Abancedisi bamachiza ngabancedisi kunye nabancedisi abasetyenziselwa ukuveliswa kwamayeza kunye nokuqulunqa imimiselo, kwaye bayinxalenye ebalulekileyo yamalungiselelo amayeza. Njengomathiriyeli wendalo owenziwe ngepolymer, i-cellulose ether ineempawu zokungaguquguquki, ukungabi natyhefu, kunye nexabiso eliphantsi, njenge-sodium carboxymethyl cellulose, i-methyl cellulose, i-hydroxypropyl methyl cellulose, i-hydroxypropyl cellulose,I-cellulose ethersezifana ne-hydroxyethyl cellulose kunye ne-ethyl cellulose zinexabiso elibalulekileyo lesicelo kwi-excipients zamayeza. Okwangoku, iimveliso zamashishini amaninzi e-cellulose ether asekhaya asetyenziswa kakhulu kwiindawo eziphakathi kunye nezisezantsi kwishishini, kwaye ixabiso elongezelelweyo alikho phezulu. Ishishini kufuneka litshintshe kwaye liphucule kwaye liphucule usetyenziso oluphezulu lweemveliso.
Abancedisi bamayeza badlala indima ebalulekileyo ekuphuhliseni nasekuveliseni imixube. Ngokomzekelo, kumalungiselelo okukhutshwa okuzinzileyo, izinto ze-polymer ezifana ne-cellulose ethers zisetyenziswa njenge-excipients zonyango kwiipellets zokukhululwa okuqhubekayo, i-matrix eyahlukeneyo yokukhutshwa kwe-formulation, i-coated-release-release formulations, i-capsules ekhutshwe ngokuqhubekayo, iifilimu zeziyobisi ezizinzileyo, kunye ne-release-release-release-release. Amalungiselelo kunye namalungiselelo okukhutshwa kolwelo oluzinzileyo asetyenziswe ngokubanzi. Kule nkqubo, ii-polymers ezifana ne-cellulose ethers zisetyenziswa ngokubanzi njengabathwali beziyobisi ukulawula izinga lokukhululwa kweziyobisi emzimbeni womntu, oko kukuthi, kufuneka zikhutshwe ngokukhawuleza emzimbeni ngesantya esimiselweyo ngaphakathi kwexesha elithile ukufezekisa injongo yonyango olusebenzayo.
Ngokweenkcukacha-manani zeSebe lezoNxibelelwano kunye noPhando, kukho malunga ne-500 yeentlobo ze-excipients kwimarike kwilizwe lam, kodwa xa kuthelekiswa ne-United States (ngaphezu kweentlobo ze-1500) kunye ne-European Union (ngaphezu kweentlobo ze-3000), kukho umahluko omkhulu, kwaye iindidi zisencinci. abaxhamli bamayeza belizwe lam Amandla ophuhliso lwemarike makhulu. Kuyaqondwa ukuba ii-excipients ezilishumi eziphezulu zamachiza kwisikali semarike yelizwe lam ziyi-capsules ze-gelatin yamayeza, i-sucrose, isitashi, i-fiber coating powder, i-1,2-propylene glycol, i-PVP, i-hydroxypropyl methylcellulose (HPMC), kunye ne-microcrystalline fibers. Vegetarian, HPC, lactose.
"I-ether ye-cellulose yendalo ligama eliqhelekileyo loluhlu lwee-cellulose derivatives eziveliswa yi-reaction ye-alkali cellulose kunye ne-etherifying agent phantsi kweemeko ezithile, kwaye imveliso apho amaqela e-hydroxyl kwi-cellulose macromolecule athathwe ngokuyinxenye okanye athathelwe indawo ngokupheleleyo ngamaqela e-ethers. I-ethers ye-cellulose isetyenziswa ngokubanzi kwimihla ngemihla, iikhemikhali zemihla ngemihla, iikhemikhali zemihla ngemihla, iikhemikhali zemichiza kunye ne-petroleum yokutya. amasimi, iimveliso ezikumgangatho ophakathi kunye nesiphelo esiphezulu soshishino kwaye zinexabiso eliphezulu elongezelelweyo Ngenxa yeemfuno ezingqongqo zomgangatho, ukuveliswa kwe-ethers ye-cellulose ye-pharmacy-grade nayo inzima kakhulu iipilisi ze-matrix ezikhutshwa ngokuzinzileyo, izinto zokugquma i-gastric-soluble, izinto zokupakisha ze-microcapsule ezizinzileyo, izixhobo zefilimu ezikhutshwa ngokuzinzileyo, njl.
I-sodium carboxymethyl cellulose (CMC-Na) yi-ether ye-cellulose enemveliso enkulu kunye nokusetyenziswa ekhaya nakwamanye amazwe. Yi-ionic cellulose ether eyenziwe kwikotoni kunye nemithi ngokusebenzisa i-alkalization kunye ne-etherification nge-chloroacetic acid. I-CMC-Na sisixhobo esixhaphakileyo sokwenza amayeza. Ihlala isetyenziswa njengesibophelelo kumalungiselelo aqinileyo kwaye njenge-ejenti yokuqina, ukujiya kunye nokuxhoma kumalungiselelo olwelo. Inokusetyenziswa kwakhona njenge-matrix enyibilikayo yamanzi kunye nefilimu yokwenza ifilimu. Ihlala isetyenziswa njengesixhobo sefilimu yeziyobisi esizinzileyo kunye nethebhulethi ye-matrix ekhutshiweyo ngokuqhubekayo (elawulwayo) ekukhululweni kweefomyula.
Ukongeza kwi-sodium carboxymethyl cellulose njengabancedisi bamayeza, i-croscarmellose sodium inokusetyenziswa njengabancedisi bamayeza. I-Cross-linked carboxymethyl cellulose sodium (i-CCMC-Na) yinto engenamanzi enokuthi i-carboxymethyl cellulose iphendule kunye ne-agent edibeneyo kwiqondo lokushisa elithile (40-80 ° C) phantsi kwesenzo se-inorganic acid catalyst kwaye ihlanjululwe. I-agent ye-crosslinking ingaba yipropylene glycol, i-succinic anhydride, i-anhydride ye-maleic, i-anhydride ye-adipic, kunye nokunye okunjalo. I-Croscarmellose sodium isetyenziswe njenge-disintegrant kwiipilisi, ii-capsules kunye ne-granules kumalungiselelo omlomo. Ixhomekeke kwi-capillary kunye nemiphumo yokudumba ukuphumeza ukuhlukana. Inoxinzelelo oluhle kunye nokuqhekeka okuqinileyo. Uphononongo lubonise ukuba idigri yokudumba ye-croscarmellose yesodium emanzini inkulu kuneyo ye-disintegrants eqhelekileyo efana ne-low-substituted sodium carboxymethyl cellulose kunye ne-hydrated microcrystalline cellulose.
I-Methyl cellulose (MC) yi-non-ionic cellulose monoether eyenziwe ngekotoni kunye nemithi ngokusebenzisa i-alkalization kunye ne-methyl chloride etherification. I-Methyl cellulose ine-solubility egqwesileyo yamanzi kwaye izinzile kuluhlu lwe-pH lwe-2.0 ukuya kwi-13.0. Isetyenziswa ngokubanzi kwii-excipients zamachiza, kwaye isetyenziswe kwiipilisi ezingaphantsi kweelwimi, ii-injection ze-intramuscular, amalungiselelo ophthalmic, ii-capsules zomlomo, ukumiswa komlomo, iipilisi zomlomo kunye namalungiselelo e-topical. Ukongezelela, ekuqulunqweni kokukhutshwa okuzinzileyo, i-MC ingasetyenziselwa njenge-hydrophilic gel matrix eqhubekayo yokukhutshwa, i-gastric-soluble coating material, i-microcapsule yokupakisha i-microcapsule eqhubekayo, i-release-release-release drug film film, njl.
IHydroxypropyl methylcellulose (HPMC) yi-cellulose engeyoyo-ionic exutywe ne-ether eyenziwe kwikotoni kunye nemithi ngokusebenzisa i-alkalization kunye ne-etherification yepropylene oxide kunye ne-methyl chloride. Ayinavumba, ayinancasa, ayinatyhefu, iyanyibilika emanzini abandayo, kunye neejeli emanzini ashushu. IHydroxypropyl methylcellulose luhlobo lwe-cellulose exutywe ne-ether eye yanda ngokukhawuleza kwimveliso, ukusetyenziswa kunye nomgangatho kwiminyaka eyi-15 edlulileyo. Ikwayenye yezona zinto zinceda kakhulu kumayeza asetyenziswa ekhaya naphesheya. Isetyenziswe njengesixhobo sokwenza amayeza phantse iminyaka engama-50. Iminyaka yembali. Okwangoku, ukusetyenziswa kwe-HPMC kubonakaliswa ikakhulu kule miba mihlanu ilandelayo:
Enye ifana nesibophelelo kunye ne-disintegrant. I-HPMC njenge-binder ingenza ukuba ichiza libe lula ukumanzisa, kwaye linokwandisa amaxesha amaninzi emva kokufunxa amanzi, ngoko kunokuphucula kakhulu ukuchithwa okanye ukukhululwa kwethebhulethi. I-HPMC ine-viscosity eyomeleleyo, kwaye inokwandisa i-viscosity yamasuntswana kwaye iphucule ukunyanzeliswa kwezinto ezikrwada kunye ne-crisp okanye i-hard texture. I-HPMC ene-viscosity ephantsi ingasetyenziswa njenge-binder kunye ne-disintegrant, kunye ne-HPMC ene-viscosity ephezulu ingasetyenziswa kuphela njenge-binder.
Okwesibini, isetyenziswe njengento eqhubekayo kunye nelawulwayo yokukhululwa kumalungiselelo omlomo. I-HPMC sisixhobo esisetyenziswa ngokuqhelekileyo se-hydrogel ye-matrix kumalungiselelo okukhululwa okuqhubekayo. I-HPMC yomgangatho we-viscosity ephantsi (5～50mPa·s) ingasetyenziswa njenge-binder, i-viscosity eyonyusa i-arhente kunye ne-arhente exhomayo, kunye ne-HPMC yomgangatho ophezulu we-viscosity (4000～100000mPa·s) ingasetyenziselwa ukulungisa imathiriyeli exutyiweyo ye-matrix kunye ne-blocker-release tablets kunye ne-capsule ezinzileyo ye-hydrophilic tablets iipilisi ezikhutshwa ngokuqhubekayo. I-HPMC iyanyibilika kulwelo lwesisu, ineengenelo zokucinezeleka kakuhle, ukuqukuqela okulungileyo, umthamo oqinileyo wokulayisha ichiza kunye neempawu zokukhutshwa kweziyobisi ezingachatshazelwa yi-pH. Yimathiriyeli ethwala i-hydrophilic ebaluleke kakhulu kwiinkqubo zokulungiselela ukukhutshwa okuzinzileyo kwaye ihlala isetyenziswa njenge-hydrophilic gel matrix kunye nemathiriyeli yokugquma yamalungiselelo okukhutshwa okuzinzileyo, kwaye isetyenziswa kumalungiselelo okudada kwesisu kunye nokukhutshwa okuzinzileyo kwembrane yeziyobisi encedisayo.
Eyesithathu ifana ne-ejenti yokufaka ifilimu.HPMCineempawu ezilungileyo zokwenza ifilim. Ifilimu eyenziwe yiyo ifanayo, icacile, kwaye inzima, kwaye akulula ukubambelela ngexesha lemveliso. Ngokukodwa kumachiza alula ukufunxa umswakama kwaye angazinzanga, ukuwusebenzisa njengomaleko wokuzihlukanisa unokuphucula kakhulu ukuzinza kweyeza kunye nokuthintela Ifilimu iguqula umbala. I-HPMC ineentlobo ngeentlobo zenkcazo ye-viscosity. Ukuba ikhethwe ngokufanelekileyo, umgangatho kunye nokubonakala kweepilisi ezifakwe emanzini zingcono kunezinye izinto, kwaye ukugxilwa kwayo okuqhelekileyo ku-2% ukuya kwi-10%.
Isine sisetyenziswa njengesixhobo se-capsule. Kwiminyaka yakutshanje, ngokuqhambuka rhoqo kwezifo zezilwanyana zehlabathi, xa kuthelekiswa neecapsules zegelatin, iicapsules zezityalo ziye zaba yeyona nto intsha kumashishini amayeza kunye nokutya. I-Pfizer ikhuphe ngempumelelo i-HPMC kwizityalo zendalo kwaye ilungiselele ii-capsules zemifuno ye-VcapTM. Xa kuthelekiswa ne-gelatin yemveli yee-capsules ezingenanto, i-capsules yemifuno ineenzuzo zokuguquguquka okubanzi, akukho mngcipheko we-cross-linking reaction, kunye nokuzinza okuphezulu. Izinga lokukhutshwa kwechiza lizinzile, kwaye ukungafani komntu ngamnye kuncinci. Emva kokuqhekeka emzimbeni womntu, awufuntshwa kwaye unokukhutshwa. Ikhutshwe emzimbeni. Ngokumalunga neemeko zokugcina, emva kovavanyo oluninzi, luphantse lungabikho phantsi kweemeko zomswakama ophantsi, kwaye iipropathi zegobolondo ye-capsule zisazinzile phantsi komswakama ophezulu, kwaye izalathisi ezahlukahlukeneyo zeepilisi zezityalo phantsi kweemeko zokugcina ezigqithiseleyo azichaphazeleki. Ngokuqondwa kwabantu ngee-capsules zezityalo kunye nokuguqulwa kweengqikelelo zamayeza oluntu ekhaya nakwamanye amazwe, imfuno yentengiso yee-capsules zezityalo iya kukhula ngokukhawuleza.
Eyesihlanu injenge-arhente exhomayo. Ukulungiswa kolwelo lodidi olumisiweyo luhlobo lwedosi yekliniki esetyenziswa ngokuqhelekileyo, eyinkqubo yokusasazwa okungafaniyo apho amachiza aqinileyo angenakunyibilika asasazwe kwindawo yolwelo lokusasazwa. Ukuzinza kwenkqubo kumisela umgangatho wamalungiselelo olwelo lokumiswa. Isisombululo se-HPMC se-colloidal sinokunciphisa ukuxinana kwe-slid-liquid interfacial, ukunciphisa umphezulu wamandla wamahhala wamasuntswana aqinileyo, kunye nokuzinzisa inkqubo yokusasazwa kwe-heterogeneous. Yeyona arhente ibalaseleyo yokuxhoma. I-HPMC isetyenziswa njenge-thickener ye-eye drops, kunye nomxholo we-0.45% ukuya kwi-1.0%.
I-Hydroxypropyl cellulose (HPC) yi-non-ionic cellulose monoether eyenziwe kumqhaphu kunye nemithi ngokusebenzisa i-alkalization kunye ne-propylene oxide etherification. I-HPC idla ngokunyibilika emanzini angaphantsi kwe-40 ° C kunye nenani elikhulu le-solvents ye-polar, kwaye ukusebenza kwayo kuhambelana nomxholo we-hydroxypropyl kunye neqondo le-polymerization. I-HPC inokuhambelana neziyobisi ezahlukeneyo kwaye ine-inertness elungileyo.
Iselulosi yehydroxypropyl efakwe endaweni ephantsi(L-HPC)isetyenziswa ikakhulu njenge tablet disintegrant kunye nesibophelelo. Iimpawu zayo zezi: kulula ukucofa kunye nefom, ukusetyenziswa okunamandla, ngokukodwa kunzima ukwenza, iplastiki kunye neepilisi ezinqabileyo, zongeza i-L - HPC inokuphucula ubunzima bethebhulethi kunye nokukhanya kwembonakalo, kwaye inokwenza ukuba ithebhulethi idibanise ngokukhawuleza, iphucule umgangatho wangaphakathi wethebhulethi, kwaye iphucule umphumo wonyango.
I-high substituted hydroxypropyl cellulose (H-HPC) ingasetyenziswa njenge-agent ebophelelayo kwiipilisi, iigranules kunye ne-fine granules kwintsimi yamachiza. I-H-HPC ineempawu ezibalaseleyo zokwenza ifilimu, kwaye ifilimu ephumela kuyo inzima kwaye i-elastic, enokuthelekiswa ne-plasticizers. Ngokuxuba kunye nezinye i-anti-wet-coating agents, ukusebenza kwefilimu kunokuphuculwa ngakumbi, kwaye isetyenziswa rhoqo njengento yokugqoka ifilimu kwiipilisi. I-H-HPC inokusetyenziswa njengesixhobo se-matrix ukulungiselela iipilisi ezikhutshwa ngokuqhubekayo ze-matrix, iipellets ezikhutshwa ngokuqhubekayo kunye neepilisi zokukhululwa okuphindwe kabini.
I-Hydroxyethyl cellulose (HEC) yi-non-ionic cellulose monoether eyenziwe ngekotoni kunye nemithi ngokusebenzisa i-alkalization kunye ne-ethylene oxide etherification. I-HEC isetyenziswa kakhulu njenge-thickener, i-agent ekhuselayo ye-colloidal, i-adhesive, i-dispersant, i-stabilizer, i-agent yokumisa, i-agent-forming agent kunye ne-slow-release-release material in the field medical. Inokuthi isetyenziswe kwi-emulsions, i-ointments, kunye ne-eye drops kwiyeza eliqhelekileyo. Ulwelo lomlomo, iipilisi eziqinileyo, iicapsules kunye nezinye iifom zedosi. I-Hydroxyethyl cellulose ifakwe kwi-US Pharmacopoeia / i-US National Formulary kunye ne-European Pharmacopoeia.
I-Ethyl cellulose (EC) yenye yezona zinto zisetyenziswa kakhulu kwi-cellulose engenamanzi. I-EC ayinayo ityhefu, izinzile, ayinyibiliki emanzini, i-asidi okanye izisombululo ze-alkaline, kwaye zinyibilika kwii-solvents eziphilayo ezifana ne-ethanol kunye ne-methanol. I-solvent esetyenziswa ngokuqhelekileyo yi-solvent edibeneyo ye-toluene / i-ethanol 4/1 (ubunzima). I-EC ineendlela ezininzi zokusetyenziswa kumalungiselelo okukhululwa kweziyobisi, kwaye isetyenziswa ngokubanzi njenge-carrier kunye ne-microcapsules, i-coating film-forming materials, njl njl. yamalungiselelo okukhululwa okuqhubekayo, njenge-tablet retarders, i-adhesives, izinto zokugquma ifilimu, njl. iipellets ezizinzileyo, njengento encedisayo ye-encapsulation ukulungiselela ukukhutshwa okuqhubekayo kwe-microcapsules; inokusetyenziswa ngokubanzi njengento yokuthwala Isetyenziselwa ukulungisa i-dispersions eqinile; inokusetyenziswa ngokubanzi kwitheknoloji yonyango njengento yokwenza ifilimu kunye nokukhusela okukhuselekileyo, kwaye ingasetyenziselwa njenge-binder kunye ne-filler. Njengengubo ekhuselayo yeepilisi, inokunciphisa uvakalelo lwamacwecwe kumswakama kwaye ithintele amayeza ukuba angabi nombala kwaye abonakaliswe ngumswakama; inokwenza umaleko weglue ocothayo kunye ne-microencapsulate i-polymer ukukhulula ngokuqhubekayo umphumo weziyobisi.
Isishwankathelo, i-sodium carboxymethyl cellulose enyibilikayo emanzini, i-methyl cellulose, i-hydroxypropyl methyl cellulose, i-hydroxypropyl cellulose, i-hydroxyethyl cellulose kunye ne-oyile e-soluble ethyl cellulose zonke zisekwe ngokwazo. amalungiselelo, ukugquma ii-agent ezenza ifilimu, izixhobo ze-capsule kunye nee-agent zokumisa. Ukujonga ihlabathi, iinkampani ezininzi zamazwe ngamazwe (Shin-Etsu Japan, Dow Wolff kunye ne-Ashland) zaqaphela imarike enkulu ye-cellulose yamayeza e-China kwixesha elizayo, kwaye mhlawumbi imveliso eyandisiweyo okanye ukudibanisa, baye bandisa ubukho babo kule ntsimi. Utyalo-mali kwisicelo. U-Dow Wolff ubhengeze ukuba iya kwandisa ingqalelo ekuqulunqweni, izithako kunye neemfuno zemarike yokulungiselela amayeza aseTshayina, kwaye uphando lwayo lwesicelo luya kuzama ukusondela kwimarike. ICandelo leWolff Cellulose yeDow Chemical kunye neColorcon Corporation yase-United States iseke umanyano lolungiselelo oluzinzileyo nolulawulwayo kwihlabathi liphela. Inabasebenzi abangaphezu kwe-1,200 kwiidolophu ze-9, amaziko e-asethi angama-15 kunye neenkampani ze-6 GMP. Iingcali zophando ezisetyenziswayo zibonelela ngeenkonzo kubathengi kumazwe amalunga ne-160. I-Ashland ineziseko zokuvelisa eBeijing, eTianjin, eShanghai, eNanjing, eChangzhou, eKunshan naseJiangmen, kwaye ityale imali kumaziko amathathu ophando lweteknoloji eShanghai naseNanjing.
Ngokwezibalo ezivela kwiwebhusayithi ye-China Cellulose Association, kwi-2017, imveliso yasekhaya ye-cellulose ether yayiyi-373,000 yeetoni kwaye umthamo wokuthengisa wawungama-360 amawaka eetoni. Kwi-2017, umthamo wangempela wokuthengisa we-ionicCMCkwaba 234,000 iitoni, ukwanda 18.61% unyaka-on-unyaka, kunye umthamo yokuthengisa non-ionic CMC kwaba 126,000 iitoni, ukwanda 8.2% unyaka nonyaka. Ukongeza kwi-HPMC (ibakala lezinto zokwakha) iimveliso ezingezo-ionic,HPMC(ibakala lamachiza), i-HPMC (ibakala lokutya), i-HEC, i-HPC, i-MC, i-HEMC, njl.njl zonke ziye zavuka ngokuchasene nomkhwa, kwaye imveliso kunye nokuthengisa kuye kwaqhubeka ukwanda. Ii-ether ze-cellulose zasekhaya bezikhula ngokukhawuleza ngaphezu kweminyaka elishumi, kwaye imveliso iye yaba yeyokuqala ehlabathini. Nangona kunjalo, uninzi lweemveliso zeenkampani ze-cellulose ether zisetyenziswa kakhulu phakathi kunye nesiphelo esisezantsi soshishino, kwaye ixabiso elongezelelweyo alikho phezulu.
Okwangoku, uninzi lwamashishini e-cellulose ether asekhaya akwixesha elibalulekileyo lenguqu kunye nokuphuculwa. Bafanele baqhubeke nokwandisa uphando lwemveliso kunye neenzame zophuhliso, ngokuqhubekayo betyebisa iintlobo zemveliso, basebenzise ngokupheleleyo i-China, imarike enkulu yehlabathi, kunye nokwandisa iinzame zokuphuhlisa iimarike zangaphandle ukuze amashishini akwazi ukwandisa ngokukhawuleza. Gqibezela inguqu kunye nokuphucula, faka phakathi ukuya phezulu ekupheleni kweshishini, kwaye ufezekise uphuhliso oluhle kunye nohlaza.
Ixesha lokuposa: Apr-25-2024