Joseph Brama ya kirkiro tsarin extrusion don samar da bututun gubar a ƙarshen karni na 18.Sai a tsakiyar karni na 19 ne aka fara amfani da fasahar extrusion mai zafi a masana'antar robobi.An fara amfani da shi a cikin samar da insulating polymer coatings ga lantarki wayoyi.A yau zafi narke extrusion fasahar da aka yadu amfani ba kawai a cikin samar da polymer kayayyakin, amma kuma a cikin samarwa da kuma hadawa na polymers kansu.A halin yanzu, fiye da rabin kayayyakin robobi, da suka hada da buhunan robobi, zanen robobi da bututun roba, ana yin su ta hanyar amfani da wannan tsari.
Daga baya, wannan fasaha ta bullo a hankali a fannin harhada magunguna kuma a hankali ta zama fasahar da ba ta da makawa.Yanzu mutane amfani da zafi-narke extrusion fasaha don shirya granules, ci gaba-saki Allunan, transdermal da transmucosal miyagun ƙwayoyi bayarwa tsarin da dai sauransu Me ya sa mutane fi son wannan fasaha a yanzu?Dalilin shi ne yafi saboda idan aka kwatanta da tsarin samar da al'ada a baya, fasahar narke mai zafi yana da fa'idodi masu zuwa:
Inganta yawan narkar da kwayoyi marasa narkewa
Akwai fa'idodi don shirya tsararren-saki
Shirye-shiryen abubuwan sakin gastrointestinal tare da madaidaicin matsayi
Haɓaka matsi mai ƙarfi
Ana aiwatar da tsarin slicing a mataki ɗaya
Bude sabon hanya don shirye-shiryen micropellets
Daga cikin su, ether cellulose yana taka muhimmiyar rawa a cikin wannan tsari, bari mu dubi aikace-aikacen ether na cellulose a ciki!
Amfani da ethyl cellulose
Ethyl cellulose wani nau'i ne na hydrophobic ether cellulose.A cikin Pharmaceutical filin, ta yanzu amfani a cikin microencapsulation na aiki abubuwa, ƙarfi da kuma extrusion granulation, kwamfutar hannu bututu da kuma a matsayin shafi na sarrafawa saki Allunan da beads.Ethyl cellulose na iya ƙara nau'o'in nauyin kwayoyin halitta daban-daban.Matsakaicin canjin gilashin sa shine digiri 129-133 ma'aunin celcius, kuma wurin narkewar crystal ɗinsa ya rage ma'aunin Celsius 180.Ethyl cellulose zabi ne mai kyau don extrusion saboda yana nuna kaddarorin thermoplastic sama da yanayin canjin gilashin sa da kuma ƙasa da yanayin ƙazanta.
Don rage yawan zafin jiki na gilashin gilashin polymers, hanyar da ta fi dacewa ita ce ƙara masu filastik, don haka ana iya sarrafa shi a ƙananan zafin jiki.Wasu kwayoyi na iya yin aiki azaman masu yin filastik da kansu, don haka babu buƙatar sake ƙara masu yin filastik yayin aikin samar da magunguna.Alal misali, an gano cewa fina-finai da aka fitar da ke dauke da ibuprofen da ethyl cellulose suna da ƙananan zafin jiki na gilashi fiye da fina-finan da ke dauke da ethyl cellulose kawai.Ana iya yin waɗannan fina-finai a cikin dakin gwaje-gwaje tare da masu fitar da tagwayen dunƙule masu juyawa.Masu binciken sun kuma nika shi a cikin foda sannan suka yi nazarin yanayin zafi.Ya juya cewa ƙara yawan ibuprofen na iya rage yawan zafin jiki na gilashin.
Wani gwaji shine don ƙara abubuwan haɓaka hydrophilic, hypromellose, da xanthan danko zuwa ethylcellulose da ibuprofen micromatrices.An kammala cewa micromatrix da aka samar ta hanyar fasahar extrusion mai zafi mai zafi yana da tsarin shayar da ƙwayoyi akai-akai fiye da samfuran da ake da su na kasuwanci.Masu binciken sun samar da micromatrix ta amfani da saitin dakin gwaje-gwaje mai jujjuyawar haɗin gwiwa da mai fitar da tagwaye tare da mutuwar silinda na 3-mm.Zane-zanen da aka yanke da hannu sun kasance tsawon mm 2.
Amfani da Hypromellose
Hydroxypropyl methylcellulose shine ether na cellulose na hydrophilic wanda ke kumbura zuwa cikin bayani mai haske ko dan kadan mai girgije a cikin ruwan sanyi.Maganin ruwa mai ruwa yana da aikin saman, babban nuna gaskiya da kwanciyar hankali.Solubility ya bambanta da danko.Ƙananan danko, mafi girma da solubility.Kaddarorin hydroxypropyl methylcellulose tare da ƙayyadaddun ƙayyadaddun bayanai daban-daban sun bambanta, kuma ƙimar pH ba ta shafar rushewarta a cikin ruwa.
A cikin Pharmaceutical masana'antu, shi ne sau da yawa amfani a sarrafawa saki matrix, kwamfutar hannu shafi aiki, m granulation, da dai sauransu The gilashin mika mulki zafin jiki na hydroxypropyl methylcellulose ne 160-210 digiri Celsius, wanda ke nufin cewa idan ya dogara a kan sauran musanya, ta ƙasƙanta zafin jiki. ya wuce digiri Celsius 250.Saboda tsananin zafin canjin sa na gilashi da ƙarancin ƙarancin lalacewa, ba a amfani da shi sosai a cikin fasahar narkewar zafi mai zafi.Domin fadada iyakokin amfani da shi, hanya ɗaya ita ce kawai a haɗa babban adadin filastik a cikin tsari kamar yadda malaman biyu suka ce, kuma a yi amfani da tsarin matrix na extrusion wanda nauyin filastik ya kai akalla 30%.
Ethylcellulose da hydroxypropylmethylcellulose za a iya haɗa su ta hanya ta musamman a cikin isar da magunguna.Ɗaya daga cikin waɗannan nau'o'in nau'i shine amfani da ethylcellulose a matsayin bututu na waje, sannan a shirya nau'in hypromellose A daban.Base cellulose core.
Ana samar da bututun ethylcellulose ta hanyar amfani da narke mai zafi a cikin injin haɗin gwiwa a cikin dakin gwaje-gwaje ana saka bututun zobe na karfe, wanda ake yin sa da hannu ta hanyar dumama taron har sai ya narke, sannan a sanya homogenization.Ana ciyar da ainihin kayan da hannu a cikin bututun.Manufar wannan binciken shine don kawar da tasirin popping wanda wani lokaci yakan faru a cikin allunan matrix hydroxypropyl methylcellulose.Masu binciken ba su sami wani bambanci ba a cikin adadin sakin hydroxypropyl methylcellulose na danko iri ɗaya, duk da haka, maye gurbin hydroxypropyl methylcellulose tare da methylcellulose ya haifar da saurin sakin.
Outlook
Ko da yake zafi narke extrusion ne in mun gwada da sabon fasaha a cikin Pharmaceutical masana'antu, ya jawo hankalin mai yawa da kuma amfani da su inganta samar da yawa daban-daban sashi siffofin da kuma tsarin.Hot-narke extrusion fasaha ya zama manyan fasaha domin shirya m watsawa a kasashen waje.Saboda ka'idodinsa na fasaha sun yi kama da yawancin hanyoyin shirye-shirye, kuma an yi amfani da shi a wasu masana'antu shekaru da yawa kuma ya tara kwarewa mai yawa, yana da ci gaba mai girma.Tare da zurfafa bincike, an yi imanin cewa za a ƙara fadada aikace-aikacensa.A lokaci guda, fasahar extrusion mai zafi mai zafi yana da ƙarancin hulɗa da kwayoyi da kuma babban digiri na atomatik.Bayan canzawa zuwa masana'antar harhada magunguna, an yi imanin cewa canjin GMP ɗin sa zai yi sauri.
Lokacin aikawa: Dec-16-2022