Mukuedza uye kugadzirwa kwakawanda kwemapiritsi e nifedipine anoramba achiburitswa, mapiritsi ekudzivirira kubata pamuviri, mahwendefa emudumbu, ferrous fumarate mapiritsi, buflomedil hydrochloride mapiritsi, nezvimwewo, tinoshandisa.hydroxypropyl methylcellulose (HPMC)mvura, Hydroxypropyl methylcellulose uye polyacrylic acid resin liquid, Opadry (yakapiwa neColorcon, UK), nezvimwewo zvinwiwa zvekuputira firimu, izvo zvakabudirira kushandisa tekinoroji yekupfekedza firimu, asi zvakasangana nematambudziko mukugadzirwa kwekuyedza nekugadzira. Mushure memamwe matambudziko ehunyanzvi, isu tave kutaurirana nevamwe vatinoshanda navo nezve matambudziko akajairika uye mhinduro mukuita kwekuvhara firimu.
Mumakore achangopfuura, tekinoroji yekupfekedza firimu yakashandiswa zvakanyanya mukugadzirira kwakasimba. Iyo firimu yekuvhara inogona kuchengetedza mushonga kubva kuchiedza, unyoro uye mhepo kuti uwedzere kugadzikana kwemushonga; mask kuravira kwakashata kwemushonga uye kuita kuti murwere atore; kudzora nzvimbo yekuburitsa uye kuburitsa kumhanya kwemushonga; kudzivirira kuenderana kushanduka kwemushonga; kunatsiridza kutaridzika kwehwendefa Mira. Iyo ine zvakare zvakanakira zvishoma maitiro, ipfupi nguva, yakaderera mashandisiro esimba, uye kushomeka kwehuremu hwepiritsi. Hunhu hwemahwendefa akaputirwa nefirimu anonyanya kuenderana nekuumbwa uye kunaka kweiyo piritsi core, kunyorerwa kwemvura yekuputira, iyo yekuvhara mamiriro ekushanda, kurongedza uye kuchengetedza mamiriro, nezvimwe. Kuumbwa uye kunaka kweiyo piritsi core zvinonyanya kuratidzwa mune zvinoshanda zveiyo piritsi core, akasiyana excipients uye chitarisiko, kuomarara, brittle zvidimbu, uye chimiro chepiritsi. Iko kuumbwa kweiyo yekuputira mvura inowanzo ine yakakwira molecular polymers, plasticizers, dhayi, zvinonyungudutsa, nezvimwewo, uye mamiriro ekushanda eiyo coating ndiwo chiyero chesimba chekupfapfaidza nekuomesa uye michina yekupfekedza.
1.One-sided abrasion, film edge cracking and peeling
Kuoma kwepamusoro pepamusoro pepiritsi core ndiyo idiki, uye inoiswa nyore pasi pekukakavadzana kwakasimba uye kunetseka panguva yekuputira, uye imwe-sided poda kana zvimedu zvinodonha, zvichiita kuti pave nemapockmarks kana pores pamusoro peiyo piritsi core, inova imwe-side-kupfeka, kunyanya ine yakanyorwa Marked film. Iyo inonyanya kunetseka chikamu chemufirimu mufirimu-yakavharwa piritsi ndiyo makona. Kana kusungirirwa kana kusimba kwemufirimu kusina kukwana, kuputika uye kuputika kwemipendero yefirimu zvinogona kuitika. Izvi zvinodaro nekuti kuvhuvhuta kweiyo solvent kunoita kuti firimu riderere, uye kuwedzera kwakanyanya kweiyo firimu yekuputira uye iyo yakakosha kunowedzera kushushikana kwemukati kwemufirimu, iyo inopfuura simba rekusimba rekuvhara firimu.
1.1 Ongororo yezvikonzero zvikuru
Nekuda kweiyo chip core ine chekuita, chikonzero chikuru ndechekuti mhando yechip core haina kunaka, uye kuoma uye brittleness idiki. Munguva yekuputira, iyo tablet core inotarisana nekukakavadzana kwakasimba kana ichikunguruka mumucheka wekuputira, uye zvakaoma kutsungirira simba rakadaro pasina kuoma kwakakwana, iyo inobatana nekugadzirisa uye nzira yekugadzirira yepiritsi core. Patakarongedza mahwendefa e nifedipine anoramba akasunungurwa, nekuda kwekuoma kuduku kwepiritsi core, poda yakaonekwa kune rumwe rutivi, zvichiita kuti pave nemapores, uye firimu-yakavharidzirwa yepiritsi firimu yakanga isina kutsvedzerera uye ine chimiro chisina kunaka. Mukuwedzera, kukanganisa uku kwekuvhara kunobatanawo nemhando yepiritsi. Kana iyo firimu isingafadzi, kunyanya kana iyo firimu ine logo pakorona, inonyanya kutaridzika kune rimwe divi kupfeka.
Mukushanda kwekuputira, kunonoka kupfapfaidza kumhanyisa uye kupinza kwemhepo yakakura kana tembiricha yemhepo inopinza inotungamira kukurumidza kuomesa, kunonoka kuumbwa kwefirimu remahwendefa cores, kureba idling nguva yehwendefa cores mupani yekupfeka, uye nguva refu yekupfeka. Chechipiri, iyo atomization pressure yakakura, viscosity yemvura yekuputira yakaderera, madonhwe ari muatomization centre akabatanidzwa, uye solvent inoputika mushure mokunge madonhwe apararira, zvichiita kuti kushushikana kukuru kwemukati; panguva imwecheteyo, kukakavara pakati peimwe-side-side surfaces kunowedzerawo kushushikana kwemukati kwefirimu uye kunowedzera firimu. Mipendero yakatsemuka.
Mukuwedzera, kana kutenderera kwekutenderera kwepani yekuputira kwakakurumidza kana kuti baffle kugadzika kusinganzwisisike, simba rekukwevera pahwendefa richava rakakura, kuitira kuti mvura yekuputira isapararira zvakanaka, uye kuumbwa kwefirimu kunonoka, izvo zvichaita kuti rimwe divi ripfeke.
Kubva pamvura yekuputira, inonyanya kukonzerwa nekusarudzwa kwepolymer mukugadzirisa uye yakaderera viscosity (concentration) yemvura inoputika, uye kusvibiswa kusina kunaka pakati pefirimu yekuputira uye tablet core.
1.2 Solution
Imwe ndeyekugadzirisa kunyorerwa kana kugadzirwa kwepiritsi kuti uvandudze kuoma kweiyo piritsi core. HPMC chinhu chinowanzo shandiswa coating material. Iko kusungirirwa kwemapiritsi ekuwedzera kune hukama nemapoka e-hydroxyl pamamolekemu anobatsira, uye mapoka e-hydroxyl anoumba hydrogen bonds nemapoka anowirirana eHPMC kuti abudise kunamatira kwepamusoro; Iko kusungirirwa kunopera simba, uye imwe-side uye firimu yekuputira inowanzoparadzana. Huwandu hwemapoka e-hydroxyl pacheni yemamorekuru yemicrocrystalline cellulose yakakwira, uye ine simba rekunamatira rakakura, uye mahwendefa akagadzirirwa kubva kulactose uye mamwe mashuga ane simba rekunamatira rine mwero. Kushandiswa kwemafuta, kunyanya hydrophobic lubricants yakadai se stearic acid, magnesium stearate, uye glyceryl stearate, ichaderedza hydrogen bonding pakati pehwendefa core uye polymer mumushonga wekuputira, zvichiita kunamatira Simba rinoderera, uye nekuwedzera kwemafuta, simba rekunamatira rinopera zvishoma nezvishoma. Kazhinji, kunyanya kuwanda kwemafuta, kunyanya kunamatira kunopera simba. Uye zvakare, mukusarudzwa kwemhando yepiritsi, iyo yakatenderedza biconvex piritsi yemhando inofanirwa kushandiswa zvakanyanya sezvinobvira pakuputira, izvo zvinogona kuderedza kuitika kwekuremara kwekupfeka.
Chechipiri ndechekugadzirisa kunyorerwa kwemvura yekuputira, kuwedzera kuomarara kwemukati mumvura yekuputira kana viscosity yemvura yekuputira, uye kuvandudza kusimba uye kunamatira kweiyo firimu rekuvhara, iyo iri nyore nzira yekugadzirisa dambudziko. Kazhinji, iyo yakasimba yemukati mune aqueous coating system i12%, uye iyo yakasimba yemukati muorganic solvent system i5% kusvika 8%.
Musiyano muviscosity yemvura inoputira inokanganisa kumhanya uye dhigirii rekupinda kweiyo yekuputira mvura mukati meiyo piritsi core. Kana paine zvishoma kana pasina kupinda, kunamatira kwakaderera zvakanyanya. Iyo viscosity yemvura yekuputira uye zvimiro zveiyo firimu rekuputira zvine hukama neavhareji mamorekuru huremu hwepolymer mukuumbwa. Iyo yakakwirira yeavhareji yehuremu hwema molecular, iyo yakakura kuoma kweiyo firimu yekupfekedza, kuderera kuderera uye kusagadzikana kwekupfeka. Semuyenzaniso, inotengeswa HPMC ine akasiyana viscosity mamakisi ekusarudza nekuda kwekusiyana kweavhareji mamorekuru huremu. Mukuwedzera kune pesvedzero yepolymer, kuwedzera plasticizers kana kuwedzera zvirimo zvetalc zvinogona kuderedza kuitika kwemupendero wemupendero wefirimu, asi kuwedzera kwemavara iron oxide uye titanium dioxide inogonawo kukanganisa simba rekuvhara firimu, saka rinofanira kushandiswa zvine mwero.
Chechitatu, mukushanda kwekuputira, zvakakosha kuwedzera kukurumidza kupfapfaidza, kunyanya kana kuvhara kunotanga kutanga, kupfapfaidza kukurumidza kunofanira kunge kwakakurumidza zvishoma, kuitira kuti chidimbu chepiritsi chifukidzwe nechidimbu chefirimu munguva pfupi, iyo inobata basa rekudzivirira tablet core. Kuwedzera mwero wekupfapfaidza kunogona zvakare kuderedza tembiricha yemubhedha, evaporation rate uye tembiricha yefirimu, kuderedza kushushikana kwemukati, uye zvakare kuderedza chiitiko chekutsemuka kwefirimu. Panguva imwecheteyo, gadzirisa kutenderera kwekutenderera kwepani yekuputira kune yakanakisa mamiriro, uye isa baffle zvine musoro kuderedza kukweshera uye kupfeka.
2.Kunamatira uye kuputika
Mukuita kwekuputira, kana kubatana kweiyo interface pakati pezvimedu zviviri yakakura kupfuura simba rekuparadzanisa mamorekuru, zvimedu zvakati wandei (zvimedu zvakawanda) zvinosunga kwenguva pfupi uye zvobva zvaparadzana. Kana kuenzana pakati pekupfapfaidza nekuomeswa kusina kunaka, iyo firimu yakanyanyisa kunyorova, iyo firimu inonamatira kumadziro ehari kana kunamatira kune mumwe nemumwe, asiwo inokonzera kuputika kwefirimu panzvimbo yekunamatira; Mukupfapfaidza, kana madonhwe asina kuomeswa zvakakwana, madonhwe asina kuputika acharamba ari mufirimu yekuputira yemunharaunda, kune mabhuru maduku, achigadzira bubble coating layer, kuitira kuti jira rekuputira rionekwe mabhubhu.
2.1 Ongororo yezvikonzero zvikuru
Kuwanda uye chiitiko chehuhu hwekuputira chinokanganisa chinonyanya kukonzerwa nekugadzirisa mamiriro ekushanda, kusaenzana pakati pepfapfaidzo nekuoma. Sipidhi yekupfapfaidza inokurumidza kana huwandu hwegasi reatomi rakakurisa. Iyo yekuomesa inomhanyisa inononoka nekuda kweiyo yakaderera air inlet vhoriyamu kana yakaderera air inlet tembiricha uye yakaderera tembiricha yemubhedha wepepa. Iyo shiti haina kuomeswa layer ne layer munguva uye adhesions kana mabhuru anoitika. Uye zvakare, nekuda kwekusina kupfapfaidza Angle kana chinhambwe, koni inoumbwa nepfapfaidzo idiki, uye iyo yekuputira mvura inonangana mune imwe nzvimbo, zvichikonzera kunyorova kwenzvimbo, zvichikonzera kunamatira. Iko kune inononoka yekuputira poto, simba recentrifugal rakanyanya kudiki, kutenderera kwefirimu hakuna kunaka kunoburitsawo kunamatira.
Coating liquid viscosity yakakura kwazvo, zvakare chimwe chezvikonzero. Zvipfeko zvemvura viscosity zvakakura, zviri nyore kuumba madonhwe makuru emhute, kukwanisa kwayo kupinda mukati mepakati kune urombo, kuwedzera kune rimwe-sided aggregation uye kunamatira, panguva imwechete, kuwanda kwefirimu kwakashata, mabhuru akawanda. Asi izvi hazvina zvakawanda zvazvinoita pakunamatira kwenguva pfupi.
Mukuwedzera, mhando yefirimu isina kunaka ichaonekwawo kunamatira. Kana iyo furati firimu muhari yekuputira ichikunguruka isina kunaka, ichapindirana pamwe chete, zviri nyore kukonzera kaviri kana akawanda-layer firimu. Mukuedza kwedu kugadzirwa kwemapiritsi e-buflomedil hydrochloride, zvimedu zvakawanda zvinopindirana zvakaonekwa mumvura yakajairwa machestnuts ekuputira poto nekuda kweiyo flat coating.
2.2 Mhinduro
Inonyanya kugadzirisa kupfapfaidza uye kuomesa nekukurumidza kuti uwane dynamic balance. Deredza kumhanya kwekupfapfaidza, wedzera inlet mhepo vhoriyamu uye tembiricha yemhepo, wedzera tembiricha yemubhedha uye nekuomesa nekukurumidza. Wedzera nzvimbo yekuvhara yepfapfaidzo, dzikisa avhareji saizi yemadonhwe ekupfapfaidza kana gadzirisa chinhambwe pakati pepfuti yekupfapfaidza nemubhedha wepepa, kuitira kuti chiitiko chekunamatira kwenguva pfupi chidzikire nekugadziriswa kwechinhambwe pakati pepfuti yekupfapfaidza nemubhedha wepepa.
Gadzirisa chirevo chekugadzirisa kugadziriswa, kuwedzera zvinyorwa zvakasimba mukugadzirisa kugadzirisa, kuderedza kuwanda kwekunyungudutsa kana kuwedzera kusanganiswa kwe ethanol zvakakodzera mukati mehutano hwe viscosity; Anti-adhesive inogonawo kuwedzerwa zvakakodzera, senge talcum powder, magnesium stearate, silica gel poda kana oxide peptide. Inogona kunyatso kusimudzira kumhanya kwepoto yekuputira, kuwedzera centrifugal simba remubhedha.
Sarudza yakakodzera sheet coating. Nekudaro, kumashizha akatsetseka, akadai semahwendefa e-buflomedil hydrochloride, kupfekedza kwacho kwakabudirira kuitwa gare gare nekushandisa pani yekuputira inoshanda kana nekuisa baffle mune yakajairwa coating pani kukurudzira kupetwa kwepepa.
3.One-sided rough uye wrinkled ganda
Mukuita kwekuputira, nekuti iyo yekuputira mvura haina kunyatsopararira, iyo polymer yakaomeswa haina kuparadzirwa, isina kujairika deposition kana kunamatira pamusoro peiyo firimu, zvichikonzera murombo ruvara uye kusaenzana kwepamusoro. Ganda rakaunyana imhando yenzvimbo yakakwasharara, yakanyanya rough yekuona kuratidzwa.
3.1 Ongororo yezvikonzero zvikuru
Yekutanga inoenderana neiyo chip core. Iyo yakakura iyo yekutanga yepamusoro yehukukutu hwepakati ndeye, iyo yakakura roughness yepasi yechigadzirwa chakavharwa ichave.
Chechipiri, ine hukama hukuru neiyo coating solution prescription. Zvinowanzo davirwa kuti huremu hwemamorekuru, kutariswa uye zvinowedzera zvepolymer mune yekubikira mhinduro zvine hukama nekushata kwepamusoro kwebhaisikopo. Vanoita nekukanganisa viscosity yemushonga wekuputira, uye kushata kweiyo firimu kupfekedzwa kunenge kwakaenzana neiyo viscosity yemhinduro yekuputira, ichiwedzera nekuwedzera kweiyo viscosity. Yakawandisa yakasimba yemukati mukugadzirisa mhinduro inogona kukonzera nyore kune rimwe divi kukoromoka.
Pakupedzisira, inobatana nekushanda kwekuvhara. Iyo atomization yekumhanyisa yakadzikira kana yakawandisa (iyo atomization mhedzisiro haina kunaka), izvo zvisina kukwana kuparadzira madonhwe emhute uye kugadzira ganda rakakwinya rimwe divi. Uye yakawandisa vhoriyamu yemhepo yakaoma (kupedza mhepo yakakura kwazvo) kana yakanyanya tembiricha, kukurumidza kubuda, kunyanya kuyerera kwemhepo kwakakura kwazvo, kuburitsa eddy ikozvino, zvakare kuita kuti donhwe ripararire harina kunaka.
3.2 Mhinduro
Yokutanga ndeyekuvandudza kunaka kweiyo core. Pachimiro chekuona kunaka kweiyo core, gadzirisa iyo coating solution prescription uye uderedze viscosity (concentration) kana solid content yecoating solution. Doro-soluble kana doro-2-water coating solution inogona kusarudzwa. Zvadaro gadzirisa mamiriro ekushanda, zvakakodzera kunatsiridza kukurumidza kwehari yekuputira, ita kuti firimu iite zvakafanana, kuwedzera kupesana, kukurudzira kupararira kwemvura yekuputira. Kana tembiricha yemubhedha yakakwira, dzikisa huwandu hwemhepo yekutora uye tembiricha yemhepo. Kana pane zvikonzero zvekupfapfaidza, atomization kumanikidzwa kunofanira kuwedzerwa kukurumidza kupfapfaidza kukurumidza, uye atomization dhigirii uye pfapfaidzo vhoriyamu inofanira kuvandudzwa kuti mhute madonhwe kupararira nechisimba pamusoro pepa, kuitira kuti kuumba madonhwe mhute ane diki avhareji dhayamita uye kudzivirira kuitika kwemahombe mhute madonhwe, kunyanya pakuputira mvura ine viscosity hombe. Nharaunda pakati pepfuti yekupfapfaidza nemubhedha wepepa inogonawo kugadziriswa. Pfuti yekupfapfaidza ine dhayamita diki yemuromo (015 mm ~ 1.2 mm) uye yakanyanya kuyerera mwero weatomizing gasi inosarudzwa. Chimiro chekupfapfaidza chinogadziriswa kune yakafara cone Angle fog kuyerera, kuitira kuti madonhwe akaparadzirwa munzvimbo yakakura yepakati.
4.Ziva zambuko
4.1 Ongororo yezvikonzero zvikuru
Izvi zvinoitika kana pamusoro pefirimu pakaiswa chiratidzo kana kucherechedzwa. Nekuti zvipfeko membrane inokwereta zvine musoro memechani ma paramita, senge yakakwira elasticity coefficient, simba remufirimu rakashata, kusanamatira zvakanaka, nezvimwewo, mukugadzirwa kwembatya membrane kuomeswa kunoburitsa kudhonzera kumashure, kubva muhembe membrane pamusoro imprinting, membrane retraction uye bhiriji kunoitika, ita rimwe-side notch rakanyangarika kana logo haina kujeka, zvikonzero zvechiitiko ichi chiri mugwaro remvura.
4.2 Solution
Rongedza chirevo chekugadzirisa kugadzirisa. Shandisa yakaderera molecular uremu mapolymer kana yakakwirira adhesion firimu kugadzira zvinhu; Wedzera huwandu hwekunyungudika, kuderedza viscosity yekuputira mhinduro; Wedzera huwandu hweplasticizer, kuderedza kushushikana kwemukati. Yakasiyana plasticizer mhedzisiro yakasiyana, polyethylene glycol 200 iri nani pane propylene glycol, glycerin. Inogonawo kuderedza kumhanya kwepfapfaidzo. Wedzera tembiricha yemhepo inopinza, wedzera tembiricha yemubhedha wepepa, kuitira kuti iyo yakaumbwa yakajairwa yakasimba, asi kudzivirira kumucheto kuputika. Mukuwedzera, mukugadzirwa kwechiratidzo chekufa, tinofanira kubhadhara kuhupamhi hweAngle yekucheka uye dzimwe pfungwa dzakanaka, sezvinobvira kudzivirira kuitika kwebhiriji chiitiko.
5.Kupfeka membrane chromatism
5.1 Ongororo yezvikonzero zvikuru
Mune akawanda ekuputira mhinduro kune pigment kana dhayi iyo yakaturikwa mune yekubikira mhinduro uye nekuda kwekusashanda kwekuvhara, kugovaniswa kwemavara hakuna kufanana uye kusiyana kwemavara kunogadzirwa pakati pezvimedu kana muzvikamu zvakasiyana zvezvidimbu. Chikonzero chikuru ndechekuti kukurumidza kwepoto yekuputira kunononoka kana kusanganisa kusanganisa kwakashata, uye yunifomu yekuputira mhedzisiro haigone kuwanikwa pakati pezvidimbu munguva yakajairika yekupfeka; Iko kusanganiswa kwepigment kana dhayi mumucheka wekuputira mvura yakanyanyisa kana kuti yakasimba yakanyanyisa, kana kupfapfaidza kukurumidza kwemvura yekuputira inokurumidza, tembiricha yemubhedha yakakwira zvakanyanya, kuitira kuti iyo ine mavara inoputira mvura isatenderedzwa nenguva; Kunamatira kwefirimu kunogonawo kukonzerwa; Chimiro chechidimbu hachina kukodzera, senge chidimbu chakareba, capsule yakaumbwa chidimbu, nekuda kwekukunguruka sechidimbu chakatenderedza, kuchaitawo mutsauko wemavara.
5.2 Solution
Wedzera kukurumidza kwepani yekuputira kana nhamba yebhaffle, gadzirisa kune iyo yakakodzera mamiriro, kuitira kuti pepa riri mupani rakaenzana roll. Deredza kuvhara mvura yekupfapfaidza kumhanya, kuderedza tembiricha yemubhedha. Muchinyorwa chekugadzirwa kwemavara ekuputira mhinduro, iyo dosage kana yakasimba yepigment kana dhayi inofanira kuderedzwa, uye iyo pigment ine chifukidziro chakasimba inofanira kusarudzwa. Iyo pigment kana dhayi inofanirwa kuve yakatetepa uye zvimedu zvidiki. Madhayi asingasviki emvura ari nani pane madhayi anonyungudika emvura, madhayi asina kunyungudika haafambi nemvura nyore nyore sedhayi inonyungudika yemvura, uye shading, kugadzikana uye mukuderedza mhute yemvura, oxidation pakupera kwefirimu iri naniwo pane dhayi dzinonyungudika mvura. Uyewo sarudza rudzi rwakakodzera rwechidimbu. Mukuita kwekuputira firimu, kazhinji kune matambudziko akasiyana-siyana, asi zvisinei kuti ndeapi matambudziko, izvo zvinhu zvakawanda, zvinogona kugadziriswa nekuvandudza kunaka kweiyo core, kugadzirisa iyo coating prescription uye kushanda, kuitira kuti uwane kuchinjika application uye dialectical mashandiro. Nehunyanzvi hwekugadzira tekinoroji, kusimudzira uye kushandiswa kwemichina mitsva yekupfekedza uye firimu rekupfekedza zvinhu, tekinoroji yekupfekedza ichavandudzwa zvakanyanya, kupfekedza firimu kuchawanawo kukurumidza kusimudzira mukugadzirwa kwegadziriro dzakasimba.
Nguva yekutumira: Kubvumbi-25-2024