Ngokujula kocwaningo lwesistimu yokulethwa kwezidakamizwa kanye nezidingo eziqinile, izinto ezintsha ezisizayo zemithi ziyavela, phakathi kwazo i-hydroxypropyl methylcellulose esetshenziswa kabanzi.Leli phepha libuyekeza ukusetshenziswa kwasekhaya nokwangaphandle kwe-hydroxypropyl methylcellulose.Indlela yokukhiqiza kanye nezinzuzo zayo kanye nokubi, ubuchwepheshe bemishini kanye namathemba okuthuthukiswa kwasekhaya, kanye nokusetshenziswa kwayo emkhakheni wezinto ezisizayo zemithi.
Amagama angukhiye: ama-excipients emithi;i-hydroxypropyl methylcellulose;ukukhiqizwa;isicelo
1 Isingeniso
Ama-excipients emithi abhekisela egameni elivamile lazo zonke ezinye izinto zokwelapha ezingezwe ekulungiseni ngaphandle komuthi oyinhloko ukuze kuxazululwe ukwakheka, ukutholakala nokuphepha kokulungiswa ohlelweni lokukhiqiza nokuklama ukulungiswa.Ama-excipients emithi abaluleke kakhulu emalungiselelweni emithi.Kunezinhlobo eziningi zezinto ezisiza ekwenziweni kwemithi emalungiselelweni asekhaya nakwamanye amazwe, kodwa eminyakeni yamuva, izidingo zokuhlanzeka, ukuchithwa, ukuzinza, i-bioavailability ku-vivo, ukuthuthukiswa komphumela wokwelapha kanye nokunciphisa imiphumela emibi yezidakamizwa ziya ngokuya zikhuphuka., okwenza ukuvela okusheshayo kwabasizi abasha kanye nezinqubo zocwaningo ukuze kuthuthukiswe ukusebenza kahle kokulungiswa kwezidakamizwa kanye nekhwalithi yokusetshenziswa.Inombolo enkulu yesibonelo sedatha ibonisa ukuthi i-hydroxypropyl methylcellulose ingahlangabezana nalezi zidingo ezingenhla njengesithako sekhwalithi esiphezulu sezemithi.Isimo samanje socwaningo nokukhiqizwa kwamanye amazwe kanye nokusetshenziswa kwalo emkhakheni wamalungiselelo emithi kuphinde kufingqwe.
2 Uhlolojikelele lwezakhiwo ze-HPMC
I-HPMC iyimpushana emhlophe noma ephuzi kancane, engenaphunga, engenaphunga, engenabuthi etholwe nge-etherification ye-alkali cellulose, i-propylene oxide ne-alkyl chloride.Incibilika kalula emanzini angaphansi kuka-60°C kanye no-70% we-ethanol ne-acetone, i-isoacetone, ne-dichloromethane solvent exubile;I-HPMC inokuqina okuqinile, ebonakaliswa ngokuyinhloko: okokuqala, isisombululo sayo esinamanzi asinakho ukukhokhiswa futhi asiphenduli ngosawoti wensimbi noma i-ionic organic compounds;okwesibili, iphinde imelane nama-acids noma izisekelo.Izinzile.Yizici zokuzinza ze-HPMC ezenza ikhwalithi yemithi ene-HPMC njengezihlanganisi zizinze kakhulu kunaleyo enezinto ezisizayo zendabuko.Ocwaningweni lwe-toxicology lwe-HPMC njengezihlanganisi, kuboniswa ukuthi i-HPMC ngeke igaywe emzimbeni, futhi ayihlanganyeli kumetabolism yomzimba womuntu.Ukunikezwa kwamandla, akukho toxic kanye nemiphumela engemihle yezidakamizwa, izinsiza eziphephile zemithi.
3 Ucwaningo ngokukhiqizwa kwe-HPMC ngaphakathi nangaphandle
3.1 Uhlolojikelele lobuchwepheshe bokukhiqiza be-HPMC ekhaya naphesheya
Ukuze ubhekane kangcono nezidingo ezikhula njalo nezikhulayo zamalungiselelo emithi ekhaya naphesheya, ubuchwepheshe bokukhiqiza kanye nenqubo ye-HPMC nakho kuthuthuka njalo emgwaqeni ohlukumezayo futhi omude.Inqubo yokukhiqiza ye-HPMC ingahlukaniswa ngendlela yeqoqo kanye nendlela eqhubekayo.Izigaba eziyinhloko.Inqubo eqhubekayo ivame ukusetshenziswa phesheya, kanti inqubo yeqoqo isetshenziswa kakhulu eChina.Ukulungiswa kwe-HPMC kufaka phakathi izinyathelo zokulungiselela i-alkali cellulose, ukusabela kwe-etherification, ukwelashwa kokucwenga, kanye nokwelashwa komkhiqizo ophelile.Phakathi kwazo, kunezinhlobo ezimbili zemigudu yenqubo yokusabela kwe-etherification.: Indlela yesigaba segesi kanye nendlela yesigaba se-liquid.Uma kuqhathaniswa, indlela yesigaba segesi inezinzuzo zomthamo omkhulu wokukhiqiza, izinga lokushisa eliphansi lokusabela, isikhathi esifushane sokusabela, nokulawula ukusabela okunembile, kodwa ingcindezi yokusabela inkulu, ukutshalwa kwezimali kukhulu, futhi uma inkinga seyenzekile, kulula ukuyilungisa. dala izingozi ezinkulu.Indlela yesigaba se-liquid ngokuvamile inezinzuzo zokucindezela okuphansi kokusabela, ubungozi obuphansi, izindleko eziphansi zokutshala imali, ukulawulwa kwekhwalithi okulula, kanye nokushintshwa kalula kwezinhlobonhlobo;kodwa ngesikhathi esifanayo, i-reactor edingwa indlela yesigaba se-liquid ayikwazi ukuba nkulu kakhulu, futhi ikhawulela umthamo wokusabela.Uma kuqhathaniswa nendlela yesigaba segesi, isikhathi sokusabela side, amandla okukhiqiza mancane, imishini edingekayo miningi, ukusebenza kuyinkimbinkimbi, nokulawula okuzenzakalelayo nokunemba kuphansi kunendlela yesigaba segesi.Njengamanje, amazwe athuthukile njengeYurophu ne-United States ikakhulukazi asebenzisa indlela yesigaba segesi.Kunezidingo eziphezulu mayelana nobuchwepheshe kanye nokutshalwa kwezimali.Uma sibheka isimo sangempela ezweni lethu, inqubo yesigaba samanzi ivame kakhulu.Kodwa-ke, kunezindawo eziningi eShayina eziqhubeka nokulungisa nokusungula ubuchwepheshe, zifunda emazingeni athuthukile angaphandle, futhi ziqale izinqubo ezingaqhubeki.Noma umgwaqo wokwethula indlela yesigaba segesi yangaphandle.
3.2 Ukuthuthukiswa kobuchwepheshe bokukhiqiza kwe-HPMC yasekhaya
I-HPMC ezweni lami inamandla amakhulu okuthuthuka.Ngaphansi kwamathuba anjalo avumayo, kuwumgomo wawo wonke umcwaningi ukuqhubeka nokuthuthukisa ubuchwepheshe bokukhiqiza be-HPMC nokunciphisa igebe phakathi kwemboni yasekhaya ye-HPMC namazwe angaphandle athuthukile.Inqubo ye-HPMC Sonke isixhumanisi senqubo yokuhlanganiswa sibaluleke kakhulu kumkhiqizo wokugcina, phakathi kwawo ukusabela kwe-alkalization kanye ne-etherification [6] kubaluleke kakhulu.Ngakho-ke, ubuchwepheshe bokukhiqiza be-HPMC obukhona basekhaya bungenziwa kusukela kulezi zindlela ezimbili.Uguquko.Okokuqala, ukulungiswa kwe-alkali cellulose kufanele kwenziwe ekushiseni okuphansi.Uma umkhiqizo we-viscosity ephansi ulungiswa, amanye ama-oxidants angangezwa;uma umkhiqizo we-viscosity ephezulu ulungiswa, indlela yokuvikela igesi ye-inert ingasetshenziswa.Okwesibili, ukusabela kwe-etherification kwenziwa ekushiseni okuphezulu.Faka i-toluene emshinini wokufaka i-etherification kusenesikhathi, thumela i-alkali cellulose emshinini ngepompo, bese wengeza inani elithile le-isopropanol ngokwezidingo.Yehlisa isilinganiso se-solid-liquid.Futhi sebenzisa isistimu yokulawula ikhompuyutha, engakwazi ukuphendula ngokushesha izinga lokushisa, Amapharamitha okucubungula afana nokucindezela ne-pH alungiswa ngokuzenzakalelayo.Vele, ukuthuthukiswa kobuchwepheshe bokukhiqiza be-HPMC kungabuye kuthuthukiswe kusukela emzileni wenqubo, ukusetshenziswa kwempahla eluhlaza, ukwelashwa kokucwenga nezinye izici.
4 Ukusetshenziswa kwe-HPMC emkhakheni wezokwelapha
4.1 Ukusetshenziswa kwe-HPMC ekulungiseni amaphilisi akhishwa isikhathi eside
Eminyakeni yamuva nje, ngokujula okuqhubekayo kocwaningo lwesistimu yokulethwa kwezidakamizwa, ukuthuthukiswa kwe-HPMC ene-viscosity ephezulu ekusetshenzisweni kwamalungiselelo okukhishwa okuqhubekayo kudonse ukunaka okukhulu, futhi umphumela wokukhishwa okuqhubekayo muhle.Uma kuqhathaniswa, kusenegebe elikhulu ekusetshenzisweni kwamathebulethi e-matrix akhishwa njalo.Isibonelo, uma kuqhathaniswa i-HPMC yasekhaya neyangaphandle yamaphilisi okukhishwa okuqhubekayo kwe-nifedipine futhi njenge-matrix yamaphilisi e-matrix e-propranolol hydrochloride, kutholakala ukuthi Ukusetshenziswa kwe-HPMC yasekhaya emalungiselelweni okukhishwa okuqhubekayo kudinga ukuthuthukiswa okuqhubekayo ukuze kuthuthukiswe ngokuqhubekayo. izinga lamalungiselelo asekhaya.
4.2 Ukusetshenziswa kwe-HPMC ekuqiniseni izithambisi zezokwelapha
Ngenxa yezidingo zokuhlolwa noma zokwelashwa kwezinye izisetshenziswa zezokwelapha namuhla, lapho ungena noma uphuma ezithweni zomuntu nezicubu, ingaphezulu ledivayisi kufanele libe nezindawo ezithile zokugcoba, futhi i-HPMC inezici ezithile zokugcoba.Uma kuqhathaniswa namanye amafutha okugcoba, i-HPMC ingasetshenziswa njengento yokugcoba yezokwelapha , engakwazi ukunciphisa ukugqoka kwemishini kuphela, kodwa futhi ihlangabezane nezidingo zokugcoba kwezokwelapha nokunciphisa izindleko.
4.3 Ukusetshenziswa kwe-HPMC njengefilimu yemvelo yokupakisha encibilika emanzini e-antioxidant kanye nezinto zokumboza ifilimu nezinto zokwakha ifilimu.
Uma kuqhathaniswa nezinye izinto zamathebulethi ezinamekwe zendabuko, i-HPMC inezinzuzo ezisobala mayelana nobulukhuni, ukuqina kanye nokumuncwa komswakama.I-HPMC yamabanga ahlukene e-viscosity ingasetshenziswa njengamaphakeji ancibilikayo emanzini amaphilisi namaphilisi.Ingasetshenziswa futhi njengefilimu yokupakisha yezinhlelo ze-organic solvent.Kungashiwo ukuthi i-HPMC iyinto esetshenziswa kakhulu ukuhlanganisa ifilimu ezweni lami.Ngaphezu kwalokho, i-HPMC ingasetshenziswa futhi njengento yokwenza ifilimu ku-ejenti yefilimu, futhi ifilimu yokupakisha e-anti-oxidative yamanzi encibilikayo esekelwe ku-HPMC isetshenziswa kakhulu ekulondolozeni ukudla, ikakhulukazi izithelo.
4.4 Ukusetshenziswa kwe-HPMC njengempahla yegobolondo le-capsule
I-HPMC ingasetshenziswa futhi njengento yokulungiselela amagobolondo we-capsule.Izinzuzo zamaphilisi e-HPMC ukuthi anqoba umphumela wokuxhumanisa ama-gelatin capsules, ahambisana kahle nezidakamizwa, abe nokuzinza okuphezulu, angakwazi ukulungisa nokulawula ukuziphatha kokukhishwa kwezidakamizwa, athuthukise ikhwalithi yezidakamizwa, Inezinzuzo zokukhululwa kwezidakamizwa ezinzile. inqubo.Ngokusebenza, amaphilisi e-HPMC angashintsha ngokuphelele amaphilisi e-gelatin akhona, amele isiqondiso sokuthuthukiswa kwesikhathi esizayo samaphilisi aqinile.
4.5 Ukusetshenziswa kwe-HPMC njenge-ejenti emisiwe
I-HPMC isetshenziswa njenge-ejenti emisiwe, futhi umphumela wayo wokumisa muhle.Futhi ucwaningo lubonisa ukuthi ukusebenzisa ezinye izinto ezivamile ze-polymer njenge-ejenti elengayo ukuze kulungiswe ukumiswa okomile kuqhathaniswa ne-HPMC njenge-ejenti yokumisa ukuze kulungiswe ukumiswa okomile.Ukumiswa okomile kulula ukulungiselela futhi kunokuzinza okuhle, futhi ukumiswa okwakhiwa kuhlangabezana nezidingo zezinkomba ezihlukahlukene zekhwalithi zokumiswa okomile.Ngakho-ke, i-HPMC ivame ukusetshenziswa njenge-ejenti yokumisa ukulungiswa kwe-ophthalmic.
4.6 Ukusetshenziswa kwe-HPMC njengesivimbeli, i-ejenti ekhipha kancane kanye ne-porogen
I-HPMC ingasetshenziswa njenge-ejenti evimbelayo, i-ejenti yokukhululwa okuqhubekayo kanye ne-ejenti eyenza izimbotshana ukubambezeleka nokulawula ukukhishwa kwezidakamizwa.Namuhla, i-HPMC isetshenziswa kabanzi ekulungiseleleni ukukhishwa okuqhubekayo kanye namalungiselelo ayinhlanganisela yemithi yendabuko yamaShayina, njengamaphilisi e-matrix e-Tianshan Snow Lotus akhishwa okuqhubekayo.Isicelo, umphumela wawo wokukhululwa oqhubekayo muhle, futhi inqubo yokulungiselela ilula futhi izinzile.
4.7 Ukusetshenziswa kwe-HPMC njengeglue evikelayo eqinile ne-colloid
I-HPMC ingasetshenziswa njenge-thickener [9] ukwenza ama-colloid avikelayo, futhi izifundo zokuhlola ezifanele zibonise ukuthi ukusebenzisa i-HPMC njengesishuqulu kungathuthukisa ukuzinza kwekhabhoni ecushiwe yomuthi.Isibonelo, isetshenziswa kakhulu ekulungiseni ijeli yamehlo elungele ukusetshenziswa i-pH i-levofloxacin hydrochloride ophthalmic elungele ukusetshenziswa.I-HPMC isetshenziswa njenge-thickener.
4.8 Ukusetshenziswa kwe-HPMC njenge-bioadhesive
Izinamatheliso ezisetshenziswa kubuchwepheshe be-bioadhesion ziyizinhlanganisela ze-macromolecular ezinezakhiwo ze-bioadhesive.Ngokunamathela ku-mucosa yamathumbu, i-mucosa yomlomo nezinye izingxenye, ukuqhubeka nokuqina kokuxhumana phakathi kwesidakamizwa kanye ne-mucosa kuyaqiniswa ukuze kuzuzwe imiphumela engcono yokwelapha..Inani elikhulu lezibonelo zohlelo lokusebenza libonisa ukuthi i-HPMC ingahlangabezana kahle nezidingo ezingenhla njenge-bioadhesive.
Ukwengeza, i-HPMC ingasetshenziswa futhi njengesivimbeli semvula yamajeli we-topical kanye nezinhlelo ze-self-microemulsifying, futhi embonini ye-PVC, i-HPMC ingasetshenziswa njengesivikelo sokuhlakazeka ku-polymerization ye-VCM.
5 Isiphetho
Ngamafuphi nje, i-HPMC isetshenziswe kabanzi ekulungiseleleni imithi nakwezinye izici ngenxa yezakhiwo zayo ezihlukile ze-physicochemical kanye ne-biological.Noma kunjalo, i-HPMC isenezinkinga eziningi emalungiselelweni emithi.Ithini indima ethile ye-HPMC ekusetshenzisweni;indlela yokunquma ukuthi inomphumela we-pharmacological;inaziphi izici endleleni yokukhishwa kwayo, njll. Kungabonakala ukuthi nakuba i-HPMC isetshenziswa kabanzi, izinkinga eziningi zidinga ukuxazululwa ngokushesha .Futhi abacwaningi abaningi ngokwengeziwe benza umsebenzi omningi wokusetshenziswa okungcono kwe-HPMC kwezokwelapha, ngaleyo ndlela baqhubekisela phambili ukuthuthukiswa kwe-HPMC emkhakheni wezisiza zemithi.
Isikhathi sokuthumela: Nov-02-2022