcezu eziningana (izinhlayiya eziningi) zizobopha ngamafuphi bese zihlukana. Lapho ibhalansi phakathi kokufafaza nokomiswa akukuhle, ifilimu imanzi kakhulu, ifilimu liyonamathela odongeni lwebhodwe noma linamathele komunye nomunye, kodwa futhi libangela ukuqhekeka kwamafilimu endaweni yokunamathela; Esifuywayo, lapho amaconsi engamiswa ngokuphelele, amaconsi angashintshi azohlala kwifilimu yendawo ehlanganisiwe yendawo, kukhona ama-bubble amancane, abumba ungqimba lwe-bubble coating, ukuze kubonakale iphepha le-bubble coating, ukuze ishidi le-bubble coatiation, ukuze ishidi lokuhlanganisa le-bubble livele bubble.

2.1 Ukuhlaziywa kwezizathu eziphambili

Izinga kanye nezehlakalo zalesi sici sokuhlanganisa zingenxa yezimo zokusebenza ezisebenzayo, ukungalingani phakathi kwesifutho nokuwomile. Ijubane lokufafaza lishesha kakhulu noma umthamo wegesi ye-athomu likhulu kakhulu. Ijubane lokumisa lihamba kancane ngenxa yevolumu ye-inlet yomoya ephansi noma okushisa komoya okuphansi kanye nokushisa okuphansi kombhede wephepha. Ishidi alilona ungqimba olwenziwe ngesendlalelo ngesikhathi kanye nokunamathela noma ama-bubble avela. Ngaphezu kwalokho, ngenxa ye-angle yokufafaza engafanele noma ibanga, isigaxa esakhiwa yi-Spray lincane, futhi uketshezi lwe-coating lugxile endaweni ethile, okuholela ekunamanzi kwasendaweni, okuphumela ekunamanzi kwasendaweni, okuphumela ekunamanzi kwasendaweni, okubangelwa ukunamathela. Kukhona imbiza ye-speed speed coating, ama-centrifugal Force amancane kakhulu, ukugoqa ifilimu akukuhle nakho kuzokukhiqiza anamanzi.

Ukuboniswa koketshezi kukhulu kakhulu, futhi kungenye yezizathu. I-Disget Liquid Viscosity ikhulu, kulula ukwakha amaconsi enkungu enkulu yenkungu, amandla ayo okungena emgogodleni ampofu, ahlanganiswe nokunamathela okukodwa, ngasikhathi sinye, ubuningi befilimu limpofu, ama-bubble amaningi. Kepha lokhu akuba nomphumela omningi ezinamathekisayo.

Ngaphezu kwalokho, uhlobo lwefilimu olungalungile luzovela nokunamathelisa. Uma ifilimu eyisicaba ebhodlweni yebhodwe yempova ayilungile, izodlula ndawonye, ​​kulula ukudala amafilimu aphindwe kabili noma ahlukahlukene. Ekukhiqizweni kwethu kwesivivinyo samathebulethi we-bumplomloril hydrochloride, izingcezu eziningi ezigcwele ngaphezulu zivele ku-chestnut yamanzi evamile ye-coing coating for for coating.

2.2 izixazululo

Kungoko ukulungisa i-Spray ne-Speed ​​yokumisa ukuze kufinyelelwe ibhalansi enamandla. Yehlisa ijubane lokufafaza, wandise ivolumu yomoya we-inlet kanye nokushisa komoya, wandise izinga lokushisa kombhede nendawo yokusoma. Khuphula indawo yokumboza isifutho, ukunciphisa usayizi ojwayelekile wezinhlayiyana zamaconsi okufafaza noma ulungise ibanga phakathi kwesibhamu sokufafaza, ukuze izehlakalo ze-spray gun kanye nombhede we-spray, ukuze izigameko zokutholwa kwe-traple zincipha ngokulungiswa kwebanga phakathi kwesibhamu kanye nombhede wephepha.

Lungisa i-Coating Solution Recrosition, ukukhulisa okuqukethwe okuqinile kusisombululo se-coating, kunciphise inani le-solvent noma ukukhulisa ukugcwala kwe-ethanol ngokufanele ngaphakathi kwebanga lokubonakala; Anti-Adhesive angangezwa ngendlela efanele, njenge-talcum powder, i-magnesium stearate, i-silica gel powder noma i-oxide! Ingathuthukisa kahle ijubane lembiza ye-coation, yandisa amandla we-centrifugal wombhede.

Khetha i-COST evikelekile eshidi. Kodwa-ke, amashidi acwebezelayo, anjenge-buflomedil hydrochloride amaphilisi, ukuhlanganiswa kwenziwa ngempumelelo ngokuhamba kwesikhathi ngokusebenzisa ipani elisebenzayo le-pan noma ngokufaka i-baffle epanini elijwayelekile lokuhlanganisa ukuthuthukisa ukugingqa ishidi.

Isikhumba esi-3.one-sisezinhlangothi zombili

Enqubweni yokuhlangana, ngoba uketshezi oluhlanganisiwe alusatshalaliswa kahle, i-polymer eyomile ayihlakazwa, ukufakwa noma ukunamathela ebusweni befilimu, okuholela kombala ongemuhle. Isikhumba esihlanganisiwe uhlobo olunomoya olunzima, luyisibonisi esibonakalayo esibi ngokweqile.

3.1 Ukuhlaziywa kwezizathu eziphambili

Owokuqala uhlobene ne-chip core. Okukhudlwana ubuqili bokuqala bokuqina komgogodla, ubukhulu bokuqina komkhiqizo ohlanganisiwe kuzoba.

Okwesibili, inobudlelwano obuhle ne-coating yesisombululo sokuphakanyiswa. Ngokuvamile kuzwakala ukuthi isisindo samangqamuzana, okuhlushwa kanye nezithasiselo ze-polymer esixazululweni se-coating zihlobene nobulukhuni bendawo yokuhlanganiswa ifilimu. Benza ngokuthinta ukubonakala kwesisombululo se-coating, futhi ubulukhuni be-coatics yefilimu bucishe balayini nge-viscosity yesisombululo se-coating, sanda ngokwanda kokubonakala. Okuqukethwe okuqinile ngokweqile kusisombululo sokuhlanganisa kungadala kalula ukubangela okukodwa.

Ekugcineni, kuhlobene nokusebenza kwe-coating. Ijubane le-atomization liphansi kakhulu noma liphezulu kakhulu (umphumela we-atomization awumuhle), akwanele ukusakaza amaconsi enkungu futhi wakhe isikhumba esinamahlathi ahlangene. Futhi umthamo owedlulele komoya owomile (umoya wokuphekela ngokweqile mkhulu kakhulu) noma ukushisa okuphezulu kakhulu, ukuhwamuka okusheshayo, ikakhulukazi ukuhamba komoya kukhulu kakhulu, kukhiqiza i-eddy yamanje, futhi yenza ukusakazeka kwe-droplet akukuhle.

3.2 izixazululo

Owokuqala ukuthuthukisa ikhwalithi yomgogodla. Esisekelweni sokuqinisekisa ikhwalithi yomgogodla, shintsha umuthi kadokotela we-coating, futhi wehlise ukubonwa (okuhlushwa) noma okuqukethwe okuqinile kwesisombululo se-coating. Kukhethwe isixazululo se-soluble-soluble noma sotshwala-2-samanzi. Bese ulungisa izimo zokusebenza, uthuthukise ngokufanelekile ijubane lembiza ye-coation, yenza i-film roll ngokulinganayo, yandisa ukuxabanisa, ukukhuthaza ukusakazeka koketshezi lwe-coating. Uma izinga lokushisa lombhede liphezulu, yehlisa umthamo womoya wokudla kanye nokuphuza lokushisa komoya. Uma kukhona izizathu zokufafaza, ingcindezi yokungenisa i-atomization kufanele inyuswe ukuze isheshise isivinini sokufafaza, futhi i-atomization degree kanye nevolumu yokufafaza kufanele ithuthukiswe ukwenza inselelo yehla iye phezulu ebusweni beshidi, ukuze ithole amaconsi enkungu nge-infler Ububanzi obumaphakathi futhi uvikele ukwenzeka kweconsi lenkungu enkulu, ikakhulukazi ngoketshezi lwe-coating nge-viscosity enkulu. Ibanga phakathi kwesibhamu sokufafaza nombhede wephepha lingashintshwa futhi. Isibhamu sokufafaza nge-nozzle ububanzi obuncane (015 mm ~ 1.2 mm) kanye nezinga eliphakeme lokugeleza kwegesi eliphakeme kukhethiwe. Isimo sokufafaza sishintshelwa kuhlu olubanzi lokugeleza kwenkungu okufuywayo, ukuze amaconsi ahlakazeke endaweni enkulu ephakathi nendawo.

I-4.Identive Bridge

Ukuhlaziywa kwezizathu eziphambili

Lokhu kwenzeka lapho ingaphezulu lefilimu limakwe noma limakwe. Ngoba ulwelwesi lwezingubo zokugqoka lukweleta amapharamitha afanelekile emishini, njenge-coefficity ephezulu, amandla amafilimu ampofu, anama-adhesion ampofu, njll. I-notch enecala elilodwa yanyamalala noma uphawu alucaci, izizathu zalesi simo zilele ku-coatid fluid kadokotela.

Isixazululo

Lungisa umuthi wesisombululo se-coating. Sebenzisa ama-polymers wesisindo esiphansi noma izinto eziphakeme zefilimu eyakha izinto zokwakha; Khuphula inani le-solvent, yehlisa i-viscosity yesisombululo se-coating; Khulisa inani le-Plisticler, wehlise ukucindezelwa kwangaphakathi. Umphumela wenqubo ehlukile yepulasitiki uhlukile, i-polyethylene glycol 200 ingcono kune-plylene glycol, glycerin. Futhi kunganciphisa isivinini sokufafaza. Khulisa izinga lokushisa komoya, wandise izinga lokushisa lombhede wephepha, ukuze ukuhlanganiswa okwakhiwe kuqinile, kepha ukuvikela ukuqhekeka komngcele. Ngaphezu kwalokho, ekwakhiweni okumakiwe kufa, kufanele sinake ububanzi be-angle yokusika namanye amaphuzu amahle, ngangokunokwenzeka ukuvimbela ukwenzeka kwe-Bridge Penomenon.

5.Cloting chromatism

5.1 Ukuhlaziywa kwezizathu eziphambili

Ezixazululweni eziningi ze-coating kukhona imibala noma amadayi amiswe esixazululweni se-coating futhi ngenxa yokusebenza okungafanele ukumbamba, ukusatshalaliswa kombala akuwona umfaniswano futhi umehluko wombala ukhiqizwa phakathi kwezingcezu noma ezingxenyeni ezihlukene zezingcezu. Isizathu esiyinhloko ukuthi ijubane lembiza ye-coating lihamba kancane noma ukusebenza kahle kokuxuba kumpofu, futhi umphumela wokuhlangana we-Uniform angeke atholakale phakathi kwezicucu ngesikhathi esijwayelekile sokuhlangana kwenhlanganisela; Ukuqoqwa kwezingulube noma udayi kuwuketshezi olunemibala ephezulu kakhulu noma okuqukethwe okuqinile kuphezulu kakhulu, noma ijubane lokufafaza uketshezi lwe-coating lushesha kakhulu, ukuze uketshezi lombhede luphezulu kakhulu, ukuze uketshezi lombhede luphakeme kakhulu ngokuhamba kwesikhathi; Ukunamathelisa kwefilimu nakho kungabangelwa; Ukwakheka kwengxenye akufanelekile, njengengcezu ende, ucezu olubunjiwe, ngenxa yokugoqa njengengxenye eyindilinga, kuzodala futhi umehluko wombala.

5.2 Isixazululo

Khulisa ijubane lepani le-coating noma inombolo ye-abfle, shintshanisa nesimo esifanele, ukuze ishidi lisepanini liqine ngokulinganayo. Yehlisa isivinini sokufafaza se-coatium, yehlisa izinga lokushisa kombhede. Ekwakhiweni kadokotela wesixazululo esinemibala enemibala, umthamo noma okuqukethwe okuqinile kombala noma udayi kufanele kuncishiswe, futhi i-pigment enesembozo esinamandla kufanele ikhethwe. I-pigment noma udayi kufanele ibe buntekenteke futhi izinhlayiya kufanele zibe zincane. Amadayi we-infesbeble wamanzi angcono kunamadayi ancibilikise amanzi, amadayi we-water incoluble awasuki ngamadayi ancibilikisiwe ancibilikisiwe, kanye nokuqina, ukuqina kanye nokunciphisa umphunga wamanzi, i-oxidation ekuhlinzekeni kwamafilimu nawo angcono kunamadayi ancibilikisiwe amanzi. Futhi khetha uhlobo olufanele lwecezu. Esezinhlelweni zokuhlanganiswa kwefilimu, kuvame ukuba nezinkinga ezahlukahlukene, kepha noma ngabe zinhlobonhlobo zibe hlobo luni lwezinkinga, lezi zinto eziningi, zingaxazululwa ngokwenza ngcono ikhwalithi yomongo, ukulungisa ikhwalithi yoMnyango kanye nokusebenza, ukuze kufinyelelwe ku-COALIVER NEBULL NOKWENZA nokusebenza kwezimo ezihlekisayo. Nge-Mastery of Coap Technology, ukuthuthukiswa kanye nokusetshenziswa kwemishini emisha ye-coating kanye nezinto zokwakha amafilimu, ubuchwepheshe be-coating buzothuthukiswa kakhulu, i-film coatis izothola ukuthuthukiswa okusheshayo ekukhiqizweni kwamalungiselelo aqinile.


Isikhathi sePosi: APR-25-2024