Hydroxypropyl Methylcellulose (HPMC)ndi semi-synthetic nonionic cellulose ether yomwe imagwiritsidwa ntchito kwambiri m'makampani opanga mankhwala, makamaka pamapangidwe amapiritsi. Chifukwa cha mawonekedwe ake abwino kwambiri opanga mafilimu, zomatira, zokhuthala komanso zotulutsa mosalekeza, HPMC imagwira ntchito zingapo zofunika pokonzekera piritsi.
1. Monga chomangira (Binder)
HPMC ali wabwino zomatira katundu ndipo akhoza mwamphamvu kumanga mankhwala ufa ndi excipients kupanga particles ndi kuuma kwina, potero kuwongolera compressibility pa tableting. Poyerekeza ndi zomangira zachikhalidwe (monga starch slurry kapena PVP), HPMC ili ndi izi:
Kusungunuka kwamadzi bwino: Itha kumwazikana m'madzi ozizira kuti ipange yankho la viscous, loyenera kunyowa granulation.
Low hygroscopicity: Imachepetsa kuyamwa kwa mapiritsi panthawi yosungira komanso kumapangitsa kuti pakhale bata.
Sichimakhudza kupasuka: Mukagwiritsidwa ntchito pang'onopang'ono, sichidzatalikitsa nthawi ya kupasuka kwa mapiritsi.
Kugwirizana kwa HPMC kumadalira kulemera kwake kwa maselo ndi ndende. Mitundu yotsika kwambiri (monga E5 ndi E15) imagwiritsidwa ntchito ngati zomatira.
2. Monga matrix okhazikika (Matrix Former)
HPMC ndi imodzi mwazinthu zofunikira kwambiri pokonzekera mapiritsi otulutsidwa mosalekeza. Ma gel osakaniza a hydrophilic amatha kugwiritsidwa ntchito powongolera kuchuluka kwa kutulutsidwa kwa mankhwala. Dongosolo la zochita zake ndi motere:
Gel wosanjikiza wopangidwa pamene wakhudzana ndi madzi: Pambuyo pa piritsi pamwamba pa madzi a m'thupi, HPMC imatenga madzi ndikutupa kupanga chotchinga cha gel, ndipo mankhwalawa amamasulidwa pang'onopang'ono kupyolera mu kufalikira kapena kukokoloka kwa gel.
Mlingo womasulidwa wosinthika: Posintha kalasi ya viscosity (monga K4M, K15M, K100M) kapena mlingo wa HPMC, mlingo wotulutsa mankhwala ukhoza kusinthidwa kuti upeze zotsatira zotuluka za 12 mpaka maola 24.
Mapiritsi otulutsidwa ndi HPMC ndi oyenera kusungunuka m'madzi komanso mankhwala osasungunuka bwino, monga mapiritsi a metformin hydrochloride, mapiritsi otulutsidwa ndi nifedipine, ndi zina zambiri.
3. Monga chopangira filimu (Film Coating Agent)
HPMC ndi chinthu chodziwika bwino chopangira filimu chopaka filimu yamapiritsi. Ntchito zake zazikulu ndi izi:
Kupititsa patsogolo maonekedwe: kupereka chosanjikiza chosalala ndi yunifolomu kuti aphimbe fungo loipa kapena mtundu wa mankhwala.
Kuteteza chinyezi: kuchepetsa kukhudzidwa kwa chinyezi cha chilengedwe pa piritsi pachimake ndikuwongolera bata.
Kutulutsa kowongolera: kuphatikiza ndi mapulasitiki (monga PEG) kapena ma polima ena (monga ethyl cellulose), zokutira za enteric kapena zotulutsa zokhazikika zimatha kukonzedwa.
Mitundu yomwe imagwiritsidwa ntchito kwambiri ndi HPMC ndi E5 ndi E15, yomwe nthawi zambiri imagwiritsidwa ntchito limodzi ndi utoto ndi zoteteza ku dzuwa (monga titanium dioxide).
4. Monga gawo lothandizira la disintegrants (Disintegrant)
Ngakhale HPMC payokha siiphatikizire bwino kwambiri, imatha kugwira ntchito mogwirizana ndi zosokoneza zina (monga carboxymethyl cellulose sodium) m'mapangidwe apadera:
Kupititsa patsogolo kutupa: Mphamvu yotupa ya HPMC imatha kulimbikitsa mapangidwe a pores mkati mwa piritsi ndikufulumizitsa kulowa kwa madzi.
Kuchepetsa zotsatira zoyipa za omanga: Pamene HPMC imagwiritsidwa ntchito ngati chomangira, mlingo uyenera kuyendetsedwa kuti upewe kuchedwa kwambiri pakutha.
5. Kupititsa patsogolo kutha kwa mankhwala
Kwa mankhwala osasungunuka bwino, HPMC imatha kusintha kusungunuka kudzera m'njira zotsatirazi:
Ziletsani mankhwala crystallization: monga chonyamulira mu olimba dispersions, kukhala amorphous boma la mankhwala.
Kuonjezera wettability: gel osakaniza wosanjikiza amalimbikitsa kukhudzana mankhwala ndi kuvunda sing'anga.
Zofunikira pakusankha HPMC
Kalasi ya viscosity: kukhuthala kotsika (3-15 cP) kumagwiritsidwa ntchito pomatira kapena zokutira, ndipo kukhuthala kwakukulu (4000-100000 cP) kumagwiritsidwa ntchito popanga matrices omasulidwa.
Digiri ya m'malo: zimakhudza solubility ndi gel osakaniza mphamvu ndipo ayenera kusintha malinga ndi katundu wa mankhwala.
HPMC ndi multifunctional excipient mu mapiritsi formulations, yokhala ndi ntchito zingapo monga kumangirira, kumasulidwa kosalekeza, zokutira ndi kusungunuka bwino. Kutetezedwa kwake kwakukulu (kuvomerezedwa ndi FDA) komanso kugwiritsidwa ntchito kwakukulu kumapangitsa kukhala chinthu chofunikira kwambiri pakupanga zokonzekera zamakono. Kusankhidwa koyenera kwa mitundu ya HPMC ndi kuchuluka kwake kumatha kukulitsa magwiridwe antchito, kukhazikika komanso kuchiritsa kwa mapiritsi.
Nthawi yotumiza: Apr-08-2025