Pharmaceutical Excipients Cellulose Ether
Natural cellulose ether izwi rinowanzoreva nhevedzano yecellulose derivativesinogadzirwa nekuita kwealkali cellulose uye etherifying agent pasi pemamwe mamiriro. Icho chigadzirwa umo mapoka e-hydroxyl pa cellulose macromolecules anotsiviwa zvishoma kana zvachose nemapoka ether. Cellulose ethers inoshandiswa zvakanyanya muminda yepetroleum, zvekuvaka, machira, chikafu, mishonga, uye makemikari ezuva nezuva. Muminda yakasiyana-siyana, mishonga-giredhi zvigadzirwa zviri kunyanya pakati uye yepamusoro-yekupedzisira minda yeindasitiri, ine yakakwirira yakawedzera kukosha. Nekuda kwehutano hwakasimba hunodiwa, kugadzirwa kwemishonga-giredhi cellulose ether zvakare kwakaoma. Zvinogona kutaurwa kuti mhando yezvigadzirwa zvemishonga-giredhi inogona kumiririra iyo tekinoroji simba remabhizinesi e-cellulose ether. Cellulose ether inowanzowedzerwa se blocker, matrix material uye thickener kugadzira mahwendefa e-matrix anoramba achiburitswa, gastric-soluble coating materials, inosimudzira-inosunungura microcapsule coating materials, inosimudzira-inobudisa zvinodhaka firimu zvinhu, nezvimwewo.
Sodium carboxymethyl cellulose:
Carboxymethyl cellulose sodium (CMC-Na) ndiyo cellulose ether yakasiyana ine yakakura kugadzira uye kushandiswa kumba nekune dzimwe nyika. Iyo ionic cellulose ether yakagadzirwa kubva mudonje nehuni kuburikidza nealkalization uye etherification ine chloroacetic acid. CMC-Na inowanzoshandiswa mishonga yemishonga. Inowanzo shandiswa sebhainda rekugadzirira kwakasimba, gobvu agent, thickening agent, uye suspending agent yekugadzirira mvura. Inogona zvakare kushandiswa semvura-inonyungudika matrix uye firimu-kugadzira zvinhu. Inowanzo shandiswa seyakagadziriswa-inoburitsa zvinodhaka firimu zvinhu uye yakatsiga-kuburitsa matrix piritsi mune inotsigirwa (inodzorwa) yekuburitsa gadziriro.
Pamusoro pe sodium carboxymethylcellulose sechinhu chinobatsira chemishonga, croscarmellose sodium inogona zvakare kushandiswa semushonga wemishonga. Croscarmellose sodium (CCMC-Na) chigadzirwa chisina kunyungudika chemvura che carboxymethylcellulose ichiita neyakachinjika mumiririri pane imwe tembiricha (40-80 ° C) pasi pekuita kweinorganic acid inokonzeresa uye yakacheneswa. Seyo crosslinking agent, propylene glycol, succinic anhydride, maleic anhydride uye adipic anhydride inogona kushandiswa. Croscarmellose sodium inoshandiswa se disintegrant yemapiritsi, capsules uye granules mumuromo kugadzirira. Inovimba necapillary uye kuzvimba mhedzisiro kuti iparare. Iyo ine yakanaka compressibility uye yakasimba disintegration simba. Zvidzidzo zvakaratidza kuti dhigirii yekuzvimba yecroscarmellose sodium mumvura yakakura kupfuura yeanowanzo disintegrants senge yakaderera-inotsiva carmellose sodium uye hydrated microcrystalline cellulose.
Methylcellulose:
Methyl cellulose (MC) isiri-ionic cellulose imwe ether yakagadzirwa kubva mudonje nehuni kuburikidza nealkalization uye methyl chloride etherification. Methylcellulose ine yakanakisa kunyungudika kwemvura uye yakagadzikana muhuwandu hwepH2.0 ~ 13.0. Inoshandiswa zvakanyanya mumishonga yemishonga, uye inoshandiswa mumapiritsi emitauro, intramuscular jekiseni, ophthalmic kugadzirira, oral capsules, oral suspensions, oral tablets uye topical kugadzirira. Uye zvakare, mukugadzirira-kuburitswa kwakasimba, MC inogona kushandiswa se hydrophilic gel matrix inosimudzira-kuburitswa gadziriro, gastric-soluble coating zvinhu, inosimudzira-kuburitswa microcapsule yekuputira zvinhu, inosimudzira-inoburitsa zvinodhaka firimu zvinhu, nezvimwe.
Hydroxypropyl methyl cellulose:
Hydroxypropyl methylcellulose (HPMC) isiri-ionic cellulose yakasanganiswa ether yakagadzirwa kubva mudonje nehuni kuburikidza nealkalization, propylene oxide uye methyl chloride etherification. Haina hwema, haina kunaka, haina chepfu, inonyungudika mumvura inotonhora uye gelled mumvura inopisa. Hydroxypropyl methylcellulose is a cellulose yakasanganiswa ether akasiyana ayo magadzirirwo, dosi uye mhando zvave kuwedzera nekukurumidza muChina mumakore gumi nemashanu apfuura. Iyo zvakare imwe yeanonyanya kushandiswa emishonga excipients kumba nekune dzimwe nyika. makore enhoroondo. Parizvino, kushandiswa kweHPMC kunonyanya kuratidzwa mune zvinotevera zvishanu zvinhu:
Imwe yakaita sebhainda uye disintegrant. Semubhainda, HPMC inogona kuita kuti mushonga uve nyore kunyorova, uye inogona kuwedzera mazana enguva mushure mekutora mvura, saka inogona kuvandudza zvakanyanya chiyero chekuparara kana kuburitswa kwehwendefa. HPMC ine viscosity yakasimba, iyo inogona kukwidziridza iyo particle viscosity uye kuvandudza kusungirirwa kwezvinhu zvakabikwa zvine crisp kana brittle manyorerwo. HPMC ine yakaderera viscosity inogona kushandiswa sebhainda uye disintegrant, uye avo vane viscosity yakakwirira inogona kushandiswa sebhainda.
Yechipiri yakaita seyakagadziriswa uye inodzorwa yekuburitsa zvinhu zvekugadzirira nemuromo. HPMC inowanzoshandiswa hydrogel matrix zvinhu mukuchengetedza-kuburitswa gadziriro. Low-viscosity giredhi (5-50mPa · s) HPMC inogona kushandiswa sebhainda, viscosifier uye suspending agent, uye high-viscosity giredhi (4000-100000mPa · s) HPMC inogona kushandiswa kugadzira zvakasanganiswa zvinhu Kuvharira agent yema capsules, hydrogel matrix. mahwendefa akawedzerwa-kusunungurwa. HPMC inonyungudika mugastrointestinal fluid, ine zvakanakira kudzvanya kwakanaka, kuyerera kwakanaka, simba rekurodha zvinodhaka, uye hunhu hwekuburitsa zvinodhaka husina kukanganiswa nePH. Iyo yakakosha zvakanyanya hydrophilic inotakura zvinhu mune inosimudzira-kuburitswa gadziriro masisitimu uye inowanzoshandiswa seHydrophilic gel matrix uye zvekuputira zvigadziriso zvekugara-kuburitswa gadziriro, pamwe nezvinhu zvekubatsira zvegastric inoyangarara gadziriro uye inoenderera-kuburitsa-kuburitsa zvinodhaka firimu gadziriro.
Yechitatu ndeyekupfekedza firimu-inogadzira agent. HPMC ine yakanaka yekugadzira firimu zvinhu. Iyo firimu yakaumbwa nayo yakafanana, yakajeka uye yakaoma, uye haisi nyore kunamatira panguva yekugadzirwa. Kunyanya kumishonga iyo iri nyore kutora unyoro uye isina kugadzikana, kuishandisa sechinhu chekuzviparadzanisa kunogona kuvandudza zvakanyanya kugadzikana kwemishonga uye kudzivirira Iyo firimu inoshandura ruvara. HPMC ine akasiyana e viscosity yakatarwa. Kana yakasarudzwa zvakanaka, kunaka uye kutaridzika kwemapiritsi akavharidzirwa ari pamusoro pezvimwe zvinhu. Iyo yakajairwa fungidziro ndeye 2% kusvika 10%.
Yechina yakaita se capsule material. Mumakore achangopfuura, nekubuda kwakawanda kwezvirwere zvemhuka zvepasirese, zvichienzaniswa negelatin capsules, macapsules emiriwo ave mudiwa mutsva weindasitiri yemishonga neyekudya. Pfizer yeUnited States yakabudirira kubvisa HPMC kubva mumiti yakasikwa uye yakagadzirira VcapTM yemiriwo capsules. Kuenzaniswa neyechinyakare gelatin hollow capsules, chirimwa macapsules ane zvakanakira kuchinjika kwakafara, hapana njodzi yekuyambuka-inobatanidza maitiro uye kugadzikana kwakanyanya. Mutengo wekuburitsa zvinodhaka wakanyanya kugadzikana, uye misiyano yemunhu idiki. Mushure mekuparara kwemuviri wemunhu, haibatiki uye inogona kubudiswa Mushonga wacho unobudiswa kubva mumuviri. Panyaya yemamiriro ekuchengetedza, mushure mehuwandu hukuru hwekuyedzwa, inenge isina brittle pasi pehunyoro hunyoro, uye zvimiro zvekapule shell zvichiri kugadzikana pasi pemamiriro ehunyoro hwepamusoro, uye zviratidzo zvechirimwa capsules hazvikanganisike pasi pekuchengetedza kwakanyanya. mamiriro. Nekunzwisisa kwevanhu kwemakapisi echirimwa uye shanduko yepfungwa dzemishonga yeruzhinji kumba nekune dzimwe nyika, kudiwa kwemusika kwemakapisi echirimwa kuchakura nekukurumidza.
Yechishanu yakaita semumiririri wekumisa. Suspension-type liquid gadziriro inowanzoshandiswa kukiriniki dosage fomu, iri heterogeneous dispersion system umo isinganyunguriki yakasimba mishonga inoparadzirwa mumvura yekuparadzira svikiro. Iko kugadzikana kwegadziriro inogadzirisa hutano hwekugadzirisa mvura yekugadzirira. HPMC colloidal mhinduro inogona kuderedza iyo yakasimba-yemvura yepakati tension, kuderedza pamusoro pemahara simba rezvimedu zvakasimba, uye kudzikamisa iyo heterogeneous dispersion system. Iyo yakanakisa suspending agent. HPMC inoshandiswa semukobvu wemadonhwe emeso, ine zvinyorwa zve 0.45% kusvika 1.0%.
Hydroxypropyl cellulose:
Hydroxypropyl cellulose (HPC) isiri-ionic cellulose imwe ether yakagadzirwa kubva mudonje nehuni kuburikidza nealkalization uye propylene oxide etherification. HPC inowanzonyungudika mumvura iri pasi pe40 ° C uye nhamba yakawanda ye polar solvents, uye kushanda kwayo kunoenderana nezviri muboka re hydroxypropyl uye chiyero chepolymerization. HPC inogona kuenderana nemishonga yakasiyana-siyana uye ine inertia yakanaka.
Yakaderera-inotsiva hydroxypropyl cellulose (L-HPC) inonyanya kushandiswa sepiritsi disintegrant uye binder. -HPC inogona kuvandudza kuoma uye kupenya kwehwendefa, uye inogonawo kuita kuti tablet racho riparare nokukurumidza, kuvandudza mukati mehutano hwepiritsi, uye kuvandudza maitiro ekurapa.
Highly substituted hydroxypropyl cellulose (H-HPC) inogona kushandiswa sebhainda remapiritsi, magranules, uye magranules akanaka mumunda wemishonga. H-HPC ine yakanakisa firimu-inogadzira zvimiro, uye iyo yakawanikwa firimu yakaoma uye elastic, iyo inogona kufananidzwa ne plasticizers. Kuita kwefirimu kunogona kuvandudzwa nekusanganiswa nemamwe majeti anodzivirira kunyorova, uye inowanzoshandiswa semafirimu ekuputira mahwendefa. H-HPC inogona zvakare kushandiswa sematrix zvinhu kugadzirira matrix akasimudzira-kuburitswa mahwendefa, anoramba achiburitswa-kuburitswa mapellets uye maviri-layer akatsigira-kuburitswa mahwendefa.
Hydroxyethyl cellulose
Hydroxyethyl cellulose (HEC) isiri-ionic cellulose imwe ether yakagadzirwa kubva mudonje nehuni kuburikidza nealkalization uye etherification ye ethylene oxide. Mumunda wemishonga, HEC inonyanya kushandiswa seyakakora, colloidal inodzivirira agent, adhesive, dispersant, stabilizer, suspending agent, film-forming agent uye inochengetedza-kusunungurwa zvinhu, uye inogona kushandiswa kune topical emulsions, mafuta, madonhwe emeso, Oral liquid, yakasimba piritsi, capsule uye mamwe mafomu ekuyedza. Hydroxyethyl cellulose yakanyorwa muUS Pharmacopoeia/US National Formulary uye European Pharmacopoeia.
Ethyl cellulose:
Ethyl cellulose (EC) ndeimwe yeanonyanya kushandiswa mvura-insoluble cellulose derivatives. EC haina muchetura, yakagadzikana, isinganyungudika mumvura, asidhi kana alkali mhinduro, uye inonyungudika muorganic solvents senge ethanol uye methanol. Inonyanya kushandiswa solvent ndeye toluene/ethanol se4/1 (huremu) yakasanganiswa solvent. EC ine mashandisiro mazhinji mukugadzirira-kuburitswa kwezvinodhaka, kushandiswa zvakanyanya sevatakuri, mamicrocapsules, uye kupfekedza firimu-kugadzira zvinhu zvekugadzirira-kuburitswa gadziriro, senge mapiritsi blockers, adhesives, uye firimu rekupfekedza zvinhu, rinoshandiswa sematrix zvinhu firimu kugadzirira. marudzi akasiyana-siyana emapiritsi e-matrix akatsigira-kusunungurwa, anoshandiswa sechinhu chakavhenganiswa kugadzirira akavharidzirwa-kusunungurwa-kusunungurwa gadziriro, kusunungurwa-kusunungurwa pellets, uye kushandiswa se encapsulation zvinhu zvekubatsira kugadzirira kusunungurwa-kusunungurwa microcapsules; inogonawo kushandiswa zvakanyanya sechinhu chinotakura Pakugadzirira kwekupararira kwakasimba; yakashandiswa zvakanyanya muhunyanzvi hwekugadzira mishonga sechinhu chekugadzira firimu uye chekudzivirira, pamwe nebinder uye filler. Sekudzivirira kwekudzivirira kwepiritsi, inogona kuderedza kunzwisiswa kwehwendefa kune hunyoro uye kudzivirira mushonga kuti urege kukanganiswa nehunyoro, kupera uye kuora; inogona zvakare kugadzira inononoka-kuburitsa gel layer, microencapsulate iyo polymer, uye inogonesa kuburitswa kwakasimba kweiyo mushonga.
Nguva yekutumira: Feb-04-2023