Sinadaran da ke taimakawa wajen samar da magunguna su ne sinadaran da ke taimakawa wajen samar da magunguna da kuma samar da magunguna, kuma muhimmin bangare ne na shirye-shiryen magunguna. A matsayin wani abu da aka samo daga polymer na halitta, cellulose ether yana da halaye na rashin lalacewa, rashin guba, da kuma farashi mai rahusa, kamar su sodium carboxymethyl cellulose, methyl cellulose, hydroxypropyl methyl cellulose, hydroxypropyl cellulose,Cellulose ethersKamar su hydroxyethyl cellulose da ethyl cellulose suna da mahimmancin amfani a cikin abubuwan da ke cikin magunguna. A halin yanzu, kayayyakin da yawancin kamfanonin ether cellulose na cikin gida ake amfani da su galibi a fannoni na tsakiya da ƙananan masana'antu, kuma ƙarin ƙimar ba ta da yawa. Masana'antar tana buƙatar gyara da haɓakawa da inganta aikace-aikacen samfuran cikin gaggawa.
Magungunan da ke taimakawa wajen samar da magunguna suna taka muhimmiyar rawa wajen haɓaka da kuma samar da magunguna. Misali, a cikin shirye-shiryen da ke taimakawa wajen sakewa, ana amfani da kayan polymer kamar cellulose ethers a matsayin abubuwan taimako na magunguna a cikin ƙwayoyin da ke taimakawa wajen sakewa, nau'ikan magungunan da ke taimakawa wajen sakewa, magungunan da ke taimakawa wajen sakewa, ƙwayoyin da ke taimakawa wajen sakewa, da magungunan da ke taimakawa wajen sakewa. An yi amfani da shirye-shirye da shirye-shiryen da ke taimakawa wajen sakewa da ruwa sosai. A cikin wannan tsarin, ana amfani da polymers kamar cellulose ethers a matsayin masu ɗaukar magunguna don sarrafa yawan sakin magunguna a jikin ɗan adam, wato, ana buƙatar a saki su a hankali a cikin jiki a wani ƙayyadadden lokaci a cikin wani takamaiman lokaci don cimma manufar ingantaccen magani.
A bisa kididdigar Sashen Ba da Shawara da Bincike, akwai nau'ikan sinadaran magani kusan 500 a kasuwa a ƙasata, amma idan aka kwatanta da Amurka (sama da nau'ikan 1500) da Tarayyar Turai (sama da nau'ikan 3000), akwai babban bambanci, kuma nau'ikan har yanzu ƙanana ne. Sinadaran magunguna na ƙasata. Ƙarfin ci gaban kasuwa yana da girma. An fahimci cewa manyan sinadaran magani guda goma a cikin kasuwar ƙasata sune capsules na gelatin na magani, sucrose, sitaci, foda mai rufe fuska, 1,2-propylene glycol, PVP, hydroxypropyl methylcellulose (HPMC), da zare microcrystalline. Masu cin ganyayyaki, HPC, lactose.
"Ether na halitta na cellulose shine kalma ta gabaɗaya don jerin abubuwan da aka samo daga cellulose ta hanyar amsawar alkali cellulose da wakilin etherifying a ƙarƙashin wasu yanayi, kuma samfuri ne wanda ƙungiyoyin ether ke maye gurbin ƙungiyoyin hydroxyl akan cellulose macromolecule wani ɓangare ko gaba ɗaya. Ana amfani da ethers na cellulose sosai a fannonin man fetur, kayan gini, rufi, abinci, magani da sinadarai na yau da kullun. A duk fannoni, samfuran da aka samo daga magunguna suna cikin yankuna na tsakiya da na sama na masana'antu kuma suna da ƙarin ƙima. Saboda ƙaƙƙarfan buƙatun inganci, samar da ethers na cellulose na magunguna shi ma yana da wahala. Ana iya cewa ingancin samfuran da aka samo daga magunguna na iya wakiltar ƙarfin fasaha na kamfanonin ether na cellulose. Yawanci ana ƙara cellulose ether azaman retarder, kayan matrix da mai kauri don yin allunan matrix masu dorewa, kayan shafa mai narkewa daga ciki, kayan marufi na microcapsule masu dorewa, kayan fim na magunguna masu dorewa, da sauransu.
Sodium carboxymethyl cellulose (CMC-Na) shine cellulose ether wanda ke da mafi girman fitarwa da amfani a gida da waje. Yana da ionic cellulose ether da aka yi da auduga da itace ta hanyar alkalization da etherification tare da chloroacetic acid. CMC-Na wani abu ne da ake amfani da shi wajen samar da magunguna. Sau da yawa ana amfani da shi azaman abin ɗaurewa don shirye-shiryen ƙarfi da kuma azaman abin kauri, kauri da dakatarwa don shirye-shiryen ruwa. Hakanan ana iya amfani da shi azaman matrix mai narkewa cikin ruwa da kayan samar da fim. Sau da yawa ana amfani da shi azaman kayan fim na magani mai dorewa da kwamfutar hannu mai sakin dindindin a cikin tsarin fitarwa mai dorewa (wanda aka sarrafa).
Baya ga sodium carboxymethyl cellulose a matsayin abubuwan da ke taimakawa wajen samar da magunguna, ana iya amfani da croscarmellose sodium a matsayin abubuwan da ke taimakawa wajen samar da magunguna. Sodium carboxymethyl cellulose mai haɗin gwiwa (CCMC-Na) wani abu ne da ba ya narkewa a ruwa wanda carboxymethyl cellulose ke amsawa da wani abu mai haɗin gwiwa a wani zafin jiki (40-80°C) a ƙarƙashin aikin mai haɗa sinadarai na inorganic kuma ana tsarkake shi. Maganin haɗin gwiwa na iya zama propylene glycol, succinic anhydride, maleic anhydride, adipic anhydride, da makamantansu. Ana amfani da Croscarmellose sodium a matsayin mai wargaza ƙwayoyin cuta, capsules da granules a cikin shirye-shiryen baki. Yana dogara ne akan tasirin capillary da kumburi don cimma wargajewa. Yana da kyakkyawan matsewa da ƙarfi na wargajewa. Nazarin ya nuna cewa matakin kumburi na croscarmellose sodium a cikin ruwa ya fi na na wargajewar da aka saba samu kamar sodium carboxymethyl cellulose mai ƙarancin maye gurbinsa da hydrated microcrystalline cellulose.
Methyl cellulose (MC) wani sinadari ne na cellulose wanda ba ionic ba wanda aka yi da auduga da itace ta hanyar amfani da alkalization da kuma methyl chloride etherification. Methyl cellulose yana da kyakkyawan narkewar ruwa kuma yana da karko a cikin pH na 2.0 zuwa 13.0. Ana amfani da shi sosai a cikin abubuwan da ke taimakawa wajen samar da magunguna, kuma ana amfani da shi a cikin allunan da ke ƙarƙashin harshe, allurar jijiyoyi ta cikin jijiyoyi, shirye-shiryen ido, capsules na baki, dakatarwar baki, allunan baki da shirye-shiryen shafawa na waje. Bugu da ƙari, a cikin shirye-shiryen da ke dawwama, ana iya amfani da MC azaman tsarin gel matrix mai dorewa-saki, kayan shafa na ciki-mai narkewa, kayan marufi na microcapsule mai dorewa-saki, kayan fim na magunguna mai dorewa-saki, da sauransu.
Hydroxypropyl methylcellulose (HPMC) wani gaurayen ether ne wanda ba ionic ba wanda aka yi da auduga da itace ta hanyar alkali da kuma etherification na propylene oxide da methyl chloride. Ba shi da wari, ba shi da ɗanɗano, ba shi da guba, yana narkewa a cikin ruwan sanyi, kuma gels ne a cikin ruwan zafi. Hydroxypropyl methylcellulose nau'in ether ne na cellulose wanda ya karu cikin sauri a samarwa, amfani da inganci a cikin shekaru 15 da suka gabata. Hakanan yana ɗaya daga cikin manyan abubuwan da ke taimakawa wajen samar da magunguna a gida da waje. An yi amfani da shi azaman maganin magunguna na kusan shekaru 50. Shekaru na tarihi. A halin yanzu, amfani da HPMC galibi yana bayyana a cikin waɗannan fannoni guda biyar:
Ɗaya shine a matsayin abin ɗaurewa da kuma narkar da abu. HPMC a matsayin abin ɗaurewa zai iya sa maganin ya jike da sauƙi, kuma yana iya faɗaɗa sau ɗaruruwa bayan shan ruwa, don haka zai iya inganta narkewa ko sakin kwamfutar hannu sosai. HPMC yana da ƙarfi sosai, kuma yana iya haɓaka ɗanɗanon barbashi da inganta matsewar kayan da aka yi da kayan da aka yi da ƙwaya ko mai tauri. HPMC mai ƙarancin ɗanɗano za a iya amfani da shi azaman abin ɗaurewa da narkar da abu, kuma HPMC mai babban ɗanɗano za a iya amfani da shi kawai azaman abin ɗaurewa.
Abu na biyu, ana amfani da shi azaman kayan saki mai dorewa kuma mai sarrafawa don shirye-shiryen baki. HPMC kayan hydrogel ne da aka saba amfani da shi a cikin shirye-shiryen sakin mai dorewa. HPMC mai ƙarancin ƙimar danko (5~50mPa·s) ana iya amfani da shi azaman mai ɗaurewa, wakili mai ƙara danko da wakili mai dakatarwa, kuma HPMC mai babban matakin danko (4000~100000mPa·s) ana iya amfani da shi don shirya allunan matrix masu dorewa da kuma mai dorewa mai dorewa mai dorewa don capsules da allunan gel matrix masu dorewa. HPMC yana narkewa a cikin ruwan ciki, yana da fa'idodin matsi mai kyau, ruwa mai kyau, ƙarfin ɗaukar magunguna mai ƙarfi da halayen sakin magunguna waɗanda pH ba ya shafar su. Abu ne mai matuƙar mahimmanci ga hydrophilic a cikin tsarin shirye-shiryen sakin mai dorewa kuma ana amfani da shi sau da yawa azaman matrix na hydrophilic gel da kayan shafa na shirye-shiryen sakin mai dorewa, kuma ana amfani da shi a cikin shirye-shiryen iyo na ciki da kayan taimako na membrane na maganin da ke dorewa.
Na uku kuma a matsayin wakilin samar da fim ne.HPMCyana da kyawawan halaye na samar da fim. Fim ɗin da aka yi da shi yana da daidaito, bayyananne, kuma mai tauri, kuma ba shi da sauƙin mannewa yayin samarwa. Musamman ga magungunan da ke da sauƙin sha danshi kuma ba su da ƙarfi, amfani da shi azaman layin keɓewa na iya inganta kwanciyar hankali na maganin sosai kuma ya hana. Fim ɗin yana canza launi. HPMC yana da nau'ikan ƙayyadaddun ɗanko iri-iri. Idan aka zaɓa shi da kyau, inganci da bayyanar allunan da aka shafa sun fi sauran kayan aiki kyau, kuma yawansa shine 2% zuwa 10%.
Ana amfani da guda huɗu a matsayin kayan capsule. A cikin 'yan shekarun nan, tare da barkewar annobar dabbobi a duniya akai-akai, idan aka kwatanta da ƙwayoyin gelatin, ƙwayoyin shuka sun zama sabon abin sha'awa ga masana'antun magunguna da abinci. Pfizer ya yi nasarar cire HPMC daga tsire-tsire na halitta kuma ya shirya ƙwayoyin kayan lambu na VcapTM. Idan aka kwatanta da ƙwayoyin gelatin na gargajiya, ƙwayoyin kayan lambu suna da fa'idodin daidaitawa mai faɗi, babu haɗarin amsawar haɗin gwiwa, da kwanciyar hankali mai yawa. Yawan sakin maganin yana da daidaito, kuma bambance-bambancen mutum ɗaya kaɗan ne. Bayan wargajewa a jikin ɗan adam, ba a sha shi kuma ana iya fitar da shi. Ana fitar da shi daga jiki. Dangane da yanayin ajiya, bayan gwaje-gwaje da yawa, kusan ba ya karyewa a ƙarƙashin yanayin ƙarancin danshi, kuma halayen harsashin capsule har yanzu suna da ƙarfi a ƙarƙashin babban danshi, kuma nau'ikan ƙwayoyin shuka daban-daban a ƙarƙashin yanayin ajiya mai tsanani ba su shafi ba. Tare da fahimtar mutane game da ƙwayoyin shuka da canjin ra'ayoyin magungunan jama'a a gida da waje, buƙatar kasuwa na ƙwayoyin shuka za ta girma da sauri.
Na biyar shine a matsayin maganin dakatarwa. Tsarin ruwa na nau'in dakatarwa nau'in tsari ne da ake amfani da shi a asibiti, wanda shine tsarin watsawa iri-iri wanda magungunan da ba sa narkewa sosai ake watsawa a cikin wani ruwa mai watsawa. Kwanciyar tsarin yana tantance ingancin shirye-shiryen ruwan dakatarwa. Maganin colloidal na HPMC zai iya rage tashin hankali tsakanin ruwa mai ƙarfi da ruwa, rage kuzarin da ba ya cikin saman barbashi mai ƙarfi, da kuma daidaita tsarin watsawa iri-iri. Kyakkyawan wakili ne na dakatarwa. Ana amfani da HPMC azaman mai kauri don digowar ido, tare da abun ciki na 0.45% zuwa 1.0%.
Hydroxypropyl cellulose (HPC) wani sinadari ne na cellulose wanda ba ionic ba wanda aka yi shi da auduga da itace ta hanyar alkalization da propylene oxide etherification. HPC yawanci yana narkewa a cikin ruwa ƙasa da 40°C da kuma adadi mai yawa na sinadarai masu ƙarfi na polar, kuma aikinsa yana da alaƙa da abun ciki na hydroxypropyl da matakin polymerization. HPC na iya dacewa da magunguna daban-daban kuma yana da kyakkyawan rashin aiki.
Cellulose hydroxypropyl mai ƙarancin maye gurbinsa(L-HPC)Ana amfani da shi galibi azaman na'urar wargaza kwamfutar hannu da kuma abin ɗaure ta. Halayensa sune: sauƙin matsewa da siffantawa, ƙarfin amfani, musamman wahalar siffantawa, allunan filastik da masu karyewa, ƙara L －HPC na iya inganta taurin kwamfutar hannu da hasken bayyanar, kuma yana iya sa kwamfutar ta wargaje da sauri, inganta ingancin kwamfutar hannu ta ciki, da kuma inganta tasirin warkarwa.
Ana iya amfani da sinadarin hydroxypropyl cellulose mai yawan maye gurbinsa (H-HPC) a matsayin wakili mai ɗaurewa ga allunan magani, granules da ƙananan granules a fannin magunguna. H-HPC yana da kyawawan halaye na samar da fim, kuma fim ɗin da aka samar yana da tauri da roba, wanda za a iya kwatanta shi da masu amfani da filastik. Ta hanyar haɗawa da sauran sinadaran rufewa masu hana danshi, ana iya ƙara inganta aikin fim ɗin, kuma sau da yawa ana amfani da shi azaman kayan shafa fim don allunan. Hakanan ana iya amfani da H-HPC azaman kayan matrix don shirya allunan da ke sakin matrix mai dorewa, allunan da ke sakin dawwama da allunan da ke sakin dawwama masu dorewa masu layuka biyu.
Hydroxyethyl cellulose (HEC) wani sinadari ne na cellulose wanda ba ionic ba wanda aka yi da auduga da itace ta hanyar alkalization da ethylene oxide etherification. Ana amfani da HEC galibi azaman mai kauri, wakili mai kariya daga colloidal, manne, mai wargazawa, mai daidaita, wakili mai dakatarwa, wakili mai samar da fim da kayan da ke sakin a hankali a fannin likitanci. Ana iya amfani da shi a cikin emulsions, man shafawa, da digo na ido don maganin shafawa. Ruwan sha, allunan tauri, capsules da sauran nau'ikan allurai. An haɗa Hydroxyethyl cellulose a cikin US Pharmacopoeia/US National Formulary da European Pharmacopoeia.
Ethyl cellulose (EC) yana ɗaya daga cikin abubuwan da aka fi amfani da su wajen samar da cellulose marasa narkewa a ruwa. EC ba shi da guba, tsayayye, ba ya narkewa a cikin ruwa, ruwan acid ko alkaline, kuma yana narkewa a cikin sinadaran sinadarai na halitta kamar ethanol da methanol. Maganin da aka fi amfani da shi shine cakuda mai narkewa na toluene/ethanol 4/1 (nauyi). EC yana da amfani da yawa a cikin shirye-shiryen sakin magani, kuma ana amfani da shi sosai a matsayin mai ɗaukar kaya da ƙananan capsules, kayan shafa fim, da sauransu na shirye-shiryen sakin jiki masu dorewa, kamar masu hana ƙwayoyin cuta, manne, kayan shafa fim, da sauransu. Ana amfani da shi azaman fim ɗin matrix don shirya nau'ikan allunan sakin jiki daban-daban, azaman kayan gauraye don shirya shirye-shiryen sakin jiki masu dorewa da ƙananan ƙwayoyin sakin jiki masu dorewa, azaman kayan taimako na ɓoyewa don shirya ƙananan capsules masu dorewa; Hakanan ana iya amfani da shi sosai azaman kayan ɗaukar kaya. Ana amfani da shi don shirya watsawa mai ƙarfi; ana iya amfani da shi sosai a cikin fasahar magunguna azaman abu mai samar da fim da murfin kariya, kuma ana iya amfani da shi azaman abin ɗaurewa da cikawa. A matsayin kariya ga allunan, zai iya rage saurin jin daɗin allunan ga danshi kuma ya hana magungunan su canza launi da lalacewa ta hanyar danshi; Hakanan yana iya samar da wani manne mai sakin hankali a hankali sannan ya lulluɓe polymer ɗin don ci gaba da fitar da tasirin maganin.
A taƙaice, sodium carboxymethyl cellulose mai narkewa cikin ruwa, methyl cellulose, hydroxypropyl methyl cellulose, hydroxypropyl cellulose, hydroxyethyl cellulose da ethyl cellulose mai narkewa cikin mai duk sun dogara ne akan halayensu. Ana amfani da halayen samfurin a cikin abubuwan haɗin magunguna azaman manne, abubuwan narkewa, kayan fitarwa masu dorewa da sarrafawa don shirye-shiryen baki, wakilan samar da fim, kayan capsules da wakilan dakatarwa. Idan aka duba duniya, kamfanoni da yawa na ƙasashen waje na ƙasashen waje (Shin-Etsu Japan, Dow Wolff da Ashland) sun gano babbar kasuwa ga cellulose na magunguna a China a nan gaba, kuma ko dai ƙara yawan samarwa ko haɗuwa, sun ƙara kasancewarsu a wannan fanni. Zuba jari a cikin aikace-aikacen. Dow Wolff ta sanar da cewa za ta ƙara mai da hankali kan tsari, sinadaran da buƙatun kasuwar shirya magunguna ta China, kuma binciken aikace-aikacenta zai kuma yi ƙoƙarin kusantar kasuwa. Sashen Wolff Cellulose na Dow Chemical da Colorcon Corporation na Amurka ya kafa kawancen shirye-shiryen fitarwa mai ɗorewa da sarrafawa a duk duniya. Tana da ma'aikata sama da 1,200 a birane 9, cibiyoyin kadarori 15 da kamfanonin GMP 6. Ƙwararrun masu bincike suna ba da ayyuka ga abokan ciniki a 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 bincike na fasaha guda uku a Shanghai da Nanjing.
A bisa kididdiga daga shafin yanar gizo na kungiyar Sin Cellulose Association, a shekarar 2017, samar da sinadarin cellulose ether a cikin gida ya kai tan 373,000, kuma yawan tallace-tallace ya kai tan 360,000. A shekarar 2017, ainihin adadin tallace-tallace na ionicCMCya kasance tan 234,000, karuwar kashi 18.61% a kowace shekara, kuma yawan tallace-tallace na CMC mara ionic shine tan 126,000, karuwar kashi 8.2% a kowace shekara. Baya ga samfuran HPMC (matakin kayan gini) marasa ionic,HPMC(matsayin magunguna), HPMC (matsayin abinci), HEC, HPC, MC, HEMC, da sauransu duk sun tashi a kan wannan yanayi, kuma samarwa da tallace-tallace sun ci gaba da ƙaruwa. Ethers na cellulose na cikin gida suna girma cikin sauri fiye da shekaru goma, kuma fitarwa ta zama ta farko a duniya. Duk da haka, yawancin samfuran kamfanonin cellulose ether galibi ana amfani da su ne a tsakiyar da ƙananan masana'antu, kuma ƙarin ƙimar ba ta da yawa.
A halin yanzu, yawancin kamfanonin cellulose ether na cikin gida suna cikin mawuyacin lokaci na canji da haɓakawa. Ya kamata su ci gaba da ƙara himma wajen bincike da haɓaka samfura, ci gaba da wadatar da nau'ikan samfura, yin amfani da China, babbar kasuwa a duniya, da kuma ƙara himma wajen haɓaka kasuwannin ƙasashen waje ta yadda kamfanoni za su iya faɗaɗa da wuri-wuri. Kammala canji da haɓakawa, shiga tsakani zuwa babban ɓangaren masana'antar, da kuma cimma ci gaba mai kyau da kore.
Lokacin Saƙo: Afrilu-25-2024