Ihe ndị na-enye ọgwụ bụ ihe ndị na-enye ọgwụ na ihe ndị na-enye aka nke a na-eji emepụta ọgwụ na nhazi ọgwụ, ha bụkwa akụkụ dị mkpa nke nkwadebe ọgwụ. Dịka ihe sitere na polymer sitere n'okike, cellulose ether nwere njirimara nke biodegradability, enweghị nsí, yana ọnụ ala dị ala, dịka sodium carboxymethyl cellulose, methyl cellulose, hydroxypropyl methyl cellulose, hydroxypropyl cellulose,Cellulose ethersdị ka hydroxyethyl cellulose na ethyl cellulose nwere uru dị mkpa n'ọrụ na ihe mgbakwunye ọgwụ. Ugbu a, a na-ejikarị ngwaahịa nke ọtụtụ ụlọ ọrụ cellulose ether eme ihe n'ọhịa etiti na nke dị ala nke ụlọ ọrụ ahụ, uru agbakwunyere adịghịkwa elu. Ụlọ ọrụ ahụ kwesịrị ịgbanwe ma melite ma melite ngwa ngwa nke ngwaahịa.
Ihe ndị na-enye ọgwụ na-arụ ọrụ dị mkpa n'ịmepụta na imepụta usoro ọgwụ. Dịka ọmụmaatụ, na nkwadebe ndị na-enye ọgwụ na-adịgide adịgide, a na-eji ihe polymer dị ka cellulose ethers dị ka ihe ndị na-enye ọgwụ na pellet ndị na-adịgide adịgide, ụdị dị iche iche nke matrix na-adịgide adịgide, ụdị ihe ndị a kpuchiri ekpuchi, mkpụrụ ọgwụ ndị na-adịgide adịgide, ihe nkiri ọgwụ ndị na-adịgide adịgide, na ọgwụ resin ndị na-adịgide adịgide. A na-eji nkwadebe na nkwadebe ndị na-adịgide adịgide nke mmiri mmiri eme ihe nke ukwuu. N'ime usoro a, a na-ejikarị polymers dị ka cellulose ethers dị ka ndị na-ebu ọgwụ iji chịkwaa ọnụego mwepụta nke ọgwụ n'ahụ mmadụ, ya bụ, a chọrọ ka a tọhapụ ha nwayọ nwayọ n'ahụ na ọnụego a kapịrị ọnụ n'ime oge ụfọdụ iji mezuo ebumnuche nke ọgwụgwọ dị irè.
Dịka ọnụọgụgụ nke ngalaba ndụmọdụ na nyocha si kwuo, e nwere ihe dị ka ụdị ihe mgbakwunye 500 n'ahịa na mba m, mana ma e jiri ya tụnyere mba United States (ihe karịrị ụdị 1500) na mba Europe (ihe karịrị ụdị 3000), enwere nnukwu ọdịiche, ụdị ndị ahụ ka dịkwa obere. Ihe mgbakwunye ọgwụ nke mba m. Ike mmepe nke ahịa dị ukwuu. A ghọtara na ihe mgbakwunye ọgwụ iri kachasị elu n'ahịa mba m bụ capsules gelatin ọgwụ, sucrose, starch, ntụ ntụ mkpuchi ihe nkiri, 1,2-propylene glycol, PVP, hydroxypropyl methylcellulose (HPMC), na eriri microcrystalline. Vegetarian, HPC, lactose.
"Ether eke cellulose bụ okwu izugbe maka usoro ihe ndị sitere na cellulose nke mmeghachi omume nke alkali cellulose na ihe na-eme ka etherifying pụta n'okpuru ọnọdụ ụfọdụ, ọ bụkwa ngwaahịa ebe otu ether na-anọchi otu hydroxyl dị na cellulose macromolecule n'akụkụ ma ọ bụ kpamkpam. A na-ejikarị cellulose ethers eme ihe n'ọhịa mmanụ ala, ihe owuwu ụlọ, mkpuchi, nri, ọgwụ na kemịkalụ kwa ụbọchị. N'ọhịa niile, ngwaahịa ndị sitere na ọgwụ dị n'etiti na nke dị elu nke ụlọ ọrụ ahụ ma nwee uru agbakwunyere dị elu. N'ihi ihe achọrọ nke ọma, mmepụta nke cellulose ethers nke ọgwụ dịkwa oke njọ. Enwere ike ikwu na ịdị mma nke ngwaahịa ndị sitere na ọgwụ nwere ike ịnọchite anya ike teknụzụ nke ụlọ ọrụ cellulose ether. A na-agbakwụnyekarị cellulose ether dị ka ihe na-egbochi, ihe matrix na ihe na-eme ka ọ dị arọ iji mepụta mbadamba matrix ndị na-adịgide adịgide, ihe mkpuchi gastric-soluble, ihe nkwakọ ngwaahịa microcapsule na-adịgide adịgide, ihe nkiri ọgwụ ndị na-adịgide adịgide, wdg.
Sodium carboxymethyl cellulose (CMC-Na) bụ cellulose ether nke nwere mmepụta na oriri kachasị ukwuu n'ụlọ na mba ofesi. Ọ bụ ionic cellulose ether nke e ji owu na osisi mee site na alkalization na etherification na chloroacetic acid. CMC-Na bụ ihe na-enye ọgwụ a na-ejikarị eme ihe. A na-ejikarị ya eme ihe dị ka ihe na-ejikọ ihe siri ike na dị ka ihe na-eme ka ihe sie ike, na-eme ka ihe sie ike ma na-egbochi mmiri. Enwere ike iji ya dị ka ihe na-agbaze mmiri na ihe na-emepụta ihe nkiri. A na-ejikarị ya eme ihe dị ka ihe nkiri ọgwụ na-adịgide adịgide na mbadamba matrix na-adịgide adịgide na usoro mwepụta na-adịgide adịgide (achịkwa).
Na mgbakwunye na sodium carboxymethyl cellulose dị ka ihe mgbakwunye ọgwụ, enwere ike iji croscarmellose sodium dị ka ihe mgbakwunye ọgwụ. Cross-linked carboxymethyl cellulose sodium (CCMC-Na) bụ ihe na-anaghị agbaze mmiri nke carboxymethyl cellulose na-emeghachi omume na ihe njikọ cross-linked na okpomọkụ ụfọdụ (40-80°C) n'okpuru ọrụ nke inorganic acid catalyst ma dị ọcha. Ihe njikọta crosslinking nwere ike ịbụ propylene glycol, succinic anhydride, maleic anhydride, adipic anhydride, na ihe ndị yiri ya. A na-eji Croscarmellose sodium dị ka ihe na-agbaze maka mbadamba, capsules na granules na nkwadebe ọnụ. Ọ na-adabere na mmetụta capillary na ọzịza iji nweta mmebi. Ọ nwere ezigbo mkpakọ na ikewapụ siri ike. Ọmụmụ ihe egosila na ọkwa ọzịza nke croscarmellose sodium na mmiri karịrị nke nke ndị na-agbaze nkịtị dị ka sodium carboxymethyl cellulose dị ala na hydrated microcrystalline cellulose.
Methyl cellulose (MC) bụ monoether cellulose na-abụghị ionic nke e ji owu na osisi mee site na alkalization na methyl chloride etherification. Methyl cellulose nwere ezigbo mmiri na-agbaze ma kwụsie ike na pH nke 2.0 ruo 13.0. A na-ejikarị ya eme ihe n'ọtụtụ ihe ndị na-enye ọgwụ, a na-ejikwa ya na mbadamba ndị na-abụghị asụsụ, ọgwụ intramuscular, nkwadebe anya, capsules ọnụ, nkwusioru ọnụ, mbadamba ọnụ na nkwadebe ihe ndị dị n'elu. Na mgbakwunye, na nhazi ndị na-adịgide adịgide, enwere ike iji MC dị ka usoro gel matrix hydrophilic nke na-adịgide adịgide, ihe mkpuchi gastric-soluble, ihe nkwakọ ngwaahịa microcapsule na-adịgide adịgide, ihe nkiri ọgwụ na-adịgide adịgide, wdg.
Hydroxypropyl methylcellulose (HPMC) bụ ngwakọta ether nke na-abụghị ionic nke e ji owu na osisi mee site na alkalization na etherification nke propylene oxide na methyl chloride. Ọ dịghị isi, enweghị uto, ọ naghị egbu egbu, a na-agbaze na mmiri oyi, yana gels na mmiri ọkụ. Hydroxypropyl methylcellulose bụ ụdị ether agwakọtara cellulose nke na-amụba ngwa ngwa na mmepụta, oriri na ịdị mma n'ime afọ 15 gara aga. Ọ bụkwa otu n'ime ihe ndị kachasị ukwuu e ji agwọ ọrịa n'ụlọ na mba ofesi. Ejirila ya dị ka ihe na-agwọ ọrịa ruo ihe fọrọ nke nta ka ọ bụrụ afọ 50. Afọ akụkọ ihe mere eme. Ugbu a, ojiji nke HPMC na-egosipụtakarị n'akụkụ ise ndị a:
Otu bụ ihe na-ejikọ ma na-agbaze. HPMC dị ka ihe na-ejikọ nwere ike ime ka ọgwụ ahụ dị mfe ịgba mmiri, ọ nwekwara ike ịgbasa ọtụtụ narị ugboro mgbe ọ mịkọrọ mmiri, ya mere ọ nwere ike ime ka mgbaze ma ọ bụ ntọhapụ nke mbadamba ahụ ka mma nke ukwuu. HPMC nwere ike ịgbaze ma ọ bụ tọhapụ ya nke ọma, ọ nwekwara ike ime ka viscosity nke ihe ndị ahụ dịkwuo mma ma melite mkpakọ nke ihe ndị e ji ihe mee site na udidi siri ike ma ọ bụ nke siri ike. Enwere ike iji HPMC nwere obere viscosity dị ka ihe na-ejikọ ma na-agbaze, HPMC nwere viscosity dị elu naanị dị ka ihe na-ejikọ.
Nke abụọ, a na-eji ya dị ka ihe mwepụta na-adịgide adịgide ma na-achịkwa maka nkwadebe ọnụ. HPMC bụ ihe hydrogel matrix a na-ejikarị eme ihe na nkwadebe ntọhapụ na-adịgide adịgide. Enwere ike iji HPMC nke ọkwa viscosity dị ala (5~50mPa·s) dị ka ihe njikọta, ihe na-abawanye viscosity na ihe na-egbochi, enwere ike iji HPMC nke ọkwa viscosity dị elu (4000~100000mPa·s) kwadebe mbadamba ihe ngwakọta matrix na-adịgide adịgide na ihe na-egbochi ntọhapụ na-adịgide adịgide maka capsules na mbadamba gel hydrophilic gel matrix na-adịgide adịgide. HPMC na-agbaze na mmiri eriri afọ, nwere uru nke ezigbo mkpakọ, ezigbo mmiri mmiri, ikike ibu ọgwụ siri ike na njirimara ntọhapụ ọgwụ nke pH anaghị emetụta. Ọ bụ ihe dị oke mkpa maka ibu hydrophilic na sistemụ nkwadebe ntọhapụ na-adịgide adịgide ma a na-ejikarị ya dị ka ihe na-eme ka gel hydrophilic na ihe mkpuchi nke nkwadebe ntọhapụ na-adịgide adịgide, a na-ejikwa ya na nkwadebe mmiri gastric na ihe enyemaka membrane ọgwụ na-adịgide adịgide.
Nke atọ bụ dịka ihe mkpuchi ihe nkiri.HPMCnwere ezigbo ihe ndị na-eme ka ihe nkiri dị mma. Ihe nkiri ahụ nke o mepụtara bụ otu, doro anya, ma sie ike, ọ dịghịkwa mfe ịrapara n'oge mmepụta ya. Karịsịa maka ọgwụ ndị dị mfe ịmịkọrọ mmiri ma na-adịghị akwụsi ike, iji ya dị ka oyi akwa nkewapụ nwere ike ime ka nkwụsi ike nke ọgwụ ahụ ka mma ma gbochie ya. Ihe nkiri ahụ na-agbanwe agba. HPMC nwere ọtụtụ nkọwapụta viscosity. Ọ bụrụ na ahọpụtara ya nke ọma, àgwà na ọdịdị nke mbadamba mkpuchi ahụ ka mma karịa ihe ndị ọzọ, ọnụ ọgụgụ ya na-adịkarị bụ 2% ruo 10%.
A na-eji anọ eme ihe dị ka ihe e ji eme kapsụl. N'afọ ndị na-adịbeghị anya, ebe ọrịa anụmanụ na-efe efe n'ụwa niile na-agbasa ugboro ugboro, ma e jiri ya tụnyere kapsụl gelatin, kapsụl osisi aghọọla ihe ọhụrụ a ma ama n'ụlọ ọrụ ọgwụ na nri. Pfizer ewepụtala HPMC site na osisi ndị sitere n'okike ma kwadebe kapsụl akwụkwọ nri VcapTM. Ma e jiri ya tụnyere kapsụl gelatin ọdịnala, kapsụl akwụkwọ nri nwere uru nke mgbanwe dị ukwuu, enweghị ihe egwu nke mmeghachi omume njikọ, na nkwụsi ike dị elu. Ọnụego mwepụta ọgwụ ahụ kwụsiri ike, ọdịiche dị n'otu n'otu dịkwa obere. Mgbe ọ gbasasịrị n'ahụ mmadụ, a naghị etinye ya ma enwere ike iwepụ ya. A na-ewepụ ya n'ahụ. Banyere ọnọdụ nchekwa, mgbe ọtụtụ ule gasịrị, ọ fọrọ nke nta ka ọ ghara ịgbaji n'okpuru ọnọdụ iru mmiri dị ala, ihe onwunwe nke kapsụl ahụ ka kwụsiri ike n'okpuru oke iru mmiri, ihe dị iche iche nke kapsụl osisi n'okpuru ọnọdụ nchekwa dị oke njọ anaghị emetụta. Site na nghọta ndị mmadụ banyere kapsụl osisi na mgbanwe nke echiche ọgwụ ọha na eze n'ụlọ na mba ofesi, ọchịchọ ahịa maka kapsụl osisi ga-eto ngwa ngwa.
Nke ise bụ dịka ihe na-egbochi ihe. Nkwadebe mmiri mmiri ụdị nkwụsịtụ bụ ụdị ọgwụ a na-ejikarị eme ihe, nke bụ usoro mgbasa dị iche iche ebe a na-agbasa ọgwụ siri ike na-anaghị agbaze na mmiri mgbasa. Nkwụsi ike nke sistemụ ahụ na-ekpebi ụdị nkwadebe mmiri nkwụsịtụ. Ngwọta colloidal HPMC nwere ike ibelata nrụgide dị n'etiti mmiri siri ike na mmiri mmiri, belata ike enweghị elu nke ihe siri ike, ma mee ka sistemụ mgbasa dị iche iche kwụsie ike. Ọ bụ ihe na-egbochi ihe nkwụsịtụ dị mma. A na-eji HPMC eme ihe dị ka ihe na-eme ka anya dị nkọ, nke nwere ọdịnaya dị n'etiti 0.45% ruo 1.0%.
Hydroxypropyl cellulose (HPC) bụ monoether cellulose na-abụghị ionic nke e ji owu na osisi mee site na alkalization na propylene oxide etherification. A na-agbaze HPC na mmiri n'okpuru 40°C na nnukwu ihe mgbaze polar, arụmọrụ ya na-adabere na ọdịnaya nke hydroxypropyl na ogo nke polymerization. HPC nwere ike dakọtara na ọgwụ dị iche iche ma nwee ezigbo enweghị ike.
hydroxypropyl cellulose nke nwere obere mgbanwe(L-HPC)A na-ejikarị ya eme ihe dị ka ihe na-emebi ihe na ihe na-ejikọ ya. Ihe ndị e ji mara ya bụ: ọ dị mfe ịpị ma mepụta, ọ na-esi ike nke ukwuu, ọ na-esikwa ike ịkpụ, mbadamba plastik na ndị na-agbawa agbawa, L －HPC nwere ike ime ka ike nke mbadamba ahụ na ịdị mma nke ọdịdị ya ka mma, ọ nwekwara ike ime ka mbadamba ahụ gbawaa ngwa ngwa, melite ịdị mma nke mbadamba ahụ, ma melite mmetụta ọgwụgwọ.
Enwere ike iji hydroxypropyl cellulose (H-HPC) nke nwere nnukwu nnọchi anya dị ka ihe na-ejikọ mbadamba, granules na obere granules n'ọhịa ọgwụ. H-HPC nwere ezigbo ihe ndị na-emepụta fim, ihe nkiri ahụ siri ike ma na-agbanwe agbanwe, nke enwere ike iji ya tụnyere ihe ndị na-eme ka plastik dị nro. Site na ịgwakọta ya na ihe mkpuchi ndị ọzọ na-egbochi mmiri mmiri, arụmọrụ nke ihe nkiri ahụ nwere ike ime ka ọ ka mma, a na-ejikwa ya eme ihe dị ka ihe mkpuchi fim maka mbadamba. Enwere ike iji H-HPC dị ka ihe matrix iji kwadebe mbadamba ndị na-adịgide adịgide nke matrix, pellet ndị na-adịgide adịgide na mbadamba ndị na-adịgide adịgide nke nwere okpukpu abụọ.
Hydroxyethyl cellulose (HEC) bụ monoether cellulose na-abụghị ionic nke e ji owu na osisi mee site na alkalization na ethylene oxide etherification. A na-ejikarị HEC eme ihe dị ka ihe na-eme ka ihe dị arọ, ihe nchebe colloidal, ihe na-arapara, ihe na-agbasa, ihe na-eme ka ihe kwụsie ike, ihe na-eme ka ihe dị nro, ihe na-emepụta ihe nkiri na ihe na-ewepụta nwayọ nwayọ n'ọhịa ahụike. Enwere ike itinye ya na emulsions, mmanụ, na mmiri anya maka ọgwụ dị n'elu. Mmiri mmiri ọnụ, mbadamba siri ike, capsules na ụdị dose ndị ọzọ. A tinyela Hydroxyethyl cellulose na US Pharmacopoeia/US National Formulary na European Pharmacopoeia.
Ethyl cellulose (EC) bụ otu n'ime ihe ndị e ji emepụta cellulose mmiri na-anaghị agbaze. EC abụghị ihe na-egbu egbu, kwụsiri ike, anaghị agbaze na mmiri, mmiri acid ma ọ bụ alkaline, ma na-agbaze na ihe mgbaze organic dịka ethanol na methanol. Ihe mgbaze a na-ejikarị eme ihe bụ ihe mgbaze agwakọtara nke toluene/ethanol 4/1 (ibu). EC nwere ọtụtụ ojiji na nkwadebe ọgwụ na-adịgide adịgide, a na-ejikwa ya nke ukwuu dị ka ihe ebu na microcapsules, ihe mkpuchi ihe nkiri, wdg. nke nkwadebe na-adịgide adịgide, dị ka mbadamba ihe mgbochi, ihe mgbaze, ihe mkpuchi ihe nkiri, wdg. A na-eji ya dị ka ihe nkiri matrix iji kwadebe ụdị mbadamba matrix dị iche iche, dị ka ihe agwakọtara iji kwadebe nkwadebe na-adịgide adịgide na pellets na-adịgide adịgide, dị ka ihe enyemaka encapsulation iji kwadebe microcapsules na-adịgide adịgide; enwere ike iji ya mee ihe dị ka ihe ebu. A na-eji ya akwado mgbasa siri ike; enwere ike iji ya mee ihe n'ọtụtụ ebe na teknụzụ ọgwụ dị ka ihe na-emepụta fim na mkpuchi nchebe, enwere ike iji ya dị ka ihe na-ejikọta ihe na ihe njupụta. Dịka ihe mkpuchi nchebe maka mbadamba, ọ nwere ike ibelata mmetụta nke mbadamba na iru mmiri ma gbochie ọgwụ ndị ahụ ịgbanwe agba na mmebi site na mmiri; ọ nwekwara ike ịmepụta oyi akwa gluu na-ewepụta nwayọ nwayọ ma mechie polima ahụ iji wepụta mmetụta ọgwụ ahụ mgbe niile.
Na nchịkọta, sodium carboxymethyl cellulose nke mmiri na-agbaze, methyl cellulose, hydroxypropyl methyl cellulose, hydroxypropyl cellulose, hydroxyethyl cellulose na ethyl cellulose nke na-agbaze mmanụ dabere na njirimara ha. A na-eji njirimara nke ngwaahịa a na ihe mgbakwunye ọgwụ dị ka ihe na-ejikọ, ihe ndị na-emebi ihe, ihe ndị na-adịgide adịgide na ndị a na-achịkwa maka nkwadebe ọnụ, ihe mkpuchi ihe nkiri, ihe ndị dị na kapsụl na ihe ndị na-egbochi ihe. N'ileba anya n'ụwa, ọtụtụ ụlọ ọrụ mba ofesi (Shin-Etsu Japan, Dow Wolff na Ashland) ghọtara nnukwu ahịa maka cellulose ọgwụ na China n'ọdịnihu, ma mmụba mmepụta ma ọ bụ njikọta, ha amụbaala ọnụnọ ha na ngalaba a. Itinye ego n'ime ngwa ahụ. Dow Wolff kwupụtara na ọ ga-eme ka nlebara anya ya dịkwuo elu na nhazi, ihe ndị mejupụtara na mkpa nke ahịa nkwadebe ọgwụ China, nyocha ngwa ya ga-agbakwa mbọ ịbịaru nso n'ahịa. Ngalaba Wolff Cellulose nke Dow Chemical na Colorcon Corporation nke United States eguzobela njikọ nkwadebe ntọhapụ na-adịgide adịgide na nke a na-achịkwa n'ụwa niile. O nwere ihe karịrị ndị ọrụ 1,200 n'obodo 9, ụlọ ọrụ akụ 15 na ụlọ ọrụ GMP 6. Ndị ọkachamara n'ihe gbasara nyocha etinyere na-enye ọrụ nye ndị ahịa na ihe dị ka mba 160. Ashland nwere ebe mmepụta ihe na Beijing, Tianjin, Shanghai, Nanjing, Changzhou, Kunshan na Jiangmen, ma tinyela ego na ebe nyocha teknụzụ atọ na Shanghai na Nanjing.
Dịka ọnụọgụgụ sitere na weebụsaịtị nke China Cellulose Association si kwuo, na 2017, mmepụta cellulose ether n'ime obodo bụ tọn 373,000 ebe olu ahịa ya bụ tọn puku 360. Na 2017, olu ahịa nke ionic n'ezieCMCbụ tọn 234,000, mmụba nke 18.61% kwa afọ, na olu ahịa nke CMC na-abụghị ionic bụ tọn 126,000, mmụba nke 8.2% kwa afọ. Na mgbakwunye na ngwaahịa HPMC (ọkwa ihe owuwu) na-abụghị ionic,HPMC(ọkwa ọgwụ), HPMC (ọkwa nri), HEC, HPC, MC, HEMC, wdg. Arịgola megide usoro a, mmepụta na ire ere anọgidewokwa na-amụba. Ether cellulose dị n'ime ụlọ anọwo na-eto ngwa ngwa ruo ihe karịrị afọ iri, mmepụta ya aghọọla nke mbụ n'ụwa. Agbanyeghị, ọtụtụ ngwaahịa ụlọ ọrụ cellulose ether ka a na-ejikarị eme ihe n'etiti na nke dị ala nke ụlọ ọrụ ahụ, uru agbakwunyere adịghịkwa elu.
Ugbu a, ọtụtụ n'ime ụlọ ọrụ cellulose ether dị n'ime obodo nọ n'oge mgbanwe na nkwalite dị oke mkpa. Ha kwesịrị ịnọgide na-eme ka nnyocha na mmepe ngwaahịa dịkwuo elu, na-eme ka ụdị ngwaahịa dị iche iche baa ọgaranya mgbe niile, na-eji China, ahịa kachasị ukwuu n'ụwa, ma na-eme ka mgbalị dị ukwuu iji mepụta ahịa mba ọzọ ka ụlọ ọrụ wee nwee ike ịgbasa ozugbo enwere ike. Mezue mgbanwe na nkwalite, banye n'akụkụ etiti ruo na elu nke ụlọ ọrụ ahụ, ma nweta mmepe dị mma na nke na-acha akwụkwọ ndụ akwụkwọ ndụ.
Oge ozi: Eprel-25-2024