Zinthu zophatikizika ndi zinthu zophatikizika ndi zinthu zophatikizika zomwe zimagwiritsidwa ntchito popanga mankhwala ndi kupanga mankhwala, ndipo ndi gawo lofunikira kwambiri pakukonzekera mankhwala. Monga chinthu chachilengedwe chochokera ku polima, cellulose ether ili ndi mawonekedwe a kuwonongeka kwachilengedwe, osakhala poizoni, komanso mtengo wotsika, monga sodium carboxymethyl cellulose, methyl cellulose, hydroxypropyl methyl cellulose, hydroxypropyl cellulose,Ma ether a cellulosemonga hydroxyethyl cellulose ndi ethyl cellulose ndizofunikira kwambiri muzinthu zothandizira mankhwala. Pakadali pano, zinthu zomwe makampani ambiri opanga cellulose ether amagwiritsa ntchito m'mafakitale ambiri zimagwiritsidwa ntchito makamaka m'magawo apakati ndi otsika, ndipo mtengo wowonjezera si wokwera kwambiri. Makampaniwa akufunika kusintha mwachangu ndikukweza ndikukonza momwe zinthu zimagwiritsidwira ntchito kwambiri.
Zinthu zothandizira mankhwala zimagwira ntchito yofunika kwambiri pakupanga ndi kupanga mankhwala. Mwachitsanzo, pokonzekera zotulutsa mankhwala mokhazikika, zinthu za polima monga ma cellulose ethers zimagwiritsidwa ntchito ngati zinthu zothandizira mankhwala m'ma pellets otulutsidwa mokhazikika, mitundu yosiyanasiyana ya matrix sustained-release formulations, ma coated sustained-release formulations, ma capsules otulutsidwa mokhazikika, mafilimu a mankhwala otulutsidwa mokhazikika, ndi mankhwala a resin otulutsidwa mokhazikika. Zokonzekera ndi zokonzekera zamadzimadzi zotulutsidwa mokhazikika zakhala zikugwiritsidwa ntchito kwambiri. Mu dongosololi, ma polima monga ma cellulose ethers nthawi zambiri amagwiritsidwa ntchito ngati zonyamulira mankhwala kuti azilamulira kuchuluka kwa mankhwala otulutsidwa m'thupi la munthu, ndiko kuti, amafunika kutulutsidwa pang'onopang'ono m'thupi pamlingo wokhazikika mkati mwa nthawi inayake kuti akwaniritse cholinga chochiza bwino.
Malinga ndi ziwerengero za Dipatimenti Yoona za Uphungu ndi Kafukufuku, pali mitundu pafupifupi 500 ya zinthu zowonjezerera zomwe zili pamsika mdziko langa, koma poyerekeza ndi United States (mitundu yoposa 1500) ndi European Union (mitundu yoposa 3000), pali kusiyana kwakukulu, ndipo mitunduyo ikadali yaying'ono. Zinthu zowonjezerera mankhwala mdziko langa Mphamvu yakukula kwa msika ndi yayikulu. Zikumveka kuti zinthu khumi zapamwamba zowonjezerera mankhwala pamsika mdziko langa ndi makapisozi a gelatin, sucrose, starch, ufa wokutira filimu, 1,2-propylene glycol, PVP, hydroxypropyl methylcellulose (HPMC), ndi ulusi wa microcrystalline. Zamasamba, HPC, lactose.
"Natural cellulose ether ndi dzina lathunthu la mndandanda wa zinthu zochokera ku cellulose zomwe zimapangidwa ndi alkali cellulose ndi etherifying agent pansi pa mikhalidwe ina, ndipo ndi chinthu chomwe magulu a hydroxyl pa cellulose macromolecule amalowetsedwa pang'ono kapena kwathunthu ndi magulu a ether. Cellulose ethers amagwiritsidwa ntchito kwambiri m'magawo a mafuta, zipangizo zomangira, zokutira, chakudya, mankhwala ndi mankhwala a tsiku ndi tsiku. M'magawo onse, zinthu zopangira mankhwala zimakhala m'magawo apakati komanso apamwamba kwambiri m'makampani ndipo zimakhala ndi phindu lalikulu. Chifukwa cha zofunikira kwambiri paubwino, kupanga ma cellulose ethers a mankhwala kumakhala kovuta. Tikhoza kunena kuti ubwino wa zinthu zopangira mankhwala ukhoza kuyimira mphamvu yaukadaulo ya makampani a cellulose ether. Cellulose ether nthawi zambiri imawonjezedwa ngati retarder, matrix material ndi thickener kuti apange mapiritsi a matrix otulutsidwa nthawi yayitali, zinthu zopangira zophimba zosungunuka m'mimba, zinthu zopangira ma microcapsule zotulutsidwa nthawi yayitali, zinthu zopangira filimu ya mankhwala otulutsidwa nthawi yayitali, ndi zina zotero.
Sodium carboxymethyl cellulose (CMC-Na) ndi cellulose ether yomwe imatulutsa komanso imagwiritsa ntchito kwambiri kunyumba ndi kunja. Ndi ionic cellulose ether yopangidwa kuchokera ku thonje ndi matabwa kudzera mu alkalizing ndi etherification ndi chloroacetic acid. CMC-Na ndi mankhwala ogwiritsidwa ntchito kwambiri. Nthawi zambiri imagwiritsidwa ntchito ngati chomangira chokonzekera zolimba komanso ngati cholimbikitsira, chokulitsa, komanso choyimitsa zinthu zopangira madzi. Ingagwiritsidwenso ntchito ngati matrix yosungunuka m'madzi komanso chinthu chopanga filimu. Nthawi zambiri imagwiritsidwa ntchito ngati filimu yotulutsa mankhwala yotulutsa mankhwala yotulutsa komanso piritsi la matrix yotulutsa yotulutsa mu njira zotulutsira zokhazikika (zolamulidwa).
Kuwonjezera pa sodium carboxymethyl cellulose monga zinthu zothandizira mankhwala, croscarmellose sodium ingagwiritsidwenso ntchito ngati zinthu zothandizira mankhwala. Cross-linked carboxymethyl cellulose sodium (CCMC-Na) ndi chinthu chosasungunuka m'madzi chomwe carboxymethyl cellulose imakumana ndi chinthu cholumikizirana pa kutentha kwina (40-80°C) pansi pa mphamvu ya inorganic acid catalyst ndipo imayeretsedwa. Chothandizira cholumikiziranacho chingakhale propylene glycol, succinic anhydride, maleic anhydride, adipic anhydride, ndi zina zotero. Croscarmellose sodium imagwiritsidwa ntchito ngati chosakaniza mapiritsi, makapisozi ndi granules mu zokonzekera zamlomo. Imadalira zotsatira za capillary ndi kutupa kuti iwonongeke. Ili ndi kupsinjika kwabwino komanso kusweka kwamphamvu. Kafukufuku wasonyeza kuti kuchuluka kwa kutupa kwa croscarmellose sodium m'madzi ndi kwakukulu kuposa kwa zosweka wamba monga sodium carboxymethyl cellulose yotsika komanso hydrated microcrystalline cellulose.
Methyl cellulose (MC) ndi monoether ya cellulose yosakhala ionic yopangidwa kuchokera ku thonje ndi matabwa kudzera mu alkaliization ndi methyl chloride etherification. Methyl cellulose ili ndi madzi osungunuka bwino ndipo imakhala yokhazikika pa pH ya 2.0 mpaka 13.0. Imagwiritsidwa ntchito kwambiri mu zosakaniza zamankhwala, ndipo imagwiritsidwa ntchito m'mapiritsi a sublingual, jakisoni wa intramuscular, mankhwala opangidwa ndi maso, makapisozi omwa, mankhwala otsukira pakamwa, mapiritsi omwa ndi mankhwala opangidwa ndi pamwamba. Kuphatikiza apo, mu mankhwala opangidwa ndi suspension-release, MC ingagwiritsidwe ntchito ngati hydrophilic gel matrix supplement-release formulation, gastric-soluble coating material, supplement-release microcapsule packaging material, supplement-release drug film material, ndi zina zotero.
Hydroxypropyl methylcellulose (HPMC) ndi ether yosakanikirana ya cellulose yopangidwa kuchokera ku thonje ndi matabwa kudzera mu alkaliization ndi etherification ya propylene oxide ndi methyl chloride. Ndi yopanda fungo, yopanda kukoma, yopanda poizoni, yosungunuka m'madzi ozizira, ndi ma gels m'madzi otentha. Hydroxypropyl methylcellulose ndi mtundu wa ether wosakanikirana wa cellulose womwe wakhala ukuwonjezeka mofulumira popanga, kugwiritsa ntchito komanso khalidwe m'zaka 15 zapitazi. Ndi imodzi mwa zinthu zazikulu kwambiri zogwiritsira ntchito mankhwala zomwe zimagwiritsidwa ntchito kunyumba ndi kunja. Yagwiritsidwa ntchito ngati chowonjezera cha mankhwala kwa zaka pafupifupi 50. Zaka zambiri za mbiri. Pakadali pano, kugwiritsa ntchito HPMC kumawonekera makamaka m'mbali zisanu zotsatirazi:
Chimodzi ndi chomangirira ndi chopatukana. HPMC ngati chomangira chingapangitse kuti mankhwalawa anyowe mosavuta, ndipo amatha kufutukuka kambirimbiri atamwa madzi, kotero amatha kusintha kwambiri kusungunuka kapena kutulutsidwa kwa piritsi. HPMC ili ndi kukhuthala kwamphamvu, ndipo imatha kuwonjezera kukhuthala kwa tinthu tating'onoting'ono ndikukweza kupsinjika kwa zinthu zopangira ndi kapangidwe kolimba kapena kolimba. HPMC yokhala ndi kukhuthala kochepa ingagwiritsidwe ntchito ngati chomangirira ndi chopatukana, ndipo HPMC yokhala ndi kukhuthala kwakukulu ingagwiritsidwe ntchito ngati chomangira.
Kachiwiri, imagwiritsidwa ntchito ngati zinthu zotulutsira madzi zomwe zimakonzedwa pakamwa. HPMC ndi chinthu chogwiritsidwa ntchito kwambiri cha hydrogel matrix mu zokonzekera zotulutsira madzi zomwe zimakonzedwa nthawi zonse. HPMC ya kalasi yotsika ya viscosity (5 ~ 50mPa·s) ingagwiritsidwe ntchito ngati chomangirira, chowonjezera viscosity ndi choyimitsa, ndipo HPMC ya kalasi yotsika ya viscosity (4000 ~ 100000mPa·s) ingagwiritsidwe ntchito pokonzekera mapiritsi osakanikirana a matrix sustainable-release ndi Blocker sustainable-release ya makapisozi ndi mapiritsi a hydrophilic gel matrix sustainable-release. HPMC imasungunuka m'madzi am'mimba, ili ndi ubwino wopanikizika bwino, kusinthasintha bwino, mphamvu yayikulu yonyamula mankhwala komanso mawonekedwe otulutsa mankhwala osakhudzidwa ndi pH. Ndi chinthu chofunikira kwambiri chonyamula madzi m'makonzedwe okonzekera otulutsidwa nthawi zonse ndipo nthawi zambiri chimagwiritsidwa ntchito ngati hydrophilic gel matrix ndi zinthu zokutira za zokonzekera zotulutsidwa nthawi zonse, ndipo imagwiritsidwa ntchito mu zokonzekera zoyandama m'mimba ndi zinthu zothandizira za nembanemba ya mankhwala.
Chachitatu ndi chopangira filimu.HPMCIli ndi mphamvu zabwino zopangira filimu. Filimu yopangidwa nayo ndi yofanana, yowonekera bwino, komanso yolimba, ndipo sikophweka kuimamatira panthawi yopanga. Makamaka mankhwala omwe ndi osavuta kuyamwa chinyezi komanso osakhazikika, kugwiritsa ntchito ngati gawo lodzipatula kungathandize kwambiri kukhazikika kwa mankhwala ndikuletsa Filimuyo imasintha mtundu. HPMC ili ndi mitundu yosiyanasiyana ya ma viscosity. Ngati yasankhidwa bwino, ubwino ndi mawonekedwe a mapiritsi ophimbidwa ndi abwino kuposa zipangizo zina, ndipo kuchuluka kwake kofala ndi 2% mpaka 10%.
Four imagwiritsidwa ntchito ngati kapisozi. M'zaka zaposachedwa, chifukwa cha kufalikira kwa miliri ya ziweto padziko lonse lapansi, poyerekeza ndi makapisozi a gelatin, makapisozi a zomera akhala okondedwa atsopano m'makampani opanga mankhwala ndi chakudya. Pfizer yatulutsa bwino HPMC kuchokera ku zomera zachilengedwe ndi kukonza makapisozi a masamba a VcapTM. Poyerekeza ndi makapisozi achikhalidwe a gelatin, makapisozi a masamba ali ndi ubwino wosinthasintha kwambiri, palibe chiopsezo cha cross-linking reaction, komanso kukhazikika kwakukulu. Kuchuluka kwa mankhwala otulutsidwa ndi kokhazikika, ndipo kusiyana kwa munthu payekha kumakhala kochepa. Pambuyo powonongeka m'thupi la munthu, siimayamwa ndipo imatha kutulutsidwa. Imachotsedwa m'thupi. Ponena za momwe zinthu zimasungidwira, pambuyo pa mayeso ambiri, imakhala yosalimba kwambiri pansi pa chinyezi chochepa, ndipo mawonekedwe a chipolopolo cha kapisozi akadali okhazikika pansi pa chinyezi chambiri, ndipo ma index osiyanasiyana a makapisozi a zomera pansi pa malo osungira kwambiri sakhudzidwa. Ndi kumvetsetsa kwa anthu makapisozi a zomera ndi kusintha kwa malingaliro azachipatala apagulu kunyumba ndi kunja, kufunikira kwa msika wa makapisozi a zomera kudzakula mwachangu.
Chachisanu ndi chopangira mankhwala oletsa kuipitsa. Kukonzekera kwa madzi amtundu wa suspension ndi njira yodziwika bwino yogwiritsira ntchito, yomwe ndi njira yosiyana yofalitsira mankhwala momwe mankhwala olimba omwe sangasungunuke kwambiri amamwazidwira mu njira yofalitsira madzi. Kukhazikika kwa dongosololi kumatsimikizira mtundu wa mankhwala oletsa kuipitsa. HPMC colloidal solution imatha kuchepetsa kupsinjika kwa madzi olimba, kuchepetsa mphamvu yopanda pamwamba ya tinthu tolimba, ndikukhazikitsa njira yofalitsira yosiyana. Ndi njira yabwino kwambiri yofalitsira. HPMC imagwiritsidwa ntchito ngati chokhuthala cha madontho a m'maso, chokhala ndi 0.45% mpaka 1.0%.
Hydroxypropyl cellulose (HPC) ndi monoether ya cellulose yosakhala ionic yopangidwa kuchokera ku thonje ndi matabwa kudzera mu alkalization ndi propylene oxide etherification. HPC nthawi zambiri imasungunuka m'madzi pansi pa 40°C komanso kuchuluka kwa ma polar solvents, ndipo magwiridwe ake amakhudzana ndi kuchuluka kwa hydroxypropyl ndi kuchuluka kwa polymerization. HPC imatha kugwirizana ndi mankhwala osiyanasiyana ndipo imakhala ndi kusakhala bwino kwa zinthu.
Hydroxypropyl cellulose yosinthidwa pang'ono(L-HPC)imagwiritsidwa ntchito makamaka ngati chosungunula piritsi ndi chomangira. Makhalidwe ake ndi awa: osavuta kukanikiza ndi kupanga, kugwiritsa ntchito mwamphamvu, makamaka kovuta kupanga, mapiritsi apulasitiki ndi osweka, kuwonjezera L -HPC kumatha kulimbitsa kuuma kwa piritsi ndi kuwala kwa mawonekedwe, ndipo kungapangitsenso piritsi kusweka mwachangu, kukweza khalidwe lamkati la piritsi, ndikuwonjezera mphamvu yochiritsa.
Hydroxypropyl cellulose (H-HPC) yosinthidwa kwambiri ingagwiritsidwe ntchito ngati chomangira mapiritsi, ma granules ndi ma granules abwino m'munda wa mankhwala. H-HPC ili ndi mphamvu zabwino kwambiri zopangira filimu, ndipo filimu yomwe imachokera ndi yolimba komanso yotanuka, yomwe ingayerekezeredwe ndi ma plasticizers. Posakaniza ndi zinthu zina zoteteza kunyowa, magwiridwe antchito a filimuyi amatha kuwongoleredwa, ndipo nthawi zambiri imagwiritsidwa ntchito ngati zinthu zotetezera filimu pamapiritsi. H-HPC ingagwiritsidwenso ntchito ngati zinthu zotetezera matrix kukonzekera mapiritsi oteteza matrix, ma granules oteteza matrix ndi mapiritsi oteteza matrix awiri.
Hydroxyethyl cellulose (HEC) ndi monoether ya cellulose yosakhala ionic yopangidwa kuchokera ku thonje ndi matabwa kudzera mu alkalizing ndi ethylene oxide etherification. HEC imagwiritsidwa ntchito makamaka ngati chokhuthala, choteteza colloidal, chomatira, chosungunula, chokhazikika, choyimitsa, chopangira filimu komanso chotulutsa pang'onopang'ono m'munda wazachipatala. Itha kugwiritsidwa ntchito pa emulsions, mafuta odzola, ndi madontho a maso ngati mankhwala apakhungu. Madzi omwa, mapiritsi olimba, makapisozi ndi mitundu ina ya mlingo. Hydroxyethyl cellulose yaphatikizidwa mu US Pharmacopoeia/US National Formulary ndi European Pharmacopoeia.
Ethyl cellulose (EC) ndi imodzi mwa zinthu zomwe zimagwiritsidwa ntchito kwambiri popanga cellulose zomwe sizisungunuka m'madzi. EC si poizoni, yokhazikika, yosasungunuka m'madzi, acid kapena alkaline solutions, ndipo imasungunuka mu organic solvents monga ethanol ndi methanol. Chosungunulira chomwe chimagwiritsidwa ntchito kwambiri ndi chosungunulira chosakanikirana cha toluene/ethanol 4/1 (kulemera). EC imagwiritsidwa ntchito kwambiri popanga mankhwala otulutsidwa nthawi zonse, ndipo imagwiritsidwa ntchito kwambiri ngati chonyamulira ndi microcapsules, zokutira filimu, ndi zina zotero monga zopangira zotulutsidwa nthawi zonse, monga mapiritsi oletsa mapiritsi, zomatira, zipangizo zokutira filimu, ndi zina zotero. Imagwiritsidwa ntchito ngati filimu ya matrix kukonzekera mitundu yosiyanasiyana ya mapiritsi otulutsidwa nthawi zonse, ngati zinthu zosakanikirana zokonzekera zopangira zotsekedwa nthawi zonse ndi ma pellets otulutsidwa nthawi zonse, ngati chinthu chothandizira chopangira ma microcapsules otulutsidwa nthawi zonse; ingagwiritsidwenso ntchito kwambiri ngati chinthu chonyamulira. Imagwiritsidwa ntchito pokonzekera zosakaniza zolimba; ingagwiritsidwe ntchito kwambiri muukadaulo wamankhwala ngati chinthu chopangira filimu ndi chophimba choteteza, ndipo ingagwiritsidwenso ntchito ngati chomangirira ndi chodzaza. Monga chophimba choteteza mapiritsi, chingachepetse kukhudzidwa kwa mapiritsi ndi chinyezi ndikuletsa mankhwalawo kuti asasinthe mtundu ndi kuwonongeka ndi chinyezi; chingapangenso guluu wotulutsa pang'onopang'ono ndikuyika pang'onopang'ono polima kuti atulutse mphamvu ya mankhwalawa mosalekeza.
Mwachidule, sodium carboxymethyl cellulose yosungunuka m'madzi, methyl cellulose, hydroxypropyl methyl cellulose, hydroxyethyl cellulose ndi ethyl cellulose yosungunuka ndi mafuta zonse zimadalira zomwe zili. Makhalidwe a mankhwalawa amagwiritsidwa ntchito mu zinthu zosakaniza mankhwala monga zomatira, zosungunuka, zinthu zotulutsidwa zomwe zimasungidwa komanso zolamulidwa kuti zigwiritsidwe ntchito pakamwa, zopangira mafilimu, zinthu zopangira makapisozi ndi zinthu zomangira. Poyang'ana padziko lonse lapansi, makampani angapo akunja (Shin-Etsu Japan, Dow Wolff ndi Ashland) adazindikira msika waukulu wa cellulose ya mankhwala ku China mtsogolo, ndipo mwina atawonjezera kupanga kapena kuphatikizana, awonjezera kupezeka kwawo m'munda uno. Ndalama zomwe zimagwiritsidwa ntchito. Dow Wolff yalengeza kuti iwonjezera chidwi chake pakupanga, zosakaniza ndi zosowa za msika wokonzekera mankhwala waku China, ndipo kafukufuku wake wogwiritsa ntchito adzayesetsanso kuyandikira msika. Dipatimenti ya Wolff Cellulose ya Dow Chemical and Colorcon Corporation ya ku United States yakhazikitsa mgwirizano wokhazikika komanso wolamulidwa padziko lonse lapansi. Ili ndi antchito oposa 1,200 m'mizinda 9, mabungwe 15 a chuma ndi makampani 6 a GMP. Akatswiri ofufuza omwe amagwiritsa ntchito ntchito amapereka chithandizo kwa makasitomala m'maiko pafupifupi 160. Ashland ili ndi malo opangira zinthu ku Beijing, Tianjin, Shanghai, Nanjing, Changzhou, Kunshan ndi Jiangmen, ndipo yayika ndalama m'malo atatu ofufuzira zaukadaulo ku Shanghai ndi Nanjing.
Malinga ndi ziwerengero kuchokera patsamba lawebusayiti la China Cellulose Association, mu 2017, kupanga kwa cellulose ether m'nyumba kunali matani 373,000 ndipo kuchuluka kwa malonda kunali matani 360,000. Mu 2017, kuchuluka kwenikweni kwa malonda a ionicCMCinali matani 234,000, kuwonjezeka kwa 18.61% pachaka, ndipo kuchuluka kwa malonda a non-ionic CMC kunali matani 126,000, kuwonjezeka kwa 8.2% pachaka. Kuwonjezera pa HPMC (gulu la zipangizo zomangira) zinthu zosakhala ionic,HPMC(mankhwala), HPMC (chakudya), HEC, HPC, MC, HEMC, ndi zina zotero zonse zakwera motsutsana ndi zomwe zikuchitika, ndipo kupanga ndi kugulitsa kwapitirira kukwera. Ma ether a cellulose apakhomo akhala akukula mofulumira kwa zaka zoposa khumi, ndipo zokolola zake zakhala zoyamba padziko lonse lapansi. Komabe, zinthu zambiri za makampani a cellulose ether zimagwiritsidwa ntchito makamaka pakati ndi pansi pamakampani, ndipo mtengo wowonjezera si wapamwamba.
Pakadali pano, makampani ambiri a cellulose ether akunyumba ali mu nthawi yovuta kwambiri yosintha ndi kukweza. Ayenera kupitiriza kuwonjezera kafukufuku wazinthu ndi chitukuko, kupititsa patsogolo mitundu yazinthu nthawi zonse, kugwiritsa ntchito bwino China, msika waukulu kwambiri padziko lonse lapansi, ndikuwonjezera khama lopanga misika yakunja kuti mabizinesi athe kukula mwachangu momwe angathere. Malizitsani kusintha ndikusintha, lowani pakati mpaka kumapeto kwa makampani, ndikukwaniritsa chitukuko chabwino komanso chobiriwira.
Nthawi yotumizira: Epulo-25-2024