Tare da zurfafa bincike na tsarin isar da magunguna da buƙatu masu tsauri, sabbin abubuwan haɓaka magunguna suna fitowa, daga cikinsu ana amfani da hydroxypropyl methylcellulose sosai.Wannan takarda tana nazarin aikace-aikacen gida da na waje na hydroxypropyl methylcellulose.Hanyar samarwa da fa'ida da rashin amfaninsa, fasahar kayan aiki da haɓakar haɓaka cikin gida, da aikace-aikacen sa a fagen haɓakar magunguna.
Mahimman kalmomi: magungunan magunguna;hydroxypropyl methylcellulose;samarwa;aikace-aikace
1 Gabatarwa
Pharmaceutical excipients yana nufin gabaɗaya ga duk sauran kayan magani da aka kara a cikin shirye-shiryen sai dai babban magani domin warware tsari, samuwa da kuma aminci na shirye-shiryen a kan aiwatar da samar da kuma zayyana shirye-shirye.Abubuwan da ake amfani da su na magunguna suna da mahimmanci a cikin shirye-shiryen magunguna.Akwai nau'ikan magunguna da yawa a cikin shirye-shiryen gida da na waje, amma a cikin 'yan shekarun nan, buƙatun don tsabta, rushewa, kwanciyar hankali, bioavailability a cikin vivo, haɓaka tasirin warkewa da rage tasirin sakamako na kwayoyi suna samun girma da girma., Yin saurin fitowar sababbin abubuwan haɓakawa da hanyoyin bincike don inganta ingantaccen shirye-shiryen miyagun ƙwayoyi da ingancin amfani.Yawancin misali bayanai sun nuna cewa hydroxypropyl methylcellulose na iya saduwa da buƙatun da ke sama a matsayin babban kayan aikin magunguna.A halin yanzu halin da ake ciki na bincike da samar da kasashen waje da kuma aikace-aikacensa a fagen shirye-shiryen magunguna an kara taƙaice.
2 Bayanin kaddarorin HPMC
HPMC fari ne ko rawaya dan kadan, mara wari, mara wari, foda mara guba da aka samu ta hanyar etherification na alkali cellulose, propylene oxide da alkyl chloride.Sauƙi mai narkewa a cikin ruwa ƙasa da 60 ° C da 70% ethanol da acetone, isoacetone, da dichloromethane gauraye sauran ƙarfi;HPMC yana da kwanciyar hankali mai ƙarfi, galibi yana bayyana: na farko, maganin sa na ruwa ba shi da wani caji kuma baya amsawa da gishirin ƙarfe ko mahaɗan kwayoyin ionic;na biyu, shi ma yana da juriya ga acid ko tushe.Ingantacciyar kwanciyar hankali.Halayen kwanciyar hankali na HPMC ne ke sa ingancin magunguna tare da HPMC a matsayin abubuwan haɓakawa sun fi kwanciyar hankali fiye da waɗanda ke da abubuwan haɓaka na gargajiya.A cikin binciken toxicology na HPMC a matsayin abubuwan haɓakawa, an nuna cewa HPMC ba za ta kasance cikin jiki ba, kuma baya shiga cikin metabolism na jikin mutum.Samar da makamashi, babu mai guba da illa ga magunguna, amintattun kayan aikin magunguna.
3 Bincike kan samar da HPMC na gida da waje
3.1 Bayanin fasahar samarwa na HPMC a gida da waje
Domin ya fi dacewa da ci gaba da haɓaka da haɓaka buƙatun shirye-shiryen magunguna a gida da waje, fasahar samarwa da tsarin na HPMC suma suna ci gaba da bunƙasa akan hanya mai wahala da tsayi.Ana iya raba tsarin samar da HPMC zuwa hanyar tsari da hanya mai ci gaba.Manyan nau'ikan.Ana amfani da ci gaba da tsarin gabaɗaya a ƙasashen waje, yayin da tsarin batch galibi ana amfani dashi a China.A shirye-shiryen na HPMC ya hada da matakan alkali cellulose shiri, etherification dauki, refining jiyya, da kuma gama samfurin magani.Daga cikin su, akwai nau'ikan hanyoyin aiwatarwa guda biyu don amsawar etherification.: Hanyar lokaci na iskar gas da hanyar lokaci na ruwa.Dangantakar da magana, hanyar lokaci na iskar gas yana da fa'idodi na babban ƙarfin samarwa, ƙananan zafin jiki, ɗan gajeren lokacin amsawa, da daidaitaccen kulawar amsawa, amma matsin lamba yana da girma, saka hannun jari yana da girma, kuma da zarar matsala ta faru, yana da sauƙi. haifar da manyan hadura.The ruwa lokaci hanya kullum yana da abũbuwan amfãni daga low dauki matsa lamba, low hadarin, low zuba jari kudin, sauki ingancin iko, da kuma sauki sauyawa iri;amma a lokaci guda, reactor da ake buƙata ta hanyar tsarin lokaci na ruwa ba zai iya girma da yawa ba, wanda kuma yana iyakance ƙarfin amsawa.Idan aka kwatanta da hanyar lokaci na gas, lokacin amsawa yana da tsawo, ƙarfin samar da ƙananan ƙananan, kayan aikin da ake buƙata suna da yawa, aikin yana da wuyar gaske, kuma sarrafawa ta atomatik da daidaito sun fi ƙasa da hanyar gas.A halin yanzu, kasashen da suka ci gaba irinsu Turai da Amurka sun fi amfani da hanyar iskar gas.Akwai manyan buƙatu dangane da fasaha da saka hannun jari.Idan aka yi la’akari da ainihin halin da ake ciki a ƙasarmu, tsarin tsarin ruwa ya fi yawa.Duk da haka, akwai yankuna da yawa a kasar Sin da ke ci gaba da yin kwaskwarima da sabunta fasahohi, da koyo daga matakan ci gaba na kasashen waje, da kuma fara aiwatar da matakai na gaba kadan.Ko hanyar bullo da hanyar samar da iskar gas na kasashen waje.
3.2 Inganta fasahar samarwa na HPMC na gida
HPMC a cikin ƙasata yana da babban ƙarfin ci gaba.A karkashin irin wannan dama mai kyau, shi ne burin kowane mai bincike don ci gaba da inganta fasahar samar da HPMC tare da rage gibin da ke tsakanin masana'antun HPMC na cikin gida da kasashen waje masu ci gaba.Tsarin HPMC Kowane hanyar haɗin gwiwa a cikin tsarin haɗawa yana da mahimmanci ga samfur na ƙarshe, daga cikinsu alkalization da halayen etherification [6] sune mafi mahimmanci.Don haka, ana iya aiwatar da fasahar samar da HPMC ta cikin gida daga waɗannan hanyoyi guda biyu.Sauyi.Da farko, ya kamata a gudanar da shirye-shiryen alkali cellulose a ƙananan zafin jiki.Idan an shirya samfurin ƙananan danko, ana iya ƙara wasu oxidants;idan an shirya samfurin mai girma, ana iya amfani da hanyar kariya ta iskar gas.Abu na biyu, ana aiwatar da halayen etherification a babban zafin jiki.Saka toluene a cikin kayan aikin etherification a gaba, aika alkali cellulose a cikin kayan aiki tare da famfo, kuma ƙara wani adadin isopropanol bisa ga bukatun.Rage rabo mai ƙarfi-ruwa.Kuma yi amfani da tsarin sarrafa kwamfuta, wanda zai iya saurin mayar da martani ga zafin jiki, ana daidaita sigogin tsari kamar matsa lamba da pH ta atomatik.Tabbas, ana iya inganta haɓaka fasahar samar da HPMC ta hanyar hanya, amfani da albarkatun ƙasa, jiyya mai tacewa da sauran fannoni.
4 Aikace-aikacen HPMC a fagen magani
4.1 Amfani da HPMC a cikin shirye-shiryen dorewa-saki Allunan
A cikin 'yan shekarun nan, tare da ci gaba da zurfafa bincike na tsarin bayarwa na miyagun ƙwayoyi, haɓakar HPMC mai girma a cikin aikace-aikacen shirye-shiryen ci gaba da ci gaba ya jawo hankali sosai, kuma sakamakon da aka ci gaba yana da kyau.A kwatankwacin, har yanzu akwai babban gibi a aikace-aikacen allunan matrix mai ɗorewa.Misali, lokacin da aka kwatanta HPMC na gida da na waje don allunan ci gaba na nifedipine kuma azaman matrix don allunan matrix na propranolol hydrochloride, an gano cewa Amfani da HPMC na cikin gida a cikin shirye-shiryen sakewa na buƙatar ƙarin haɓakawa don ci gaba da haɓakawa. matakin shirye-shiryen gida.
4.2 Aikace-aikacen HPMC a cikin kauri na kayan shafawa na likita
Saboda bukatu na dubawa ko kula da wasu na'urorin likitanci a yau, lokacin shiga ko barin gabobin jikin mutum da kyallen takarda, dole ne saman na'urar ya kasance yana da wasu kayan shafawa, kuma HPMC yana da wasu kayan shafawa.Idan aka kwatanta da sauran man shafawa, HPMC za a iya amfani da a matsayin likita lubricating abu , wanda ba zai iya kawai rage lalacewa na kayan aiki, amma kuma saduwa da bukatun likita lubrication da kuma rage farashin.
4.3 Aikace-aikacen HPMC azaman fim ɗin marufi na ruwa mai narkewa mai narkewa da kayan shafa fim da kayan ƙirƙirar fim.
Idan aka kwatanta da sauran kayan al'ada mai rufi na al'ada, HPMC yana da fa'ida a bayyane ta fuskar taurin kai, jurewa da sha.Ana iya amfani da HPMC na maki daban-daban danko azaman marufi mai narkewa don allunan da kwaya.Hakanan za'a iya amfani dashi azaman fim ɗin marufi don tsarin narkewar kwayoyin halitta.Ana iya cewa HPMC ita ce kayan shafa fim da aka fi amfani da su a cikin ƙasata.Bugu da kari, HPMC kuma za a iya amfani da a matsayin fim-forming abu a cikin fim wakilin, da anti-oxidative ruwa mai narkewa marufi fim dangane da HPMC ne yadu amfani da adanar abinci, musamman 'ya'yan itace.
4.4 Aikace-aikacen HPMC azaman kayan harsashi na capsule
Hakanan ana iya amfani da HPMC azaman abu don shirya harsashi na capsule.A abũbuwan amfãni daga cikin HPMC capsules ne cewa sun shawo kan giciye-linking sakamako na gelatin capsules, da kyau karfinsu da kwayoyi, da high kwanciyar hankali, iya daidaita da sarrafa saki hali na kwayoyi, inganta miyagun ƙwayoyi quality, Yana da abũbuwan amfãni daga barga miyagun ƙwayoyi saki. tsari.Aiki, HPMC capsules iya gaba daya maye gurbin data kasance gelatin capsules, wakiltar nan gaba ci gaban shugabanci na wuya capsules.
4.5 Aikace-aikacen HPMC azaman wakili mai dakatarwa
Ana amfani da HPMC azaman wakili mai dakatarwa, kuma tasirin dakatarwarsa yana da kyau.Kuma gwaje-gwajen sun nuna cewa yin amfani da sauran kayan aikin polymer na yau da kullun azaman wakili na dakatarwa don shirya busassun dakatarwa ana kwatanta shi da HPMC azaman wakili mai dakatarwa don shirya busassun dakatarwa.Dakatar da bushewa yana da sauƙin shirya kuma yana da kwanciyar hankali mai kyau, kuma dakatarwar da aka kafa ya dace da buƙatun alamomin inganci daban-daban na dakatarwar bushewa.Don haka, ana amfani da HPMC sau da yawa azaman wakili mai dakatarwa don shirye-shiryen ido.
4.6 Aikace-aikacen HPMC azaman mai toshewa, wakilin jinkirin saki da porogen
Ana iya amfani da HPMC azaman wakili mai toshewa, wakili mai ɗorewa da wakili mai ƙira don jinkirtawa da sarrafa sakin miyagun ƙwayoyi.A zamanin yau, ana amfani da HPMC sosai a cikin shirye-shiryen sakewa da kuma shirye-shirye na magungunan gargajiya na kasar Sin, kamar su a cikin Tianshan Snow Lotus allunan ci gaba da sakin matrix.Aikace-aikacen, tasirin sa na ci gaba yana da kyau, kuma tsarin shirye-shiryen yana da sauƙi kuma barga.
4.7 Aikace-aikacen HPMC azaman mai kauri da manne mai kariyar colloid
Ana iya amfani da HPMC azaman mai kauri [9] don samar da colloid masu kariya, kuma binciken gwaji masu dacewa ya nuna cewa yin amfani da HPMC azaman mai kauri na iya haɓaka kwanciyar hankali na carbon da aka kunna na magani.Misali, ana yawan amfani dashi a cikin shirye-shiryen pH-m levofloxacin hydrochloride ophthalmic shirye-shiryen gel.Ana amfani da HPMC azaman mai kauri.
4.8 Aikace-aikacen HPMC azaman bioadhesive
Abubuwan da ake amfani da su a cikin fasahar bioadhesion sune mahadi macromolecular tare da kaddarorin bioadhesive.Ta hanyar ɗorawa ga ƙwayar gastrointestinal, mucosa na baki da sauran sassa, ci gaba da matsawa na hulɗar da ke tsakanin miyagun ƙwayoyi da mucosa suna ƙarfafa don cimma sakamako mai kyau na warkewa..Misalai masu yawa na aikace-aikacen sun nuna cewa HPMC na iya cika buƙatun da ke sama a matsayin mai amfani da kwayoyin halitta.
Bugu da kari, HPMC kuma za a iya amfani da a matsayin hazo hanawa ga Topical gels da kai-microemulsifying tsarin, da kuma a cikin PVC masana'antu, HPMC za a iya amfani da a matsayin watsawa kariya a VCM polymerization.
5 Kammalawa
A cikin kalma, HPMC an yi amfani da shi sosai a cikin shirye-shiryen magunguna da sauran fannoni saboda keɓaɓɓen kayan aikin sinadarai da na halitta.Duk da haka, HPMC har yanzu yana da matsaloli da yawa a cikin shirye-shiryen magunguna.Menene takamaiman aikin HPMC a aikace;yadda za a ƙayyade ko yana da tasirin pharmacological;waɗanne halaye ne yake da shi a cikin tsarin sakin sa, da sauransu. Ana iya ganin cewa yayin da ake amfani da HPMC da yawa, ana buƙatar magance ƙarin matsaloli cikin gaggawa.Kuma da yawa masu bincike suna yin ayyuka da yawa don ingantaccen aikace-aikacen HPMC a cikin magani, don haka ci gaba da haɓaka haɓakar HPMC a fagen haɓakar magunguna.
Lokacin aikawa: Nov-02-2022