Abubuwan da ake amfani da su na magunguna sune abubuwan da ake amfani da su a cikin samar da magunguna da tsara magunguna, kuma wani muhimmin sashi ne na shirye-shiryen magunguna. Kamar yadda wani halitta polymer samu abu, cellulose ether yana da halaye na biodegradability, ba guba, da kuma low price, kamar sodium carboxymethyl cellulose, methyl cellulose, hydroxypropyl methyl cellulose, hydroxypropyl cellulose.Cellulose ethersirin su hydroxyethyl cellulose da ethyl cellulose suna da mahimmancin aikace-aikacen ƙima a cikin kayan aikin magunguna. A halin yanzu, samfuran mafi yawan kamfanonin ether na cikin gida ana amfani da su a tsakiya da ƙananan ƙananan masana'antu, kuma ƙarin darajar ba ta da yawa. Masana'antu cikin gaggawa suna buƙatar canzawa da haɓakawa da haɓaka manyan aikace-aikacen samfuran.
Magungunan magunguna suna taka muhimmiyar rawa wajen haɓakawa da samar da abubuwan da aka tsara. Alal misali, a cikin shirye-shiryen ci gaba da ci gaba, ana amfani da kayan polymer irin su cellulose ethers a matsayin magungunan ƙwayoyi a cikin nau'i-nau'i masu ɗorewa, nau'i-nau'i na matrix daban-daban, nau'i-nau'i mai ɗorewa-saki, capsules-cire-saki, ci gaba-sakin fina-finai na miyagun ƙwayoyi, da kuma ci gaba da sakewar magunguna. An yi amfani da shirye-shirye da shirye-shiryen ci gaba da fitowar ruwa. A cikin wannan tsarin, gabaɗaya ana amfani da polymers irin su cellulose ethers a matsayin masu ɗaukar magunguna don sarrafa yawan sakin magungunan a cikin jikin ɗan adam, wato, ana buƙatar su sannu a hankali a cikin jiki a ƙayyadaddun adadin lokaci don cimma manufar magani mai inganci.
Bisa kididdigar kididdigar da Sashen Tuntuba da Bincike, akwai kusan nau'ikan abubuwan kara kuzari guda 500 a kasuwa a cikin kasata, amma idan aka kwatanta da Amurka (fiye da nau'ikan 1500) da Tarayyar Turai (fiye da nau'ikan 3000), akwai babban bambanci, kuma nau'ikan suna kanana. Abubuwan da ake amfani da su na magunguna na ƙasata Ƙarfin ci gaban kasuwa yana da yawa. An fahimci cewa manyan kayan aikin magunguna goma a cikin sikelin kasuwa na ƙasa sune maganin gelatin capsules, sucrose, sitaci, foda mai rufin fim, 1,2-propylene glycol, PVP, hydroxypropyl methylcellulose (HPMC), da fibers microcrystalline. Mai cin ganyayyaki, HPC, lactose.
"Natural cellulose ether ne general lokaci ga jerin cellulose samu ta hanyar dauki alkali cellulose da etherifying wakili a karkashin wasu yanayi, kuma shi ne wani samfurin a cikin abin da hydroxyl kungiyoyin a kan cellulose macromolecule an partially ko gaba daya maye gurbinsu da ether kungiyoyin. Cellulose ethers suna ko'ina amfani a cikin filayen na man fetur, da kayayyakin abinci, da kayayyakin abinci na yau da kullum. Pharmaceutical-sa kayayyakin ne m a tsakiya da kuma high-karshen yankunan na masana'antu da kuma suna da high kara darajar Saboda m ingancin bukatun, da samar da Pharmaceutical-sa cellulose ethers ne kuma in mun gwada da wuya Ana iya cewa ingancin Pharmaceutical-sa kayayyakin iya m wakiltar da fasaha ƙarfi na cellulose ether Enterprises, wanda aka kara da cewa matrix ether Allunan matrix ci gaba-saki, kayan shafa mai-mai narkewa mai narkewa, kayan marufi mai ɗorewa na microcapsule, kayan aikin fim ɗin ci gaba, da sauransu.
Sodium carboxymethyl cellulose (CMC-Na) shine ether cellulose tare da mafi girma fitarwa da amfani a gida da waje. Ita ce ether cellulose ionic da aka yi daga auduga da itace ta hanyar alkalization da etherification tare da chloroacetic acid. CMC-Na abu ne da aka saba amfani da shi na kayan aikin magunguna. Ana amfani da shi sau da yawa azaman mai ɗaure don shirye-shirye masu ƙarfi kuma azaman thickening, thickening da suspending wakili don shirye-shiryen ruwa. Hakanan za'a iya amfani dashi azaman matrix mai narkewa da ruwa da kayan ƙirƙirar fim. Yawancin lokaci ana amfani da shi azaman kayan fim ɗin magani mai ɗorewa da ɗorewa-saki matrix kwamfutar hannu a cikin tsarukan sakin (sarrafawa).
Bugu da ƙari, sodium carboxymethyl cellulose a matsayin magungunan magunguna, croscarmellose sodium kuma za'a iya amfani dashi azaman kayan aikin magunguna. Carboxymethyl cellulose sodium (CCMC-Na) mai haɗin haɗin giciye abu ne wanda ba a iya narkewa da ruwa wanda carboxymethyl cellulose yana amsawa tare da wakili mai haɗin kai a wani zafin jiki (40-80 ° C) a ƙarƙashin aikin mai kara kuzari na inorganic acid kuma an tsarkake shi. Wakilin crosslinking zai iya zama propylene glycol, succinic anhydride, maleic anhydride, adipic anhydride, da makamantansu. Ana amfani da Croscarmellose sodium azaman mai rarrabawa ga allunan, capsules da granules a cikin shirye-shiryen baka. Ya dogara da tasirin capillary da kumburi don cimma rarrabuwa. Yana da kyau damfara da ƙarfi tarwatsewa. Nazarin ya nuna cewa kumburin digiri na croscarmellose sodium a cikin ruwa ya fi na na kowa disintegrats kamar ƙananan maye gurbin sodium carboxymethyl cellulose da hydrated microcrystalline cellulose.
Methyl cellulose (MC) monoether ne wanda ba na ionic cellulose wanda aka yi daga auduga da itace ta hanyar alkalization da etherification na methyl chloride. Methyl cellulose yana da kyakkyawan narkewar ruwa kuma yana da ƙarfi a cikin kewayon pH na 2.0 zuwa 13.0. Ana amfani dashi sosai a cikin abubuwan haɓaka magunguna, kuma ana amfani dashi a cikin allunan sublingual, alluran intramuscular, shirye-shiryen ido, capsules na baka, dakatarwar baka, allunan baka da shirye-shirye na Topical. Bugu da kari, a cikin ci gaba-saki formulations, MC za a iya amfani da a matsayin hydrophilic gel matrix ci gaba-saki tsari, ciki-mai narkewa kayan shafa, ci gaba-saki microcapsule marufi, ci-release miyagun ƙwayoyi film abu, da dai sauransu.
Hydroxypropyl methylcellulose (HPMC) wani ether ne wanda ba na ionic ba wanda aka yi shi daga auduga da itace ta hanyar alkalization da etherification na propylene oxide da methyl chloride. Ba shi da wari, mara daɗi, mara guba, mai narkewa a cikin ruwan sanyi, da gels a cikin ruwan zafi. Hydroxypropyl methylcellulose wani nau'in ether ne na cellulose da aka haɗe wanda ke haɓaka cikin sauri a samarwa, amfani da inganci a cikin shekaru 15 da suka gabata. Har ila yau, yana daya daga cikin manyan kayan aikin magunguna da ake amfani da su a gida da waje. An yi amfani da shi azaman kayan haɓakar magunguna kusan shekaru 50. Shekaru na tarihi. A halin yanzu, aikace-aikacen HPMC yana nunawa a cikin abubuwa biyar masu zuwa:
Daya a matsayin mai ɗaure da tarwatsewa. HPMC a matsayin mai ɗaure na iya sa maganin cikin sauƙin jika, kuma yana iya faɗaɗa ɗaruruwan lokuta bayan shayar da ruwa, don haka yana iya inganta narkewa ko sakin kwamfutar hannu sosai. HPMC yana da ɗanko mai ƙarfi, kuma yana iya haɓaka ɗanɗanon ɗanɗano da haɓaka damfarar albarkatun ƙasa tare da kintsattse ko rubutu mai wuya. HPMC tare da ƙananan danko za a iya amfani da shi azaman mai ɗaure da tarwatsewa, kuma HPMC tare da babban danko za a iya amfani dashi azaman ɗaure kawai.
Abu na biyu, ana amfani da shi azaman abin sakewa mai dorewa da sarrafawa don shirye-shiryen baka. HPMC abu ne da aka saba amfani da shi na matrix hydrogel a cikin shirye-shiryen ɗorewa. HPMC na low danko sa (5 ~ 50mPa·s) za a iya amfani da a matsayin mai ɗaure, danko ƙara wakili da kuma dakatar wakili, da kuma HPMC na high danko sa (4000 ~ 100000mPa·s) za a iya amfani da shirya gauraye abu matrix ci-saki Allunan da kuma ci gaba-saki-sakin hydrochloride matrix da capsulease. allunan. HPMC yana narkewa a cikin ruwan ciki na ciki, yana da fa'idodin matsawa mai kyau, mai kyau ruwa, ƙarfin ɗaukar miyagun ƙwayoyi mai ƙarfi da halayen sakin magunguna waɗanda pH ba ta shafa ba. Yana da mahimmancin mahimmancin kayan ɗaukar ruwa na hydrophilic a cikin tsarin shirye-shiryen ci gaba mai ɗorewa kuma ana amfani dashi sau da yawa azaman The hydrophilic gel matrix da kayan shafa na shirye-shiryen ɗorewa-saki, kuma ana amfani da su a cikin shirye-shiryen iyo shirye-shirye na ciki da kuma ci gaba-saki kayan taimako na membrane membrane.
Na uku shi ne a matsayin mai shafi mai samar da fim.HPMCyana da kyawawan kaddarorin yin fim. Fim ɗin da aka samar da shi bai dace ba, a bayyane, kuma mai tauri, kuma ba shi da sauƙi a riko da shi yayin samarwa. Musamman ga magungunan da ke da sauƙi don shayar da danshi kuma ba su da kwanciyar hankali, yin amfani da shi a matsayin keɓewar keɓewa zai iya inganta kwanciyar hankali na miyagun ƙwayoyi da kuma hana Fim ɗin yana canza launi. HPMC yana da ƙayyadaddun ƙayyadaddun danko iri-iri. Idan an zaɓa da kyau, inganci da bayyanar allunan da aka rufe sun fi sauran kayan aiki, kuma yawan taro na yau da kullun shine 2% zuwa 10%.
Ana amfani da hudu azaman kayan capsule. A cikin 'yan shekarun nan, tare da barkewar annobar dabbobi a duniya akai-akai, idan aka kwatanta da capsules na gelatin, capsules na shuka ya zama sabon masoyi na masana'antun magunguna da abinci. Pfizer ya sami nasarar fitar da HPMC daga tsire-tsire na halitta da kuma shirya capsules na kayan lambu na VcapTM. Idan aka kwatanta da na al'ada gelatin m capsules, kayan lambu capsules suna da abũbuwan amfãni daga m adaptability, babu hadarin giciye-linked dauki, da high kwanciyar hankali. Adadin sakin miyagun ƙwayoyi yana da ɗan kwanciyar hankali, kuma bambance-bambancen mutum kaɗan ne. Bayan tarwatsewa a cikin jikin mutum, ba a tsotse shi kuma ana iya fitar da shi. Fitowa daga jiki. Dangane da yanayin ajiya, bayan gwaje-gwaje da yawa, kusan ba ya raguwa a ƙarƙashin yanayin ƙarancin zafi, kuma kaddarorin harsashi na capsule har yanzu suna kan kwanciyar hankali a ƙarƙashin zafi mai zafi, kuma ba a shafi ma'auni daban-daban na capsules na shuka a ƙarƙashin matsanancin yanayin ajiya. Tare da fahimtar mutane game da capsules na tsire-tsire da kuma canza ra'ayoyin magungunan jama'a a gida da waje, kasuwa na buƙatar capsules na shuka zai girma cikin sauri.
Na biyar shine a matsayin wakili mai dakatarwa. Dakatar da irin ruwa shiri ne fiye da amfani da asibiti sashi nau'i, wanda shi ne a iri-iri watsawa tsarin a cikin abin da wuya mai narkewa m kwayoyi suna tarwatsa a cikin wani ruwa watsawa matsakaici. Zaman lafiyar tsarin yana ƙayyade ingancin shirye-shiryen ruwa na dakatarwa. HPMC colloidal bayani zai iya rage m-ruwa interfacial tashin hankali, rage surface free makamashi na m barbashi, da kuma daidaita da iri-iri watsawa tsarin. Yana da kyakkyawan wakili mai dakatarwa. Ana amfani da HPMC azaman mai kauri don zubar da ido, tare da abun ciki na 0.45% zuwa 1.0%.
Hydroxypropyl cellulose (HPC) wani monoether ne wanda ba na ionic cellulose wanda aka yi daga auduga da itace ta hanyar alkalization da etherification na propylene oxide. HPC yawanci mai narkewa ne a cikin ruwa da ke ƙasa da 40 ° C da babban adadin kaushi na polar, kuma aikin sa yana da alaƙa da abun ciki na hydroxypropyl da matakin polymerization. HPC na iya dacewa da magunguna daban-daban kuma yana da inertness mai kyau.
Low-masanya hydroxypropyl cellulose(L-HPC)galibi ana amfani dashi azaman mai tarwatsewa da ɗaure. Its halaye ne: sauki latsa da kuma forming, karfi applicability, musamman wuya a samar, filastik da kuma gaggautsa Allunan, ƙara L -HPC iya inganta taurin kwamfutar hannu da haske na bayyanar, da kuma shi kuma iya sa kwamfutar hannu tarwatsa da sauri, inganta ciki ingancin kwamfutar hannu, da kuma inganta curative sakamako.
Ana iya amfani da babban maye gurbin hydroxypropyl cellulose (H-HPC) azaman wakili mai ɗaure don allunan, granules da granules masu kyau a cikin filin magunguna. H-HPC yana da kyawawan kaddarorin samar da fina-finai, kuma fim ɗin da aka samu yana da tauri da na roba, wanda za'a iya kwatanta shi da filastik. Ta hanyar haɗuwa tare da sauran magungunan rigakafin rigar, za a iya inganta aikin fim ɗin, kuma ana amfani da shi sau da yawa azaman kayan shafa na fim don allunan. Hakanan za'a iya amfani da H-HPC azaman kayan matrix don shirya allunan ci gaba na matrix, ɗorewa-saki pellets da kuma allunan ci gaba mai ɗorewa.
Hydroxyethyl cellulose (HEC) wani monoether ne wanda ba na ionic cellulose wanda aka yi daga auduga da itace ta hanyar alkalization da etherification na ethylene oxide. Ana amfani da HEC galibi azaman mai kauri, wakili na kariya na colloidal, m, tarwatsawa, stabilizer, wakili mai dakatarwa, mai samar da fim da kayan jinkirin sakin abu a fagen likitanci. Ana iya shafa shi a kan emulsion, man shafawa, da kuma zubar da ido don magani na gida. Ruwan baka, m allunan, capsules da sauran nau'ikan sashi. An haɗa Hydroxyethyl cellulose a cikin Tsarin Pharmacopoeia/US na Amurka da Pharmacopoeia na Turai.
Ethyl cellulose (EC) yana ɗaya daga cikin abubuwan da aka fi amfani da su na cellulose na ruwa wanda ba zai iya narkewa ba. EC ba mai guba bane, barga, maras narkewa a cikin ruwa, acid ko alkaline mafita, kuma mai narkewa a cikin kaushi na halitta kamar ethanol da methanol. Maganin da aka saba amfani da shi shine gauraye na toluene/ethanol 4/1 (nauyi). EC yana da amfani da yawa a cikin shirye-shiryen ci gaba da sakewa, kuma ana amfani da shi sosai azaman mai ɗaukar hoto da microcapsules, kayan samar da fim, da sauransu na shirye-shiryen ci gaba, kamar su kwamfutar hannu retarders, adhesives, kayan shafa fim, da dai sauransu An yi amfani da shi azaman fim ɗin matrix abu don shirya nau'ikan matrix ci gaba-saki-saki Allunan, kamar yadda aka haɗa shirye-shiryen ci gaba. pellets, azaman kayan taimako na encapsulation don shirya ɗorewa-saki microcapsules; Hakanan za'a iya amfani dashi ko'ina azaman kayan jigilar kaya Ana amfani dashi don shirya tsayayyen tarwatsewa; ana iya amfani dashi a ko'ina a cikin fasahar harhada magunguna azaman sinadari mai yin fim da suturar kariya, kuma ana iya amfani dashi azaman ɗaure da filler. A matsayin kariya mai kariya ga allunan, zai iya rage hankali na allunan zuwa zafi kuma ya hana magungunan su zama masu launi da lalacewa ta hanyar danshi; Hakanan zai iya samar da layin manne mai saurin sakin layi da microencapsulate da polymer don ci gaba da sakin tasirin miyagun ƙwayoyi.
A taƙaice, da ruwa-mai narkewa sodium carboxymethyl cellulose, methyl cellulose, hydroxypropyl methyl cellulose, hydroxypropyl cellulose, hydroxypropyl cellulose, hydroxyethyl cellulose da mai-mai narkewa ethyl cellulose duk dogara ne a kan su Game da halaye na samfurin da ake amfani da Pharmaceutical excipients a matsayin manne, ko sarrafa fim da aka rufe da kayan aiki, da kuma sarrafa dismesives. wakilai, kayan capsule da wakilai masu dakatarwa. Idan aka dubi duniya, kamfanoni da dama na kasashen waje (Shin-Etsu Japan, Dow Wolff da Ashland) sun fahimci babbar kasuwa ta cellulose na harhada magunguna a kasar Sin a nan gaba, kuma ko dai ya kara samar da kayayyaki ko kuma hadewa, sun kara yawan kasancewarsu a wannan fanni. Zuba jari a cikin aikace-aikacen. Dow Wolff ya sanar da cewa, zai kara mai da hankali kan samar da kayayyaki, da kayan masarufi da bukatun kasuwar hada magunguna ta kasar Sin, kuma bincikensa na aikace-aikace zai yi kokarin kusantar kasuwar. Sashen Wolff Cellulose na Dow Chemical da Kamfanin Colorcon na Amurka sun kafa ƙawancen shirye-shiryen saki mai dorewa da sarrafawa a duniya. Yana da ma'aikata sama da 1,200 a cikin biranen 9, cibiyoyin kadara 15 da kamfanonin GMP 6. Kwararrun bincike da aka yi amfani da su suna ba da sabis ga abokan ciniki a cikin ƙasashe kusan 160. Ashland tana da sansanonin samar da kayayyaki a Beijing, Tianjin, Shanghai, Nanjing, Changzhou, Kunshan da Jiangmen, kuma ta zuba jari a cibiyoyin binciken fasaha guda uku a Shanghai da Nanjing.
Bisa kididdigar da aka samu daga shafin intanet na kungiyar Cellulose ta kasar Sin, a shekarar 2017, yawan amfanin da ake samu na ether a cikin gida ya kai ton 373,000, kuma yawan tallace-tallace ya kai tan dubu 360. A cikin 2017, ainihin girman tallace-tallace na ionicCMCya kasance ton 234,000, karuwa na 18.61% kowace shekara, kuma yawan tallace-tallace na CMC da ba na ionic ya kasance ton 126,000, karuwa na 8.2% kowace shekara. Baya ga HPMC (jinin kayan gini) samfuran da ba na ionic ba,HPMC(Pharmaceutical grade), HPMC (abinci grade), HEC, HPC, MC, HEMC, da dai sauransu duk sun tashi a kan yanayin, kuma samarwa da tallace-tallace sun ci gaba da karuwa. Ethers cellulose na cikin gida suna girma cikin sauri fiye da shekaru goma, kuma abin da aka fitar ya zama na farko a duniya. Duk da haka, yawancin samfuran kamfanonin ether na cellulose ana amfani da su a tsakiya da ƙananan ƙarshen masana'antu, kuma ƙarin darajar ba ta da yawa.
A halin yanzu, yawancin kamfanonin ether cellulose na cikin gida suna cikin wani muhimmin lokaci na canji da haɓakawa. Ya kamata su ci gaba da kara yin bincike da kokarin raya kayayyaki, da ci gaba da inganta nau'ikan kayayyaki, da yin cikakken amfani da kasar Sin, babbar kasuwa a duniya, da kara kokarin raya kasuwannin ketare, ta yadda kamfanoni za su iya fadada cikin sauri. Kammala canji da haɓakawa, shigar da tsakiyar-zuwa-ƙarshen ƙarshen masana'antar, da samun ci gaba mai kyau da kore.
Lokacin aikawa: Afrilu-25-2024