Ama-Execipieetietical Exechients yi-Excipients kanye nama-adjuvants asetshenziswa ekukhiqizweni kwemithi nokwakha imiyalo, futhi kuyingxenye ebalulekile yamalungiselelo emithi. Njenge-polymer yemvelo ethathwe, i-cellulose ether inezimpawu ze-biodegradability, okungeyona ubuthi, nentengo ephansi, njenge-sodium carloxymethyllls celtuleose, hydroxypropyl methyl cellulose, hydroxypropyl methyl cellulose,I-Cellulose AfersNjengo-Hydroxyyethyl cellulose kanye ne-ethyl cellulose banenani elibalulekile lesicelo kuma-Excipietieticals. Njengamanje, imikhiqizo yamabhizinisi ama-ether amabhizinisi amaningi asekhaya asetshenziswa ikakhulukazi emasimini aphakathi nendawo aphansi embonini, nenani elingeziwe aliphezulu. Imboni idinga ukuguqula futhi ithuthukise futhi ithuthukise ukusetshenziswa okuphezulu kwemikhiqizo.
Ama-Execipieetieticals e-Pharmaceutical adlala indima ebalulekile ekuthuthukisweni nasekukhiqizweni kokwakheka. Isibonelo, kumalungiselelo wokukhulula okuqhubekayo, izinto ze-polymer ezinjenge-cellulose afesthers ezisetshenziselwa ama-pellets ezisuswayo, ukwakheka kwezidakamizwa okugciniwe, amafilimu okukhishwa kwezidakamizwa, nezidakamizwa zokukhipha izidakamizwa ezikhulelwe. Ukulungiselela kanye namalungiselelo wokukhulula okulondoloziwe asetshenziswe kabanzi. Kulesi simiso, ama-polymers anjenge-cellulose iziphotha ngokuvamile asetshenziswa njengezithwalweni zezidakamizwa ukulawula isilinganiso sokukhishwa komzimba emzimbeni womuntu ngaphakathi kwebanga lesikhathi esithile ukuze ufinyelele inhloso yokuthola injongo ethile.
Ngokwezibalo zoMnyango wokubonisana kanye nocwaningo, kunezinhlobo ezingaba ngu-500 ze-Excipients emakethe ezweni lami, kodwa uma kuqhathaniswa ne-United States (izinhlobo ezingaphezu kuka-15000) kanye nomehluko omkhulu, futhi izinhlobo zisencane. I-Executient yezwe lami lezemithi amathuba okuthuthukiswa kwemakethe makhulu. Kuyaqondakala ukuthi ama-excipie aphezulu amakhamikhali aphezulu emakethe yezwe lami ama-gelatin wezokwelapha we-gelatin, i-sucrose, isitashi, i-hydroxyprollylylylylylylylylylylylyllose methylcellulose (HPMC), kanye ne-microcrystalline fibers. Imifino, i-HPC, i-lactose.
"I-ether yemvelo yemvelo yigama elijwayelekile lochungechunge lwe-cellulose derivativeves ekhiqizwa ukusabela kwe-alkali cellulose kanye namaqembu athethelwa ngokuphelele emasimini athile, futhi athetheke izithako lapho amakhemikhali e-cellulose asetshenziswa kakhulu. Zonke izinkambu, imikhiqizo yebanga lemithi ngokuyisisekelo ezindaweni eziphakathi nendawo eziphakemeyo zomkhakha futhi inenani eliphakeme lezengezona. Kungashiwo ukuthi ikhwalithi yemikhiqizo ye-Cellulose Ether Interpreses. Yenza amaphilisi we-matrix akhishwe ngokuqhubekayo, izinto ezi-gangric ezingenazikhazi, ezisetshenziselwa izitolo zezinto ezigciniwe nge-microcapsapsule, izinto zokwakha izidakamizwa ezigciniwe, njll.
I-Sodium Carboxymethyl Cellulose (CMC-NE) yi-cellulose ether ngokukhipha okukhulu kakhulu kanye nokusetshenziswa ekhaya nakwamanye amazwe. Kuyinto i-ionic cellulose ether eyenziwe ngokotoni nangokhuni nge-alkalization kanye nokuthezeka nge-chlororoacetic acid. I-CMC-NA i-Execipieint evame ukusetshenziswa kwekhemisi. Imvamisa isetshenziswa njenge-binder yamalungiselelo aqinile futhi njengokuqina, ukuqina nokumisa i-ejenti ngamalungiselelo awuketshezi. Ingasetshenziswa futhi njenge-matrix ensolule yamanzi nezinto zokwakha amafilimu. Imvamisa isetshenziswa njengezinto ezisetshenziselwa izidakamizwa ezigcina izidakamizwa kanye nethebhulethi ye-matrix ekhishwa okuqhubekayo ezindaweni ezigcinwe (ezilawulwayo) zokukhishwa.
Ngaphezu kwe-sodium carboxyyl cellulose njenge-excipietics yezemithi, i-croscarnetsel sodium nayo ingasetshenziswa njenge-excipieticals yezemithi. I-carboxyboxylyl exhumene ne-crossboxylyl cellulose sodium (CCMC-NE) iyinto enamanzi ayi-callolubleyl cellulose aphendulwa nge-ejenti exhumanisayo endaweni ethile yokushisa (40-80 ° C) ngaphansi kwesenzo se-inorganic acid catalyst futhi ihlanzwe. Umenzeli we-Crosslinking angaba yi-PlyLyene Glycol, i-Succinic Anhydride, i-Anhydride ye-Anhydride, i-anipic anhydride, nokunye. I-CroscarMellose Sodium isetshenziswa njengokuqhekeka kwamathebulethi, amaphilisi kanye nama-granule kumalungiselelo omlomo. Ithembela emiphumeleni ye-capillary kanye nokuvuvukala ukufeza ukuhlukaniswa. Inokuxineka okuhle nokuqhekeka okunamandla. Ucwaningo luye lwabonisa ukuthi izinga lokuvuvukala le-croscarmellose sodium emanzini likhulu kunalezo ezijwayelekile ezinjenge-sodium callothesylyllylsylsylylsyl pultule
I-Methyl celtuleose (MC) iyi-moullebe ye-monno ngasekotini nokhuni nge-alkalization kanye ne-methyl chloride ukuhelika. I-methyl celtulose ine-solubility enhle kakhulu yamanzi futhi isitebelelo kuhlu lwe-pH lwe-2.0 kuya ku-13.0. Isetshenziswa kabanzi kumathebuli e-pharmaceutical, futhi isetshenziswa kumathebulethi angenayo, imijovo ye-intramuscular, amalungiselelo omlomo, ukumiswa komlomo, amaphilisi omlomo, amaphilisi omlomo namalungiselelo aphezulu. Ngaphezu kwalokho, ekwakhiweni okusetshenziselwa okuqhubekayo, i-MC ingasetshenziswa njenge-hydrophilic gel matrix esetshenziselwa ukukhishwa kwe-hydrophilic, indawo yokufaka ama-microcapsoluble, impahla yokupakisha ye-microcapsure eqhubekayo, impahla yefilimu yokukhishwa kwezidakamizwa, njll.
I-Hydroxypropyl Methylcellulose (HPMC) yi-ethelsose engekho i-ether ehlanganisiwe eyenziwe ngokotini nangokhuni nge-alkalization kanye nokuthezeka kwe-propylene oxide ne-methyl chloride. Kuyinto engenamphundla, engenambitha, ayinangozi, incibilika emanzini abandayo, nama-gels emanzini ashisayo. I-Hydroxypropyllykyl methylcellulose iyinhlangano exubile exubile eye yanda ngokushesha ekukhiqizweni, ukusetshenziswa kanye nekhwalithi eminyakeni eyi-15 edlule. Futhi kungenye ye-Exessient enkulu yezemithi esetshenziswa ekhaya nakwamanye amazwe. Kusetshenziswe njenge-Excipoint yezemithi cishe iminyaka engama-50. Iminyaka yomlando. Njengamanje, ukusetshenziswa kwe-HPMC kuboniswa ikakhulukazi kulezi zinto ezinhlanu ezilandelayo:
Eyokuqala injenge-binder nokuqhekeka. I-HPMC njenge-binder ingenza ukuthi umuthi ube lula ukumanzi, futhi ungakhulisa amakhulukhulu amahlandla ngemuva kokuthola amanzi, ngakho-ke kungathuthukisa kakhulu ukuchithwa noma ukukhishwa kwethebhulethi. I-HPMC inokubona okuqinile, futhi ingathuthukisa i-viscosity yezinhlayiyana futhi ithuthukise ukucindezelwa kwezinto zokusetshenziswa eziluhlaza ngoCrisp noma ukuthungwa okunzima. I-HPMC enokubonakala okuphansi ingasetshenziswa njenge-binder nokuqhekeka, ne-HPMC enokubonakala okuphezulu kungasetshenziswa kuphela njenge-binder.
Okwesibili, isetshenziswa njengezinto zokukhishwa eziqinile nezilawulwa zokulungiselela ngomlomo. I-HPMC iyinto evame ukusetshenziswa i-hydrogel matrix impahla kumalungiselelo wokukhulula okuqhubekayo. I-HPMC yebanga eliphansi le-viscosity (5 ~ 50MPA- s) lingasetshenziswa njenge-ejenti, ne-ejenti yokumisa i-ejenti, futhi i-HPMC yebanga eliphakeme lokugcina i-matrix (4000 ~ 100MPPAS) lingasetshenziswa ukulungiselela amaphilisi we-caplule nama-hydrophilic gel matrix anqunyelwe amaphilisi wokukhishwa. I-HPMC iyanyibilika ngoketshezi lwesisu, inezinzuzo zokuxineka okuhle, uketshezi oluhle, umthamo onamandla wokulayisha izidakamizwa kanye nezimpawu zokukhishwa kwezidakamizwa ezingathintwa yi-PH. Kuyinto ebaluleke kakhulu ye-hydrophilic carliers ezintweni ezinhlelweni zokulungiselela ukukhishwa futhi isetshenziswa kaningi njenge-hydrophilic gel matrix kanye nezinto zokugcina zokugcina okuqhubekayo, futhi kusetshenziswe amalungiselelo okugcwala kwezidakamizwa asuswayo.
Okwesithathu kunjenge-ejenti eyakha amafilimu.I-HPMCinezakhiwo ezinhle ezenziwe ngefilimu. Ifilimu eyakhiwa yi-IYIMIMTHOMELWE, Esobala, futhi inzima, futhi akulula ukunamathela ngesikhathi sokukhiqiza. Ikakhulu izidakamizwa ezilula ukudonsa umswakama futhi ungazinzile, uyisebenzise njengesendlalelo sezokwahlukaniswa ingathuthukisa kakhulu ukuqina kwesidakamizwa futhi ivikele amafilimu aguqula umbala. I-HPMC inezincazelo ezahlukahlukene ze-viscosity. Uma kukhethwe kahle, ikhwalithi nokubukeka kwamathebhulethi ahlanganisiwe kungcono kunezinye izinto, futhi okuhlushwa kwayo okujwayelekile kungu-2% kuya ku-10%.
Ezine zisetshenziswa njengezinto ze-capsule. Eminyakeni yamuva nje, ngokuqubuka okuvame ukuqubuka kwezifo zezilwane zomhlaba wonke, uma kuqhathaniswa namaphilisi we-gelatin, amaphilisi wezitshalo asephenduke ama-darling amasha emikhakha yezemithi nokudla. I-PFizer ikhishwe ngempumelelo i-HPMC kusuka ezitshalweni zemvelo kanye nama-vcaptm imifino yemifino elungiselelwe. Uma kuqhathaniswa nama-gelatin we-gelatin azwakalayo, ama-caplule yemifino anezinzuzo zokuvumelana okubanzi, akukho bungozi bokuphendula okuxhumanisayo, kanye nokuqina okuphezulu. Izinga lokukhishwa kwezidakamizwa lizinzile, futhi umehluko ngamunye mncane. Ngemuva kokuhlukaniswa emzimbeni womuntu, akumuzwanga futhi kungakhishwa i-epocret. Kukhishwe emzimbeni. Ngokuya kwezimo zokugcina, ngemuva kokuhlolwa okuningi, cishe akuwona ngaphansi kwezimo zomswakama ophansi, futhi izakhiwo ze-capsule Shell zisazinzile ngaphansi komswakama ophezulu, kanye nezinkomba ezahlukahlukene zezimo zezitshalo ezingathinteki. Ngokuqonda kwabantu ngamaphilisi wezitshalo kanye noguquko lwemiqondo yemithi yomphakathi ekhaya nakwamanye amazwe, isidingo semakethe sezindawo zezitshalo sizokhula ngokushesha.
Okwesihlanu kunjenge-ejenti esombile. Uhlobo lokumiswa kokulungiselela uketshezi luyindlela ejwayelekile esetshenziswa emtholampilo ye-delinical umthamo, okuyindlela yokuhlakazeka ye-heterogeneous lapho izidakamizwa eziqinile ze-soluble zihlakazwa ngendlela ehlukile yokuhlakazeka. Ukuqina kohlelo kunquma ikhwalithi yokumiswa koketshezi. I-HPMC Colloidal Solution inganciphisa ukungezwani okuqinile okukodwa, yehlisa amandla wamahhala wezinhlayiya eziqinile, futhi aqinise uhlelo lokuhlakazeka kwe-heterogeneous. Kungumenzeli omuhle kakhulu wokumisa. I-HPMC isetshenziswa njengesikhulu samaconsi wamehlo, ngokuqukethwe okungu-0.45% kuya ku-1.0%.
I-Hydroxypropyl Cellulose (HPC) iyi-celtulose engeyona eye-monother enziwe ngokotoni nangokhuni nge-alkalization kanye ne-propelene oxide ukusheshisa. I-HPC ivame ukuncibilika emanzini ngaphansi kwama-40 ° C nenani elikhulu le-polar solvents, futhi ukusebenza kwawo kuhlobene nokuqukethwe kwe-hydroxypropyl kanye nezinga le-polymerization. I-HPC ingahambelana nezidakamizwa ezahlukahlukene futhi inobudlova obuhle.
I-Hydroxyproproses ephansi ephansi(L-HPC)isetshenziswa ikakhulukazi njengethebhulethi ukuqhekeka kanye ne-binder. Izici zalo yilezi: Kulula ukucindezela nokwakha, ukusebenza okunamandla, ikakhulukazi ukukwenza, amatafula we-L -HPC angathuthukisa ubulukhuni bethebhulethi, futhi kungenza futhi ithebhulethi yethebhulethi, futhi inenze ikhwalithi yangaphakathi yethebhulethi, futhi ithuthukise umphumela owelashwa.
I-hydroxyproppropyllopyllopylls ephakeme (H-HPC) ingasetshenziswa njenge-ejenti ebophayo yamathebulethi, ama-granules kanye nemifino emihle emkhakheni wezemithi. I-H-HPC inezakhiwo ezinhle kakhulu zefilimu, futhi ifilimu eliphumayo linzima futhi linwebekile, elingaqhathaniswa namapulasitiki. Ngokuxubana nezinye izinhlanga ezilwa namanzi, ukusebenza kwefilimu kungathuthukiswa futhi, futhi kuvame ukusetshenziswa njengezinto ezihlanganayo zefilimu zamathebulethi. I-H-HPC ingaphinde isetshenziswe njengezinto ze-matrix ukulungiselela amaphilisi we-matrix wokukhishwa kwe-matrix, ama-pellets wokukhipha okuqhubekayo kanye namathebulethi akhethekile alengiswa kabili.
IHydroxYethyl Cellulose (I-HEC) iyinhlangano ye-moulsose engekho e-moneether eyenziwe ngokotoni nangokhuni nge-alkalization kanye ne-ethylene oxide ukusheshisa. I-HEC isetshenziswa ikakhulukazi njenge-reathener, i-ejenti evikelayo, enamathela, i-disphendis, i-stabilizer, ukumisa i-ejenti, umenzeli wefilimu, umenzeli wezokwelapha emkhakheni wezokwelapha. Ingasetshenziswa kuma-emulsions, ama-ointry, namaconsi eso emithini ye-topical. Uketshezi ngomlomo, amaphilisi aqinile, ama-caplule namanye amafomu dosage. I-Hydroxyyethyl celtulose ifakiwe e-US pharmacopoeia / i-US Litional National Activary and European Pharmacopoeia.
I-Ethyl Cellulose (EC) ingenye yezinto ezisetshenziswayo ezisetshenziswa kakhulu zama-cellulose zamanzi ezisetshenziswayo. I-EC ayinobuthi, izinzile, insoluble emanzi, acid noma i-alkaliotions, futhi incibilika ezinhlafunweni ze-organic njenge-ethanol ne-methanol. I-solvent esetshenziswa kakhulu yi-solvent exubile ye-toluene / ethanol 4/1 (isisindo). I-EC isebenzisa okuningi kumalungiselelo okukhishwa kwezidakamizwa, futhi isetshenziswa kabanzi njengenkampani yenethiwekhi kanye ne-microcapsops, njll. Kusetshenziswa amalungiselelo e-matrix, njengezinto ezihlanganisiwe zokulungiselela ukukhishwa kwamashephu agciniwe futhi Ama-pellets akhipha okuqhubekayo, njengezinto ezisetshenziswayo ezishukumisayo ukuze alungiselele ama-microcappules aphelelwe amandla; Kungasetshenziswa futhi kabanzi njengezinto zokwethulwa ezisetshenziselwa ukulungiselela ukuhlukaniswa okuqinile; Ingasetshenziswa kabanzi kubuchwepheshe bezemithi njengento eyakha amafilimu nokuzivikela, futhi nayo ingasetshenziswa njenge-binder ne-filler. Njengomhlanganisela wokuvikela amaphilisi, kunganciphisa ukuzwela kwamathebulethi anomswakama futhi kuvikele izidakamizwa ukuthi zingabikwa futhi ziwohloke ngomswakama; Kungakha futhi ungqimba lwe-glue olwalula kancane kanye ne-microancaps
Ngokufingqa, i-sodium carboxylyl lyrulelyl cellulose, i-hydroxyprosel methyl cellulose, i-hydroxypropyl cellulose, i-hydroxypypropyl cellulose, ama-ethroxypylyl celtule Okululula ngomlomo, ama-ejenti akha amafilimu, ama-capsule wokwenziwa kanye nama-ejenti okumisa. Uma ubheka umhlaba, izinkampani ezimbalwa zamazwe ahlukahlukene (iShin-Etsu Japan, dow Wolff kanye no-Ashff) zabona imakethe enkulu ye-cellulose yezemithi e-China ngokuzayo, futhi kuhlanganiswe ukukhiqizwa kwazo kulo mkhakha. Ukutshalwa kwezimali ngaphakathi kohlelo lokusebenza. UDow Wolff umemezele ukuthi uzokwandisa ukunaka kwawo ukwakhiwa, izithako kanye nezidingo zemakethe yokulungiselela amakhemisi yaseChina, futhi ucwaningo lwalo luzolwela ukusondela emakethe. I-Wolff Cellulose Divort ye-DOW Chexji Chemical and Colorical Corporation ye-United States isungule ukulungiswa okuqinile nokulawulwa kokukhishwa emhlabeni jikelele. Inabasebenzi abangaphezu kwe-1,200 emadolobheni ayi-9, izikhungo zempahla eziyi-15 nezinkampani eziyi-6 ze-GMP. Ochwepheshe bocwaningo osetshenzisiwe bahlinzeka ngezinsizakalo kumakhasimende emazweni acishe abe ngu-160. I-Ashland inezisekelo zokukhiqiza eBeijing, eTianjin, eShanghai, i-Nanjing, e-Changzhou, kunshan neJiangmen, futhi sezitshalile imali ezikhungweni ezintathu zocwaningo zobuchwepheshe eShanghai naseNanjing.
Ngokusho kwezibalo ezivela kuwebhusayithi yeChina Multulose Association, ngonyaka we-2017, ukukhiqizwa kwasekhaya kwe-cellulose ether kwakungamathani angama-373,000 kanye nevolumu yokuthengisa kwakungamathani ayizinkulungwane ezingama-360. Ngo-2017, umthamo wangempela wokuthengisa we-ionicCmKwakungamathani angama-234,000, kwanda ngo-18.61% ngonyaka, kanye nevolumu yokuthengisa ye-nonic CMC yayingamathani ayi-126,000, kwanda ngo-8.2% unyaka nonyaka. Ngaphezu kwe-HPMC (ibanga lezinto ezibonakalayo) Imikhiqizo engeyona eye-ionic,I-HPMC(Ibanga lezemithi), i-HPMC (ibanga lokudla), i-HEC, i-HPC, i-MC, i-hemc, njll. Yizo zonke zivuke ngenkani, futhi ukukhiqizwa kanye nokuthengisa sebeqhubekile. Izimpikiswano ze-cellulose ezifuywayo bezikhula ngokushesha iminyaka engaphezu kweyishumi, futhi okuphumayo sekuye kwaba ngumhlaba wokuqala. Kodwa-ke, iningi lemikhiqizo yezinkampani zeCellulose Ether zisetshenziswa ikakhulukazi emaphethelweni aphakathi nendawo aphansi embonini, nenani elingeziwe aliphezulu.
Njengamanje, iningi lamabhizinisi e-cellulose ether amabhizinisi asesikhathini esibucayi senguquko kanye nokwenza ngcono. Kufanele baqhubeke ukukhulisa ucwaningo lomkhiqizo kanye nemizamo yentuthuko, ngokuqhubekayo shushise izinhlobo zomkhiqizo, zisebenzise ngokugcwele iChina, imakethe enkulu kunazo zonke emhlabeni, futhi yandise imizamo yokuthuthukisa izimakethe zakwamanye amazwe ukuze amabhizinisi azokwazi ukunwebeka ngokushesha ngangokunokwenzeka. Qedela ukuguqulwa futhi uthuthukise, faka ukuphela okuphakathi kwemboni, futhi uzuze ukuthuthuka nokuthuthuka okuluhlaza.
Isikhathi sePosi: APR-25-2024