Hydroxypropyl methylcellulose (HPMC) ni ether itandukanye, idafite ionic selulose ether hamwe nibikorwa byinshi mubikorwa bitandukanye, harimo ubwubatsi, imiti, ibiryo, no kwita kubantu. Guhitamo icyiciro gikwiye cya HPMC mubikorwa byinganda bikubiyemo gusuzuma witonze ibintu byinshi kugirango umenye neza imikorere, igiciro-cyiza, no kubahiriza amabwiriza.
1. Kwishishanya
Viscosity nimwe mubintu bikomeye cyane muguhitamo icyiciro cya HPMC. Ihindura imikorere yibikoresho mubisabwa nka:
Ubwubatsi: Indangamanota yo hejuru yubukorikori ikoreshwa kenshi mugufata amatafari, plaster, hamwe no guhindura kugirango amazi agabanuke, akora, hamwe nibiranga.
Imiti ya farumasi: Icyiciro cyo hasi cyiciriritse cya viscosity amanota akundwa kububiko bwa tablet hamwe nibintu bikora firime.
Ibiryo: Viscosity igira ingaruka kumiterere no guhagarara kwibicuruzwa byibiribwa nka sosi no kwambara.
Icyifuzo cyifuzwa gishobora kuva kuri hasi (5 mPa.s) kugeza hejuru cyane (200.000 mPa.s), kandi iri hitamo rishingiye kubikorwa. Ababikora mubisanzwe batanga imyirondoro irambuye kugirango bafashe muguhitamo.
2. Urwego rwo gusimbuza
Urwego rwo gusimbuza (DS) no gusimbuza umubyimba (MS) ni ibipimo byingenzi byerekana umubare wa mikorerexy (-OCH3) na hydroxypropyl (-OCH2CHOHCH3) ifatanye numugongo wa selile. Izi nsimburangingo zigira ingaruka:
Gukemura: Urwego rwo hejuru rusimburwa rutezimbere amazi.
Ubushyuhe bwa Thermal Gelation: Gusimbuza bigira ingaruka ku bushyuhe HPMC ikemura, ingenzi mubikorwa nko gutanga ibiyobyabwenge no gutunganya ibiryo.
Ibikoresho bya mashini: Guhindura urwego rwo gusimbuza birashobora guhindura imbaraga zumukanishi no guhinduka kwa firime ya HPMC.
3. Isuku no kubahiriza amabwiriza
Isuku ya HPMC ni ngombwa, cyane cyane mu gukoresha imiti n’ibiribwa aho bigomba kubahirizwa:
Icyiciro cya farumasi: Ugomba kubahiriza ibipimo bya farumasi nka USP, EP, cyangwa JP. Umwanda nkibyuma biremereye, ibishishwa bisigaye, nibirimo mikorobe bikenera kugenzurwa cyane.
Icyiciro cyibiribwa: Ugomba kubahiriza ibipimo byashyizweho ninzego nka FDA cyangwa EFSA, ukareba ko hatabaho umwanda wangiza.
Inganda zikoreshwa mu nganda zishobora kuba zifite isuku nke zisabwa ariko ziracyasaba guhuzagurika no kwizerwa.
4. Ingano nini no gukwirakwiza
Imiterere ifatika ya HPMC, harimo ingano nogukwirakwiza, bigira ingaruka kubikorwa byayo, igipimo cyo gusesa, nibikorwa rusange:
Ifu nziza: Kunyonga vuba kandi ni ingirakamaro mubisabwa bisaba kwihuta.
Ifishi isunitswe: Kugabanya ivumbi no kunoza imitekerereze, inyungu mubikorwa byo gukora.
5. Ibisabwa mu mikorere
Buri nganda isaba inganda isaba ibintu byihariye biva muri HPMC:
Kubyimba: Ibyingenzi byo gutwikira, gufatira, no guhagarikwa.
Gukora firime: Ningirakamaro muri farumasi yimyenda, no mubicuruzwa byumuntu kugiti cye.
Emulising and Stabilizing: Nibyingenzi mubicuruzwa byibiribwa no kwisiga kugirango bikomeze kandi bihamye.
Kubika Amazi: Ni ngombwa mubikoresho byubwubatsi kugirango ukire neza kandi ukore neza.
6. Guhuza nibindi bikoresho
HPMC igomba guhuzwa nibindi bice bigize formulaire kugirango wirinde ibibazo nkimvura, gutandukana kwicyiciro, cyangwa gutesha agaciro:
pH Ibyiyumvo: HPMC ihagaze neza murwego rwagutse rwa pH, ariko muri rusange pH irashobora kugira ingaruka kumikorere yayo.
Imikoranire n'Umunyu hamwe na Surfactants: Ibi birashobora kugira ingaruka no kwikemurira ibibazo bya HPMC. Kurugero, umunyu mwinshi urashobora kugabanya ubukonje.
7. Guhagarara neza
Porogaramu yubushyuhe bwa porogaramu itegeka ko hakenewe ituze ryumuriro muri HPMC:
Porogaramu Yubushyuhe Bwinshi: Ibikoresho byubwubatsi nka plaster na minisiteri bisaba amanota ya HPMC ashobora kwihanganira ubushyuhe bwo hejuru nta gutesha agaciro.
Porogaramu Ubushyuhe Buke: Bimwe mubiryo na farumasi birashobora gukenera HPMC ikomeza gukora mubushyuhe buke.
8. Ibitekerezo
Impamvu zubukungu zihora zitekerezwa mubikorwa byinganda:
Igiciro cyibikoresho bito: Biratandukanye nu ntera nubuziranenge bwa HPMC. Amanota yo hejuru hamwe nibisobanuro byihariye bitwara amafaranga menshi.
Amafaranga yo gutunganya: Kuborohereza gukemura, guseswa, no guhuza bishobora kugira ingaruka kumafaranga yo gutunganya muri rusange no gukora neza.
Imikorere nigiciro: Impirimbanyi hagati yikiguzi ninyungu zikorwa zitangwa nicyiciro cyihariye cya HPMC.
9. Abatanga isoko kwizerwa no gushyigikirwa
Guhitamo ibicuruzwa byizewe byemeza ubuziranenge buhoraho no gutanga amasoko ahamye:
Ubwishingizi Bwiza: Guhuza mubyiciro-by-icyiciro ni ngombwa, cyane cyane kubisabwa bifite kwihanganira cyane.
Inkunga ya Tekinike: Kuboneka inkunga ya tekiniki yo guteza imbere formulaire, gukemura ibibazo, no kwihitiramo.inyandiko zubahiriza no gutanga amabwiriza.
10. Ibitekerezo by’ibidukikije n’umutekano
Ingaruka ku bidukikije n’umutekano biragenda byingenzi mubikorwa byinganda:
Ibinyabuzima bishobora kwangirika: HPMC irashobora kwangirika, ariko hagomba gutekerezwa ikirenge cy’ibidukikije cyo kubyaza umusaruro no kujugunya.
Uburozi n’umutekano: Ntabwo ari uburozi kandi bwizewe bwo gukoresha ibiryo na farumasi, ariko impapuro zumutekano zigomba gusubirwamo kubisabwa byihariye.
Kuramba: Guhitamo amasoko arambye hamwe nuburyo bwo gukora.
Guhitamo icyiciro gikwiye cya HPMC mubikorwa byinganda bikubiyemo isuzumabumenyi rusange ryibisobanuro bya tekiniki, ibisabwa mu mikorere, kubahiriza amabwiriza, hamwe nubukungu. Gusobanukirwa ibikenewe byihariye bya porogaramu no kuyihuza n'imiterere y'amanota atandukanye ya HPMC itanga imikorere myiza kandi neza. Gufatanya nabatanga isoko no gukoresha ubuhanga bwabo birashobora kurushaho kunonosora inzira yo gutoranya, biganisha kubikorwa kandi birambye.
Inkunga igenga: Imfashanyo hamwe na com
Igihe cyo kohereza: Gicurasi-29-2024