Ama-Execipieetietical Exechients yi-Excipients kanye izengezo ezisetshenziswa ekukhiqizweni kwemithi nemiyalelo, futhi kuyingxenye ebalulekile yamalungiselelo emithi. Njenge-polymer yemvelo ethathwe, i-cellulose ether iyi-biodebradable, ayinangozi, futhi eshibhile, efana ne-sodium calloxymelyl cellulose, i-hydroxypropyl cellulose, i-hydroxypropylllose, i-hydroxypropylllose, i-hydroxypropyl cellulose, i-hydroxypropylllose, i-hydroxypropyllles, i-ethylsose i-cellulose, i-ethylsose aphonsela isicelo, i-ethyl cellulose, i-ethylpulese Njengamanje, imikhiqizo yamabhizinisi ama-ether amabhizinisi amaningi asekhaya asetshenziswa ikakhulukazi emasimini aphakathi nendawo aphansi embonini, nenani elingeziwe aliphezulu. Imboni ngokuphuthumayo idinga ukuguqulwa kanye nokwenza ngcono ukuthuthukisa ukusetshenziswa okuphezulu kwemikhiqizo.
Amandla emakethe we-ExePients yezemithi makhulu
Ama-Execipieetieticals e-Pharmaceutical adlala indima ebalulekile ekuthuthukisweni nasekukhiqizweni kokwakheka. Isibonelo, kumalungiselelo wokukhulula okuqhubekayo, izinto ze-polymer ezinjenge-cellulose ether zisetshenziswa njenge-exteres ye-cellulose ephepheni ama-pellets asuswayo, amalungiselelo okukhishwa akhona, ama-caplules asetshenziselwa izidakamizwa, kanye nama-restin izidakamizwa amalungiselelo okukhishwa kwezidakamizwa. Ukulungiselela kanye namalungiselelo wokukhulula okulondoloziwe asetshenziswe kabanzi. Kulesi simiso, ama-polymers afana ne-cellulose ether ngokuvamile asetshenziswa njengezithwalweni zezidakamizwa ukulawula isilinganiso sokukhishwa kwezidakamizwa emzimbeni womuntu, okungukuthi, kuyadingeka ukukhulula kancane emzimbeni ngesilinganiso esithile sokuthola inhloso yokwelashwa okusebenzayo.
Ngokusho kwezibalo ezivela emnyangweni wokucwaninga nge-Zhiyan Consulting, kunezinhlobo ezingaba ngu-500 ze-Excipied ezibalwe ezweni lami, kodwa uma kuqhathaniswa ne-United States (izinhlobo ezingaphezu kuka-1,500) kanye ne-European Union (izinhlobo ezingaphezu kwezingu-3,000), kanti izinhlobo ezingaphezu kuka-3,000), futhi izinhlobo ezingaphezu kwezingu-3,000), futhi izinhlobo zisencane. Amandla okuthuthukisa imakethe makhulu. Kuyaqondakala ukuthi ama-excipie aphezulu amakhamishini aphezulu engosimu yezentengiso yezwe lami angamakhandlela we-gelatin amakhemisi, i-sucrose, isitashi, i-hvp, i-hvp, i-hvp, i-lactose cellulose yemifino, i-hpc, i-lactose.
Izindawo eziyisithupha ezenziwa ngemithi i-cellulose ether
I-Natural CelLose Ether yigama elijwayelekile lochungechunge lwe-cellulose derivatives ekhiqizwa ukusabela kwe-Alkali Cellulose kanye ne-ejenti ethembisa ngaphansi kwezimo ezithile. Kungumkhiqizo lapho amaqembu ama-hydroxyl kuma-cellulose macromolecule ngokwengxenye noma ngokungenamikhawulo afakwa esikhundleni ngokuphelele ngamaqembu ether. I-Cellulose Afers isetshenziswa kabanzi emikhakheni ye-petroleum, izinto zokwakha, ukumboza, ukudla, umuthi, kanye namakhemikhali nsuku zonke. Emikhakheni ehlukahlukene, imikhiqizo yebanga lemithi ngokuyisisekelo emasimini aphakathi nendawo aphezulu embonini embonini, enenani eliphakeme elingeziwe. Ngenxa yezidingo ezisezingeni elifanele, ukukhiqizwa kwe-ether yebanga lemithi futhi kunzima futhi. Kungashiwo ukuthi ikhwalithi yemikhiqizo yebanga lemithi ingamelela ngokuyisisekelo amandla obuchwepheshe amabhizinisi we-cellulose ether. I-Cellulose ETR ivame ukungezwa njenge-blocker, impahla ye-matrix kanye ne-matringer ukwenza amaphilisi we-matrix akhishwe ezindaweni, izinto ezisetshenziswayo ze-microcappule, izinto zokwakha izidakamizwa ezikhulelwe, njll.
Sodium carboxymethyl cellulose
I-Carboxymethyl Cellulose Sodium (CMC-NE) yi-cellulose ether ngokukhiqizwa okukhulu kakhulu 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, i-viscosity - ekhulayo, ukuqina nokumisa i-ejenti yokulungiselela uketshezi, futhi futhi ingasetshenziswa njenge-matrix esondelana ngamanzi nezinto zokwakha amafilimu. Imvamisa isetshenziswa njengezinto ezisetshenziselwa izidakamizwa ezisetshenziselwa izidakamizwa ezigciniwe kanye nethebhulethi ye-matrix ekhishwa ekugcineni (okulawulwa) ukukhulula amalungiselelo.
Ngokungeziwe ku-sodium carboxyyllose njenge-excipietical yekhamishini, i-croscarnetse sodium nayo ingasetshenziswa njenge-excipietical yekhambi. ICroscarmellose Sodium (CCMC-NE) ingumkhiqizo wamanzi we-carboxymethylcelcelceseose ephendula nge-ejenti elixhumanisayo endaweni ethile yokushisa (40-80 ° C) ngaphansi kwesenzo se-inorganic acid catalyst futhi ehlanziwe. Njengomenzeli we-crosslinking, i-plyylene glycol, i-succunic anhydride, i-anhydride ye-anhydride ne-anipic anhydride ingasetshenziswa. I-CroscarMellose Sodium isetshenziswa njengokuqhekeka kwamathebulethi, amaphilisi kanye nama-granule kumalungiselelo omlomo. Ithembela emiphumeleni ye-capillary kanye nokuvuvukala ukuze ihlukaniswe. Inokuxineka okuhle namandla okuqhekeka okuqinile. Ucwaningo selukhombisile ukuthi izinga lokuvuvukala le-croscarmellose sodium emanzini likhulu kunale elijwayelekile lokuhlakazeka njenge-calmelose eliphansi le-carmellose sodium kanye ne-hydrated microcrystaline celtulose.
Methylcellulose
I-Methyl Cellulose (MC) yi-nonic cellulose ye-cellulose eyodwa eyenziwe ngokotoni nangokhuni nge-alkalization kanye ne-methyl chloride ukuhelika. I-methylcellulose ine-solubility enhle kakhulu yamanzi futhi iqinile ebangeni le-PH2.0 ~ 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, kumalungiselelo wokukhulula okuqhubekayo, i-MC ingasetshenziswa njenge-hydrophilic gel matrix amalungiselelo okukhulula okususelwa esigabeni, izinto ezisetshenziswayo ze-microcapsapson coating, izinto zokwakha izidakamizwa ezikhulelwe, njll.
Hydroxypropylmethylcellellulose
I-Hydroxypropyl Methylcellulose (HPMC) yi-etherlilose engekho i-ether ethe xaxa eyenziwe kusuka kukotini nangokhuni nge-alkalization, i-propelene oxide kanye ne-methyl chloride ukuhelika. Kuyinto engenamphundla, engenambitha, ayinobuthi, incibilika emanzini abandayo futhi yagcwala emanzini ashisayo. I-Hydroxypropylm methylcellulose iyi-cellulose exutshwe ama-ether e-ether e-ether akhiqiza umkhiqizo wayo, umthamo kanye nekhwalithi yanda ngokushesha eChina eminyakeni eyi-15 edlule. Futhi kungenye ye-Exessient esetshenziswa kakhulu yezemithi ekhaya nakwamanye amazwe. iminyaka yomlando. Njengamanje, ukusetshenziswa kwe-HPMC kuboniswa ikakhulukazi kulezi zinto ezinhlanu ezilandelayo:
Eyokuqala injenge-binder nokuqhekeka. Njenge-binder, i-HPMC ingenza umuthi ube lula ukuba manzi, futhi ungakhulisa amakhulukhulu amahlandla ngemuva kokuthola amanzi, ngakho-ke kungathuthukisa kakhulu izinga lokuchitheka noma isilinganiso sokukhishwa kwethebhulethi. I-HPMC inokuvunywa okuqinile, okungakhulisa i-viscosity yezinhlayiyana futhi ithuthukise ukucindezelwa kwezinto zokusetshenziswa eziluhlaza nge-crisp noma i-brittle ukuthungwa. I-HPMC ene-viscosity ephansi ingasetshenziswa njenge-binder nokuqhekeka, futhi labo abanokubonakala okuphezulu bangasetshenziswa kuphela njenge-binder.
Okwesibili kunjengezinto zokukhishwa eziqinile nezilawulwayo zokulungiselela ngomlomo. I-HPMC iyinto evame ukusetshenziswa i-hydrogel matrix impahla kumalungiselelo wokukhulula okuqhubekayo. Ibanga eliphansi le-viscosisity (5-50mpa · s) lingasetshenziswa njenge-binder, i-viscosifier kanye ne-ejenti esomisayo, kanye nebanga eliphakeme (4000-100x000mpla) ukulungiselela amaphilisi okuvinjwa kwezinto ezihlanganisiwe zamaphilisi, amaphilisi wokukhishwa kwe-hydrophilic gel matrix. I-HPMC iyanyibilika ngoketshezi lwesisu, inezinzuzo zokuncipha okuhle, uketshezi oluhle, umthamo onamandla wokulayisha umuthi, kanye nezimpawu zokukhishwa kwezidakamizwa ezingathintwa yi-pH. Kuyinto ebaluleke kakhulu ye-hydrophilic ye-hydrophilic ohlelweni lokulungiselela ukukhishwa okugciniwe futhi ivame ukusetshenziswa njenge-hydrophilic gel matrix kanye nezinto zokulungiselela ukukhishwa kwezindawo, kanye nezinto zokulungiselela amafilimu asuselwa esitolo.
Okwesithathu kunjenge-ejenti eyakha amafilimu. I-HPMC inezakhiwo ezinhle ezakha amafilimu. Ifilimu eyakhiwa yi-It Univesirm, 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 kuphezulu kwezinye izinto. Ukuhlushwa okuvame ukusetshenziswa kungu-2% kuye ku-10%.
Okwesine kunjengezinto ze-capsule. Eminyakeni yamuva nje, ngokuqubuka okuvame ukuqubuka kwezifo zezilwane zomhlaba wonke, uma kuqhathaniswa nama-gelatin caplule, amaphilisi emifino asephenduke isithandwa esisha semikhakha yezemithi nokudla. I-PFizer ye-United States ikhiphe ngempumelelo i-HPMC ephumelele ezitshalweni zemvelo kanye nama-vcaptm imifino yemifino ye-vCAPTM. Uma kuqhathaniswa nama-gelatin we-gelatin anezinkomo eziyize, ama-caplule ezitshalo anezinzuzo zokuvumelana okubanzi, akukho bungozi bokuphendula okuxhumanisa ngokuwela kanye nokuqina okuphezulu. Izinga lokukhishwa kwezidakamizwa lizinzile, futhi umehluko ngamunye mncane. Ngemuva kokuhlukaniswa emzimbeni womuntu, akumuzwanga futhi kungakhishwa into into ikhishwa emzimbeni. Ngokuya kwezimo zokugcina, ngemuva kwenombolo enkulu yokuhlolwa, cishe akusona ngaphansi kwezimo zomswakama ophansi, futhi izakhiwo ze-capsule Shell zisazinza ngaphansi kwezimo zomswakama ophezulu, nezinkomba zezitshalo zezitshalo azithinteki ngaphansi kwezimo zokugcina ezedlulele. Ngokuqonda kwabantu ngamaphilisi wezitshalo kanye noguquko lwemiqondo yemithi yomphakathi ekhaya nakwamanye amazwe, isidingo semakethe sezindawo zezitshalo sizokhula ngokushesha.
Okwesihlanu kunjenge-ejenti esombile. Ukulungiswa kokulungiswa kohlobo lokumiswa kuyindlela evame ukusetshenziswa komtholampilo umthamo umthamo wemithambo, okuyisistimu yokuhlakazeka ye-heterogeneous lapho izidakamizwa eziqinile ze-infelluble zihlakazeka endaweni ehlukile yokuhlakazeka. Ukuqina kohlelo kunquma ikhwalithi yokulungiselela ukumiswa 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
I-Hydroxypropylllul (HPC) iyi-cellulose eyodwa engeyona eye-cellulose eyodwa eyenziwe ngokotini nangokhuni nge-alkalization kanye ne-propelene oxide ukusheshisa. I-HPC ivame ukuncibilika emanzini angaphansi kwama-40 ° C kanye nenani elikhulu le-solvents ye-polar, futhi ukusebenza kwawo kuhlobene nokuqukethwe kweHydroxypropp Group kanye ne-degree of polymerization. I-HPC ingahambelana nezidakamizwa ezahlukahlukene futhi ine-inertia enhle.
I-hydroxypropypropyllopyllopyllopylls ephansi (L-HPC) isetshenziswa ikakhulukazi njengethebhulethi ukuqhekeka kanye ne-binder. -HPC ingathuthukisa ubulukhuni nokukhanya kwethebhulethi, futhi kungenza futhi ukuthi ithebhulethi ihlukaniswe ngokushesha, ithuthukise ikhwalithi yangaphakathi yethebhulethi, futhi ithuthukise umphumela wokuvuselela amandla.
I-hydroxyproppropyllopyllopylls (H-HPC) ingasetshenziswa njenge-timets yamathebulethi, ama-granules, kanye nemifino emihle emkhakheni wezemithi. I-H-HPC inezakhiwo ezinhle kakhulu zefilimu, nefilimu etholakele inzima futhi i-elastic, engaqhathaniswa namapulasitiki. Ukusebenza kwefilimu kungathuthukiswa kakhulu ukuxubana namanye ama-agents amelana nomswakama-amelana nomswakama, futhi kuvame ukusetshenziswa njengezinto zokuhlangana 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
IHydroxYethyl Cellulose (HEC) yi-nonic cellulose eyodwa ether eyodwa eyenziwe ngokotoni nangokhuni nge-alkalization kanye nokuthezeka kwe-ethylene oxide. Emkhakheni wezokwelapha, i-HEC isetshenziswa ikakhulukazi njenge-reathener, i-ejenti evikelayo, enamathela, i-adfilizer, i-ejenti eyenziwe ngefilimu, futhi ingafakwa ku-ejenti eyenziwe ngefilimu, futhi ingafakwa ku-tablet eqinile, i-capsule kanye nezinye izinhlobo zamadosi. I-Hydroxyyethyl celtulose iqoshwe e-US pharmacopoeia / I-US National National Acramury kanye ne-European Pharmacopoeia, njll.
I-ethyl cellulose
I-Ethyl Cellulose (EC) ingenye yezinto ezisetshenziswayo ezisetshenziswa kakhulu zama-cellulose zamanzi ezisetshenziswayo. I-EC ayinobuthi, izinzile, insoluble kumanzi, i-acid noma i-alkali solution, futhi incibilikisa ezinhlafunweni ze-organic njenge-ethanol ne-methanol. I-solvent esetshenziswa kaningi iTolune / ethanol njenge-4/11 (isisindo) solvent exubile. I-EC isebenzisa okuningi kumalungiselelo wokukhulula izidakamizwa, asetshenziswe kabanzi njengabathwali, ama-microcapsops, kanye nezinto ezisetshenziswayo zethebhulethi ukulungiselela amalungiselelo asetshenzisiwe asetshenzisiwe, asetshenziswa ama-pellets ahlanganisiwe ukulungiselela ama-pellets asetshenzisiwe, asetshenziswa njenge Izinto zokusizakala ze-Eccopsetion Suixes ukulungiselela ama-microcappules aphelelwe amandla; Futhi kungasetshenziswa kabanzi njengezinto zokweqa zokulungiswa kwezinto eziqinile; Kusetshenziswe kabanzi kubuchwepheshe bezemithi njengento eyakha amafilimu kanye nokuzivikela okuvikelayo, kanye ne-binder ne-filler. Njengokumphakanyiswa kwethebhulethi, kunganciphisa ukuzwela kwethebhulethi kube umswakama futhi kuvikele isidakamizwa ukuthi sithintwe umswakama, ukuguquguquka nokuwohloka; Kungakha futhi ungqimba lwe-gel olude kancane, i-microancer the polymer, futhi inike amandla ukukhishwa okuqhubekayo komphumela wezidakamizwa.
Susa izinhlelo zokusebenza eziphansi okuphansi futhi usheshise ukuguqulwa kanye nokuthuthuka
Ngamafuphi, i-sodium carboxylllllls lyrulelyl cellulose, i-hydroxyprosel, i-hydroxypropyl methyl cellulose, i-hydroxypropyl cellulose, ama-hydroxypypropyl cellulose, ama-ethroxyylyl cellulose, ama-ethroxypylyl cellulose wonke asetshenziswa ama-ethysose asetshenziswayo wonke amalungiselelo omlomo, ukunamathela Ama-ejenti akha amafilimu, izinto zokwakha amakhompiyutha kanye nama-ejenti asolisayo. Ukubheka umhlaba, izinkampani ezihlukene zakwamanye amazwe (iShin-Etsu Japan, Dow Wolfe no-Ashland Cross Dragon) baye babona imakethe enkulu ye-cellulose yezemithi e-China ngokuzayo, noma ukuhlanganisa, futhi bandise imizamo yabo kulo mkhakha. ukufaka isicelo ngaphakathi. UWow Wolfe umemezele ukuthi kuzoqinisa ukugxila kwawo ekwakhekeni, izithako kanye nokufunwa kwemakethe yokulungiselela amakhemisi yaseChina, futhi ucwaningo lwalo olusetshenzisiwe luzolwela ukusondela emakethe. I-DOW Chexf Chelfliose Division kanye ne-Colorcon Corporation of I-United States isungule umfelandawonye wokwakheka okuqinile futhi olawulwayo emadolobheni angu-1, kubasebenzi abangu-6 wempahla, inani elikhulu lezinkampani zokucwaninga ezisetshenzisiwe zisebenza amaklayenti emazweni acishe abe ngu-160. I-Ashland inezisekelo zokukhiqiza eBeijing, eTianjin, eShanghai, i-Nanjing, e-Changzhou, kuKushan neJiangmen, futhi zitshalile imali ezikhungweni ezintathu zocwaningo eShanghai naseNanjing.
Ngokusho kwezibalo ezivela kuwebhusayithi yeChina Cellulose Association, ngonyaka we-2017, ukukhiqizwa kwasekhaya kwe-cellulose ether kwakungamathani angama-373,000, futhi ivolumu yokuthengisa lalingamathani angama-360,000. Ngo-2017, umthamo wangempela wokuthengisa we-Ionic CMC wawungamathani angama-234,000, kwandiswa ngonyaka we-18.61% ngonyaka, kanye nevolumu yokuthengisa ye-Nonic CMC yayingamathani angama-126,000, anyukayo ngonyaka ka-86%, ngonyaka. Ngaphezu kwe-HPMC (ibanga lezinto ezibonakalayo), imikhiqizo engeyona eye-ionic, i-HPMC (ibanga lemithi), i-HPMC (ibanga lokudla), i-HPC, i-HPC, i-MC, i-hemc, njll. I-ether yasekhaya ye-cellulose ikhule ngokushesha isikhathi esingaphezu kweminyaka eyishumi, kanti ukuphuma kwayo sekuyinto yokuqala emhlabeni. Kodwa-ke, imikhiqizo yezinkampani ze-ether ye-cellulose iningi isetshenziswa ikakhulukazi emasimini aphakathi nendawo aphansi embonini, nenani elingeziwe aliphezulu.
Njengamanje, iningi lamabhizinisi asekhaya le-cellulose ether isesikhathini esibucayi senguquko nokuthuthuka. Kufanele baqhubeke ukukhuphula imizamo yocwaningo lomkhiqizo kanye nemizamo yentuthuko, ngokuqhubekayo izinhlobo zomkhiqizo, zisebenzise ngokugcwele iChina, imakethe enkulu kunazo zonke emhlabeni, futhi yandise imizamo yokuthuthukisa izimakethe zakwamanye amazwe, futhi i-Enter-end Indm yemboni, futhi ifinyelele emkhakheni ophakathi nendawo.
Isikhathi sePosi: Jun-15-2023