Igipimo cy'ubukana bw'imitsi mu gutwikira ibinini mu nda

Gusobanukirwa uburyo bwo gusiga irangi mu miti

Enteric coating ni agace kabigenewe gakozwe muri polymer gashyirwa ku bwoko bw'ibinini bikoreshwa mu kanwa—akenshi mu miti iri mu binini, mu gikapu, cyangwa mu binini. Gafasha mu kurinda umuti ahantu hari aside nyinshi mu gifu (pH 1-3), bigatuma umuti usohorwa gusa mu gihe nta kibazo cyangwa alkaline biboneka mu mara (pH ≥ 5.5-7). Iyi mbogamizi ni ingenzi mu kurinda imiti ishobora kwanduzwa na aside, kugabanya uburibwe mu gifu, no kuyobora imiti mu bice by’amara byibasiwe.

Gusiga irangi mu mubiri (Enteric Coating) ni iki?

Ibisobanuro: Imiti irinda indwara ya enteric ikoresha urwego rudashonga mu mazi rushobora kwihanganira aside yo mu gifu ariko rugashonga vuba cyangwa rugatangira kwinjira mu mara.
Ibikoresho Bisanzwe: Izi mpako zikunze gukoresha copolymers za aside methacrylic, hydroxypropyl methylcellulose (HPMC), cellulose acetate, polyvinyl acetate, cyangwa uruvange rwa polymer karemano nka alginate na pectin.
Uburinzi ku bushyuheImiti myinshi irakora neza iyo irimo aside. Ifu ikoreshwa mu gutwikira mu nda igabanya ubushyuhe bw'amazi, ogisijeni, cyangwa kristali mu gihe inyura mu gifu.
Gutanga Ibikenewe mu buryo bwihariye: Mu kuguma mu mubiri kugeza ugeze muri duodenum cyangwa kure y’inzira y’igifu, ibinini bitwikiriwe n’imiti bituma imiti yinjira ahantu heza, bikongera ubushobozi bwo kuyikoresha no kuyikoresha.

Intego: Kurinda ubusugire bw'ibiyobyabwenge no kubireka byibasiwe

Reba izindi porogaramu

Ibinini n'udupira twa Enteric Coated kugira ngo wongere imiti

Imiterere y'igipimo: Ibinini, Ibinini, na Kapsules bya Enteric

Imiterere ya Monolithic: Ibi birimo sisitemu imwe nk'ibinini bitwikiriwe na enteric, ibinini, na capsules. Copolymers za aside ya Methacrylic akenshi ni zo zikunze gukundwa muri izi porogaramu bitewe n'uko zirwanya aside.
Sisitemu z'uduce twinshi: Gusiga irangi mu mubiri (enteric coating) nabyo bishyirwa ku duce duto, utunyangingo, cyangwa utunyangingo duto. Ubu buryo bushobora gutuma imiti isohoka neza kandi bukagabanya ihindagurika ry’ibice, ibyo bikaba ari ingenzi ku miti isanzwe n’ibicuruzwa byihariye.
Ingero:
- Ibinini bya Pantoprazole: Ifite enteric-coated kugira ngo itinde kurekurwa, ikarinda ikoreshwa rya proton pump inhibitor kwangirika kw'igifu.
- Sisitemu ya poroteyine y'ibimera ikozwe muri microcapsule: Ifite irangi ryo kurinda no gutanga intungamubiri ku buryo bugamije.

Kurinda isohoka ry'imiti itaragera mu bidukikije birimo aside

Udupira two mu nda dukoresha uburyo bwa pH mu kurinda imiti:

Kudashobora gushonga kwa polymer kuri pH iri hasi: Matrix ya polymer yakozwe kugira ngo igume imeze neza muri aside yo mu gifu. Urugero, copolymer za aside methacrylic zishonga gusa iyo pH izamutse hejuru ya 5.5—pH isanzwe y'amara yo hejuru.
Uburyo bwo Kwihisha Bufatika n'UbuhangaIbikoresho bigezweho bikoresha silika cyangwa ibisasu bya 3D kugira ngo bikomeze gukumira kurekura kugeza igihe ingano ya pH yihariye izujujwe.
Ibikoresho bya pulasitiki n'ibindi bikoresho: Ibinyabutabire nka Polysorbate 80 byongera ubworoherane kandi bigafasha mu kunoza imiterere y’ibinyabutabire, bigatuma irangi riguma rikora neza kandi rihuye mu gihe cyo gukora no kubika.

Uburinganire n'Isuzuma ry'Imvange

Gupima ubuziranenge bw'ibirahure ni ingenzi cyane. Kutabikora neza bishobora gutuma imiti ishonga vuba, cyangwa ingaruka mbi ziyongera. Inganda zikoresha uburyo bwo gupima ubuziranenge bw'ibirahure mu bucuruzi kugira ngo imiti ikomeze kuba myiza.ubushyuhe bwo gutwikira—uburyo bw'ingenzi bwo gupima ubukana bw'ibinure bukurikiranwa binyuze mu gupima ubukana bw'ibinure no kugenzura ubukana bw'ibinure mu murongo. Ubukana bwiza bwo gusiga ibinure ku binini bya enteric ni ingenzi kugira ngo filime igaragare neza, ifatanye, kandi ikore neza.

Muri make, irangi rya enteric rikomeza ubuziranenge bw'imiti no kuyisohora mu buryo bugenzurwa, rigakoresha ubumenyi bw'ibikoresho ndetse n'uburyo ikorwamo neza. Inyungu zo gusiga enteric zifasha kunoza uburyo imiti iguma neza, kuyikura mu buryo bwizewe, ndetse no kuvura mu kanwa mu buryo bwizewe.

Ibintu by'ingenzi bikenewe kugira ngo irangi rikore neza

Ubudahangarwa bw'aside n'uburyo bwo kuyirinda

Kugira ngo ibinini bikingira neza ibintu bikora imiti birwanya aside yo mu gifu, ibinini bitwikiriwe na enterike bigomba kuba uruzitiro ruramba kandi rudakingira aside. Uru ruzitiro rurinda isohoka ry’imiti imburagihe no kwangirika mu gihe cy’igifu. Polymeri zikora neza muri matrix y’igipfundikizo ziguma zidashonga ku gifu kiri hasi (1-3), zishonga cyangwa zigatatana gusa iyo zihuye na pH iri hejuru y’amara (ubusanzwe pH ≥ 5.5-7). Urugero, uruvange nka alginate na pectin—cyane cyane iyo bivanze na glycerol monostearate (GMS)—byagaragaye ko bigumana ubuziranenge bwabyo kandi bikabuza isohoka ry’imiti mu gihe cy’amasaha 2 mu mazi y’igifu yiganye, bisubiza vuba iyo pH yo mu gifu igezweho. Ibisubizo nk'ibi bihuye n'ibisabwa kugira ngo imiti itinde irekurwa muri Leta Zunze Ubumwe za Amerika (USP), bitanga imiti ku giti cyayo kandi bikagabanya ingaruka mbi ku gifu.

Ubunini bw'ingenzi bwo gusiga kugira ngo bikore neza

Ubushobozi bw'imyambaro yo mu bwoko bwa enteric bufitanye isano itaziguye n'ubugari bw'ifirime ikoreshwa. Imyambaro idahagije ituma aside yinjira, bigahungabanya uburinzi. Uburyo bugezweho bwo gufata amashusho nka optique coherence tomography (OCT) bwashyizeho urugero rw'ingenzi—hafi 27.4 µm—kugira ngo habeho ubudahangarwa bw'aside ku binini bya enteric. Polima zicuruzwa akenshi zikenera ubunini bunini cyane: Acryl-Eze® (68 µm), Aquarius™ ENA (69 µm), na Nutrateric® (65 µm). Munsi y'izi gaciro, ibyago byo kwinjira kwa aside no gusohora imiti itaragera ni byinshi. OCT ituma habaho isuzuma ry'imyambaro mu buryo butangiza, mu gihe nyacyo mu ntambwe zo gushushanya enteric, rishyigikira ko ibyara neza kandi rikubahirizwa n'amategeko.

Akamaro ko gusiga kimwe no gupima ubucucike

Ubugari bw'igipfundikizo, haba imbere no hagati y'ibinini, ni ingenzi cyane kugira ngo ibinini bishobore gukora neza no kurekura imiti. Itandukaniro ry'ubugari rishobora gutuma bimwe mu bice binanirwa kurwanya igifu (niba bipfundikishijwe) cyangwa bigatinda kurekura cyane (niba bipfundikishijwe cyane). Ubucucike bw'igipfundikizo bwuzuza ubunini bugira ingaruka ku buryo firime isohoka n'ishonga. Igipfundikizo cy'ubugari—ubusanzwe gituruka ku bintu bifasha mu gupima neza ubushyuhe—bituma habaho kugabanuka kw'ubugari bw'ibinini no kurinda aside cyane. Udushya nkakugenzura ubukana bw'umuvuduko mu murongoku bijyanye no gusiga no gupima ubukana buhoraho mu nganda zikora imiti ubu bituma habaho kugenzura ibikorwa neza, bigabanyiriza itandukaniro hagati y’ibicuruzwa n’ibindi.

Ibintu Bisanzwe Bikoreshwa mu Gutera Indwara n'Ibintu Bikora Filimi Bikoreshwa mu Binini Bitwikiriwe na Enteric

Polymers zikora filime

Polymeri ikora filime ni yo shingiro ry'igitambaro icyo ari cyo cyose cya enteric, gishinzwe gushonga kw'ingufu mu guhitamo pH:

Polymeri za Methakrilate(urugero, Eudragit® L100, S100): Ishongesha kuri pH iri hejuru ya 6.0/7.0, ikoreshwa cyane bitewe n'ingano ya pH ihamye n'ubudahangarwa bukomeye bwa aside.
Polyvinyl Acetate Phthalate (PVAP):Itanga uburinzi bukomeye bw'igifu, cyane cyane ku bicuruzwa bitinda kurekurwa.
Polymers karemano:Alginate, pectin, shellac, na carboxymethyl starch (CMS) ni ubundi buryo "bw’icyatsi kibisi" bufite ubushobozi bwo kudakoresha aside. Iterambere mu bintu bifasha mu mikorere y’umubiri rireba uburyo bwo kubungabunga ubuzima no kurinda umutekano w’abarwayi.

Ibikoresho bya pulasitiki n'ibindi bikoresho

Imashini zikora pulasitiki nka glycerol, sorbitol, PEG 3350, na triacetin zihindura imiterere y’urukiramende, zikarinda gucikagurika, kandi zigashyigikira uburyo bwo gutunganya:

PEG 3350:Ikomeza ubuziranenge bw'ibinyabutabire, ikarinda gushonga kw'ibinyabutabire, kandi ikarushaho gutuma imiti idahinduka.
Triasetin:Yongera ubushobozi bwo koroshya firime ariko ishobora kwimukira mu gice cy'imbere cya tableti, rimwe na rimwe igahungabanya ubushobozi bwo gukora ibintu by'ibanga.
Gliseroli/Sorbitol:By’umwihariko, bigira ingaruka nziza muri sisitemu za polymer karemano kugira ngo byongere ubushobozi bwo gukora no gukomera.
Glycerol Monostearate (GMS):Yongera ubushobozi bwo kudakoresha amazi, yongera cyane ubushobozi bwo kurwanya aside mu bisigazwa by’umwimerere bishingiye kuri polymer.
Izindi nyongeramusaruro:Imiti irangi, imiti irwanya gufunga, n'imashini zikora imyenge (urugero: talc, titanium dioxide, polysorbates) bitanga akamaro mu mikorere no mu gutunganya.

Inyongeramusaruro zo kurwanya aside n'inyongeramusaruro zikoreshwa

Ibinini-bitwikiriwe-na-enteric-bishonga he

Imbogamizi mu kugera ku bufatanye mu gusiga no gukora neza

Impinduka mu bunini bw'ibice by'imbere n'ibice by'imbere mu biti mu gusiga

Kugira ngo ibinini bitwikiriwe neza mu mubiri bigere ku bunini buhamye ni ingenzi cyane. Itandukaniro ry’ibinini hagati y’ibinini rigaragaza itandukaniro ry’ubunini ku binini bimwe, mu gihe itandukaniro ry’ibinini hagati y’ibinini ripima itandukaniro hagati y’ibinini mu itsinda rimwe. Byombi bigira uruhare mu mikorere y’ibicuruzwa bya nyuma.

Ingaruka z'imyambaro idasa n'imwe ku irekurwa ry'imiti n'imikorere yayo

Udupira tw’imiti tudahuje bigira ingaruka ku buryo butaziguye ku miterere y’imiti isohoka. Ihindagurika ry’ubugari rishobora kwangiza ubushobozi bwo kurwanya aside, bigatuma imiti isohoka itaragera. Urugero, utwo dupira tw’imiti dushyirwa kuri abiraterone acetate twongereye ubwiyongere bw’umubiri inshuro 2.6 ugereranije n’utwo tudapfutse, bifitanye isano no kunoza uburyo bwo kurinda igifu. Ku rundi ruhande, utwo dupira twa pantoprazole tudahuye neza twateje imikorere idahwitse no kuboneka mu mubiri, cyane cyane hagati y’ibicuruzwa bisanzwe n’ibicuruzwa by’ikirango.

Gusohora imiti mu duce dupfutse bireba ubunini n'imiterere ya polymer. Gupfuka igihe kirekire no kongera umuvuduko wa atomi bishobora gutanga firime nini, ariko gukoresha nabi bitera imikorere idasobanutse neza.

Ibintu bibangamira ibidukikije: Ubushuhe, Ubushyuhe, Imiterere y'umuvuduko

Ibipimo by’ibidukikije mu gihe na nyuma y’uburyo bwo gusiga irangi mu nda bigira ingaruka zikomeye ku buryo irangi ringana kandi ritameze neza. Ubushyuhe bwinshi bwo kumisha n’ubushuhe buke byihutisha kumisha ariko byongera ibyago byo kurema imivundo no kwangirika k’ubuso. Kumisha vuba akenshi bitera inenge mu miterere y’umubiri, harimo no kuvunika cyangwa gucika intege, cyane cyane mu bimera bikozwe mu turemangingo na za poroteyine.

Uburyo bwo kubika nyuma yo gupfuka nabwo ni ingenzi. Ahantu harangwa n'ubushuhe bwinshi ku bushyuhe buke bituma habaho kuvunika kw'ingufu, mu gihe ubushuhe bwinshi ku bushyuhe bwinshi bushobora gutera kwivanga no gufatana kw'ingufu. Ubuhanga nko gupima mikorosikopi ya elegitoroniki (SEM) na X-ray computed tomography (CT) bugaragaza ko imiyoboro mito cyangwa kwivanga bihindura imikorere y'ingufu no guhindura imiterere y'imiti.

Uruhare rw'Ibipimo byo Gutunganya (Ubwoko bwa polymer, Plasticizer, Umushongi)

Uburyo bwo gusiga irangi rya enteric bugena imikorere y'umubiri n'imiterere y'imiti. Guhitamo imiterere ya polymer—ubwoko bwa cellulosic, acrylic-based, cyangwa synthetic nka PLGA—bigira ingaruka ku kudakomera kwa aside no ku busugire bwa mekanike. Plastizer yongera ubushobozi bwo koroha no kugabanya ibyago byo kwangirika. Plastizer zikoresha hydrophilic (PEG 400, PEG 6000) zongerera ubushobozi bwo kwinjira ariko zishobora kwangiza kudakomera kwa aside zigakora nk'imyenge, bigatinda gusohora imiti. Plastizer zikoresha hydrophobic (urugero: dibutyl sebacate, acetyl tributyl citrate) zikomeza kugumana imiterere ya firime n'imiterere y'imbogamizi.

Imisemburo igira ingaruka ku ikoreshwa n'uburyo yuma. Imvange ya Isopropyl alcohol n'amazi ituma habaho filime imwe hamwe na sisitemu ya ethylcellulose-hypromellose matrix. Igipimo n'ubwoko bwa solvent bigomba guhuzwa n'amahitamo ya polymer na plasticizer kugira ngo habeho uburinganire bunini bw'igitambaro, hagenzurwe uburyo bwo kwinjira no kugumana aside.

Guhuza polymer, plasticizer, na solvent systems ni ingenzi kugira ngo habeho umusaruro mwiza wo gusiga enteric. Inganda zikora imiti zishingira ku buryo bunonosoye kugira ngo zigire umusaruro mwiza mu binini bitandukanye, ibinini, n'ubwoko butandukanye bw'ibinini bitwikiriwe na enteric.Gupima ubukana bw'umuvuduko mu gihe nyacyono kugenzura birushaho gutuma habaho kugenzura neza ubukana bw'ubushyuhe bw'ibirahure, bikerekana ko ubukana bwiza bw'ubushyuhe bw'ibinini bya enteric bushoboka kandi bigafasha mu gupima ubunini bw'ubushyuhe mu miti.

Uburyo bwo gusiga irangi rya Enteric

Incamake y'Inzira yo Gusiga Indabyo mu Ntambwe ku Ntambwe

Gutegura umuti wo gusiga

Gukora ibinini, ibinini, n'imiti ifite uduce twinshi bitangirira ku guhitamo neza polimeri na plastike. Polymeri zisanzwe zirimo ibikomoka kuri selulosi n'ibikoresho bishingiye kuri methacrylate nka DRUGCOAT® L 100-55. Ibikoresho bya plastike nka triethyl citrate (TEC), polyethylene glycol (PEG 400, 6000), diethyl phthalate, na triacetin bishyirwamo kugira ngo byongere ubwiyongere bw'urumuri n'imbaraga za mekanike.igisubizoGutegura bikubiyemo gushonga cyangwa gukwirakwiza polymer na plasticizer mu mazi cyangwa mu binyabutabire by’umwimerere, uvanze neza kugira ngo haboneke ubukana bwiza bwo gusiga ibinini bya enteric, akenshi hagati ya 50–100 cP bitewe n’uburyo bwo gutera no gupima atomization. Gupima ubukana buhoraho mu gukora imiti—hakoreshejwe sisitemu zo gupima ubukana bw’imiti mu bucuruzi—bituma habaho imiterere myiza kandi bigatuma filime ikora neza. Gukurikirana ubukana bw’imiti mu buryo burambuye bigabanya ibyago byo kudahuza kandi bikarinda ibibazo byo gufatana.

Uburyo bwo gukoresha: Gusiga irangi mu isafuriya no gusiga irangi mu buriri

Gusiga irangi bikoreshwa hakoreshejwe uburyo bwo gusiga irangi ku isafuriya cyangwa uburyo bwo gusiga irangi ku gitanda, bigatoranywa hakurikijwe ubwoko bw'igicuruzwa n'imiterere ya firime wifuza.

Igipfunyika cyo mu isafuriya: Ibinini bishyirwa mu isafuriya ifite imyenge cyangwa isanzwe igwa mu gihe umuti wo gusiga urimo guterwa mu binini. Umwotsi ushyushye urahuhwa kugira ngo wumuke vuba. Gusiga isafuriya bikwiriye ibinini n'ibinini bitwikiriwe n'ibinini ariko bishobora gutuma habaho ubugari butandukanye bw'igitambaro kandi ntibikwiriye cyane ku buryo bw'uduce twinshi. Kugira ingano imwe bishingiye ku muvuduko uhoraho w'isafuriya, umuvuduko uhoraho w'igitambaro, no kugenzura ubushyuhe.

Igitambaro cyo ku buriri gifite amazi: Ibinini cyangwa uduce duto dushyirwa mu kirere gishyushye mu gihe umuti urimo gupfuka ukoresheje atome. Imiterere irimo spray yo hejuru, spray yo hasi (uburyo bwa Wurster), cyangwa spray ya tangential. Gupfuka ukoresheje fluid bituma habaho kugenzura neza ubugari bwa firime n'uburyo ikoreshwa, bigatuma biba byiza ku miti ikoresha enteric coating isaba imiterere nyayo yo kurekura. Udushya nka sisitemu ya rotary fluidized bed (RFB) twongera uburyo bwo gufata neza imiterere ya pellets. Gupima uburinganire bw'uduce duto mu miti bikorwa buri gihe mu gihe cyo kuyikoresha na nyuma yo kuyikoresha kugira ngo byemezwe ko ikwirakwizwa neza kandi ko ikwirakwizwa neza.

Kumisha no Gutunganya: Ingaruka ku buryo ibintu bingana, ubucucike, no kurwanya aside

Iyo irangi rimaze gushyirwaho, ibinini bihita byumye kandi bigakira kugira ngo firime ihore imeze neza. Ibipimo by'umusemburo wo kumisha—ubushyuhe, ubushuhe, umuyaga utembera—ni ingenzi cyane mu gukora firime kandi bigomba kugenzurwa neza. Gukamura firime bisaba gushyira ibinini bitwikiriwe ku bushyuhe bwinshi cyangwa ubushuhe mu gihe runaka (bitahinduka: kugeza ku masaha 24, bihinduka: amasaha 3-4). Ubu buryo bunoza ubwiyongere bw'uruhererekane rwa polymer, byongera imbaraga zo gukurura, kandi byongera ubudahangarwa bw'aside mu gice cy'imbere.

Igihe cyo kuma no gushya bigira ingaruka ku bucucike bw'igipfundikizo n'uburyo gihuye. Gushya neza bishobora gutuma habaho uburinzi buke kuri aside yo mu gifu, bigatera ibibazo mu gutanga imiti. Ku rundi ruhande, gushya igihe kirekire bishobora kugabanya uburyo amazi anyuramo binyuze muri firime, bikongera ubushobozi bwo kurwanya aside. Ku rugero rwo hagati rwo gushya (ubunini ≈ 7.5%), igihe cyo gushya bigira ingaruka nke, mu gihe ku rugero rwo hasi cyangwa hejuru bisaba kugenzura neza. Gukurikirana buri gihe ubunini n'imiterere ya firime bituma firime ihura n'ibipimo byayo.

Ibipimo by'ingenzi byo kugenzura inzira (CPK)

Kugenzura ibikorwa mu gutwikira mu nda byibanda ku bipimo byinshi by'ingenzi bigira ingaruka ku bwiza bw'umusaruro wa nyuma:

Ingufu zinjira mu kirere: Igenzura umuvuduko w'umuvuduko w'umukungugu n'ikorwa ryawo.
Umuvuduko wa pan(mu gipfundikizo cy'isafuriya): Bigira ingaruka ku buryo igipfundikizo gisa n'aho gikwirakwira mu buryo bungana.
Ubushyuhe bw'umwuka: Igira ingaruka zitaziguye ku gushonga kw'ibinyabutabire no guhuza polymer.
Igihe cyo gutwikira: Igena imiterere yose ya firime n'ubugari bwayo.
Igitutu cya atome: Igenzura ingano y'ibitonyanga n'uburyo bikwirakwira mu gipfundikizo—icya ngombwa cyane mu gutuma ibikubiye mu gipfundikizo bingana.
Igitutu cy'umufana: Igira ingaruka ku gusubika ibinini mu buryo bwo kuryamamo amazi.

Ibikoresho byo kugenzura ibikorwa by’imibare nka Plackett-Burman igishushanyo mbonera bigaragaza ibipimo bigira ingaruka nziza. Gupima ibikoresho buri gihe no gupima ubukana buhoraho bigumana ubukana. Urugero, ubukana bw’imiti mu binini bitwikiriwe n’ibinini biterwa cyane n’umuvuduko uhoraho w’ibinini n’umuvuduko ugenzurwa neza wo gutera imiti. Gupima ubukana binyuze mu gupima mu murongo birinda guhindagurika mu gihe cyo gukora.

Kugenzura ko ibicuruzwa bihora bihagaze neza kandi birinzwe igihe cyose bimara

Kugira ngo imiti irinda indwara ikomeze guhagarara neza mu gihe kirekire ni ingenzi kugira ngo ikomeze gukora neza igihe ivamo irekurwa. Kugenzura ubuziranenge birimo uburyo bwo gusesengura nka:

Isuzuma ry'isesengura: Ituma aside idakomeza kubaho kandi ikemeza ko imiti irekurwa ku gipimo cya pH mu mara.
Igipimo cy'ubunini: Igenzura ikoreshwa ry’agapira k’imbere mu mubiri rikwiye kandi rimwe.
Gukurikirana ibidukikije: Ibungabunga ubushuhe n'ubushyuhe bikwiye mu gihe cyo kubika no gukora.
Isesengura ry'ihindagurika rya Calorimetry/Thermogravimetric: Isuzuma impinduka mu miterere ya filime uko igihe kigenda gihita.

Gukurikiza amabwiriza agenga (GMP, FDA, ICH Q8/Q9) ni itegeko mu gihe cyose cyo kwemeza, gukora no kugenzura ubuziranenge. Inyandiko z'ibipimo by'ingenzi byo kugenzura inzira no kugenzura buri gihe ubuziranenge bw'ibicuruzwa. Urugero: Mu bushakashatsi bugereranya ubuziranenge bw'ibinini byasizwe mu nda, imiterere y'ibice byangiritse n'ubuziranenge bw'igitambaro bigenzurwa kugeza ku mezi 24 kugira ngo byemezwe ko ibisabwa mu gihe cyo kubikwa byujuje ibisabwa.

Gutunganya imikoreshereze y'ibikoresho, kugenzura ibikoresho neza, no gukurikirana ubushyuhe buri hagati y'imirongo bituma habaho gukora ibintu mu buryo buhoraho no kugira akamaro gahamye ko gusiga irangi ry'imiti inyobwa.

Menya byinshi ku bipimo by'ubucucike

Viscometer y'inganda iri ku murongo

Viscometer y'ubushyuhe bwinshi

Viscometer yo mu murongo

Viscometer y'irangi riri ku murongo

Ibindi bipimo by'imikorere kuri interineti

Igipimo cy'ubucucike bwa lpg lng kirimo gukorwa

Igipimo cy'ubucucike bwa LPG LNG kiri ku murongo

Igipimo cy'ubucucike bwa peteroli ku murongo

Igipimo cy'Ubucucike bwa Coriolis

Igipimo cy'ubucucike bw'inzoga

Akamaro ko gusiga irangi mu buryo bwo gusiga irangi mu maraso

Ubushyuhe bwo gutwikira ni cyo gipimo cy’ubushyuhe bw’umuti mu gutemba, kandi ni ingenzi mu miti ikingira imisemburo no kurinda uburyo bumwe bwo kuyirinda. Kugenzura ubushyuhe bituma icyuma gikwirakwira, ubunini, no kudakira aside ku binini n’ibinini bikingira imisemburo. Ubushyuhe bwiza bwo gutwikira ibinini bikingira imisemburo butuma bikoreshwa buri gihe nta gucika intege, gukwirakwira mu buryo butaringaniye, cyangwa kubangamira imikorere y’ibicuruzwa, bigira ingaruka ku buryo ubushyuhe n’imikorere yabyo bikwirakwira.

Ingaruka zo gusiga irangi ku gusiga irangi risanzwe

Ubukana bukwiye ni ingenzi cyane kugira ngo habeho uburinganire mu mikorere yo gutwikira imvange. Ubukana busanzwe butuma imiti irekurwa neza kandi ikarinda aside cyane - inyungu z'ingenzi zo gutwikira imvange. Iyo ubukana bukabije, amazi yo gutwikira ashobora gutemba cyangwa agacika, bigatuma habaho utudomo duto cyangwa tutuzura neza; hejuru cyane, kandi bishobora kuziba atomizer cyangwa bikabuza gukwirakwira, bigatera inenge zo gutwikira cyangwa filimi mbi. Ubuhanga nka terahertz pulsed imaging (TPI) na Raman mapping bipima kandi bigasuzuma uburinganire bw'imvange, bigasuzuma ibibazo bifitanye isano n'ubukana budasanzwe nk'ubunini buhindagurika n'ubucucike ku buso bw'ibinini. Ubushakashatsi bwemeza ko ibisubizo byinshi byo gutwikira, cyane cyane ibirimo polymeri nini, bitanga filimi zifite ubunini bunini kandi zigabanya ubukana, bikongera ubushobozi bwo kudakora neza kw'aside no gutinda gusohora imiti.

Isano iri hagati y'ubushyuhe bwo gusiga n'imiterere ya firime

Ubucucike bwo gusiga bugira imiterere itaziguye y’imiterere ya firime nko kuba ubwinshi, ubunini, uburinganire, imbaraga zo gukurura, no kwinjira mu mubiri. Ubucucike bunini kandi bwiza buturuka ku buryo bwiza bwo gukamura, burinda kubyimba imburagihe, kwangirika, cyangwa kunanirwa kw’amazi yo mu gifu yigana. Ubucucike buke cyane bushobora gutera imiterere mibi ya mashini no kudakomera kwa aside, mu gihe ubucucike bukozwe ku bucucike bwinshi bugaragaza imiterere myiza n’imikorere y’insinga. Ingano ya pulasitiki n’urwego rwa polimeri ni byo bigena imiterere y’ubucucike—uburinganire bwabyo bugira ingaruka ku bucucike bwa nyuma. Urugero:

Ibinini bya Pantoprazole:Ubucucike bugira ingaruka ku bunini n'ubucucike, bityo bigira ingaruka ku miterere y'irekurwa ry'ibice bitinze ndetse no ku miterere y'ishonga.
Filime za Chitosan/zein:Ubwiyongere bwa pulasitiki bugabanya ubukana n'uburyo ibintu bihindukamo, bukongera ubworoherane ariko bugagabanya imiterere y'imbogamizi.

Gupima ubuziranenge bw'ibice mu miti bikoresha buri gihe amashusho (TPI, SEM) na Raman mapping kugira ngo harebwe isano iri hagati y'ubukana, imiterere ya firime, n'imikorere yizewe y'ibice by'imbere.

Ibintu Bigira Ingaruka ku Kuzura kw'Ipfundo

Uburyo bwo gushushanya

Gutunganya ni cyo kintu kiranga ubukana bw'ibinyabutabire. Ubunini bwa polymeri bwinshi bwongera ubukana bw'ibinyabutabire, bigatuma habaho filime zikomeye kandi zihuye. Ibyuma bya pulasitiki—nk'ibinyabutabire nka glycerol, PEG-400, na sorbitol—bihindura ubukana bw'ibinyabutabire binyuze mu kongera uburyo bwo kugenda kwa molekile no kongera ubworoherane, nubwo ingano irenze urugero ishobora kwangiza imikorere y'imbogamizi.

Urugero: Mu gusiga alginate ya sodium, ijanisha rya glycerol cyangwa PEG-400 rihindura ubukana bw'amazi, bityo bigahindura ubushuhe, ihame, n'ubugari bwa nyuma bw'igisiga.

Ubushyuhe

Ubushyuhe bugenzura cyane ubushyuhe. Ubushyuhe bwiyongera muri rusange bugabanya ubushyuhe, bunoza urujya n'uruza rw'ibikoresho byo gusiga. Ingero za viscosity zishongesha (Carreau na Arrhenius equations) zisobanura uburyo imiti ivangavanga ihindura ubushyuhe, bigira ingaruka ku mikorere ya firime. Ariko, ubushyuhe bukabije bushobora kugabanya cyane uburyo bwo gutegura, bigatera uburibwe cyangwa kwangiza imiti ikomeye.

Urugero: Irangi rya Eudragit L 100-55 rigaragaza ubushyuhe buke kandi rikagira imiterere myiza ya firime iyo ubushyuhe buri hejuru, iyo urugero rwa pulasitiki rugenzuwe neza.

Impinduka mu byiciro

Ihindagurika ry’ingufu hagati y’ingufu n’ingufu rigira ingaruka ku buryo busanzwe, bityo bigatuma habaho uburinganire bw’ibice by’umurangi. Itandukaniro ry’ibikoresho fatizo (ingano y’uduce, urwego rwa polymer) n’imiterere y’imikorere rishobora guhindura umuti cyangwa gushonga ubukana hagati y’uburyo umusaruro ukorwa, bigatera ikibazo cyo kongera kubyara. Gukurikirana ubukana bw’ingufu ku bicungwa—hakoreshejwe ikoranabuhanga ryo gusesengura imikorere (PAT)—bifasha gukurikirana no guhindura uburyo ibintu bihinduka mu gihe nyacyo, bishyigikira gupima ubukana mu buryo buhoraho mu gukora imiti.

Urugero: Ibinini bya sodium alginate bivuye mu byiciro bitandukanye bishobora gutandukana mu kubyimba no gushwanyagurika bitewe n’ihindagurika ry’urugero rw’imiti, bigira ingaruka ku irekurwa ry’imiti muri rusange.

Kugenzura ubushyuhe bw'ibisigazwa by'ibirahure—bikubiyemo uburyo bwo kubikora, ubushyuhe, no gucunga ibyiciro by'ibisigazwa by'ibirahure—ni ingenzi cyane ku binini bishobora kongera gukoreshwa kandi bifite akamaro ndetse no ku buryo bwiza bwo gusiga ibirahure by'ibirahure by'imiti.

Sisitemu zo gupima ubukana bw'ibicuruzwa mu buryo burambye no mu buryo buhoraho bwo gutwikira mu nda

Hakenewe Gukurikirana Ubucucike mu Gihe Nyacyo

Kugumana ubushyuhe buhoraho mu gihe cyose cyo gusiga irangi rya enterike ni ingenzi kugira ngo irangi ribe rimwe ku bicuruzwa bya farumasi nk'ibinini n'ibinini bya enterike. Ihindagurika ry'ubushyuhe rikunze gutera inenge nko kuba ubugari butaringaniye bw'irangi, gushyuha, no kugorama k'ubuso, bigira ingaruka ku buryo butaziguye ku mikorere n'isura y'umusaruro.

Gukurikirana ubushyuhe mu gihe nyacyo bitanga ibitekerezo byihuse, bigatuma ababikora bakomeza kugira ubushyuhe bwiza bwo gutwikira ibinini bya enteric mu byiciro byinshi. Ibi bigabanya ibyago byo gupima ubuziranenge bw'ubushyuhe mu miti, mu gihe bishyigikira kunoza imikorere no kugabanya imyanda ihenze cyangwa kongera gutunganya ibicuruzwa. Kubera ko ibisubizo byo gutwikira bishobora guhinduka mu bushyuhe bitewe n'impinduka z'ubushyuhe, guhumeka kw'ibinyabutabire, cyangwa ihindagurika ry'ibikoresho fatizo, gukurikirana ubushyuhe mu buryo bw'umurongo ku bifuniko bituma habaho impinduka zikomeye, gukumira ihinduka rikomeye muri buri cyiciro no gushyigikira ibisabwa n'amategeko ku miti yarangije gutwikira enteric.

Sisitemu zo gupima ubukana bw'ubucuruzi ziboneka

Ubuhanga bugezweho bwo gusiga imiti mu nganda bwatumye habaho iterambere ry’uburyo bwo gupima ubukana bw’imitsi mu bucuruzi. Ubu buryo bukoresha amahame atandukanye y’imikorere kandi butanga imiterere yihariye igenewe gukora imiti mu buryo bukomeye.

Amahame y'imikorere:

Ibipimo bya Viscometer bizenguruka:Pima imbaraga zikenewe kugira ngo uzunguruke ikintu mu mazi atwikiriye, uhindure imbaraga zikoreshwa mu gupima ubukana bwa mashini. Nubwo ari nziza, ubundi buryo bushya bushobora gutanga isuku nziza no guhuza imikorere y’ikoranabuhanga.
Utumashini dupima ibintu:Ibikoresho nkaLonnmeter Pharma ViscometerKoresha isesengura rya vibration kugira ngo umenye ubucucike bw'amazi n'ubucucike icyarimwe. Ibi bitanga ingero z'igihe nyacyo, ntibibungabungwa neza, kandi byagenewe gukoreshwa mu buryo buhoraho mu buryo bufunze kandi bufite isuku.
Viscometer za Ultrasonic na Solid-State:Sisitemu nka za viscometer za BioDE zikoresha imiraba ya ultrasonic cyangwa imiterere y’umubiri, bigatuma zirwanya ibidukikije bigoye kandi zikaba nziza cyane mu gupima ubukana buhoraho mu gukora imiti.
Ibipimo bya Rheometers za Capillary na Microfluidic:Viscometer za kinematic capillary na sisitemu za microfluidic rheology zikwiriye gupimwa ubukana bw'amazi mu buryo buciriritse kandi bunoze cyane, bikaba ingirakamaro mu gihe ukoresha imiti ihenze cyangwa idafite ubushobozi bwo gusiga.
Uburyo bwo gupima imiterere y'umubiri (Spectroscope):Uburyo bwo gupima mu buryo bwa "inline vibration" (urugero: Raman, IR) na fluorescence spectroscopic bushobora guhuzwa, akenshi bugakoresha uburyo bwa "chemometric modeling" mu gusesengura ibikorwa bigezweho.

Sisitemu z'ingenzi z'ubucuruzi:

LonnmeterIbikoresho byo kureba amashusho kuri interineti:Yagenewe gukora imiti ihoraho, itanga ubunini bunini bw'ubushyuhe, idafite ubuziranenge bwinshi, kandi ihuzwa n'imirongo ikoresha irangi.

Ibipimo ngenderwaho byo guhitamo ikoreshwa ry'imiti:
Mu guhitamo uburyo bwo gupima ubukana bw'imitsi mu bucuruzi (inline viscosity system) bwo gusiga irangi ry'imiti, shyira imbaraga kuri ibi bikurikira:

Ubuziranenge mu gihe nyacyo:Ni ngombwa mu kugenzura ibikorwa n'ubwiza bw'umusaruro.
Guhuza:Igikoresho kigomba kuba gihuye n'ubwoko bwihariye bw'uburyo bwo gusiga (gelatin, polymer-based, aqueous, sustainable-release).
Guhuza no guhuza:Igishushanyo mbonera cya modular no guhuza na sisitemu zo kugenzura zikora na framework za Industry 4.0.
Kubungabunga no Gutunganya:Gukunda ibikoresho bidakoreshwa cyane kandi byikora ku buryo bworoshye, bishobora kwihanganira imiterere y'imiti.
Ubudahangarwa ku bidukikije:Ubushobozi bwo kugumana ubuziranenge mu gihe cy'ubushyuhe butandukanye, ubushuhe, n'imiterere y'amazi.

Ibyiza byo gupima ubukana buhoraho mu kugenzura inzira yo gusiga irangi mu nda

Gupima ubukana buhoraho bihindura inzira yo gusiga irangi ry'imbere ry'umunyu hamwe n'inyungu nyinshi zishoboka:

Uburyo bumwe bwo gusiga no kwirinda inenge:Gutanga ibitekerezo ku gihe nyacyo byemeza ko irangi rya enteric rikoreshwa kimwe. Ibi bigabanya inenge nko gucikagurika, gushyuha, no gukora neza kw'imipaka, bishyigikira ibyo ibinini n'ibinini bya enteric biteze ku isoko.
Uburyo bwo gukora neza:Uburyo bwo kugenzura bwikora bugabanya igihe cyo gukora isuzuma n'ivugurura ry'ibikoresho hakoreshejwe intoki, bigatuma umusaruro usohoka neza kandi bigakoresha neza ububiko bw'ibisubizo byo gutwikira.
Kuzigama ibikoresho n'ingaruka ku bidukikije:Mu guhindura ubushyuhe mu buryo buhindagurika, sisitemu zigabanya ibintu byangiritse kandi zikirinda ikoreshwa ry’ibintu bishongesha. Ibi bifasha mu kubungabunga ibidukikije no kunoza umutungo.
Kugenzura Ireme n'Iyubahirizwa ry'Amategeko:Amakuru ahoraho kandi yanditswe atanga inyandiko kuri buri cyiciro cy’ibirahure bya enteric, binoza igenzura ry’ubuziranenge n’itangwa rya raporo ku mategeko.
Inyungu ku ishoramari:Abakora babona umusaruro warushijeho kuba mwiza, ubwiza buhoraho, no kugabanuka kw'ivugurura cyangwa kwangwa nyuma yo gushyira mu bikorwa igenzura ry'ubushyuhe bw'imyambaro. Izi ngaruka zagaragajwe mu bushakashatsi buherutse gukorwa ndetse n'ubushakashatsi bwasuzumwe n'abashakashatsi.

Muri make, sisitemu zo gupima ubukana bw'ibice by'ubucuruzi—zizenguruka, zizunguruka, zikoresha ikoranabuhanga rya ultrasonic, zikoresha imiyoboro ya capillary, zikoresha microfluidic, na spectroscopic—ni zo shingiro ry'uburyo bugezweho bwo kugenzura ubukana bw'ibice by ...

Ingamba zo Kugenzura Ubuziranenge mu Gusiga Irangi mu Nganda z'Imiti

Gupfuka ibinini bitwikiriye mu buryo bumwe ni ingenzi mu gukora ibinini bitwikiriye mu buryo bumwe, ibinini bitwikiriye mu buryo bumwe, n'ibindi binini bikoreshwa mu kunwa. Igenzura ry'ubuziranenge rigamije kubungabunga uburyo bwo gupfuka ibinini mu buryo buhamye, gushyiramo uburyo bwo kugenzura ibikorwa mu buryo bufatika, no gukemura ibibazo byihuse—buri kimwe gikomezwa n'ikoranabuhanga rikoresha ikoranabuhanga n'ikoranabuhanga.

Gukurikirana buri gihe: Ubucucike, Ubunini, n'Uburyo bumwe

Gukurikirana buri gihe ibintu biri ku murongo ni inkingi y'ingenzi yo gusiga kimwe.

Ubucucike:Sisitemu zo gupima ubukana bw'ibicuruzwa, nka viscometer zikora mu buryo bwikora, zitanga ibitekerezo bihoraho ku bukana bw'ibicuruzwa. Ibi ni ingenzi ku miti ikora mu buryo bwikora, kuko ubukana budakwiye bugira ingaruka ku miterere y'urupapuro, bigatera inenge cyangwa ubwinshi bw'ibicuruzwa bitangana. Viscometer zikora zikora neza kandi zikora neza, zigatuma umuti ufata ubukana bw'ibicuruzwa uguma mu rugero rwiza rw'ibinini bikora mu buryo bwikora kandi zikagabanya uburyo umukozi akoresha.
Ubunini:Tomography y’ubufatanye bw’amajwi (OCT) ituma hapimwa ubugari bw’igipfundikizo mu buryo butangiza, kandi bukorwa mu buryo bugaragara. Itanga amakuru y’igihe nyacyo ku bugari bwa firime, imiterere ihuye, ndetse n’ubugari bw’ubuso. Ikoranabuhanga rya OCT rifitanye isano rya hafi n’igerageza ry’ubukana n’ubukana ritari kuri interineti, rishyigikira kugenzura inzira no guteza imbere byihuse intambwe nshya zo gupfundikizo mu gipfundikizo.
Ubumwe:Isuzuma ryikora ku buso hamwe n’isesengura rya spectrophotometric bitanga igenzura ryinyongera ry’amabara, ubwiza, n’ubumwe, byose bikaba ari ibimenyetso by’ingenzi byerekana uburyo bwo gusiga amarangi mu buryo bugezweho mu buvuzi.

Sisitemu zihujwe akenshi zihuza izi sensors mu buryo bwo gutanga ibitekerezo byiteguye gukoresha IoT, zigashyigikira gahunda z’ubwiza n’igenamigambi (QbD) hamwe no kubahiriza amategeko.

Amabwiriza yo Gutanga Ingero mu Isuzumabumenyi ry'Imbere n'Irindi

Gufata ingero z'imibare bishimangira ko irangi rihuye hagati y'amatsinda n'amatsinda:

Ingero z'ibyiciro by'itsinda:Shushanya nibura uduce dutatu dutandukanye duturutse ahantu icumi hihariye mu ngoma cyangwa mu icupa ry'amavuta mu gihe cyo gukora imashini. Ibi bitanga umusaruro ugaragara mu buryo butandukanye bushoboka.
Ingero z'ibice bitandukanye:Amabwiriza agenga ikoreshwa ry’imiti asaba ko hakorwa isesengura ry’ibice bitatu byigenga, nibura hagakorwa ingero esheshatu kuri buri gice mu gihe itandukaniro riri hasi mu miterere y’ibice. Ubu buryo bwemeza ko ikoreshwa ry’ibice bitandukanye mu gupima ubuziranenge bw’ibice mu miti rishobora kuba rihagije.
Isuzuma risanzwe rikoresha ibipimo by'ubugari, igenzura ry'amaso, n'uburyo bwa spectroscopic kugira ngo byemezwe ko ari bimwe. Ibipimo byo kwemera byibanda ku gutandukana gusanzwe n'igipimo cy'impinduka, aho icyerekezo gisuzumwa uko igihe kigenda gihita kugira ngo hamenyekane ibibazo bihoraho cyangwa impinduka mu mikorere.

Gukemura ibibazo no Gukosora Inenge zo Gupfuka

Ubusembwa bwo gupfuka—nk'uburibwe bwo kugongana, gupfuka no gucika—bushobora kwangiza imikorere n'isura y'ibinini bipfuka mu nda. Gukemura ibibazo bisaba ibikorwa byihariye:

Twinning:Akenshi biterwa n'imiterere ya tableti cyangwa umuvuduko wa pan. Imiti irimo guhindura uburyo pan izunguruka, kunoza imiterere y'ibanze ya tableti, no gucunga uburyo ishyirwa mu bikorwa ry'itsinda ry'ibikoresho.
Gushushanya:Ibisubizo bivuye mu kuvanga bidahagije cyangwa gutandukanya amabara. Teza imbere binyuze mu kunoza uburyo bwo kuvanga, gutunganya neza igipimo cyo gusukura, cyangwa guhindura uburyo ibara rikwirakwira.
Gukata:Bifitanye isano n'imyambaro ishaje cyangwa imbaraga za mekanike. Kosora uhindura uburyo bwo gusiga—wongera urugero rwa pulasitiki cyangwa uhindura igipimo cyo kumisha—kugira ngo wongere ubuziranenge n'ubushobozi bwo koroshya firime.

Gukoresha uburyo bwo gukosora no gukumira (CAPA) byoroshya uburyo bwo gukemura ibibazo. Isesengura ry'impamvu nyamukuru ritandukanya inzira cyangwa ibintu bihindagurika, mu gihe ibikorwa byo gukumira binoza uburyo bwo kubikemura no kubishyiraho kugira ngo hirindwe ko byasubira.

Ibisubizo by'igihe nyacyo n'uburyo bwikora mu buryo bwo gusiga irangi

Kwikora no gutanga ibitekerezo mu gihe nyacyo bituma habaho imikorere myiza n'ubwiza mu gusiga irangi mu mubiri:

Sisitemu zo kugenzura zigezweho:Porogaramu zikoresha IoT hamwe n'ikoranabuhanga risesengura imikorere (PAT) bikusanya amakuru ahoraho mu mikorere. Sisitemu nka formulateurs za digitale n'ibidukikije bya DataFactory bikoresha AI bisesengura imiterere y'ibintu, bigafasha guhangana n'ingaruka z'umuvuduko wo gutera imiti, ubushyuhe bw'umuma, n'ubushyuhe bwo gutwikira.
Gukosora ako kanya:Sisitemu zikora zisubiza ibipimo biri ku murongo binyuze mu guhindura ibipimo by'ingenzi ako kanya, bigabanya cyane ingano y'inenge n'imyanda y'ibikoresho.
Igenzura rihoraho:Izi mbuga zishyigikira ibisabwa kugira ngo habeho igenzura ry’imikorere rihoraho (CPV) nk’uko byagaragajwe mu buyobozi bw’amategeko, bifasha abakora ibikorwa gukomeza gusiga irangi rimwe n’ubwiza mu bihe byose by’umusaruro.

Binyuze mu gushyira hamwe uburyo bwo kugenzura ubushyuhe bw’ibicuruzwa mu buryo bw’ubucuruzi, gusesengura ubunini budasenya, no kugenzura uburyo bwikora, abakora imiti bagera ku nyungu zihoraho zo gusiga ibiryo mu gihe bahura n’ibisabwa bikomeye byo kubahiriza amategeko n’imikorere bigezweho.

Ingingo z'ingenzi zo gusiga kimwe no gukora neza mu mikorere y'imiti

Ubunini bw'igitambaro gikomeye: Kugira ngo urinde aside cyane, komeza ubugari bwa enteric coat bungabunge nibura 27.4 µm. Ubugari bwa ≥ 63.4 µm butuma ibinini byose bya enteric coat byubahirije ibisabwa byo gusenyuka kandi bigatanga ibisubizo bihoraho byo kuvura. Ubugari bwa enteric bugomba kwemezwa hakoreshejwe uburyo bwo hejuru nka optical coherence tomography (OCT), butuma habaho isuzuma ry’igihe nyacyo, ritajyanye n’uko enteric coat imeze mu gihe cyo kuyikora.

Isuzuma ry'Ubumwe: Koresha uburyo bwo gukwirakwiza ibikoresho by’ikoranabuhanga n’ibipimo by’ibarurishamibare nka relative standard deviation (RSD) kugira ngo upime ubuziranenge bw’imyambaro mu byiciro bitandukanye. Sisitemu za OCT ziri ku murongo zagaragaje ko zikora neza mu bucuruzi, zihuza kandi zigakunda kurenza ubuziranenge bw’uburyo gakondo bwo gukoresha interineti binyuze mu gutanga ubunini bwa SD hagati ya tableti buri hasi ya 9 µm (hafi 13% bya RSD).

Gutunganya Ibipimo by'Inzira: Kugenzura no kunoza ibipimo by'ingenzi by'imikorere—umuvuduko w'isafuriya, igipimo cyo gusukura, uburyo umwuka winjiramo, ubushyuhe bw'umwuka usohoka, intera iri hagati y'imbunda n'igitanda, n'umuvuduko w'umwuka uva mu kirere.

Guhitamo polimeri na pulasitiki: Hitamo polymer zigezweho zoroshye kandi zoroshye kandi zigabanye igihe cyo gutunganya. Tekereza ku buryo buhamye nka PVAP, copolymers za aside methacrylic (Eudragit L/S), polyethylene glycol (PEG) nk'imashini ikora pulasitiki, cyangwa shellac karemano kugira ngo ubone uburyo bushya bwo gukoresha. Guhitamo neza bigira ingaruka ku ikorwa rya firime, kurekura imiti, kandi bishobora koroshya uburyo bwo kugenzura ibikorwa.

Guhuza sisitemu zo gupima ubukana buhoraho kugira ngo hagenzurwe neza inzira

Gukurikirana ubucucike bw'umurongo: Shyiraho sisitemu zo gupima ubukana bw'imiti mu bucuruzi kugira ngo imiti ikomeze kuba nziza ku binini bya enteric. Gupima no kugenzura mu gihe nyacyo ni ingenzi mu kugenzura ubukana bw'ubukana bw'imiti, hirindwa inenge zituruka ku miti idakomeye cyangwa idafite ubukana bwinshi.

Inyungu ku mikorere:

Igenzura ko ubushyuhe bukomeza gupimwa mu gukora imiti, igatanga igisubizo cyihuse kandi igahindura intambwe zo gusiga irangi mu maraso.
Igabanya ihindagurika ry'ingufu mu buryo butandukanye mu gihe ishyigikira igeragezwa ry'ubuziranenge bw'ingufu mu miti.
Binoza uburyo bwo guhangana n'ibibazo nko guhindura imiterere y'ibikoresho cyangwa guhindagurika kw'ibikoresho, bigatuma igihe cyo gukora imyitozo cyihuta kandi kikagabanya imyanda.

Ubu buryo bwiza, bushingiye ku bikoresho bigezweho byo gusesengura no kugenzura imikorere y’ibinyabutabire, bugena uburyo bwiza bwo gukora ibinini n’ibinini bifite ubuziranenge kandi bifatanye neza.

Ibibazo Bikunze Kubazwa

1. Gusiga ifu mu mubiri ni iki kandi kuki ari ingenzi ku miti inyobwa?

Enteric coating ni agace ka polymeri kabigenewe gashyirwa ku bipimo byo mu kanwa nk'ibinini na capsule. Intego yabyo nyamukuru ni ukurinda umuti gushonga mu gifu mu kirere cy'aside, bigatuma ikintu gikora gisohoka gusa iyo kigeze mu gace k'amara kadafite aho kabogamiye cyangwa kari mu mazi. Ibi birinda imiti ikoreshwa mu gushonga, nka enzymes zimwe na zimwe cyangwa proton pump inhibitors, kwangirika mbere yo kwinjiza. Binarinda igifu kurakara bitewe n'imiti ishobora guteza ingaruka mbi, nka NSAIDs zitarimo steroide. Urugero, abiraterone acetate ikoreshwa mu gushonga mu mazi igumaho mu gihe cyo kunyura mu gifu, bigatuma ibasha kwinjiza aho ikora neza cyane. Uburyo bwo gushonga mu gushonga mu mazuru ni ingenzi mu buhanga bwo gushonga mu mazuru mu buvuzi kandi bugira uruhare mu gutuma imiti iboneka neza, bigatuma iba ingirakamaro mu gutanga imiti mu kanwa.

2. Ni gute ubukana bw'ibinini bitwikiriwe n'ibinini bigira ingaruka ku bwiza bw'ibinini bitwikiriwe n'ibinini?

Ubushyuhe bwo gusiga—uburyo umuti wo gusiga ufite ubunini cyangwa amazi—bigira uruhare runini mu ntambwe zo gusiga amavuta mu mubiri. Ubushyuhe bw'umuti bugenzura uburyo firime ya polymer itembera, ikwirakwira, n'uburyo ifatana kuri buri kinini. Iyo ubushyuhe bwo gusiga amavuta ari hasi cyane, agapfukamunwa gashobora kuba gatandukanye, ahantu hato hadashobora kurinda umuti mu gifu. Iyo ari hejuru cyane, hashobora kubaho ubwinshi bw'ibinure nko kwangirika cyangwa "igishishwa cy'umuhondo". Kugumana ubushyuhe bwiza bwo gusiga amavuta mu binini bya firime ni ingenzi kugira ngo habeho uruzitiro rumwe rudahindagurika rutanga ubudahangarwa buhoraho bw'aside no gusohora imiti mu buryo bugenzurwa. Kugenzura neza ubushyuhe kandi birinda inenge mu gukora nko gusibanganya kandi bigatuma habaho imikorere yizewe muri buri cyiciro.

3. Ni izihe sisitemu zo gupima ubushyuhe bw'inline mu bucuruzi kandi kuki zikoreshwa mu gusiga irangi mu maraso?

Sisitemu zo gupima ubukana bw'imiti mu bucuruzi ni ibikoresho cyangwa ibikoresho bishyirwa mu buryo bw'igihe nyacyo mu mirongo yo gusiga. Izi sisitemu zihora zigenzura kandi zigenzura ubukana bw'ibisubizo byo gusiga mu gihe cyose cyo gukora. Gukurikirana ubukana bw'imiti mu buryo bw'umurongo bifasha kugumana ubukana bw'imiti, bigabanya ingero z'imiti n'intoki, kandi bigahita bimenya aho ibintu bitandukaniye. Viscometer zikoresha uburyo bwikora n'izigezweho nka kinematic capillary cyangwa microfluidic viscometers zishyigikira kugenzura ubukana bw'imiti mu gutanga ubukana buhamye kandi bushobora kongera guhindurwa. Ibi bigabanya itandukaniro mu miterere n'imikorere y'ibinini, bishimangira ubwiza bw'itsinda, kandi bifasha kubahiriza amahame meza yo gukora (GMP). Gupima ubukana mu buryo buhoraho mu gukora imiti, cyane cyane ku miti yo gusiga mu mubiri, bituma habaho inenge nke mu gusiga, kugabanuka kw'uburyo bwo kwangwa, no gukora neza kw'ibicuruzwa.

4. Kuki gusiga kimwe ari ingenzi cyane ku binini bitwikiriwe n'imiti yo mu nda?

Guhuza irangi ry’imbere bivuze ubugari n’ubwinshi buhoraho kuri buri kinini mu itsinda. Guhuza irangi ritari risanzwe bishobora gutuma habaho uburinzi buciriritse, bigatuma umuti usohokera mu gifu hakiri kare cyangwa ntiwukore nk’uko byateganijwe mu mara. Ibi bishobora kwangiza imikorere, umutekano, n’amategeko, kandi bishobora kongera ibyago byo kwangirika kw’imiti cyangwa ingaruka mbi ku murwayi. Itandukaniro rito mu bugari bw’irangi bigira ingaruka zitaziguye ku gipimo cyo gusohora imiti n’ingaruka zo kuvura. Gupima ubugari bw’irangi mu miti akenshi bishingiye ku buryo bwo gusesengura budasenya kugira ngo buri kinini gitwikiriwe n’irangi gikomeze gutanga uburinzi no kurekurwa mu buryo bugenzurwa.

Porogaramu nyinshi

Hitamo Lonnmeter kugira ngo upime neza kandi ukoresheje ubwenge!