Zothandizira zamankhwala ndizothandizira komanso zothandizira zomwe zimagwiritsidwa ntchito popanga mankhwala ndi kupanga zolemba, ndipo ndizofunikira kwambiri pokonzekera mankhwala. Monga zinthu zachilengedwe zochokera ku polima, cellulose ether ili ndi mawonekedwe a biodegradability, non-toxicity, ndi mtengo wotsika, monga sodium carboxymethyl cellulose, methyl cellulose, hydroxypropyl methyl cellulose, hydroxypropyl cellulose,Ma cellulose ethersmonga hydroxyethyl cellulose ndi ethyl cellulose ali ndi ntchito yofunikira muzothandizira zamankhwala. Pakalipano, mankhwala a makampani ambiri apanyumba a cellulose ether amagwiritsidwa ntchito makamaka pakati ndi otsika-kumapeto minda ya mafakitale, ndipo mtengo wowonjezera si mkulu. Makampaniwa akuyenera kusintha mwachangu ndikukweza ndikuwongolera magwiridwe antchito apamwamba azinthu.
Zothandizira zamankhwala zimagwira ntchito yofunika kwambiri pakupanga ndi kupanga mapangidwe. Mwachitsanzo, pokonzekera kumasulidwa kosalekeza, zipangizo za polima monga ma cellulose ethers zimagwiritsidwa ntchito ngati zowonjezera mankhwala m'ma pellets otulutsidwa mosalekeza, mitundu yosiyanasiyana ya matrix yotulutsidwa, yophimbidwa ndi kumasulidwa kosalekeza, makapisozi omasulidwa, mafilimu otulutsa mankhwala osokoneza bongo, ndi mankhwala osokoneza bongo. Kukonzekera ndi kukonzekera kwamadzimadzi kosalekeza kwagwiritsidwa ntchito kwambiri. M'dongosolo lino, ma polima monga ma cellulose ethers amagwiritsidwa ntchito ngati zonyamulira mankhwala kuti aziwongolera kuchuluka kwa mankhwala m'thupi la munthu, ndiye kuti, amafunikira kumasulidwa pang'onopang'ono m'thupi pamlingo wokhazikitsidwa mkati mwa nthawi inayake kuti akwaniritse cholinga chamankhwala othandizira.
Malinga ndi ziwerengero za Consulting and Research Department, pali mitundu pafupifupi 500 ya zinthu zothandiza pamsika m'dziko langa, koma poyerekeza ndi United States (mitundu yopitilira 1500) ndi European Union (mitundu yopitilira 3000), pali kusiyana kwakukulu, ndipo mitunduyo ikadali yaying'ono. Zothandizira zamankhwala mdziko langa Kuthekera kwa msika ndikwambiri. Zikumveka kuti zida khumi zapamwamba zopangira mankhwala pamsika wadziko langa ndi makapisozi a gelatin, sucrose, wowuma, ufa wopaka filimu, 1,2-propylene glycol, PVP, hydroxypropyl methylcellulose (HPMC), ndi ulusi wa microcrystalline. Zamasamba, HPC, lactose.
"Natural mapadi etere ndi mawu ambiri kwa mndandanda wa zotumphukira mapadi opangidwa ndi zimene alkali mapadi ndi etherifying wothandizila pa zinthu zina, ndipo ndi mankhwala imene magulu hydroxyl pa mapadi macromolecule ndi pang'ono kapena kwathunthu m'malo ndi magulu ether. minda, mankhwala-kalasi mankhwala kwenikweni pakati ndi mkulu-mapeto madera a makampani ndi mkulu anawonjezera mtengo Chifukwa okhwima zofunika khalidwe, kupanga mankhwala-kalasi mapadi ethers ndi kovuta kuti khalidwe la mankhwala-kalasi mankhwala akhoza kwenikweni kuimira mphamvu luso la cellulose etha mabizinezi owonjezera ndi mabizinesi ang'onoang'ono mapiritsi otulutsa matrix okhazikika, zida zokutira zosungunuka zam'mimba, zida zomangira za microcapsule zokhazikika, zida zamakanema zama mankhwala osokoneza bongo, etc.
Sodium carboxymethyl cellulose (CMC-Na) ndiye ether ya cellulose yomwe imakhala ndi zotulutsa zazikulu komanso zogwiritsidwa ntchito kunyumba ndi kunja. Ndi ionic cellulose ether yopangidwa kuchokera ku thonje ndi matabwa kudzera mu alkalization ndi etherification ndi chloroacetic acid. CMC-Na ndi mankhwala omwe amagwiritsidwa ntchito kwambiri. Nthawi zambiri amagwiritsidwa ntchito ngati chomangira pokonzekera zolimba komanso ngati thickening, thickening ndi kuyimitsa wothandizira pakukonzekera madzi. Itha kugwiritsidwanso ntchito ngati matrix osungunuka m'madzi komanso kupanga filimu. Nthawi zambiri amagwiritsidwa ntchito ngati filimu yamankhwala osasunthika komanso piritsi la matrix lomasulidwa mosalekeza (loyendetsedwa) lomasulidwa.
Kuphatikiza pa sodium carboxymethyl cellulose monga zopangira mankhwala, croscarmellose sodium itha kugwiritsidwanso ntchito ngati mankhwala othandizira. Cross-linked carboxymethyl cellulose sodium (CCMC-Na) ndi chinthu chosasungunuka m'madzi chomwe carboxymethyl cellulose imakhudzidwa ndi chinthu cholumikizira pa kutentha kwina (40-80 ° C) pansi pa zochita za chothandizira cha inorganic acid ndipo imayeretsedwa. The crosslinking wothandizira akhoza kukhala propylene glycol, succinic anhydride, maleic anhydride, adipic anhydride, ndi zina zotero. Croscarmellose sodium amagwiritsidwa ntchito ngati disintegrant pamapiritsi, makapisozi ndi ma granules pokonzekera pakamwa. Amadalira capillary ndi kutupa zotsatira kuti akwaniritse kupasuka. Ili ndi compressibility yabwino komanso kupatukana mwamphamvu. Kafukufuku wawonetsa kuti kuchuluka kwa kutupa kwa croscarmellose sodium m'madzi ndikwambiri kuposa zomwe zimaphatikizidwira wamba monga sodium carboxymethyl cellulose ndi hydrated microcrystalline cellulose.
Methyl cellulose (MC) ndi non-ionic cellulose monoether wopangidwa kuchokera ku thonje ndi matabwa kudzera mu alkalization ndi methyl chloride etherification. Methyl cellulose imakhala ndi kusungunuka kwamadzi bwino kwambiri ndipo imakhala yokhazikika pa pH ya 2.0 mpaka 13.0. Amagwiritsidwa ntchito kwambiri pamankhwala othandizira mankhwala, ndipo amagwiritsidwa ntchito m'mapiritsi a sublingual, jekeseni wa intramuscular, ophthalmic kukonzekera, makapisozi a m'kamwa, kuyimitsidwa kwapakamwa, mapiritsi am'kamwa ndi mankhwala apakhungu. Kuphatikiza apo, pakutulutsa kosalekeza, MC imatha kugwiritsidwa ntchito ngati hydrophilic gel matrix yokhazikika yotulutsa, chapamimba chosungunuka cham'mimba, zinthu zopangira ma microcapsule, zotulutsa zotulutsa zotulutsa, ndi zina zambiri.
Hydroxypropyl methylcellulose (HPMC) ndi cellulose yosakanizidwa ndi ether yopangidwa kuchokera ku thonje ndi nkhuni kudzera mu alkalization ndi etherification ya propylene oxide ndi methyl chloride. Ndiwopanda fungo, wosakoma, wopanda poizoni, wosungunuka m'madzi ozizira, ndi gels m'madzi otentha. Hydroxypropyl methylcellulose ndi mtundu wa ether wosakanizidwa wa cellulose womwe wakhala ukuchulukirachulukira pakupanga, kugwiritsidwa ntchito komanso mtundu wabwino m'zaka 15 zapitazi. Ndi imodzi mwazinthu zazikulu zothandizira mankhwala zomwe zimagwiritsidwa ntchito kunyumba ndi kunja. Zakhala zikugwiritsidwa ntchito ngati chithandizo chamankhwala kwa zaka pafupifupi 50. Zaka za mbiriyakale. Pakadali pano, kugwiritsa ntchito kwa HPMC kumawonekera kwambiri pazinthu zisanu izi:
Mmodzi ali ngati womangira ndi disntegrant. HPMC monga binder ikhoza kupangitsa kuti mankhwalawa akhale osavuta kunyowa, ndipo amatha kukulitsa nthawi mazanamazana atatha kuyamwa madzi, kotero amatha kusintha kwambiri kusungunuka kapena kumasulidwa kwa piritsi. HPMC ali mamasukidwe akayendedwe amphamvu, ndipo akhoza kumapangitsanso kukhuthala kwa tinthu ndi kusintha compressibility wa zipangizo ndi khirisipi kapena zolimba kapangidwe. HPMC ndi mamasukidwe otsika angagwiritsidwe ntchito ngati binder ndi disintegrant, ndi HPMC ndi kukhuthala mkulu angagwiritsidwe ntchito ngati binder.
Kachiwiri, imagwiritsidwa ntchito ngati chinthu chokhazikika komanso chowongolera pokonzekera pakamwa. HPMC ndi zinthu zomwe zimagwiritsidwa ntchito kwambiri ndi hydrogel matrix pokonzekera kumasulidwa kosalekeza. HPMC ya otsika mamasukidwe akayendedwe kalasi (5～50mPa·s) angagwiritsidwe ntchito ngati binder, mamasukidwe akayendedwe kuwonjezeka wothandizila ndi suspending wothandizira, ndi HPMC wa mkulu mamasukidwe akayendedwe kalasi (4000 ~ 100000mPa·s) angagwiritsidwe ntchito pokonzekera osakaniza zinthu masanjidwewo osalekeza-kumasulidwa mapiritsi ndi kupitiriza kumasulidwa gel osakaniza mapiritsi hydrophilic gel osakaniza. mapiritsi otulutsidwa mosalekeza. HPMC ndi sungunuka madzimadzi m'mimba, ali ubwino compressibility wabwino, fluidity, wamphamvu mankhwala Mumakonda mphamvu ndi mankhwala kumasulidwa makhalidwe osakhudzidwa ndi pH. Ndi chinthu chofunikira kwambiri chonyamula ma hydrophilic pamakina okonzekera kumasulidwa ndipo nthawi zambiri amagwiritsidwa ntchito ngati The hydrophilic gel matrix ndi zokutira pokonzekera kumasulidwa kosalekeza, ndipo amagwiritsidwa ntchito pokonzekera zoyandama zam'mimba komanso kutulutsa kosalekeza kwa nembanemba yamankhwala othandizira.
Chachitatu ndi chophikira chopangira mafilimu.Mtengo wa HPMCali ndi zinthu zabwino zopangira mafilimu. Filimu yopangidwa ndi iyo ndi yofanana, yowonekera, komanso yolimba, ndipo sikophweka kumamatira panthawi yopanga. Makamaka mankhwala omwe ndi osavuta kuyamwa chinyezi komanso osakhazikika, kugwiritsa ntchito ngati kusanjikiza kwapadera kumatha kusintha kwambiri kukhazikika kwa mankhwalawa ndikuletsa Filimuyo imasintha mtundu. HPMC ali zosiyanasiyana kukhuthala makulidwe. Ngati asankhidwa bwino, mawonekedwe ndi mawonekedwe a mapiritsi okutidwa ndi abwino kuposa zida zina, ndipo ndende yake yodziwika bwino ndi 2% mpaka 10%.
Zinayi zimagwiritsidwa ntchito ngati kapisozi. M'zaka zaposachedwa, chifukwa cha miliri yapadziko lonse lapansi ya miliri ya nyama, poyerekeza ndi makapisozi a gelatin, makapisozi a zomera akhala otchuka kwambiri m'makampani opanga mankhwala ndi zakudya. Pfizer yatulutsa bwino HPMC ku zomera zachilengedwe ndikukonza makapisozi a masamba a VcapTM. Poyerekeza ndi makapisozi amtundu wa gelatin, makapisozi amasamba ali ndi zabwino zambiri zosinthika, palibe chiopsezo cholumikizirana, komanso kukhazikika kwakukulu. Mlingo wotulutsa mankhwalawa ndi wokhazikika, ndipo kusiyana kwapayekha kumakhala kochepa. Pambuyo pakuwonongeka m'thupi la munthu, sichimatengedwa ndipo chikhoza kuchotsedwa. Kutuluka m'thupi. Pankhani yosungirako, pambuyo poyesedwa kwambiri, imakhala yosasunthika pansi pa chinyezi chochepa, ndipo katundu wa chipolopolo cha capsule akadali okhazikika pansi pa chinyezi chambiri, ndipo zolemba zosiyanasiyana za makapisozi a zomera pansi pazikhalidwe zosungirako kwambiri sizikhudzidwa. Ndi kumvetsetsa kwa anthu za makapisozi a zomera ndi kusintha kwa malingaliro amankhwala a anthu kunyumba ndi kunja, kufunikira kwa msika wa makapisozi a zomera kudzakula mofulumira.
Chachisanu ndi monga suspending agent. Kuyimitsidwa kwamadzi amtundu wa kuyimitsidwa ndi njira yomwe imagwiritsidwa ntchito kwambiri pachipatala mlingo, womwe ndi njira yosasinthika yobalalika yomwe mankhwala osasungunuka olimba amamwazikana mu sing'anga yamadzimadzi. Kukhazikika kwa dongosolo kumatsimikizira khalidwe la kuyimitsidwa kwamadzimadzi kukonzekera. HPMC colloidal njira akhoza kuchepetsa olimba-zamadzimadzi interfacial mavuto, kuchepetsa padziko ufulu mphamvu ya particles olimba, ndi kukhazikika ndi sakanikira kubalalitsidwa dongosolo. Ndi chithandizo chabwino kwambiri choyimitsa. HPMC imagwiritsidwa ntchito ngati thickener kwa madontho a maso, okhala ndi 0.45% mpaka 1.0%.
Hydroxypropyl cellulose (HPC) ndi cellulose monoether yopanda ionic yopangidwa kuchokera ku thonje ndi matabwa kudzera mu alkalization ndi propylene oxide etherification. HPC nthawi zambiri imasungunuka m'madzi pansi pa 40 ° C ndi zosungunulira zambiri za polar, ndipo ntchito yake imagwirizana ndi zomwe zili mu hydroxypropyl ndi digiri ya polymerization. HPC ikhoza kukhala yogwirizana ndi mankhwala osiyanasiyana ndipo imakhala ndi inertness yabwino.
Ma cellulose otsika m'malo mwa hydroxypropyl(L-HPC)Amagwiritsidwa ntchito makamaka ngati piritsi la disintegrant ndi binder. Makhalidwe ake ndi awa: zosavuta kusindikiza ndi kupanga, kugwiritsidwa ntchito mwamphamvu, makamaka zovuta kupanga, mapiritsi apulasitiki ndi ophulika, kuwonjezera L-HPC ikhoza kusintha kuuma kwa piritsi ndi kuwala kwa maonekedwe, komanso kungapangitse kuti piritsilo liwonongeke mofulumira, kupititsa patsogolo ubwino wa mkati mwa piritsi, ndi kupititsa patsogolo machiritso.
High substituted hydroxypropyl cellulose (H-HPC) ingagwiritsidwe ntchito ngati chomangira pamapiritsi, ma granules ndi ma granules abwino m'munda wamankhwala. H-HPC ili ndi zinthu zabwino kwambiri zopangira mafilimu, ndipo filimuyo imakhala yolimba komanso yotanuka, yomwe ingafanane ndi mapulasitiki. Pophatikizana ndi mankhwala ena oletsa kunyowa, ntchito ya filimuyo imatha kupitilira patsogolo, ndipo nthawi zambiri imagwiritsidwa ntchito ngati filimu yopangira mapiritsi. H-HPC itha kugwiritsidwanso ntchito ngati matrix pokonzekera mapiritsi otulutsa matrix, ma pellets otulutsa mosalekeza ndi mapiritsi otulutsa osanjikiza kawiri.
Hydroxyethyl cellulose (HEC) ndi non-ionic cellulose monoether opangidwa kuchokera thonje ndi nkhuni kudzera alkalization ndi ethylene oxide etherification. HEC imagwiritsidwa ntchito makamaka ngati thickener, colloidal protective agent, adhesive, dispersant, stabilizer, suspending agent, film-forming agent ndi zinthu zotulutsidwa pang'onopang'ono m'chipatala. Angagwiritsidwe ntchito emulsions, mafuta odzola, ndi madontho a maso pa mankhwala apakhungu. Madzi amkamwa, mapiritsi olimba, makapisozi ndi mitundu ina ya mlingo. Ma cellulose a Hydroxyethyl adaphatikizidwa mu US Pharmacopoeia/US National Formulary ndi European Pharmacopoeia.
Ethyl cellulose (EC) ndi imodzi mwazinthu zomwe zimagwiritsidwa ntchito kwambiri m'madzi opanda cellulose. EC ndi yopanda poizoni, yokhazikika, yosasungunuka m'madzi, asidi kapena zamchere, ndipo imasungunuka mu zosungunulira za organic monga ethanol ndi methanol. Chosungunulira chomwe chimagwiritsidwa ntchito kwambiri ndi chosungunulira chosakanikirana cha toluene/ethanol 4/1 (kulemera kwake). EC ali ndi ntchito zambiri mu mankhwala kupitiriza kumasulidwa kukonzekera, ndipo chimagwiritsidwa ntchito monga chonyamulira ndi microcapsules, ❖ kuyanika filimu kupanga zipangizo, etc. ya kukonzekera mosalekeza-kumasulidwa, monga piritsi retarders, zomatira, filimu ❖ kuyanika zipangizo, etc. Iwo amagwiritsidwa ntchito ngati masanjidwewo zinthu filimu kukonzekera mitundu yosiyanasiyana ya masanjidwewo zisathe-kumasulidwa kumasulidwa mapiritsi osakanikirana-kumasulidwa kumasulidwa, monga mankhwala osakanikirana-kumasulidwa kwa mapiritsi, ma pellets omasulidwa mosalekeza, monga chothandizira chothandizira kukonza ma microcapsules okhazikika; itha kugwiritsidwanso ntchito kwambiri ngati chonyamulira chakuthupi Imagwiritsidwa ntchito pokonzekera kufalikira kolimba; itha kugwiritsidwa ntchito kwambiri muukadaulo wamankhwala ngati chinthu chopanga filimu ndi zokutira zoteteza, ndipo itha kugwiritsidwanso ntchito ngati chomangira ndi chodzaza. Monga chophimba chotetezera mapiritsi, chikhoza kuchepetsa kukhudzidwa kwa mapiritsi ku chinyezi ndikuletsa mankhwala kuti asawonongeke ndikuwonongeka ndi chinyezi; imathanso kupanga guluu wosanjikiza pang'onopang'ono ndi microencapsulate polima kuti atulutse mosalekeza zotsatira za mankhwala.
Mwachidule, sodium carboxymethyl cellulose yosungunuka m'madzi, methyl cellulose, hydroxypropyl methyl cellulose, hydroxypropyl cellulose, hydroxyethyl cellulose ndi mafuta osungunuka a ethyl cellulose onse amatengera mawonekedwe awo. kukonzekera, zokutira zopangira mafilimu, zida za kapisozi ndi zoyimitsa. Kuyang'ana padziko lapansi, makampani angapo akunja akunja (Shin-Etsu Japan, Dow Wolff ndi Ashland) adazindikira msika waukulu wama cellulose opangira mankhwala ku China m'tsogolomu, ndipo mwina kuchuluka kwa kupanga kapena kuphatikiza, awonjezera kupezeka kwawo m'munda uno. Investment mkati mwa ntchito. Dow Wolff adalengeza kuti iwonjezera chidwi chake pakupanga, zosakaniza ndi zosowa za msika waku China wokonzekera mankhwala, ndipo kafukufuku wake wogwiritsa ntchito adzayesetsanso kuyandikira msika. Gulu la Wolff Cellulose Division la Dow Chemical ndi Colorcon Corporation la United States lakhazikitsa mgwirizano wokhazikika komanso woyendetsedwa wokonzekera kutulutsa padziko lonse lapansi. Ili ndi antchito opitilira 1,200 m'mizinda 9, mabungwe 15 azinthu ndi makampani 6 a GMP. Akatswiri ofufuza omwe agwiritsidwa ntchito amapereka chithandizo kwa makasitomala pafupifupi mayiko 160. Ashland ili ndi maziko opangira ku Beijing, Tianjin, Shanghai, Nanjing, Changzhou, Kunshan ndi Jiangmen, ndipo adayika ndalama m'malo atatu ofufuza zaukadaulo ku Shanghai ndi Nanjing.
Malinga ndi ziwerengero zochokera patsamba la China Cellulose Association, mu 2017, kupanga m'nyumba za cellulose ether kunali matani 373,000 ndipo kuchuluka kwa malonda kunali matani 360. Mu 2017, kuchuluka kwa malonda a ionicCMCanali matani 234,000, kuwonjezeka kwa 18,61% chaka ndi chaka, ndi malonda voliyumu ya sanali ionic CMC anali 126,000 matani, kuwonjezeka kwa 8,2% chaka ndi chaka. Kuphatikiza pa HPMC (kumanga zinthu kalasi) zinthu zopanda ionic,Mtengo wa HPMC(kalasi yamankhwala), HPMC (kalasi yazakudya), HEC, HPC, MC, HEMC, ndi zina zonse zawuka motsutsana ndi zomwe zikuchitika, ndipo kupanga ndi kugulitsa zikupitilira kukula. Ma cellulose ether apakhomo akhala akukula mofulumira kwa zaka zoposa khumi, ndipo zotulukapo zake zakhala zoyamba padziko lonse lapansi. Komabe, zinthu zambiri zamakampani a cellulose ether zimagwiritsidwa ntchito makamaka pakati ndi otsika kumapeto kwa mafakitale, ndipo mtengo wowonjezera siwokwera.
Pakadali pano, mabizinesi ambiri apanyumba a cellulose ether ali munthawi yovuta kwambiri yakusintha ndikukweza. Ayenera kupitiliza kukulitsa ntchito zofufuza ndi chitukuko, kupitiliza kulemeretsa mitundu yazinthu, kugwiritsa ntchito mokwanira China, msika waukulu kwambiri padziko lonse lapansi, ndikuwonjezera zoyesayesa zokulitsa misika yakunja kuti mabizinesi athe kukula mwachangu momwe angathere. Malizitsani kusintha ndi kukweza, lowetsani pakati mpaka pamwamba pamakampani, ndikupeza chitukuko chabwino komanso chobiriwira.
Nthawi yotumiza: Apr-25-2024