Iyini i-HPMC embonini yezemithi?

IHydroxypropylmethylcellulose (HPMC) iyi-polymer esebenzayo esetshenziswa kabanzi embonini yezemithi. Ingokwesigaba se-cellulose ether futhi itholakala ku-cellulose yemvelo. I-HPMC ihlanganiswa ngokwelapha i-cellulose nge-propylene oxide ne-methyl chloride, okuholela ekuhlanganisweni nokuncibilika okuthuthukisiwe nezinye izinto ezifiselekayo. Lesi sakhi semithi sisetshenziswa kakhulu ekuthuthukisweni nasekukhiqizeni amafomu emithamo ahlukahlukene, okuhlanganisa amaphilisi, amaphilisi, amalungiselelo e-ophthalmic kanye nezinhlelo zokulethwa kwezidakamizwa ezilawulwayo.

Isingeniso se-hydroxypropyl methylcellulose:

Isakhiwo samakhemikhali kanye nezakhiwo:

IHydroxypropyl methylcellulose i-semi-synthetic, inert, i-polymer encibilika emanzini. Isakhiwo sayo samakhemikhali sihlanganisa i-hydroxypropyl kanye namaqembu e-methoxy axhunywe kumgogodla we-cellulose. Izilinganiso zalezi zingxenye zingahluka, okuholela emazingeni ahlukene e-HPMC enezakhiwo ezihlukile. Iphethini yokushintsha ithinta imingcele efana ne-viscosity, ukunyibilika, nezakhiwo zejeli.

Inqubo yokukhiqiza:

Ukukhiqizwa kwe-HPMC kubandakanya ukufakwa kwe-cellulose etherification nge-propylene oxide ne-methyl chloride. Izinga lokushintsha (DS) le-hydroxypropyl namaqembu e-methoxy lingalawulwa ngesikhathi sokuhlanganiswa, okuvumela ukuthungwa kwezakhiwo ze-HPMC kuzidingo ezithile zokwenziwa kwezidakamizwa.

Izicelo embonini yezemithi:

Izibophezelo ekwakhiweni kwethebhulethi:

I-HPMC isetshenziswa kakhulu njengesihlanganisi ekwakhiweni kwethebhulethi. Izakhiwo zayo ezibophayo zisiza ekucindezeleni impushana ibe amaphilisi aqinile. Ukukhishwa okulawulwayo kwezithako zemithi esebenzayo (ama-API) kungafinyelelwa ngokusebenzisa amamaki athile e-HPMC ane-viscosity efanelekile kanye namazinga okushintsha.

I-ejenti yokugqoka ifilimu:

I-HPMC isetshenziswa njenge-ejenti yokuhlanganisa ifilimu yamaphilisi nama-granules. Ihlinzeka ngengubo yokuzivikela efanayo ethuthukisa ukubukeka, ukufihla ukunambitheka kanye nokuzinza kwamafomu omthamo. Ngaphezu kwalokho, izigqoko ezisekelwe ku-HPMC zingashintsha amaphrofayili okukhishwa kwezidakamizwa.

Ukukhishwa okusimeme nokulawulwayo:

Imvelo ye-hydrophilic yale polymer iyenza ifanelekele ukusetshenziswa ekwakhiweni kokukhishwa okuqhubekayo nokulawulwayo. I-matrix ye-HPMC ivumela ukukhishwa kwezidakamizwa okulawulwayo isikhathi eside, ukuthuthukisa ukuthobela kwesiguli kanye nokunciphisa imvamisa yokudosa.

Amalungiselelo e-Ophthalmic:

Ekwakhekeni kwe-ophthalmic, i-HPMC isetshenziselwa ukukhulisa i-viscosity yamaconsi wamehlo, ngaleyo ndlela inikeze isikhathi eside sokuhlala endaweni ye-ocular. Lokhu kuthuthukisa i-bioavailability yomuthi kanye nempumelelo yokwelapha.

I-stabilizer yokuqina:

I-HPMC isetshenziswa njenge-thickener kanye ne-stabilizer ekwakhiweni okuwuketshezi kanye ne-semi-solid njengamajeli, okhilimu kanye nokulengisa. Inikeza i-viscosity kulezi zakhiwo futhi ithuthukise izakhiwo zabo eziphelele ze-rheological.

Izici ezibalulekile ze-HPMC:

Ukunyibilika:

I-HPMC iyancibilika emanzini futhi yenza isixazululo esicacile, esingenambala. Izinga lokuqedwa lithintwa izinga lokushintshwa kanye nebanga le-viscosity.

I-Viscosity:

I-viscosity yezixazululo ze-HPMC ibalulekile ekunqumeni ukusebenza kwazo ezinhlelweni ezihlukahlukene. Amamaki ahlukene ayatholakala ngama-viscosities ahlukene, okuvumela ukulawula okunembile kwezakhiwo ze-rheological zokwakheka.

I-Thermal Gelation:

Amabanga athile e-HPMC abonisa izakhiwo ze-thermogelling, akha amajeli emazingeni okushisa aphezulu. Lesi sici sisetshenziselwa ukwenza ukwakheka okungezwani nokushisa.

ukuhambisana:

I-HPMC isebenzisana nezinhlobonhlobo zezinto ezisizayo zemithi nama-API, okuyenza ibe yinketho yokuqala kubadidiyeli. Ayisabeli noma yehlise isithunzi sezithako eziningi ezisebenzayo.

Izinselelo nokucatshangelwa:

I-Hygroscopicity:

I-HPMC iyi-hygroscopic, okusho ukuthi imunca umswakama emvelweni. Lokhu kuthinta ukuzinza nokubukeka kokubunjwa, ngakho izimo zokugcina ezifanele ziyadingeka.

Ukuhambisana namanye ama-excipients:

Nakuba ngokuvamile ihambisana, abaklami badinga ukucabangela ukuhambisana kwe-HPMC nezinye izinto ezisizayo ukuze kugwenywe ukusebenzelana okungase kuthinte ukusebenza kokwakheka.

Umthelela kwijika lokuhlakazeka:

Ukukhethwa kwebanga le-HPMC kungathinta kakhulu iphrofayili yokuqedwa yomuthi. Umqambi kufanele akhethe ngokucophelela ibanga elifanele ukuze afinyelele izici zokukhishwa azifunayo.

Ukucatshangelwa kokulawula:

I-HPMC yamukelwa kabanzi njengesithako semithi esiphephile nesisebenzayo. Ihlangabezana nezindinganiso ezihlukahlukene zokulawula futhi ifakwe kuma-pharmacopoeias emhlabeni jikelele. Abakhiqizi kumele babambelele ku-Good Manufacturing Practices (GMP) ukuze baqinisekise ikhwalithi nokuvumelana kwemikhiqizo yezemithi equkethe i-HPMC.

Ekuphetheni:

IHydroxypropylmethylcellulose (HPMC), njengesamukeli esiguquguqukayo nesisetshenziswa kabanzi, idlala indima ebalulekile embonini yezemithi. Izakhiwo zayo eziyingqayizivele ziyenza ifanelekele ukusetshenziswa ezinhlobonhlobo zamafomu omthamo, okuhlanganisa amaphilisi, amaphilisi kanye namalungiselelo e-ophthalmic. Abaqulunqi bayazuza ngokukwazi ukulungisa izici ze-HPMC ukuze zihlangabezane nezimfuneko ezithile zokwakheka, njengokukhululwa okulawulwayo nokuzinza okuthuthukisiwe. Naphezu kwezinselele ezithile, i-HPMC isalokhu iyisithako esibalulekile ekuthuthukisweni kwemikhiqizo yemithi yekhwalithi ephezulu, enikela ekuphepheni nasekusebenzeni ngempumelelo kokwenziwa kwemithi eminingi.