Iyomaitiro ekuputira piritsiinoshandura mapiritsi asina kubikwa kuita zvigadzirwa zvepamusoro zvinoenzanisa kushanda, kugadzikana, uye kukwezva kwemurwere.Kuputira firimu, danho rakakosha, rinofukidza mapiritsi nechikamu chakatetepa, chakafanana kuchengetedza zvinhu zvinoshanda zvemishonga (APIs), kudzora kuburitswa kwemishonga, kusimudzira runako, uye kuvandudza kutevedzera zvinodiwa nemurwere.
I. KunzwisisaMapiritsi Akaputirwa Nefirimu
Apiritsi rakaputirwa nefirimuimhando yakasimba yemushonga unonwiwa wakaputirwa nechikamu chakatetepa, chakavakirwa papolymer chinoshanda mabasa akasiyana-siyana, kubva pakuchengetedza API kusvika pakuwedzera kumedzwa. Kusiyana nemapiritsi asina kuputirwa, ayo ari panjodzi yekukuvadzwa kwezvakatipoteredza,kuputira firimuinopa dziviriro, inovandudza kutaridzika kwemaziso kuburikidza neruvara uye kupenya, uye inogona kugadzirisa marongero ekuburitswa kwemishonga. Maitiro aya haasi ekushongedza chete; ibasa repamusoro-soro rehunyanzvi rinoona kuti mapiritsi anosangana nemitemo yakasimba uku achigadzirisa zvinodiwa nemurwere.maitiro ekuputira firimu pamapiritsiInoshandiswa zvakanyanya nekuda kwekushanda kwayo kwakasiyana-siyana, inotsigira mishonga inoburitswa nekukurumidza (IR), inoburitswa nekunonoka, kana kuti inosunungurwa kwenguva refu yakagadzirirwa zvinangwa zvekurapa.
II. Chinangwa Chine Mativi Akawanda cheKuputira Mapiritsi
Iyomaitiro ekuputira piritsiZvakakosha mukugadzira mishonga, zvichipa mabhenefiti anosanganisira kugadzirwa, mashandiro emishonga, uye ruzivo rwemurwere. Heino chikonzero nei zvichikosha:
Kugadzikana Kwekugadzira Nekuchengetedza:
- Kuputira firimuInodzivirira maAPI kubva kuzvinhu zvinokanganisa nharaunda zvakaita sehunyoro, chiedza, uye okisijeni, izvo zvinogona kukonzera hydrolysis, oxidation, kana kuora kwechiedza. Kune mishonga inonzwa hunyoro senge ranitidine hydrochloride, kuputira nemapolymers senge polyvinyl alcohol (PVA) kana Eudragit kunowedzera kugadzikana, kuwedzera nguva yekuchengetedza uye kuchengetedza kushanda kwayo panguva yekuchengetera.
- Nekudzivirira shanduko dzemuviri dzakadai sekuzvimba kana kutsemuka, machira anoita kuti mapiritsi arambe ari mukati mepurasitiki, zvichichengetedza kunaka kwechigadzirwa.
Maitiro Ekuburitsa Mishonga Akadzorwa:
- Mapendi anogonesa kudzora kwakarurama nzvimbo, mwero, uye nguva yekuburitswa kweAPI. Mapendi anoburitswa nekukasika anonyungudika nekukurumidza mudumbu, nepo mapendi emukati, akagadzirirwa mishonga yakaita seproton pump inhibitors (semuenzaniso, omeprazole), anononoka kuburitswa kusvika muura hudiki kudzivirira maAPI kubva kuacid yemudumbu kana kudzivirira kutsamwiswa kwemudumbu.
- Kupfeka kunobuda kwenguva refu, uchishandisa mapolymer asinganyungudike mumvura senge ethyl cellulose, kunoita kuti mishonga ibude kwenguva refu, kuderedza kuwanda kwemishonga uye kuvandudza mhedzisiro yekurapa.
Kuteerera Kwakawedzerwa Kwevarwere:
- Kuputira firimuInovandudza kumedzwa kwemushonga nekugadzira pamusoro wakatsetseka uye unopenya, zvichiita kuti mapiritsi ave nyore kumedzwa, kunyanya kune vana nevakuru. Hunhu hwekuvhara kuravira hunovanza kunaka kunovava kana kusina kunaka, zvichikurudzira kutevedzera.
- Mapendi ane mavara anobatsira kuziva, kuderedza zvikanganiso zvemishonga, uye zviratidzo zvakajeka uye zvinoverengwa zvinoita kuti pave nechokwadi chekuti mishonga yacho inoteverwa zvakanaka, zvichizadzisa zvinodiwa nemitemo yekuchengetedza uye kutevedzera mitemo.
Runako uye Hunhu Hunoshanda:
- Kupfeka kwakafanana, kusina zvikanganiso kunovandudza chitarisiko chepiritsi, kuchisimbisa kuzivikanwa kwechiratidzo uye kuvimba kwevatengi. Kunoderedzawo zvikanganiso zvakaita sekusunga, kutsemuka, kana ganda reorenji, zvichiita kuti zvive pachena kuti zvinoenderana nemitemo yepamutemo.
Maitiro Ekuvhara Mapiritsi
Pan Tablet Coater
III. Maitiro eMaitiro Ekugadzira Mafirimu EmishongaMabasa
Iyomaitiro ekuputira firimu pamapiritsiibasa repamusoro-soro, rine matanho akawanda rinoda kunyatsorongeka kuti uwane mhedzisiro yakanaka uye inogara iripo. Heino tsananguro yakadzama:
Kugadzirira Kugadzira:
- Kuumbwa kwependi iyi kunosanganisa mapolymers anoita firimu (semuenzaniso, hydroxypropyl methylcellulose [HPMC], Eudragit), mapurasitiki, pigments, nezvimwe zvinowedzerwa kuti zviwane hunhu hwaunoda senge ruvara, kupenya, uye kuramba hunyoro. Kusarudzwa kwepolymer kunokanganisa zvakanyanya viscosity, izvo zvinokanganisa kupfapfaidza uye kunaka kwefirimu.
Kugadzirira Mhinduro Yekuputira:
- Upfu hwakagadzirwa kare hunosanganiswa nemvura kana organic solvent, kazhinji zvinoda maminetsi makumi mana nemashanu kuti pave nemushonga wakafanana.viscometer yekuputiraZvakakosha pano, sezvo kusviba kunokanganisa zvakananga kuumbwa kwemadonhwe uye kufanana kwefirimu. Mhinduro dze high-viscosity dzinogona kukonzera kuumbwa kwemapundu, nepo kusviba kushoma kuchivimbisa kugadzirira nekukurumidza uye kunaka kwepamusoro.
Kushandiswa kweKuputira:
- KurodhaMapiritsi anoiswa mumuchina wekuputira, senge pan coater kana fluidized bed coater, kwaanotenderera kuti ave nechokwadi chekuti anosangana zvakaenzana nemushonga wekuputira.
- Kupfapfaidza: Mushonga wekuputira unoiswa atomu kuburikidza nemuromo wekupfapfaidza, neatomization uye pattern air control droplet size uye divi rekupararira. Chiyero chemhepo-ku-spray chakaenzana (chakanaka 1:1) chinoita kuti madonhwe madiki uye kufukidzwa kwakafanana.
- Kuomesa: Mhepo inopisa inonyungudutsa mvura inonyungudutsa, zvichiita firimu rakatsetseka uye rinogara riripo. Kuomesa kwakadzorwa kunodzivirira kuoma zvakanyanya (kunokonzera nzvimbo dzakaoma) kana kuoma zvishoma (zvichikonzera kupetana kana kuungana).
Kudzora Hunhu:
- Kunyatsotarisa ukobvu hwemachira, kufanana, ruvara, uye magadzirirwo awo kunoita kuti pave nekutevedzera nzira dzakanaka dzekugadzira (GMPs). Kuyera kwakanangana, kunyanya kusimba uye kuwanda, kwakakosha kudzivirira zvikanganiso zvakaita sekuvharira, kutsemuka, kana kukwenya, sezvakaratidzwa muhurukuro dzekudzora maitiro.
Ndezvipi ZvakanakisisaMhinduro dzeKuputira Mapiritsi?
Kusarudza mushonga wekuputira wakakodzera kunoenderana nehunyanzvi hwemushonga, zvinangwa zvekurapa, uye zvipingamupinyi zvekugadzira. Nzira mbiri huru dzinonyanya kukosha:
Kuputira Firimu reOrganic Solvent:
- Zvakanakira maAPI anonzwa hunyoro, mapurasitiki e organic solvent anoshandisa ma polymer akaita se cellulose acetate phthalate kuti ape hunyoro hwakasimba, kudzivirira hydrolysis. Zvisinei, anodhura zvakanyanya, ane njodzi dzekuchengetedza nekuda kwekupisa, uye ane zvipingamupinyi zvakatipoteredza, zvinoda kugadziriswa kwakanyatsogadzirwa uye kuraswa.
Kuputira Mafirimu Emvura:
- Sarudzo inonyanya kufarirwa pakushandiswa kwakawanda, machira emvura anoshandisa mapolymer anonyungudika mumvura akadai seHPMC kana PVA, zvichipa mukana wekukwira, kuchengetedzeka, uye kuderedza kukanganisa kwezvakatipoteredza. Mafomu epamusoro anowedzera kushanda zvakanaka pamhando dzese dzemichina, zvichiita kuti ive inodhura zvishoma uye inoenderana nemaitiro emutemo, akadai sezvirambidzo pa titanium dioxide (TiO2).
IV. Kushandiswa kweMishongaKuputira Mafirimu
Iyomaitiro ekuputira piritsiinoshanda mashandisirwo akasiyana-siyana, imwe neimwe ichigadzirisa matambudziko chaiwo emishonga:
- Kuburitswa Kwemishonga Yakagadziriswa:
Kunonoka Kuburitswa Kwemishonga:
- Mapendi emukati anodzivirira mishonga ine acid-labile (semuenzaniso, esomeprazole) kana kuderedza kutsamwa kwemudumbu (semuenzaniso, pantoprazole) nekunyungudika mu pH yemudumbu diki. Mafomu maviri anononoka kuburitswa, senge dexlansoprazole, anosanganisa granules nemaitiro akasiyana e pH-dependent dissolving kuti anwe nguva yakareba.
- Mapurasitiki anonangwa nekoloni, achishandisa mapolymer anotsamira papH kana kuti anogona kuora neenzyme, anorapa zvirwere zvakaita seCrohn's disease kana kuti anovandudza bioavailability yepeptide. Matekinoroji akaita seColoPulse anobatanidza pH uye zvinokonzera mabhakitiriya kuti zvikwanise kuburitswa nemazvo.
- Kupfeka kweChronotherapeutic kunobatanidza kuburitswa kwemushonga ne circadian rhythms, sezvinoonekwa mumapiritsi e telmisartan ne pravastatin ane bilayer akaputirwa mukati medumbu, zvichiita kuti kurapwa kweBP ne cholesterol kuve kwakanaka.
Mufananidzo 1
Kapuleti yakaputirwa yairamba iine acidity uye yairatidza kuti ine pH-dependent drug release profile. Yakatanga kuburitswa kwemishonga mushure meawa imwe chete mudumbu diki uye yakaramba ichiburitswa kwenguva refu mudumbu rose.
Kuburitswa Kwemishonga Inoenderera Mberi:
- Mapolymer asinganyungudike mumvura akadai se ethyl cellulose kana polymethacrylates anogadzira ma profiles anoburitswa kwenguva refu, zvichideredza kuwanda kwedosi yemishonga yakaita se venlafaxine. Masisitimu epombi eOsmotic, akafukidzwa ne cellulose acetate, anodzora kuburitswa kwemvura kuburikidza nekupinda kwemvura uye saizi ye orifice, sezvakaratidzwa mu eperisone hydrochloride formulations.
Mufananidzo 2
Avhareji yehuwandu hweropa muropa kana ichienzaniswa nenguva yakawanikwa mushure mekupiwa mapiritsi eEperisone 150 mg CR (kusunungurwa kwakadzorwa) e osmotic uye mapiritsi ekusunungurwa pakarepo.
Kugadzikana Kwemishonga Kwakavandudzika:
- Kuputira firimuInodzivirira mishonga inonzwa hunyoro (semuenzaniso, ranitidine) kana mishonga inonzwa chiedza (semuenzaniso, nifedipine) uchishandisa mapolymers anonyungudutsa mvura, lipids, kana maopacifiers. Kusanganisa mapolymers akaita seHPMC ne suberin fatty acids kunowedzera zvipingamupinyi zvemvura, zvichiita kuti pave nekugadzikana kwenguva refu.
Kuravira Mask:
- Zvakakosha kuti vana nevana vakwegura vatevedzere zvinodiwa, machira ekudzivirira kuravira anoshandisa mapolymer akaita seethylcellulose kana hypromellose kudzivirira kuburitswa kwemishonga inovava mumuromo. Zviyero zvakagadziriswa zvemapolymer anonyungudika mumvura neasinganyungudike zvinoenzanisa kuravira nekuwanikwa kwezvinhu zvipenyu.
Kuputira Mafirimu Anoshanda:
- Maitiro aya matsva anosanganisira maAPI muchikamu chekufukidza, zvichiita kuti pave nekusanganiswa kwedosi yakatarwa (semuenzaniso, metformin neglimepiride) kana kuti kugadzikana kwemishonga yakaita sepeliglitazar kuve nani. Matambudziko anosanganisira kuwana kugoverwa kwakafanana kweAPI uye kudzora kwakarurama kwemagumo, zvichida kutariswa kwakasimba kwemaitiro.
V. Matambudziko eMaitiro muKuputira Mapiritsi
Iyomaitiro ekuputira firimu pamapiritsiinoshanduka-shanduka, nekupfapfaidza, kupararira kwependi, uye kuomesa zvichiitika panguva imwe chete. Matambudziko makuru anosanganisira:
- Kurasikirwa kweSolvent uye Kuchinja kweViscosity: Kubviswa kwemvura inonyungudutsa kunowedzera kusimba, zvichikanganisa kuumbwa kwemadonhwe uye kunaka kwefirimu. Kuwedzera zvinhu zvakatetepa nguva nenguva kunodiwa kuti kusimba kurambe kwakakodzera.
- Kuumbwa Kwezvikanganiso Zvakakwana: Matambudziko akadai sekubatanidza, kutsemuka, kuomarara kwemapundu eorenji, kana kupatsanurana kunobva mumatanho asina kunaka ekushanda, akadai semhepo isina kuenzana, saizi yemadonhwe isiriyo, kana kusanyatsooma zvakanaka.
- Miganhu Yekuyera Kwechinyakare: Zvishandiso zvisina basa zvakaita se efflux cups kana laboratory viscometers hazvina kururama uye zvinotora nguva, zvichitadza kubata mamiriro ezvinhu aripo akadai setembiricha, shear rate, kana flow dynamics.
- Kutevedzera Mutemo: Mitemo yakasimba inoda kuti mavara acho ave neruvara rwakafanana, anonyatsoverengwa, uye asina zvikanganiso, zvichiita kuti pave nekudzorwa kwenguva chaiyo kuti pave nezvinodiwa zveGMPs uye kutevedzana.
VI. Maitiro Ekugadzirisa uye Zvinhu ZvinokanganisaHunhu hweKuputira Mafirimu
Kuwana chifukidziro chakafanana uye chemhando yepamusoro kunoda kutarisisa kwakanyatsonaka kwematanho ekuita, sezvakatsanangurwa pazasi:
Kuyerera kwemhepo mupfapfaidzo:
- Kupatsanurwa kweatomu nemhepo inoyerera zvinoparadzanisa mushonga wekuputira kuita madonhwe. Chiyero che1:1 chinoderedza saizi yemadonhwe, zvichiwedzera kufanana uye kushanda zvakanaka kwemuputi. Kuyerera kwemhepo kusina kuenzana kunotungamira mukuumbwa kwemvura isina kuenzana uye zvikanganiso.
Mwero wepfapfaidzo:
- Kuwanda kwekupfapfaidza kunowedzera kukura kwemadonhwe uye kunoderedza kumhanya, zvichikanganisa kunaka kwekuputira. Chiyero cheatomization air-to-spray rate chakakosha pakuchengetedza saizi yemadonhwe yakafanana uye kugona kuomesa.
Mhepo Inopinda Nekubuda:
- Kupisa kwemhepo inopinda uye hunyoro zvinokanganisa kushanda zvakanaka kwekuomesa. Kuomesa zvakanyanya kunokonzera nzvimbo dzakaoma, ukuwo kuomesa kusina kukwana kunotungamira mukuungana kwenzvimbo. Kupisa kwemhepo inopinda kunze, kazhinji 2–3°C pamusoro petembiricha yemubhedha wepiritsi, kunotungamira pakugadzirisa kuomesa.
Saizi yeDonplet:
- Madonhwe madiki, anowanikwa kuburikidza nekuenzanisa kwemhepo uye kusimba kwakaderera, zvinoita kuti firimu rive rakafanana. Madonhwe makuru anowedzera kuomarara pamusoro, zvichikanganisa kunaka.
Zviri Mukati Zvakasimba uye Kusviba:
- Kuwanda kwemafuta akaomarara kunokurumidza kuwedzera uremu asi kunowedzera kuomarara, zvichiita kuti kupfapfaidza kuve kwakaoma. Kupisa mvura kana kugadzirisa huwandu hwemapolymer kunoderedza kuomarara, kunovandudza kugona kwayo kugadzikiswa uye kunoderedza mari.
Kureba Kubva Papfuti Kuenda Kumubhedha:
- Kureba kwakakodzera kunoita kuti madonhwe asvike pamusoro pepiritsi pasina kuoma nguva isati yakwana kana kunyorova zvakanyanya. Kureba zvakanyanya, madonhwe acho anooma ari mumhepo, zvichikonzera kukwasharara; pedyo zvakanyanya, uye pamusoro panyorova zvinoita kuti pave nekupatsanuka.
Nguva Yokurapa:
- Kuchenesa mushure mekuputira (1-awa yakati wandei) kunobvisa zvinonyungudutsa zvakasara uye kunoomesa firimu, zvichikanganisa ma profiles ekunyungudika. Kuchenesa kusina kukwana kunogona kukonzera kusangana kwema polymer zvisina kukwana.
Kumhanya kwePan uye Kufamba kweTablet:
- Kutenderera pani zvakanaka kunoita kuti mapiritsi afambe munzvimbo yekupfapfaidza nenzira dzakasiyana-siyana, zvichiita kuti pave nekuputira kwakafanana. Kumhanya kushoma kunokonzera kufukidzwa kusina kuenzana, nepo kumhanya kwakanyanya kunogona kukuvadza mapiritsi.
Kuumbwa kwemhinduro yekunamira:
- Kusarudzwa kwemapolymer, pigments, uye plasticizers kunokanganisa viscosity, surface tension, uye firimu. Mapolymers anonyungudika mumvura anowedzera viscosity, zvichida kuumbwa kwakanyatsonaka kudzivirira zvikanganiso.
VII. Basa reLonnmeter Inline Coating Viscometer
IyoLonnmeter Inline Coating Viscometerinochinja-chinjakudhinda mishongauye kufukidza nekupa kutarisa kwe viscosity panguva chaiyo, kugadzirisa zvipingamupinyi zvezvishandiso zvechinyakare. Izvi zvakafambira mberi.viscometer yekuputirainoyera viscosity zvakananga mukufamba kwemaitiro, ichitarisa zvinhu zvakaita setembiricha, mwero wekuchekwa kwemvura, uye mamiriro ekuyerera kwemvura.
Mabhenefiti eLonnmeter Inline Coating Viscometer
- Kunyatsojeka Munguva Chaiyo: Inoramba ichitarisa shanduko dze viscosity kubva pakutanga, zvichiita kuti pave nekugadzirisa nekukurumidza kune mwero we solvent kana tembiricha, ichiva nechokwadi chekuti madonhwe anogadzirwa zvakanaka uye mhando yefirimu inoenderera mberi.
- Kuderedza Zvikanganiso Zvakakwana: Inochengetedza kunaka kwakanyanya kuderedza matambudziko akadai sekupwanyika, kutsemuka, kana kukweshana kweganda reorenji, ichiva nechokwadi chekuti zvinoenderana nezvinodiwa nezvigadzirwa zvakapedzwa.
- Kushanda Nemutengo Wakanaka: Inoderedza kushandiswa kwepigment uye solvent nekuvandudza zviri mukati mayo, kuderedza mitengo yezvinhu nemarara, uye kupfupisa nguva yekugadzirisa.
- Zvakanakira Zvakatipoteredza: Inoderedza kushandiswa kwezviwanikwa, zvichienderana nemaitiro ekugadzira anochengetedza nharaunda.
- Kutevedzera Zvakawedzerwa: Inoita kuti mavara arambe akaenzana uye kuti mavara acho aonekwe zvakanaka, zvakakosha kuti pave nekuongororwa kwakanaka uye kuchengetedzeka kwemurwere.
- Kushanda Nesimba Kwemushandi: Inoita kuti kudzora viscosity kushande otomatiki, zvichiita kuti vashandisi vasunungure pfungwa dzavo pane mamwe mabasa, kusiyana nenzira dzinoshandiswa nemaoko dzinotora nguva uye dzisingachinji.
- Kukwanisa kukura: Inoenderana nemidziyo yakasiyana-siyana yekuputira (pan coaters, fluidized bed coaters) uye mafomura, zvichitsigira maitiro emvura uye organic solvent.
Kugonamaitiro ekuputira firimu pamapiritsizvinoda kunyatsorongeka, tekinoroji yepamusoro, uye kunzwisisa kwakadzama kwematanho ekuita.Lonnmeter Inline Coating Viscometerinopa simba vagadziri kuti vakunde matambudziko, vagadzirise mhando, uye vabudirire kutevedzera mitemo zviri nyore.Kumbira mutengo nhasikuti tizive kuti iyi nzira yemazuva anoviscometer yekuputirainogona kuwedzera kushanda zvakanaka, kuderedza mitengo, uye kupa mapiritsi epamusoro-soro anoenderana nezvinodiwa nemurwere uye nemutemo.
Nguva yekutumira: Nyamavhuvhu-22-2025
