Joseph Brama adayambitsa njira yotulutsira mapaipi otsogolera kumapeto kwa zaka za zana la 18. Sizinali mpaka pakati pa zaka za m'ma 1900 pomwe ukadaulo wotenthetsera wotentha wosungunuka unayamba kugwiritsidwa ntchito m'makampani apulasitiki. Anagwiritsidwa ntchito koyamba popanga zokutira zotchingira polima zamawaya amagetsi. Masiku ano umisiri wotentha wosungunula wotentha umagwiritsidwa ntchito kwambiri osati popanga zinthu za polima, komanso kupanga ndi kusakaniza ma polima okha. Pakalipano, zoposa theka la zinthu zapulasitiki, kuphatikizapo matumba apulasitiki, mapepala apulasitiki ndi mapaipi apulasitiki, amapangidwa pogwiritsa ntchito njirayi.
Pambuyo pake, ukadaulo uwu udayamba pang'onopang'ono m'munda wamankhwala ndipo pang'onopang'ono unakhala ukadaulo wofunikira kwambiri. Tsopano anthu amagwiritsa ntchito umisiri otentha-kusungunuka extrusion kukonzekera granules, kupitiriza-kumasulidwa mapiritsi, transdermal ndi transmucosal mankhwala yobweretsera dongosolo etc. N'chifukwa chiyani anthu amakonda luso limeneli tsopano? Chifukwa chake makamaka chifukwa poyerekeza ndi chikhalidwe kupanga ndondomeko m'mbuyomu, otentha Melt extrusion luso ali ndi ubwino zotsatirazi:
Limbikitsani kuchuluka kwa kusungunuka kwa mankhwala osasungunuka bwino
Pali ubwino wokonzekera makonzedwe otulutsidwa mosalekeza
Kukonzekera kwa m'mimba kumasulidwa othandizira ndi malo olondola
Kulimbikitsa excipient compressibility
The slicing ndondomeko anazindikira mu sitepe imodzi
Tsegulani njira yatsopano yokonzekera ma micropellets
Pakati pawo, ether ya cellulose imagwira ntchito yofunika kwambiri pakuchita izi, tiyeni tiwone momwe ma cellulose ether amagwirira ntchito!
Kugwiritsa ntchito ethyl cellulose
Ethyl cellulose ndi mtundu wa hydrophobic ether cellulose. M'munda mankhwala, iye tsopano ntchito mu microencapsulation wa yogwira zinthu, zosungunulira ndi extrusion granulation, piritsi piping ndi ❖ kuyanika kwa ankalamulira kumasulidwa mapiritsi ndi mikanda. Ethyl cellulose imatha kukulitsa zolemetsa zosiyanasiyana zama cell. Kutentha kwake kwa kusintha kwa magalasi ndi 129-133 madigiri Celsius, ndipo malo ake osungunuka a galasi ndi osachepera 180 digiri Celsius. Ethyl cellulose ndi yabwino kwa extrusion chifukwa imawonetsa katundu wa thermoplastic pamwamba pa kutentha kwa galasi lake komanso pansi pa kutentha kwake.
Pofuna kuchepetsa kutentha kwa galasi la ma polima, njira yodziwika kwambiri ndiyo kuwonjezera mapulasitiki, kotero akhoza kukonzedwa pa kutentha kochepa. Mankhwala ena amatha kukhala ngati mapulasitiki okha, kotero palibe chifukwa chowonjezeranso mapulasitiki panthawi yopangira mankhwala. Mwachitsanzo, zinapezeka kuti mafilimu otulutsidwa omwe ali ndi ibuprofen ndi ethyl cellulose anali ndi kutentha kwa galasi lotsika kusiyana ndi mafilimu omwe ali ndi ethyl cellulose okha. Makanemawa amatha kupangidwa mu labotale yokhala ndi ma co-rotating twin-screw extruders. Ochita kafukufukuwo adawuperanso kukhala ufa ndiyeno amayesa kutentha. Zinapezeka kuti kuwonjezera kuchuluka kwa ibuprofen kumatha kuchepetsa kutentha kwa galasi.
Kuyesera kwina kunali kuwonjezera ma hydrophilic excipients, hypromellose, ndi xanthan chingamu ku ethylcellulose ndi ibuprofen micromatrices. Zinaganiziridwa kuti micromatrix yopangidwa ndi njira yotentha yotentha yosungunuka inali ndi njira yowonjezereka yoyamwitsa mankhwala kusiyana ndi zomwe zilipo malonda. Ofufuzawo adapanga micromatrix pogwiritsa ntchito kukhazikitsidwa kwa labotale yozungulira komanso cholumikizira mapasa chokhala ndi 3-mm cylindrical die. Mapepala odulidwa ndi manja anali otalika 2 mm.
Kugwiritsa ntchito hypromellose
Hydroxypropyl methylcellulose ndi hydrophilic cellulose ether yomwe imafufuma kukhala njira yowoneka bwino kapena yamtambo pang'ono ya colloidal m'madzi ozizira. Njira yothetsera madzi imakhala ndi zochitika zapamtunda, zowonekera kwambiri komanso zokhazikika. Kusungunuka kumasiyanasiyana ndi kukhuthala. M'munsi mamasukidwe akayendedwe, kwambiri solubility. Makhalidwe a hydroxypropyl methylcellulose okhala ndi mawonekedwe osiyanasiyana ndi osiyana, ndipo kusungunuka kwake m'madzi sikukhudzidwa ndi mtengo wa pH.
M'makampani opanga mankhwala, nthawi zambiri amagwiritsidwa ntchito poyang'anira kumasulidwa kwa matrix, kutsekemera kwa piritsi, granulation yomatira, etc. Kutentha kwa galasi la hydroxypropyl methylcellulose ndi 160-210 madigiri Celsius, zomwe zikutanthauza kuti ngati zidalira m'malo ena, kutentha kwake kowonongeka. kupitirira madigiri 250 Celsius. Chifukwa cha kutentha kwake kwa galasi lapamwamba kwambiri komanso kutentha kwapansi kochepa, sikugwiritsidwa ntchito kwambiri mu teknoloji yotentha yotentha ya extrusion. Pofuna kukulitsa kuchuluka kwa ntchito yake, njira imodzi ndikungophatikiza kuchuluka kwa plasticizer mu njira yopangira monga momwe akatswiri awiriwa adanenera, ndikugwiritsa ntchito mawonekedwe a matrix extrusion omwe kulemera kwake kwa plasticizer ndi osachepera 30%.
Ethylcellulose ndi hydroxypropylmethylcellulose akhoza kuphatikizidwa m'njira yapadera popereka mankhwala. Mmodzi mwa mitundu ya mlingo ndi kugwiritsa ntchito ethylcellulose ngati chubu chakunja, kenako kukonzekera hypromellose giredi A padera. Base cellulose pachimake.
The ethylcellulose chubu amapangidwa ntchito otentha-Sungunulani extrusion mu co-azungulira makina mu labotale kuyika zitsulo mphete kufa chubu, pachimake amene anapanga pamanja ndi Kutentha msonkhano mpaka kusungunuka, kenako homogenization. Zomwe zili pachimake zimaperekedwa pamanja mupaipi. Cholinga cha phunziroli chinali kuthetsa zotsatira za kutuluka komwe nthawi zina kumapezeka pamapiritsi a hydroxypropyl methylcellulose matrix. Ofufuzawo sanapeze kusiyana pakati pa kutulutsidwa kwa hydroxypropyl methylcellulose ya viscosity yomweyi, komabe, m'malo mwa hydroxypropyl methylcellulose ndi methylcellulose kudapangitsa kuti atulutsidwe mwachangu.
Outlook
Ngakhale kutentha kusungunula extrusion ndi teknoloji yatsopano m'makampani opanga mankhwala, yachititsa chidwi kwambiri ndipo imagwiritsidwa ntchito popititsa patsogolo kupanga mitundu yosiyanasiyana ya mlingo ndi machitidwe. Kutentha-kusungunuka extrusion luso wakhala luso kutsogolera pokonzekera kubalalitsidwa olimba kunja. Chifukwa mfundo zake zaukadaulo ndizofanana ndi njira zambiri zokonzekera, ndipo zakhala zikugwiritsidwa ntchito m'mafakitale ena kwazaka zambiri ndipo zapeza zambiri, zimakhala ndi chiyembekezo chotukuka. Ndi kuzama kwa kafukufuku, akukhulupirira kuti ntchito yake idzakulitsidwanso. Panthawi imodzimodziyo, teknoloji yotentha-yotentha ya extrusion imakhala yochepa kwambiri ndi mankhwala osokoneza bongo komanso makina apamwamba kwambiri. Pambuyo pakusintha kupita kumakampani opanga mankhwala, akukhulupirira kuti kusintha kwake kwa GMP kudzakhala kofulumira.
Nthawi yotumiza: Dec-16-2022