Ihe ndị na-emepụta ọgwụ bụ ihe ndị na-emepụta ọgwụ na ndị na-emepụta ọgwụ na-emepụta ọgwụ na-emepụta ọgwụ, ma bụrụ akụkụ dị mkpa nke nkwadebe ọgwụ. Dị ka ihe sitere na polymer eke sitere n'okike, cellulose ether nwere njirimara nke biodegradability, enweghị nsi, na ọnụ ala dị ala, dị ka sodium carboxymethyl cellulose, methyl cellulose, hydroxypropyl methyl cellulose, hydroxypropyl cellulose,Cellulose ethersdị ka hydroxyethyl cellulose na ethyl cellulose nwere mkpa ngwa uru na ọgwụ excipients. Ka ọ dị ugbu a, a na-ejikarị ngwaahịa nke ọtụtụ ụlọ ọrụ cellulose ether eme ihe na mpaghara etiti na nke dị ala nke ụlọ ọrụ ahụ, uru agbakwunyere adịghịkwa elu. Ụlọ ọrụ ahụ chọrọ ngwa ngwa gbanwee ma kwalite ma melite ngwa ngwa dị elu nke ngwaahịa.
Ndị na-emepụta ọgwụ na-arụ ọrụ dị mkpa na mmepe na mmepụta nke usoro. Dịka ọmụmaatụ, n'ime nkwadebe ntọhapụ na-adịgide adịgide, a na-eji ihe polymer dị ka cellulose ethers mee ihe dị ka ihe na-emepụta ọgwụ na pellets na-adịgide adịgide, ihe dị iche iche matrix kwadoro-mwepụta ihe, usoro ntọhapụ na-adịgide adịgide, capsules na-adịgide adịgide, ihe nkiri ọgwụ na-adịgide adịgide, na nkwụsịtụ ọgwụ. Nkwadebe na nkwadebe ntọhapụ nke mmiri mmiri ejirila ọtụtụ ebe. N'ime usoro a, a na-ejikarị polymers dị ka cellulose ethers eme ihe dị ka ndị na-ebu ọgwụ iji chịkwaa ntọhapụ nke ọgwụ na ahụ mmadụ, ya bụ, a na-achọ ka ha jiri nwayọọ nwayọọ na-ahapụ n'ime ahụ na ọnụ ọgụgụ a setịpụrụ n'ime oge ụfọdụ iji nweta nzube nke ọgwụgwọ dị irè.
Dị ka ọnụ ọgụgụ nke Consulting na Research Department, e nwere banyere 500 ụdị excipients na ahịa na mba m, ma e jiri ya tụnyere United States (karịa 1500 ụdị) na European Union (karịa 3000 ụdị), e nwere nnukwu ọdịiche, na ụdị ka dị obere. ihe mgbakwunye ọgwụ nke obodo m nwere ike mmepe nke ahịa ahụ buru ibu. Aghọtara na ihe iri kachasị n'ọgwụ ọgwụ n'ahịa ahịa obodo m bụ ọgwụ gelatin capsules, sucrose, starch, ntụ ntụ mkpuchi ihe nkiri, 1,2-propylene glycol, PVP, hydroxypropyl methylcellulose (HPMC), na eriri microcrystalline. Onye anaghị eri anụ, HPC, lactose.
"Natural cellulose ether bụ n'ozuzu okwu maka usoro nke cellulose mmepụta nke mmepụta nke mmeghachi omume nke alkali cellulose na etherifying gị n'ụlọnga n'okpuru ụfọdụ ọnọdụ, na bụ ngwaahịa na nke hydroxyl iche iche na cellulose macromolecule na- partially ma ọ bụ kpamkpam dochie ether otu. Cellulose ethers na-ọtụtụ ebe na-eji n'ubi nke mmanụ ala, ọgwụ na-emepụta ihe kwa ụbọchị, ọgwụ na-emepụta ihe, ụlọ ọgwụ na ubi, ihe oriri kwa ụbọchị. Pharmaceutical-ọkwa ngwaahịa bụ ihu ọma na n'etiti na elu-ọgwụgwụ ebe nke ụlọ ọrụ na nwere elu kwukwara uru N'ihi siri àgwà chọrọ, mmepụta nke ọgwụ-ọkwa cellulose ethers bụkwa dịtụ ike Mbadamba ụrọ matriks na-ahapụ akwadoro, ihe mkpuchi afọ na-soluble, ihe nkwakọ ngwaahịa microcapsule na-adịgide adịgide, ihe nkiri ihe nkiri ọgwụ na-adịgide adịgide, wdg.
Sodium carboxymethyl cellulose (CMC-Na) bụ cellulose ether nwere nnukwu mmepụta na oriri n'ụlọ na ná mba ọzọ. Ọ bụ ether cellulose ionic nke sitere na owu na osisi sitere na alkalization na etherification na chloroacetic acid. CMC-Na bụ ihe mgbakwunye ọgwụ na-ejikarị eme ihe. A na-ejikarị ya eme ihe dị ka ihe nkedo maka nkwadebe siri ike yana dị ka ihe na-eme ka ọ sie ike, na-eme ka ọ dị arọ na onye na-akwụsịtụ maka nkwadebe mmiri mmiri. A pụkwara iji ya mee ihe dị ka matriks na-edozi mmiri na ihe na-emepụta ihe nkiri. A na-ejikarị ya dị ka ihe nkiri ihe nkiri ọgwụ akwadoro na mbadamba matriks ntọhapụ n'ụdị ntọhapụ akwadoro (achịkwa).
Na mgbakwunye na sodium carboxymethyl cellulose dị ka ọgwụ excipients, croscarmellose sodium nwekwara ike iji dị ka ọgwụ excipients. Carboxymethyl cellulose sodium (CCMC-Na) na-ejikọta cross-linked bụ ihe na-adịghị edozi mmiri nke carboxymethyl cellulose na-emeghachi omume na onye na-ejikọta ya na otu okpomọkụ (40-80 ° C) n'okpuru ọrụ nke inorganic acid catalyst ma dị ọcha. Ihe na-emekọrịta ihe nwere ike ịbụ propylene glycol, succinic anhydride, maleic anhydride, adipic anhydride na ihe ndị ọzọ. A na-eji Croscarmellose sodium mee ihe dị ka ihe na-emebi emebi maka mbadamba nkume, capsules na granules na nkwadebe ọnụ. Ọ na-adabere na capillary na mmetụta ọzịza iji nweta mgbasa. Ọ nwere ezigbo mkpakọ na mgbawa siri ike. Nnyocha e mere egosiwo na ogo ọzịza nke croscarmellose sodium n'ime mmiri dị ukwuu karịa nke ndị na-agbasasịkarị dị ka sodium carboxymethyl cellulose na-anọchi ala na microcrystalline cellulose hydrated.
Methyl cellulose (MC) bụ ihe na-abụghị ionic cellulose monoether nke sitere na owu na osisi site na alkalization na methyl chloride etherification. Methyl cellulose nwere ọmarịcha mmiri solubility ma kwụsie ike na pH nke 2.0 ruo 13.0. A na-eji ya n'ọtụtụ ebe na ihe ndị na-emepụta ọgwụ, a na-ejikwa ya na mbadamba sublingual, injections intramuscular, nkwadebe ophthalmic, capsules ọnụ, nkwụsị ọnụ, mbadamba ọnụ na nkwadebe n'elu. Na mgbakwunye, na usoro ntọhapụ na-adịgide adịgide, enwere ike iji MC mee ihe dị ka hydrophilic gel matrix na-akwado mwepụta, ihe mkpuchi gastric-soluble, ihe nkwakọ ngwaahịa microcapsule na-adịgide adịgide, ihe ihe nkiri ọgwụ na-adịgide adịgide, wdg.
Hydroxypropyl methylcellulose (HPMC) bụ ether na-abụghị ionic cellulose agwakọta nke sitere na owu na osisi site na alkalization na etherification nke propylene oxide na methyl chloride. Ọ na-esighị ísì, enweghị ụtọ, adịghị egbu egbu, na-agbaze na mmiri oyi, na gels na mmiri ọkụ. Hydroxypropyl methylcellulose bụ cellulose agwakọta ether iche iche nke na-amụba ngwa ngwa na mmepụta, oriri na ịdịmma n'ime afọ 15 gara aga. Ọ bụkwa otu n'ime akụrụngwa ọgwụ kachasị ukwuu eji n'ụlọ na mba ofesi. A na-eji ya dị ka ihe mgbakwunye ọgwụ ihe fọrọ nke nta ka ọ bụrụ afọ 50. Afọ akụkọ ihe mere eme. Ugbu a, ngwa nke HPMC na-egosipụtakarị n'akụkụ ise ndị a:
Otu dị ka ihe nkedo na nkewa. HPMC dị ka ihe nkedo nwere ike ime ka ọgwụ ahụ dị mfe mmiri, ọ pụkwara ịgbasa ọtụtụ narị ugboro mgbe ọ na-amịkọrọ mmiri, n'ihi ya, ọ nwere ike imeziwanye mgbasa ma ọ bụ ntọhapụ nke mbadamba nkume. HPMC nwere viscosity siri ike, ma nwee ike welie viscosity urughuru ma melite mkpakọ nke akụrụngwa na udidi siri ike ma ọ bụ nke siri ike. Enwere ike iji HPMC nwere viscosity dị ala dị ka ihe nkedo na disintegrant, na HPMC nwere nnukwu viscosity nwere ike iji naanị dị ka ihe nkedo.
Nke abuo, a na-eji ya dị ka ihe ntọhapụ na-akwado ma na-achịkwa maka nkwadebe ọnụ. HPMC bụ ihe matriks hydrogel nke a na-ejikarị eme ihe na nkwado nkwado nkwado. Enwere ike iji HPMC nke ọkwa viscosity dị ala (5 ~ 50mPa·s) dị ka onye na-ekekọta, onye na-amụba viscosity na onye nkwusioru, yana HPMC nke ọkwa viscosity dị elu (4000 ~ 100000mPa·s) nwere ike iji kwadebe ihe ngwakọta ihe matrix kwadoro-mwepụta mbadamba na nkwado nke gelsulease matrix na-adịgide adịgide maka matrix na-adịgide adịgide. mbadamba nkume. HPMC bụ soluble na eriri afọ eriri afọ, nwere uru nke ọma compressibility, ezi fluidity, ike ọgwụ loading ike na ọgwụ ntọhapụ àgwà adịghị emetụta pH. Ọ bụ ihe na-ebu ibu hydrophilic dị oke mkpa na sistemu nkwado nkwado na-adịgide adịgide ma na-ejikarị ya dị ka The hydrophilic gel matrix na ihe mkpuchi nke nkwadebe ntọhapụ na-adịgide adịgide, ma jiri ya mee ihe n'ime nkwadebe nke na-ese n'elu mmiri na ihe mgbakwunye ọgwụ na-eme ka akpụkpọ anụ ahụ na-enye aka.
Nke atọ dị ka ihe mkpuchi na-emepụta ihe nkiri.HPMCnwere ezigbo ihe na-emepụta ihe nkiri. Ihe nkiri a na-emepụta bụ otu, nke doro anya, na nke siri ike, ọ dịghịkwa mfe ịgbaso n'oge mmepụta. Karịsịa maka ọgwụ ndị dị mfe ịmịkọrọ mmiri ma na-ejighị n'aka, iji ya dị ka oyi akwa dịpụrụ adịpụ nwere ike ime ka nkwụsi ike nke ọgwụ ahụ dịkwuo mma ma gbochie ihe nkiri ahụ na-agbanwe agba. HPMC nwere nkọwa viscosity dị iche iche. Ọ bụrụ na ahọpụtara ya nke ọma, ịdị mma na ọdịdị nke mbadamba nkume ndị a kpuchiri ekpuchi dị mma karịa ihe ndị ọzọ, na mkpokọta ya bụ 2% ruo 10%.
A na-eji anọ eme ihe dị ka ihe capsule. N'afọ ndị na-adịbeghị anya, na ntiwapụ nke ọrịa anụmanụ zuru ụwa ọnụ ugboro ugboro, ma e jiri ya tụnyere gelatin capsules, capsules osisi aghọwo onye ọhụrụ nke ụlọ ọrụ ọgwụ na nri. Pfizer ewepụtala HPMC nke ọma site na osisi eke wee kwadoo capsules akwukwo nri VcapTM. N'iji ya na capsules oghe gelatin ọdịnala, capsules akwukwo nri nwere uru nke ngbanwe zuru oke, enweghị ihe ize ndụ nke mmeghachi omume njikọ, yana nkwụsi ike dị elu. Ọnụego ntọhapụ ọgwụ ahụ kwụsiri ike, na ndịiche dị n'otu n'otu pere mpe. Mgbe ọ gbasasịrị n'ime ahụ mmadụ, ọ naghị etinye ya n'ahụ ma nwee ike ịpụ ya. Ewepụtara ya n'ahụ. N'ihe banyere ọnọdụ nchekwa, mgbe ọtụtụ ule gasịrị, ọ fọrọ nke nta ka ọ bụrụ na ọ naghị emebi emebi n'okpuru ọnọdụ iru mmiri dị ala, na ihe onwunwe nke shei capsule ka kwụsiri ike n'okpuru oke iru mmiri, na ụdị dị iche iche nke capsules osisi n'okpuru oke nchekwa adịghị emetụta. Site na nghọta ndị mmadụ banyere capsules osisi na mgbanwe nke echiche ọgwụ ọha na eze n'ụlọ na mba ọzọ, ahịa ahịa maka capsules osisi ga-eto ngwa ngwa.
Nke ise bụ dị ka onye na-akwụsịtụ. Nkwusioru ụdị mmiri mmiri nkwadebe bụ a na-ejikarị na-adakarị usoro onunu ogwu ụdị, nke bụ a heterogeneous dispersion usoro nke siri ike soluble ọgwụ siri ike na-agbasasị na a mmiri mmiri dispersion ọkara. Nkwụsi ike nke usoro ahụ na-ekpebi ịdị mma nke nkwadebe mmiri nkwusioru. HPMC colloidal ngwọta nwere ike ibelata siri ike-mmiri mmiri interfacial esemokwu, belata n'elu free ike nke siri ike ahụ, na kwụsie ike na heterogeneous dispersion usoro. Ọ bụ ezigbo onye nkwusioru. A na-eji HPMC eme ihe dị ka ihe na-ekpu mmiri maka ọdịda anya, yana ọdịnaya nke 0.45% ruo 1.0%.
Hydroxypropyl cellulose (HPC) bụ monoether na-abụghị ionic cellulose nke sitere na owu na osisi site na alkalization na propylene oxide etherification. HPC na-abụkarị soluble na mmiri n'okpuru 40 Celsius C na nnukwu ego nke ihe mgbaze pola, na arụmọrụ ya metụtara ọdịnaya nke hydroxypropyl na ogo nke polymerization. HPC nwere ike dakọtara na ọgwụ dị iche iche ma nwee ezigbo inertness.
Hydroxypropyl cellulose dochie obere(L-HPC)a na-ejikarị dị ka mbadamba ihe na-agbasa na ihe nkedo. E ji mara ya bụ: mfe pịa ma na-etolite, ike applicability, karịsịa siri ike na-etolite, plastic na kenkuwa mbadamba, tinye L -HPC nwere ike imezi ike nke mbadamba nkume na nchapụta nke ọdịdị, na ọ nwekwara ike ime ka mbadamba nkume gbasasịa ngwa ngwa, melite esịtidem àgwà nke mbadamba nkume, na mma curative mmetụta.
Enwere ike iji hydroxypropyl cellulose dị elu dochie anya (H-HPC) dị ka ihe na-ejikọta maka mbadamba nkume, granules na granules dị mma na mpaghara ọgwụ. H-HPC nwere ọmarịcha ihe na-emepụta ihe nkiri, ihe nkiri na-esi na ya pụta siri ike ma na-agbanwe, nke enwere ike iji ya tụnyere plasticizers. Site n'ịgwakọta ihe ndị ọzọ na-egbochi mmiri na-ekpuchi mmiri, arụmọrụ nke ihe nkiri ahụ nwere ike ime ka ọ dịkwuo mma, a na-ejikarị ya eme ihe dị ka ihe mkpuchi ihe nkiri maka mbadamba nkume. H-HPC nwekwara ike iji dị ka ihe matriks iji kwadebe mbadamba ihe ntọhapụ matriks, pellet akwadoro na mbadamba ihe ntọhapụ nke okpukpu abụọ.
Hydroxyethyl cellulose (HEC) bụ monoether cellulose na-abụghị ionic nke sitere na owu na osisi site na alkalization na etherification ethylene oxide. A na-ejikarị HEC eme ihe dị ka onye na-agba ume, onye na-ahụ maka nchebe colloidal, nrapado, onye na-ekesa, stabilizer, onye na-emechi anya, onye na-emepụta ihe nkiri na ihe na-ewepụta ngwa ngwa n'ọhịa ahụike. Enwere ike itinye ya na emulsions, ointments, na drops anya maka ọgwụ n'elu. Mmiri mmiri ọnụ, mbadamba nkume siri ike, capsules na ụdị usoro ọgwụgwọ ndị ọzọ. Hydroxyethyl cellulose abanyela na US Pharmacopoeia/US National Formulary na European Pharmacopoeia.
Ethyl cellulose (EC) bụ otu n'ime ihe ndị na-emepụta mmiri na-adịghị edozi. EC abụghị ihe na-egbu egbu, kwụsiri ike, nke a na-adịghị edozi na mmiri, acid ma ọ bụ alkaline ngwọta, yana soluble na ihe mgbaze organic dị ka ethanol na methanol. Ihe mgbaze a na-ejikarị eme ihe bụ ngwakọta agwakọta nke toluene/ethanol 4/1 (arọ). EC nwere ọtụtụ ojiji na ọgwụ na-akwado mwepụta nkwadebe, a na-ejikwa ya dị ka onye na-ebu na microcapsules, mkpuchi ihe na-emepụta ihe nkiri, wdg nke nkwadebe ntọhapụ, dị ka mbadamba nkume retarder, adhesives, ihe mkpuchi ihe nkiri, wdg. pellets, dị ka ihe enyemaka encapsulation iji kwadebe microcapsules na-adịgide adịgide; a pụkwara iji ya mee ihe n'ọtụtụ ebe dị ka ihe na-ebu ibu A na-eji ya akwadebe mgbasa siri ike; enwere ike iji ya mee ihe n'ọtụtụ ebe na nkà na ụzụ ọgwụ dị ka ihe na-emepụta ihe nkiri na mkpuchi nchebe, a pụkwara iji ya mee ihe dị ka ihe nkedo na ihe nkpuchi. Dị ka ihe mkpuchi mkpuchi maka mbadamba nkume, ọ nwere ike ibelata uche nke mbadamba nkume na iru mmiri ma gbochie ọgwụ ndị ahụ ka ọ gbanwee ma mee ka mmiri dị njọ; ọ nwekwara ike ịmepụta akwa akwa gluu na-ahapụ ngwa ngwa yana microencapsulate polymer ka ọ na-ahapụ mmetụta ọgwụ ahụ.
Na nchịkọta, na mmiri-soluble sodium carboxymethyl cellulose, methyl cellulose, hydroxypropyl methyl cellulose, hydroxypropyl cellulose, hydroxyethyl cellulose na mmanụ-soluble ethyl cellulose na-niile dabeere na ha iche The àgwà nke ngwaahịa na-eji na ọgwụ excipients dị ka adhesives, ihe nkiri na-adịgide adịgide ma ọ bụ ihe na-eme ka ihe na-eme ka ihe na-eme ihe na-edozi ahụ, na-edozi ihe mkpuchi na-edozi ahụ, ndị nnọchi anya, ihe capsule na ndị na-akwụsịtụ. N'ileghachi anya na ụwa, ọtụtụ ụlọ ọrụ mba ọzọ dị iche iche (Shin-Etsu Japan, Dow Wolff na Ashland) ghọtara nnukwu ahịa maka cellulose ọgwụ na China n'ọdịnihu, ma ọ bụ ụbara mmepụta ma ọ bụ mergers, ha abawanyela ọnụnọ ha na mpaghara a. Ntinye ego n'ime ngwa. Dow Wolff kwupụtara na ọ ga-eme ka uche ya dịkwuo elu na nhazi, ihe ndị na-emepụta na mkpa nke ahịa nkwadebe ọgwụ ndị China, na nyocha ngwa ya ga-agbalịsikwa ike ịbịaru nso n'ahịa ahụ. Ngalaba Wolff Cellulose nke Dow Chemical na Colorcon Corporation nke United States ewepụtala njikọ nkwado nkwado na-akwado ma na-achịkwa n'ụwa niile. O nwere ihe karịrị ndị ọrụ 1,200 na obodo 9, ụlọ ọrụ bara uru 15 na ụlọ ọrụ GMP 6. Ndị ọkachamara nyocha etinyere n'ọrụ na-enye ndị ahịa ọrụ na ihe dịka mba 160. Ashland nwere ntọala mmepụta na Beijing, Tianjin, Shanghai, Nanjing, Changzhou, Kunshan na Jiangmen, ma tinye ego na ụlọ ọrụ nyocha teknụzụ atọ na Shanghai na Nanjing.
Dị ka ọnụ ọgụgụ sitere na weebụsaịtị nke China Cellulose Association, na 2017, mmepụta ụlọ nke cellulose ether bụ tọn 373,000 na ọnụ ahịa ahịa bụ 360 puku tọn. Na 2017, ọnụ ahịa ahịa nke ionic n'ezieCMCbụ tọn 234,000, mmụba nke 18.61% kwa afọ, na ọnụ ahịa ahịa nke CMC na-abụghị ionic bụ tọn 126,000, mmụba nke 8.2% kwa afọ. Na mgbakwunye na ngwaahịa HPMC (ihe owuwu ụlọ) ngwaahịa na-abụghị ionic,HPMC(ọkwa ọgwụ), HPMC (nri nri), HEC, HPC, MC, HEMC, wdg niile ebiliwo megide omume, na mmepụta na ahịa na-aga n'ihu na-abawanye. Ụlọ cellulose ethers na-eto ngwa ngwa ihe karịrị afọ iri, na mmepụta abụrụla nke mbụ n'ụwa. Otú ọ dị, ọtụtụ n'ime ngwaahịa ụlọ ọrụ cellulose ether bụ nke a na-ejikarị eme ihe na etiti na njedebe nke ụlọ ọrụ ahụ, uru agbakwunyere adịghịkwa elu.
Ka ọ dị ugbu a, ọtụtụ ụlọ ọrụ cellulose ether nọ n'oge mgbanwe na nkwalite dị oke egwu. Ha kwesịrị ịga n'ihu na-amụba nyocha ngwaahịa na mbọ mmepe, na-aga n'ihu na-eme ka ụdị ngwaahịa dị iche iche na-abawanye, na-eji China, bụ ahịa kacha ibu n'ụwa eme ihe n'ụzọ zuru oke, na ịbawanye mbọ iji wulite ahịa ahịa mba ofesi ka ụlọ ọrụ wee nwee ike ịgbasa ngwa ngwa o kwere omume. Mezue mgbanwe na nkwalite, banye n'etiti-na-elu njedebe nke ụlọ ọrụ, na-enweta ihe dị mma na akwụkwọ ndụ akwụkwọ ndụ mmepe.
Oge nzipu: Eprel-25-2024