Kungani i-cellulose ether isetshenziswa kabanzi e-Exessietient yezemithi?

Ama-Exencietical Axepients yi-Excipients kanye nama-adjungccts asetshenziswa ekukhiqizweni nasekusakazweni kwezidakamizwa, futhi kuyingxenye ebalulekile yamalungiselelo emithi. Cellulose ether as derived from natural polymer material, has the characteristics of biodegradable, nontoxic, cheap, such as sodium carboxymethyl cellulose, methyl cellulose, hydroxypropyl methyl cellulose, hydroxypropyl cellulose, ethyl cellulose and hydroxyethyl cellulose, cellulose ether has important application value in the pharmaceutical excipients. Njengamanje, iningi lemikhiqizo yamabhizinisi asekhaya le-cellulose ether amabhizinisi asetshenziswa kakhulu emkhakheni ophansi, inani elingeziwe aliphezulu, imboni inesidingo esiphuthumayo soshintsho nokuthuthuka, ukuthuthukisa ukusetshenziswa okuphezulu kwemikhiqizo.

Amandla wemakethe wezemithi e-Execcipents alungile

Ama-Execipieetietieutical Exessients adlala indima ebalulekile ekwakhiweni nasekukhiqizweni kokulungiselela amakhambi. Isibonelo, kumalungiselelo wokukhulula okuqhubekayo, i-cellulose ether nezinye izinto ze-polymer njengoba kusetshenziswa ama-pellets okukhishwa okuqhubekayo, ama-caplule asetshenziselwa ukukhishwa, ama-restained-film amalungiselelo wokukhulula izidakamizwa, amalungiselelo wokukhulula izidakamizwa. Kulesi simiso, i-cellulose ether namanye ama-polymers ngokuvamile asetshenziswa njengomphathi wezidakamizwa ukulawula isilinganiso sokukhishwa komzimba emzimbeni womuntu ngaphakathi kwebanga lesikhathi esithile ukuze uzuze inhloso ethile yokwelashwa okusebenzayo.

Ngokwezibalo zikaZhiyan Consulting kanye noMnyango Wezokucwaninga, iChina ifakwe kuhlu lwezinhlobo ze-Excipients, kepha uma iqhathaniswa ne-United States (izinhlobo ezingaphezu kuka-1500), igebe elingaphezu kwe-European Exescients Development COUNGSORY MARIPS MALE. Kuyaqondakala ukuthi ama-excipietie aphezulu amakhamishini aphezulu eMakethe yaseChina ama-gelatin we-gelatin, i-sucrose, isitashi, i-glycol ye-glycol, i-PVP, i-hydroxyprollylylylylylylylylylylylylylylylylylyll methyl cellulose (HPMC), i-Microcrystalline Cellulose, i-HPC, i-lactose.

Isithuphaizinhlobo zeI-Cellulose Etherphakathi kwa-Ama-Excipie athi Amakhemikhali

I-Natural CelLose Ether yi-Alkali Cellulose kanye ne-ejenti yokuthembela ngaphansi kwezimo ezithile zokusabela ukukhiqiza uchungechunge lwezinto ezifuywayo ze-cellulose, i-cellulose macromolecule hydroxyl gerivatives, i-cellulose macromolecule hydroxyl gerivatives, i-cellulose macromolecule Hydroxyl Group, itholakala ngokuphelele ngomkhiqizo. I-Cellulose Ether isetshenziswa kabanzi e-petroleum, izinto zokwakha, ukumboza, umuthi, umuthi kanye namakhemikhali, kuyo yonke imikhakha, kuyo yonke imikhakha, kuyo yonke imikhakha, kuyo yonke imikhakha, kuyo yonke imikhakha, kuyo yonke imikhakha yemboni ephezulu. Ngenxa yezidingo ezisezingeni elifanele, ukukhiqizwa kwebanga le-cellulose ether kubuye kube nzima ngokwengeziwe, kungashiwo ukuthi ikhwalithi yemikhiqizo yebanga lemithi ingamelela amandla ezobuchwepheshe amabhizinisi we-cellulose ether. I-Cellulose Ether ivame ukusetshenziswa njenge-blocker, izinto zamathambo kanye ne-viscosifier ukwengeza ithebhulethi ye-Skeleton yokukhishwa kwe-Skeleton, esiswini sokulula, ukukhishwa kwe-microcapsapleful impahla, izinto zokufaka izidakamizwa ezisetshenziselwa izidakamizwa.

Sodium carboxymethyl cellulose

I-Sodium Carboxymethyl Cellulose (CMC-NE) isivuno esikhulu kunazo zonke kanye nemithamo yezinhlobonhlobo ze-cellulose ether ekhaya nakwamanye amazwe, zenziwa ngokotini, i-chlororoacetic acid ukusheshisa nezinye izinqubo ezenziwe nge-ionic cellulose ether. I-CMC-NA uhlobo lwe-Execipietient evamile yezemithi, esetshenziswa kakhulu njengezinamathela amalungiselelo aqinile nezinto ezibonakalayo, ukuqina kanye nokumiswa kwezidingo zokumiswa kwama-matrix wamanzi kanye nama-matrix wefilimu. Ngokukhulula okuhamba kancane (okulawulwa) ukukhulula, kuvame ukusetshenziswa njengezinto zomenzeli wefilimu wezidakamizwa zokukhipha kancane kanye namaphilisi wokuluma wokukhishwa kancane.

Ngaphezu kwe-sodium carboxyyl cellulose njenge-excipietietics yezemithi, i-sodium carboxyyl cellulose esetshenzisiwe nayo ingasetshenziswa njenge-excipieticals yezemithi. I-Carsedbox motorboxylyl cellulose (CCMC-NE) iyinto ehlanzekile yokuhlanza amanzi e-carboxymetyl celtulose aphendule nge-ejenti yokuwela endaweni yokushisa okungu-40 ~ 80 ℃) ngaphansi kwesenzo se-inorganic acid catalyst. Umenzeli we-Crosslinking angaba yi-PlyLene Glycol, i-SucCinic Anhydride, i-Anhydride ye-Anhydride ne-Adipic Anyhydride. I-carsonink carboxyboxylllls celtulose isetshenziswa njenge-ejenti ehlukanisayo yamathebulethi, amaphilisi kanye nama-granules kumalungiselelo omlomo, ukuthembela ku-capillary nokuvuvukala ukuze kube nomphumela wokuqhekeka, ukuncipha kwawo okuhle, amandla aqine. Ucwaningo lukhombisile ukuthi izinga lokuvuvukala le-sodium carboxyboxlyl celtulose enkulu emanzini likhulu kune-sodium callothed pulsose kanye nama-microcrystaline we-microcrystaline we-cellulose kanye namanye ama-ejenti ajwayelekile.

Methyl cellulose

I-Methyl Cellulose (MC) iyi-ether eyodwa ye-angerlic cellulose eyenziwe kusuka kukotoni nasezinkuni nge-alkalization, chloromethane ukusheshisa nezinye izinqubo. I-methyl celtulose ine-solubility enhle kakhulu yamanzi futhi iqinile kuhlu lwe-pH lwe-2.0 ~ 13.0. Isetshenziswa kabanzi kumathebuli emithi, amaphilisi angenayo, imijovo ye-intramuscular, amalungiselelo omlomo, ukumiswa komlomo, amaphilisi omlomo, amaphilisi omlomo kanye namathebulethi endawo. Ngaphezu kwalokho, i-MC ingahle isetshenziswe njengokulungiselela i-hydrophilic gel ukulungiselela okulondoloziwe, izinto ezisetshenziswayo ze-stric soluble coating impahla, impahla esetshenziselwa izidakamizwa ezikhulelwe izidakamizwa, njll.

Hydroxypropyl methyl cellulose

I-Hydroxypropylm methyl celtule Kuyinto engenamphundla, engenambitha futhi ayinobuthi, incibilika emanzini abandayo kanye ne-gelatinous emanzini ashisayo. I-Hydroxypropyllylylylylyllose isivuno sasekhaya, umthamo kanye nekhwalithi ye-etherle Okwamanje, uhlelo lwe-HPMC lubonakala ikakhulu kulezi zinto ezinhlanu ezilandelayo:

Eyokuqala injenge-ejenti yokuqhekeka. I-HPMC njenge-binder ingenza umuthi ube lula kumanzi, futhi amanzi alo angakhulisa amakhulu amahlandla, ngakho-ke kungathuthukisa kakhulu ukuchithwa noma ukukhishwa kwamathebulethi. I-HPMC inokuvunywa okuqinile, ngoba ukuthungwa kwezinto zokwenziwa eziluhlaza ezinogqozi noma ze-brittle kanzima kungathuthukisa ukuqonda kwayo kwezinhlayiyana, ukuthuthukisa ukuzungeza kwayo. I-HPMC ephansi ye-viscosity ingasetshenziswa njenge-binder ne-ejenti ehlukanisayo, ukubonakala okuphezulu kuphela njenge-binder.

Okwesibili kunjengezinto zokukhishwa ezihamba kancane nezilawulwayo zokulungiselela ngomlomo. I-HPMC iyinto esetshenziselwa uhlaka lwe-hydrogel evame ukusetshenziswa kumalungiselelo wokukhulula okuqhubekayo. I-HPMC eneleveli ephansi ye-viscosity (5 ~ 50MPAI) ingasetshenziswa njenge-adhesive, adhesive-ukuthuthukisa usizo, ngenkathi i-HPMC enesilinganiso esiphakeme sokulungiswa kokulungiswa kwezinto ezihlanganisiwe amaphibhethekisi. I-HPMC ingachithwa ku-gastric Exery Fluid, inezinzuzo zokungconga kahle, amandla aqinile okulayisha izidakamizwa kanye nezimpawu zokukhishwa kwezidakamizwa azithinteki ngokulungiswa kwe-hydrophilic okulondoloziwe, futhi kusetshenziswa i-ejenti yokuthengisa izidakamizwa esetshenzisiwe, umenzeli wefilimu oshubile ama-Excipients.

Okwesithathu, njengefilimu ehlanganayo - kwakha i-ejenti. I-HPMC inefilimu enhle yakha, yakha umfaniswano wefilimu, esobala, okunzima, ukukhiqizwa akulula ukunamathela, ikakhulukazi ukumuncwa wonke umswakama, izidakamizwa ezingazinzile, nazo njengoba ungqimba lokuzihlukanisa kungakuthuthukisa kakhulu ukuqina kwezidakamizwa, ukuvimbela ukuguquguquka kwamafilimu. I-HPMC inezincazelo ezahlukahlukene ze-viscosity, njengokukhethwa kahle, ikhwalithi yefilimu ehlanganisiwe, ukubukeka kungcono kunezinye izinto, ukugxila kwayo okuvame ukusetshenziswa kwe-2% ~ 10%.

Okwesine kunjenge-capsule capsule impahla. Eminyakeni yamuva nje, ngokuqubuka njalo kwesifo sobhubhane sezilwane emhlabeni wonke, uma kuqhathaniswa namaphilisi we-gelatin, amaphilisi wezitshalo asephenduke isithandwa esisha somkhakha wezemithi nokudla. I-PFizer ikhiphe ngempumelelo i-HPMC ye-HPMC kusuka ezitshalweni zemvelo kanye nezitshalo ezilungiselelwe ze-VCAPPM. Uma kuqhathaniswa namaphilisi we-gelatin wendabuko azwakalayo, ama-caplule wezitshalo anezinzuzo zokuvumelana okubanzi, akukho bungozi bokuphendula oxhumanisa ngokuxhumanisa nokuqina okuphezulu. Izinga lokukhishwa kwezidakamizwa lizinzile, umehluko ngamunye umncane, futhi azange amunwe ngemuva kokuqhekeka emzimbeni womuntu, futhi angakhishwa emzimbeni ngendle. Ngokuya kwezimo zokugcina, ngenombolo enkulu yezivivinyo, ama-caplule cishe awatholakali ngaphansi kwemibandela yomswakama ephansi, futhi izakhiwo zamakhompiyutha zisazinzile ngaphansi kwezimo zomswakama ophezulu, futhi izinkomba zezitshalo zezitshalo azithinteki ngaphansi kwezimo zokugcina ngokweqile. Ngokuqonda kwabantu ngamaphilisi wesitshalo, kanye nokushintshwa komqondo wezidakamizwa zomphakathi ekhaya nakwamanye amazwe, ukufunwa kwemakethe kwezindawo zokutshala izitshalo kuzokhula ngokushesha.

Ezinhlanu zinjenge-ejenti yokumiswa. Amalungiselelo angutshani amisiwe asetshenziswa kakhulu kumafomu wemitholazo yemitholampilo, okuyizinhlelo zokuhlakazwa ze-heterogeneous zezidakamizwa eziqinile eziqinile ku-liquid Dispersion Media. Ukuqina kohlelo kunquma ikhwalithi yokulungiswa kokulungiswa okususiwe. Isixazululo se-COLLOADCAL ye-HPMC singanciphisa ukungezwani okuqinile okuwuketshezi, ukunciphisa amandla wamahhala wezinhlayiya eziqinile, ukuze uhlelo lokuhlakazeka oluhle kakhulu luvame ukubanzile, i-ejenti enhle yokumiswa kahle. I-HPMC isetshenziswa njengoMkhulu wamaconsi wamehlo, futhi okuqukethwe kungu-0.45% ~ 1.0%.

I-Hydroxypropyl cellulose

I-Hydroxypropylllul (HPC) iyi-ether eyodwa ye-angerlic cellulose eyenziwe ngokotoni nangokhuni nge-alkalization, i-propelene oxide ukusheshisa nezinye izinqubo. I-HPC ivame ukuncibilika emanzini ngaphansi kwama-40 ℃ kanye nenani elikhulu lama-sol sol sol. Izakhiwo zayo zihlobene nokuqukethwe kwe-hydroxypropyl kanye degree of polymerization. I-HPC ingahambelana nezidakamizwa ezahlukahlukene futhi ine-inertia enhle.

I-Hydroxyproppropyllopyllopyllopyllopyls ephansi (L - HPC) ikakhulukazi yethebhulethi ehlukanisayo kanye nokunamathela, izici zayo yilezi: Kulula ukucindezela ubulukhuni, ukuhlanganisa ukugqama kwefilimu, nokuqhakambisa ukugqashuka kwefilimu, futhi kuthuthukise ikhwalithi yefilimu, futhi uthuthukise umphumela ovuthayo.

I-hydroxyproppropyllocyllopyllopyllopylls (H-HPC) ingasetshenziswa njenge-binder yethebhulethi, ugogo kanye nogogo omuhle enkundleni yemithi. I-H-HPC inempahla enhle kakhulu yefilimu eyakha impahla, ifilimu etholakele inzima futhi i-elastic, futhi ingaqhathaniswa nesesitholi. Ngokuxubana namanye ama-ejenti we-anti-mingiphu e-coating, ukusebenza kwefilimu kungathuthukiswa futhi, futhi kuvame ukusetshenziswa njengezinto zokuhlanganisa amafilimu zamathebulethi. I-H-HPC nayo ingahle isetshenziswe njengezinto zohlaka ukuze kulungiswe uhlaka lwamathebhulethi okukhishwa okuqhubekayo, ama-pellets wokukhipha okugciniwe kanye namathebulethi ongezandelelo owesilisa ohambile.

IHydroxYethyl Cellulose

IHydroxYethyl Cellulose (I-HEC) iyi-ether eyodwa ye-cellulose ye-nonionic eyenziwe kusuka kukotoni nezinkuni nge-alkalization, ethylene oxide ukusheshisa nezinye izinqubo. I-HEC isetshenziswa ikakhulukazi njenge-reatriner, i-ejenti evikelayo, enamathela, i-distrilizer, i-stabilizer, i-ejenti yokumiswa, amafilimu akhipha umenzeli nezinto zokukhishwa kwezokwelapha emkhakheni wezokwelapha. Ingasetshenziswa emamugqeni wezidakamizwa endawo, ama-ointry, amaconsi wamehlo, uketshezi lomlomo, amaphilisi aqinile, amaphilisi namanye amafomu dosage. I-Hydroxyyethyl celtulose ifakiwe e-United States PharmacopoEia / United States I-National Ormulary ne-European pharmacopoeia.

I-ethyl cellulose

I-Ethyl Cellulose (EC) ingenye yezinto ezisetshenziswayo ezisetshenziswa kakhulu zama-cellulose zamanzi ezisetshenziswayo. I-EC ayinobuthi futhi iqinile, insoluble emanzi, acid noma izixazululo ze-alkali, incibilike e-ethanol, i-methanol nakwezinye izixazululo ze-organic. Izixazululo ezijwayelekile ziyi-tolune / ethanol mixtures of 4/1 ngesisindo. I-EC isebenzisa okuningi ekwakhekeni kwezidakamizwa okulawulwa izidakamizwa, isetshenziswe kabanzi njengenkampani ye-adrolled ekhishwe kanye nezinto ezihlanganisiwe, ezisetshenziswa njengephilisi elihlanganisiwe lilungiselela ipilisi elincane, esetshenziswa njengokufakwa kwezinto zokulungiswa kwe ukukhulula kancane i-micro capsule; Ingasetshenziswa kabanzi njengezinto ezithwala izinto zokulungiselela ukuhlakazeka okuqinile. Isetshenziswa kabanzi kubuchwepheshe bezemithi njengefilimu eyakhayo into kanye nokuzivikela okuhlobana, kanye ne-binder ne-filler. Njengokumphakanyiswa okuvikelayo kwamathebulethi, kunganciphisa ukuzwela kwamathebulethi kuye kumswakama futhi kuvikele izidakamizwa ukuthi zithintwe kumanzi nodonga. Kungakha futhi ungqimba olunamathela kancane kancane futhi luhlanganise i-polymer ngama-microcapsops, ukuze umphumela wezidakamizwa ungakhishwa ngokuqhubekayo.

Sizosusa maphakathi nezezicelo eziphakathi nendawo - kanye nokuphela kokuphela kanye nokusheshisa ukuguqulwa kanye nokuthuthuka

Ukufingqa, i-sodium carboxyllylls lyruleyl, i-hydroxyprosel, i-hydroxypropyl methyl cellulose, i-hydroxypropyl cellulose, amafomethi omlomo, amalungiselelo omlomo, amalungiselelo omlomo, amafomu e-capsule capsule kanye nosizo olumisiwe isetshenziswe kuma-excipietieutieticals. Ukubheka umhlaba, izinkampani ezimbalwa zamazwe ahlukahlukene (iJapan Shin-Etsu, i-United States Dow Wolf and Ashland) ibona imakethe enkulu ye-cellulose yezemithi e-China ngokuzayo, noma ukuhlanganisa, ikhulise ukutshala imali kwesicelo kule nkambu. UDow umemezele ukuthi uzokhuphula ukugxila kwawo ekwakhiweni, izithako kanye nezidingo zemakethe yezemithi yaseChina, kanye nemizamo yawo yokuletha ucwaningo oluseduze nasemakethe. Ukwahlukaniswa kwe-cellulose kaDow's noColorcon sekusungule umfelandawonye wembulunga yonke yezindlela zokukhishwa ezilawulwayo, ezinabasebenzi abangaphezu kwe-1,200 emadolobheni ayi-9, izikhungo zempahla eziyi-15 nezinkampani ezi-6 ze-GMP, kanye nenani elikhulu labasebenzi bokucwaninga abasebenza ngamakhasimende cishe namazwe angama-160 asebenza ngamakhasimende acishe abe ngamazwe ayi-160. I-Ashland inezindawo zokukhiqiza eBeijing, eTianjin, eShanghai, eNanjing, e-Changzhou, kuKushan noJiangmen, futhi zitshalile imali ezikhungweni ezintathu zocwaningo zobuchwepheshe eShanghai naseNanjing.

Ngokusho kwewebhusayithi yeChina Cellulose Ether Association, ngonyaka we-2017, ukuphuma kwasekhaya kwe-cellulose ether kwakungamathani angama-373,000, futhi ivolumu yokuthengisa lalingamathani angama-360,000. Ngo-2017, ivolumu yokuthengisa yangempela ye-Ionic CMC yayingamathani angama-234,000, up 18.61% unyaka ngonyaka, nokuthi i-CMC engeyona eye-Ionic yayingamathani ayi-126,000, up 8.2% unyaka ngonyaka. Imikhiqizo engeyona eye-ionic ngaphezu kwe-HPMC (I-HPMC (I-Pharmaceutical), i-HPMC (ukudla), i-HPC I-ether yasekhaya ye-Cellulose ikhule ngokushesha iminyaka engaphezu kweshumi, okuphumayo sekuyinto yokuqala yomhlaba, kepha iningi lemikhiqizo yamabhizinisi we-cellulose ether asetshenziswa kakhulu emkhakheni ophansi, inani elingeziwe aliphezulu.

I-Cellulose Ether Enterprise ehlukahlukene ekhaya nakwamanye amazwe, ikakhulukazi esinqumweni esibucayi soshintsho nokuthuthuka, kufanele iqhubeke nokuqinisa ukuthuthukiswa komkhiqizo, yenza umsebenzi wokuthuthukisa izinguquko kanye nokwenza ngcono endle kakhulu, qaphela kakhulu emkhakheni wezomboni, qaphela kakhulu emkhakheni wezomboni, qaphela ukuthuthuka nokuthuthuka okuluhlaza.