Ibicuruzwa bikoreshwa mu bya farumasi ni ibintu byongera imiti ikoreshwa mu gukora imiti no gutegura imiti, kandi ni igice cyingenzi mu gutegura imiti. Nka polymer karemano ikomoka kubintu, selile ether ifite ibiranga biodegradabilite, idafite uburozi, nigiciro gito, nka sodium carboxymethyl selulose, methyl selulose, hydroxypropyl methyl selulose, hydroxypropyl selulose,Ethernka hydroxyethyl selulose na Ethyl selulose bifite agaciro gakomeye mugukoresha imiti. Kugeza ubu, ibicuruzwa biva mu nganda nyinshi zo mu bwoko bwa selulose ether bikoreshwa cyane cyane mu murima wo hagati no hasi cyane mu nganda, kandi agaciro kiyongereye ntabwo kari hejuru. Inganda zikeneye byihutirwa guhindura no kuzamura no kunoza imikoreshereze yanyuma yibicuruzwa.
Ibikoresho bya farumasi bigira uruhare runini mugutezimbere no gutanga umusaruro. Kurugero, mumyiteguro irekura-isohoka, ibikoresho bya polymer nka ether ya selile ikoreshwa nkibikoresho bya farumasi bikoreshwa mu gusohora-kurekura, materique itandukanye irekura-irekura, ifatirwa-irekura-irekura, capsules irekura-irekura, firime y’ibiyobyabwenge irekura, hamwe n’ibiyobyabwenge bikomeza kurekurwa. Imyiteguro n'amazi arambye-kurekura byakoreshejwe cyane. Muri ubu buryo, polymers nka selile ya selile ikoreshwa muri rusange nk'abatwara ibiyobyabwenge kugira ngo bagenzure igipimo cyo kurekura ibiyobyabwenge mu mubiri w'umuntu, ni ukuvuga ko basabwa kurekurwa buhoro buhoro mu mubiri ku gipimo cyagenwe mu gihe runaka kugira ngo bagere ku ntego yo kuvura neza.
Dukurikije imibare y’ishami rishinzwe ubujyanama n’ubushakashatsi, ku isoko ry’igihugu cyanjye hari ubwoko 500 bw’ibicuruzwa biva mu mahanga, ariko ugereranije n’Amerika (amoko arenga 1500) n’ubumwe bw’ibihugu by’Uburayi (ubwoko burenga 3000), hari itandukaniro rinini, kandi ubwoko buracyari buto. igihugu cyanjye gikoresha imiti yimiti Iterambere ryisoko ni rinini. Byumvikane ko imiti icumi yambere yimiti ikoreshwa mubipimo byamasoko yigihugu cyanjye ni imiti ya gelatine capsules, sucrose, krahisi, ifu yo gutwika firime, 1,2-propylene glycol, PVP, hydroxypropyl methylcellulose (HPMC), hamwe na fibre microcrystalline. Ibikomoka ku bimera, HPC, lactose.
"Ether naturel ya selile ni ijambo rusange ryuruhererekane rw'ibikomoka kuri selile ikomoka ku myitwarire ya alkali selulose na etherifying agent mu bihe bimwe na bimwe, kandi ni ibicuruzwa aho amatsinda ya hydroxyl kuri macromolecule ya selulose asimburwa igice cyangwa burundu na matsinda ya ether. Ether ya selile ikoreshwa cyane mumirima ya peteroli, ibikoresho byo mu bwoko bwa farumasi, imiti, imiti, imiti, imiti, imiti, imiti, imiti, imiti, imiti, imiti, imiti, imiti, imiti, imiti, imiti, imiti, imiti, imiti, imiti, imiti, imiti, imiti, imiti, imiti, imiti, imiti, imiti, imiti, imiti, imiti, imiti, imiti, imiti, imiti, imiti, imiti, imiti, imiti, imiti, imiti, imiti, imiti, imiti, imiti, imiti. uduce twinshi two mu nganda kandi dufite agaciro kongerewe agaciro Kubera ibisabwa byujuje ubuziranenge, umusaruro wa selile yo mu rwego rwa farumasi nawo uragoye cyane Birashobora kuvugwa ko ubwiza bwibicuruzwa byo mu rwego rwa farumasi bushobora kwerekana imbaraga za tekiniki yinganda za selulose zisanzwe zongerwaho ibikoresho bya matrike irekura, ibikoresho bya gastric. ibikoresho bya firime, nibindi
Sodium carboxymethyl selulose (CMC-Na) ni selulose ether hamwe nibisohoka byinshi nibikoreshwa mugihugu ndetse no mumahanga. Ni ionic selulose ether ikozwe mu ipamba no mu biti binyuze muri alkalisation na etherification hamwe na aside ya chloroacetic. CMC-Na ni imiti ikoreshwa cyane. Bikunze gukoreshwa nkibihuza imyiteguro ihamye kandi nkibibyimba, kubyimba no guhagarika ibintu kugirango bitegure amazi. Irashobora kandi gukoreshwa nka matrike yamazi yogukoresha hamwe nibikoresho bikora firime. Bikunze gukoreshwa nkibikoresho bya firime irekura-isohora hamwe na tablet ya matrix ikomeza kurekurwa muburyo bukomeza (bugenzurwa).
Usibye sodium carboxymethyl selulose nkibikoresho bya farumasi, sodium ya croscarmellose irashobora no gukoreshwa nkibikoresho bya farumasi. Sodium ya carboxymethyl selulose (CCMC-Na) ni ikintu kidashobora gukama amazi carboxymethyl selulose ikora hamwe nu muti uhuza ubushyuhe runaka (40-80 ° C) bitewe na catalizike ya acide organique kandi igasukurwa. Umukozi uhuza ibice bishobora kuba propylene glycol, anhydride ya succinic, anhydride yumugabo, anhydride adipic, nibindi nkibyo. Sodium ya Croscarmellose ikoreshwa nkibintu bitandukanya ibinini, capsules na granules mugutegura umunwa. Yishingikiriza ku ngaruka za capillary no kubyimba kugirango igere ku gusenyuka. Ifite compressible nziza no gusenyuka gukomeye. Ubushakashatsi bwerekanye ko kubyimba sodium ya croscarmellose mu mazi ari byinshi kuruta ibyangiritse nka sodium carboxymethyl selulose isimbuwe na selile na microcrystalline selile.
Methyl selulose (MC) ni selile idafite ionic monoether ikozwe mu ipamba no mu biti binyuze muri alkalisation na methyl chloride etherification. Methyl selulose ifite amazi meza cyane kandi ihamye murwego rwa pH ya 2.0 kugeza 13.0. Ikoreshwa cyane mubikoresho bya farumasi, kandi ikoreshwa mubinini bya sublingual, inshinge zo mu nda, imyiteguro y'amaso, capsules yo mu kanwa, guhagarika umunwa, ibinini byo munwa hamwe nimyiteguro yibanze. Byongeye kandi, muburyo bwo kurekura-kurekura, MC irashobora gukoreshwa nka hydrophilique gel matrix ikomeza-gusohora, ibikoresho byo gutwika gastric-soluble, ibikoresho byo gupakira microcapsule bikomeza, ibikoresho bya firime yibiyobyabwenge, nibindi.
Hydroxypropyl methylcellulose (HPMC) ni selile ya ionic selulose ivanze ikozwe mu ipamba no mu biti binyuze muri alkalisation na etherifike ya oxyde ya propylene na methyl chloride. Ntabwo ari impumuro nziza, uburyohe, ntabwo ari uburozi, gushonga mumazi akonje, na geles mumazi ashyushye. Hydroxypropyl methylcellulose nubwoko bwa selile ivanze na ether yagiye yiyongera cyane mubikorwa, kubikoresha no mubwiza mumyaka 15 ishize. Ninimwe mu miti minini yimiti ikoreshwa mugihugu ndetse no mumahanga. Yakoreshejwe nkibikoresho bya farumasi imyaka igera kuri 50. Imyaka yamateka. Kugeza ubu, ikoreshwa rya HPMC rigaragarira cyane cyane mu bintu bitanu bikurikira:
Imwe ni nkuguhuza no gutandukana. HPMC nk'igitereko irashobora gutuma imiti yoroshye gutose, kandi irashobora kwaguka inshuro magana nyuma yo gufata amazi, bityo irashobora kunoza cyane gusesa cyangwa kurekura ibinini. HPMC ifite ububobere bukomeye, kandi irashobora kongera ububobere buke kandi igahindura ubworoherane bwibikoresho fatizo hamwe nibisobanuro byoroshye. HPMC ifite ubukonje buke irashobora gukoreshwa nkuguhuza no gutandukana, kandi HPMC ifite ubukonje bwinshi irashobora gukoreshwa gusa.
Icya kabiri, ikoreshwa nkibikoresho biramba kandi bigenzurwa byo gutegura umunwa. HPMC ni ibikoresho bisanzwe bikoreshwa na hydrogel matrike mugutegura-kurekura. HPMC yo mu rwego rwo hasi cyane (5 ～ 50mPa · s) irashobora gukoreshwa nkumuhuza, wongerera ubukana bwumukozi noguhagarika, hamwe na HPMC yo murwego rwohejuru rwinshi (4000 ～ 100000mPa · s) irashobora gukoreshwa mugutegura ibikoresho bivanze matrix ikomeza kurekura hamwe na tableti ya hydrophilique. HPMC irashobora gushonga mumazi ya gastrointestinal, ifite ibyiza byo kwikuramo neza, gutembera neza, imbaraga zikomeye zo gupakira ibiyobyabwenge nibiranga ibiyobyabwenge bitatewe na pH. Nibikoresho byingenzi bitwara hydrophilique muri sisitemu yo gutegura-kurekura kandi ikunze gukoreshwa nka materix ya hydrophilique gel hamwe nibikoresho byo gutwika bikomeza kurekurwa, kandi bigakoreshwa mumyiteguro ireremba ya gastrica hamwe nibikoresho bifasha imiti irekura.
Iya gatatu ni nkibikoresho byo gutwika firime.HPMCifite ibyiza byo gukora firime. Filime yakozwe nayo irasa, iragaragara, kandi irakomeye, kandi ntabwo byoroshye kuyikurikiza mugihe cyo kuyikora. By'umwihariko ku biyobyabwenge byoroshye gukurura ubuhehere kandi bidahindagurika, kubikoresha nk'urwego rwo kwigunga birashobora guteza imbere cyane ibiyobyabwenge kandi bikarinda Filime ihindura ibara. HPMC ifite ibisobanuro bitandukanye bya viscosity. Niba byatoranijwe neza, ubwiza nigaragara ryibinini bisize neza biruta ibindi bikoresho, kandi guhuriza hamwe ni 2% kugeza 10%.
Bane bikoreshwa nkibikoresho bya capsule. Mu myaka yashize, hamwe n’ibyorezo by’ibyorezo by’inyamaswa ku isi, ugereranije na gelatine capsules, capsules y’ibimera byahindutse umukunzi mushya w’inganda zikora imiti n’ibiribwa. Pfizer yakuye neza HPMC mubihingwa bisanzwe kandi itegura capsules yimboga za VcapTM. Ugereranije na gakondo ya gelatin hollow capsules, capsules yimboga zifite ibyiza byo guhuza n'imihindagurikire y'ikirere, nta ngaruka zo guhuza ibikorwa, no guhagarara neza. Igipimo cyo kurekura ibiyobyabwenge kirahagaze neza, kandi itandukaniro ryabantu ni rito. Nyuma yo gusenyuka mumubiri wumuntu, ntabwo yinjizwa kandi irashobora gusohoka. Yasohotse mu mubiri. Kubijyanye nuburyo bwo guhunika, nyuma y ibizamini byinshi, ntibishobora kuba byoroshye mu gihe cy’ubushyuhe buke, kandi imiterere y’igikonoshwa cya capsule iracyahagaze neza mu gihe cy’ubushyuhe bwinshi, kandi ibipimo bitandukanye bya capsules y’ibimera mu gihe cyo kubika bikabije ntabwo bigira ingaruka. Hamwe nogusobanukirwa kwabantu capsules yibihingwa no guhindura imyumvire yubuvuzi rusange mugihugu ndetse no hanze yarwo, isoko ryamasoko ya capsules iziyongera vuba.
Icya gatanu ni nkumukozi uhagarika. Gutegura ubwoko bwamazi yo guhagarika nuburyo bukoreshwa muburyo bwa clinique ya dosiye, ni uburyo bwo gukwirakwiza heterogeneous aho imiti ikomeye idashobora gukwirakwizwa ikwirakwizwa muburyo bwo gukwirakwiza amazi. Ihame rya sisitemu igena ubuziranenge bwimyiteguro yo guhagarika. HPMC ikomatanya irashobora kugabanya ubukana-bwamazi hagati yimiterere, kugabanya ingufu zubusa zubutaka bwibice bikomeye, kandi bigahindura sisitemu yo gukwirakwiza heterogeneous. Numukozi mwiza wo guhagarika. HPMC ikoreshwa nkibyimbye kumaso yijisho, hamwe nibirimo 0.45% kugeza 1.0%.
Hydroxypropyl selulose (HPC) ni selile idafite ionic selile ikozwe mu ipamba no mu biti binyuze muri alkalisation na propylene oxyde etherification. Ubusanzwe HPC irashobora gushonga mumazi ari munsi ya 40 ° C hamwe ninshi mumashanyarazi ya polar, kandi imikorere yayo ijyanye nibiri muri hydroxypropyl hamwe nurwego rwa polymerisation. HPC irashobora guhuzwa nibiyobyabwenge bitandukanye kandi ifite inertness nziza.
Hydroxypropyl selulose isimbuwe(L-HPC)ikoreshwa cyane nka tablet disintegrant na binder. Ibiranga ni: byoroshye gukanda no gukora, gukomera gukomeye, cyane cyane bigoye gukora, ibinini bya pulasitike kandi byoroshye, ongeraho L －HPC irashobora kunoza ubukana bwibinini hamwe nuburanga bwibigaragara, kandi birashobora kandi gutuma ibinini bisenyuka vuba, kuzamura ubwiza bwimbere bwikibaho, no kunoza ingaruka zo kuvura.
Hydroxypropyl selulose isimbuwe cyane (H-HPC) irashobora gukoreshwa nkigikoresho gihuza ibinini, granules na granules nziza murwego rwa farumasi. H-HPC ifite imiterere myiza yo gukora firime, kandi firime yavuyemo irakomeye kandi yoroheje, ishobora kugereranywa na plastike. Iyo uvanze nibindi bikoresho byo kurwanya anti-wet, imikorere ya firime irashobora kurushaho kunozwa, kandi ikoreshwa kenshi nkibikoresho byo gutwikira firime kubinini. H-HPC irashobora kandi gukoreshwa nkibikoresho bya matrix kugirango itegure matrix ikomeza-irekura ibinini, pellet irekura-isohoka hamwe na tableti ebyiri-ikomeza-kurekura.
Hydroxyethyl selulose (HEC) ni selile idafite ionic monoether ikozwe mu ipamba no mu biti binyuze muri alkalisation na etilene ya etilene. HEC ikoreshwa cyane cyane mubyimbye, ikingira colloidal, ikomatanya, ikwirakwiza, stabilisateur, umukozi uhagarika, umukozi ukora firime nibikoresho bisohora buhoro mubuvuzi. Irashobora gukoreshwa kuri emulisiyo, amavuta, nigitonyanga cyamaso kumiti yibanze. Amazi yo mu kanwa, ibinini bikomeye, capsules nubundi buryo bwa dosiye. Hydroxyethyl selulose yashyizwe muri Pharmacopoeia yo muri Amerika / Imiterere yigihugu ya Amerika na Pharmacopoeia yu Burayi.
Ethyl selulose (EC) nimwe mubikoreshwa cyane mumazi adashobora gushonga. EC ntabwo ari uburozi, butajegajega, budashonga mumazi, aside cyangwa alkaline, kandi bigashonga mumashanyarazi nka Ethanol na methanol. Imiti ikoreshwa cyane ni ivangwa rya toluene / Ethanol 4/1 (uburemere). EC ifite byinshi ikoresha mumyiteguro irekura-gusohora, kandi ikoreshwa cyane nkuwitwaza na microcapsules, gutwikira ibikoresho bikora firime, nibindi byimyiteguro irekura-isohoka, nka retarders tablet, adhesives, ibikoresho byo gutwikamo firime, nibindi. microcapsules; irashobora kandi gukoreshwa cyane nkibikoresho byabatwara Ikoreshwa mugutegura gutatana gukomeye; irashobora gukoreshwa cyane mubuhinga bwa farumasi nkibintu bikora firime hamwe nuburinzi, kandi birashobora no gukoreshwa nkibihuza kandi byuzuza. Nkigifuniko gikingira ibinini, kirashobora kugabanya ububobere bwibinini kubushuhe kandi bikarinda imiti guhinduka ibara no kwangirika nubushuhe; irashobora kandi gukora gahoro gahoro gahoro hamwe na microencapsulate polymer kugirango ikomeze irekure ingaruka zibiyobyabwenge.
Muri make, amazi ya elegitoronike ya sodium carboxymethyl selulose, methyl selulose, hydroxypropyl methyl selulose, hydroxypropyl selulose, hydroxyethyl selulose hamwe na etil selile yamavuta ya elegitoronike byose bishingiye kubintu byabo Ibiranga ibicuruzwa bikoreshwa mubikoresho bya farumasi bifata ibikoresho, bikomeza kandi bikagenzurwa. guhagarika abakozi. Urebye ku isi, amasosiyete menshi yo mu mahanga menshi (Shin-Etsu Ubuyapani, Dow Wolff na Ashland) yatahuye isoko rinini rya selile yimiti mu Bushinwa mu bihe biri imbere, kandi byongera umusaruro cyangwa kwibumbira hamwe, byongereye imbaraga muri uru rwego. Ishoramari muri porogaramu. Dow Wolff yatangaje ko izongera ibitekerezo byayo ku bijyanye n’ibikorwa, ibikenerwa n’ibikenerwa ku isoko ry’imiti y’imiti yo mu Bushinwa, kandi ubushakashatsi bwabyo bukoreshwa kandi bizihatira kwegera isoko. Ishami rya Wolff Cellulose ishami rya Dow Chemical na Colorcon Corporation yo muri Amerika ryashyizeho ihuriro rihoraho kandi rigenzurwa nogutegura kurekura kwisi yose. Ifite abakozi barenga 1200 mu mijyi 9, ibigo 15 by'imitungo na sosiyete 6 GMP. Inzobere mu bushakashatsi zitanga serivisi kubakiriya mu bihugu bigera ku 160. Ashland ifite ibirindiro by’ibicuruzwa i Beijing, Tianjin, Shanghai, Nanjing, Changzhou, Kunshan na Jiangmen, kandi yashora imari mu bigo bitatu by’ubushakashatsi by’ikoranabuhanga muri Shanghai na Nanjing.
Dukurikije imibare yaturutse ku rubuga rw’ishyirahamwe ry’Ubushinwa Cellulose, mu 2017, umusaruro w’imbere mu gihugu wa selulose ether wari toni 373.000 naho ibicuruzwa byari toni ibihumbi 360. Muri 2017, ingano nyayo yo kugurisha ionicCMCyari toni 234.000, yiyongereyeho 18,61% umwaka ushize, naho igurishwa rya CMC ritari ionic ryari toni 126.000, ryiyongera 8.2% umwaka ushize. Usibye HPMC (urwego rwibikoresho byo kubaka) ibicuruzwa bitari ionic,HPMC. Imikorere ya selile yo murugo ikura vuba mumyaka irenga icumi, kandi umusaruro wabaye uwambere kwisi. Nyamara, ibyinshi mubicuruzwa bya selulose ether bikoreshwa cyane cyane hagati no hepfo yinganda, kandi agaciro kiyongereye ntabwo kari hejuru.
Kugeza ubu, inganda nyinshi za selile zo mu rugo ziri mu bihe bikomeye byo guhinduka no kuzamura. Bakwiye gukomeza kongera ubushakashatsi ku bicuruzwa n’ibikorwa by’iterambere, bagahora bakungahaza ubwoko bw’ibicuruzwa, bagakoresha byimazeyo Ubushinwa, isoko rinini ku isi, kandi bakongera imbaraga mu guteza imbere amasoko y’amahanga kugira ngo ibigo bizashobore kwaguka vuba bishoboka. Uzuza impinduka no kuzamura, winjire hagati-hejuru-iherezo ryinganda, kandi ugere ku iterambere ryiza nicyatsi.
Igihe cyo kohereza: Apr-25-2024