Nekudzika kwehurongwa hwekutsvagisa zvinodhaka uye zvakaomesesa zvinodiwa, zvitsva zvemishonga zvemishonga zviri kubuda, pakati peiyo hydroxypropyl methylcellulose inoshandiswa zvakanyanya. Iri bepa rinoongorora mashandisirwo emumba uye ekunze ehydroxypropyl methylcellulose. Iyo nzira yekugadzira uye zvayakanakira nezvayakaipira, tekinoroji yemidziyo uye tarisiro yekuvandudza mudzimba, uye mashandisiro ayo mumunda wemishonga excipients.
Mazwi akakosha: mishonga yekubatsira; hydroxypropyl methylcellulose; production; application
1 Nhanganyaya
Pharmaceutical excipients inoreva izwi rakajairwa kune mamwe ese emishonga akawedzerwa pakugadzirira kunze kwemushonga mukuru kuitira kugadzirisa kuumbwa, kuwanikwa uye kuchengetedzwa kwegadziriro mukugadzira nekugadzira gadziriro. Mishonga yemishonga yakakosha zvikuru mukugadzirira kwemishonga. Kune akawanda marudzi emishonga ekubatsira mukugadzirira kwemumba nekune dzimwe nyika, asi mumakore achangopfuura, zvinodikanwa zvekuchena, kuparara, kugadzikana, bioavailability muvivo, kuvandudzwa kwemaitiro ekurapa uye kuderedzwa kwemhedzisiro yemishonga iri kuramba ichikwira. , ichiita kukurumidza kubuda kwevabatsiri vatsva uye maitiro ekutsvaga kuitira kuvandudza kushanda kwekugadzirira zvinodhaka uye kunaka kwekushandisa. Nhamba huru yemuenzaniso data inoratidza kuti hydroxypropyl methylcellulose inogona kusangana nepamusoro pezvinodiwa seyepamusoro-mhando yemishonga yemishonga. Mamiriro ezvinhu aripo ekutsvaga nekugadzirwa kwekunze uye kushandiswa kwayo mumunda wekugadzirira kwemishonga kunopfupikisa zvakare.
2 Mhedziso yezvivakwa zveHPMC
HPMC ichena kana kuti yero zvishoma, isinganhuhwi, isina kunhuwa, isina-chepfu hupfu inowanikwa ne etherification yealkali cellulose, propylene oxide uye alkyl chloride. Kunyungudika zviri nyore mumvura iri pasi pe60°C uye 70% ethanol neacetone, isoacetone, uye dichloromethane yakasanganiswa solvent; HPMC ine kugadzikana kwakasimba, kunonyanya kuratidzwa: kutanga, mhinduro yaro yemvura haina mutero uye haina kuita nesimbi yemunyu kana ionic organic compounds; chechipiri, inopesanawo nemaasidhi kana mabhesi. Zvakati dzikamei. Ndiwo maitiro ekugadzikana kweHPMC anoita kuti mhando yemishonga ine HPMC igadzikane pane iyo ine mishonga yechivanhu. Muchidzidzo chetoxicology cheHPMC sezvinobatsira, zvinoratidzwa kuti HPMC haizogadziriswi mumuviri, uye haibatanidzi mumetabolism yemuviri wemunhu. Simba rekupa, hapana chepfu uye mhedzisiro yemishonga, yakachengeteka yemishonga excipients.
3 Tsvagiridzo yekugadzirwa kwemumba nekune dzimwe nyika kweHPMC
3.1 Mhedziso yehunyanzvi hwekugadzira yeHPMC kumba nekune dzimwe nyika
Kuti ugone kurarama zvirinani nekuwedzera uye kuwedzera zvinodiwa zvekugadzirira kwemishonga kumba nekune dzimwe nyika, tekinoroji yekugadzira uye maitiro eHPMC ari kuramba achikura munzira ine nhamo uye yakareba. Iyo yekugadzira maitiro eHPMC inogona kukamurwa kuita batch nzira uye inoenderera nzira. Zvikamu zvikuru. Iyo inoenderera maitiro inowanzoshandiswa kunze kwenyika, nepo batch process inonyanya kushandiswa muChina. Kugadzirira kweHPMC kunosanganisira matanho ekugadzirisa alkali cellulose, etherification reaction, kunatsa kurapwa, uye kupera kwechigadzirwa kurapwa. Pakati pavo, kune marudzi maviri enzira dzemaitiro etherification reaction. : Gasi chikamu nzira uye mvura chikamu nzira. Zvichienderana, iyo gasi chikamu nzira ine mabhenefiti ehukuru hwekugadzira huwandu, yakaderera kuita tembiricha, ipfupi yekupindura nguva, uye chaiyo maitiro ekugadzirisa, asi maitiro ekumanikidza akakurisa, investimendi yakakura, uye kana dambudziko raitika, zviri nyore kuita. kukonzera tsaona huru. Iyo yemvura chikamu nzira inowanzo ine zvakanakira yakaderera reaction kumanikidza, njodzi yakaderera, yakaderera mutengo wekudyara, nyore kudzora mhando, uye nyore kutsiva mhando; asi panguva imwecheteyo, iyo reactor inodikanwa neiyo nzira yemvura chikamu haigone kuve yakakura kwazvo, iyo zvakare inodzikamisa maitiro ekuita. Kuenzaniswa negasi chikamu nzira, nguva yekuita yakarebesa, simba rekugadzira idiki, midziyo inodiwa yakawanda, kushanda kwakaoma, uye automation control uye kurongeka kwakadzikira pane gasi chikamu nzira. Parizvino, nyika dzakabudirira dzakadai seEurope neUnited States dzinonyanya kushandisa nzira yegasi. Pane zvinodiwa zvakanyanya maererano nehunyanzvi uye mari. Tichitarisa kubva pamamiriro ezvinhu chaiwo munyika yedu, iyo nzira yemvura inowanzoitika. Nekudaro, kune nzvimbo dzakawanda muChina dzinoramba dzichivandudza uye nekuvandudza matekinoroji, dzidza kubva kune ekunze nhanho dzepamberi, uye kutanga hafu-inoenderera maitiro. Kana mugwagwa wekuunza kunze gasi-chikamu nzira.
3.2 Kuvandudza tekinoroji yekugadzira yepamba HPMC
HPMC munyika yangu ine yakakura budiriro mukana. Pasi pemikana yakanaka yakadai, ndicho chinangwa chemuongorori wega wega kuti arambe achivandudza tekinoroji yekugadzira yeHPMC uye kuderedza mukaha uripo pakati peiyo indasitiri yeHPMC indasitiri nenyika dzekunze dzakasimukira. Maitirwo eHPMC Yese chinongedzo muchirongwa chekubatanidza chine kukosha kukuru kune chigadzirwa chekupedzisira, pakati peiyo alkalization uye etherification reactions [6] ndiyo inonyanya kukosha. Naizvozvo, iyo iripo yemumba HPMC yekugadzira tekinoroji inogona kuitwa kubva kune aya maviri nzira. Shanduko. Chokutanga pane zvose, kugadzirira kwe alkali cellulose kunofanira kuitwa pakupisa kwakadzika. Kana chigadzirwa chepasi-viscosity chakagadzirirwa, mamwe maoxidants anogona kuwedzerwa; kana chigadzirwa chepamusoro-viscosity chakagadzirirwa, nzira yekudzivirira gasi inert inogona kushandiswa. Chechipiri, iyo etherification reaction inoitwa pakupisa kwakanyanya. Isa toluene mumudziyo weetherification pachine nguva, tumira alkali cellulose mumudziyo une pombi, uye wedzera imwe isopropanol maererano nezvinodiwa. Deredza chiyero chakasimba-mvura. Uye shandisa komputa inodzora sisitimu, inogona kukurumidza mhinduro tembiricha, Maitiro maparamendi akadai sekumanikidza uye pH anogadziriswa otomatiki. Ehe, kuvandudzwa kweHPMC yekugadzira tekinoroji inogona zvakare kuvandudzwa kubva munzira yekugadzira, kushandiswa kwezvinhu zvakasvibiswa, kunatsa kurapwa uye zvimwe zvinhu.
4 Kushandiswa kweHPMC mumunda wemishonga
4.1 Kushandiswa kweHPMC mukugadzirira mahwendefa anoramba achiburitswa
Mumakore achangopfuura, nekuenderera mberi nekudzika kwekutsvagisa kwehurongwa hwekuunza zvinodhaka, kusimudzira kwepamusoro-viscosity HPMC mukushandiswa kwegadziriro-yakaburitswa gadziriro yakwezva kutarisisa kwakawanda, uye mhedzisiro-kuburitswa-yakanaka. Mukuenzanisa, kuchine gaka rakakura mukushandiswa kweyakasimba-kuburitswa matrix mapiritsi. Semuenzaniso, kana tichienzanisa HPMC yemumba uye yekune dzimwe nyika yenifedipine-yakaburitswa mahwendefa uye sematrix yepropranolol hydrochloride inosimudzira-kuburitswa matrix mahwendefa, inowanikwa kuti Kushandiswa kwemumba HPMC mukugadzirisa-kuburitswa gadziriro kunoda kumwe kuvandudzwa kuti urambe uchivandudza. mwero wegadziriro dzepamba.
4.2 Kushandiswa kweHPMC mukukora kwemafuta ekurapa
Nekuda kwezvinodiwa zvekuongororwa kana kurapwa kwezvimwe zvigadziriso zvekurapa nhasi, kana uchipinda kana kubuda nhengo dzemunhu uye matishu, pamusoro pechigadzirwa chinofanira kunge chine zvimwe zvekuzora, uye HPMC ine zvimwe zvekuzora. Kuenzaniswa nemamwe mafuta ekuzora, HPMC inogona kushandiswa senge yekurapa lubricating zvinhu , izvo zvisingakwanisi kuderedza chete kupfeka kwemidziyo, asiwo kusangana nezvinodiwa zvekuzora kwekurapa uye kuderedza mutengo.
4.3 Kushandiswa kweHPMC seyakasikwa antioxidant mvura-inonyungudika yekurongedza firimu uye firimu rekuputira zvinhu uye firimu-kugadzira zvinhu.
Kuenzaniswa nezvimwe zvechinyakare zvakavharwa piritsi zvinhu, HPMC ine zviri pachena zvakanakira maererano nekuoma, friability uye kunyura hunyoro. HPMC yeakasiyana viscosity mamakisi anogona kushandiswa semvura-soluble package yemapiritsi nemapiritsi. Inogona zvakare kushandiswa seyekurongedza firimu kune organic solvent masisitimu. Zvinogona kutaurwa kuti HPMC ndiyo inonyanya kushandiswa firimu coating material munyika yangu. Uye zvakare, HPMC inogona zvakare kushandiswa senge firimu-inogadzira zvinhu mune firimu agent, uye anti-oxidative mvura-soluble packaging firimu yakavakirwa paHPMC inoshandiswa zvakanyanya mukuchengetedza chikafu, kunyanya michero.
4.4 Kushandiswa kweHPMC se capsule shell material
HPMC inogona zvakare kushandiswa sechinhu chekugadzirira capsule shells. Zvakanakira zveHPMC capsules ndezvekuti ivo vanokunda iyo cross-linking mhedzisiro yegelatin capsules, vane kuenderana kwakanaka nemishonga, vane kugadzikana kwakanyanya, vanogona kugadzirisa nekudzora kuburitswa kwezvinodhaka, kuvandudza mhando yezvinodhaka, Iine zvakanakira kugadzikana kuburitswa kwezvinodhaka. process. Nekushanda, HPMC capsules inogona kutsiva zvachose iyo iripo gelatin capsules, inomiririra ramangwana rekusimudzira kutungamira kweakaoma capsules.
4.5 Kushandiswa kweHPMC semumiriri wekumisa basa
HPMC inoshandiswa semumiriri wekumisa, uye kumisa kwayo kuita kwakanaka. Uye zviedzo zvinoratidza kuti kushandisa zvimwe zvakajairika polymer zvinhu seanomisa mumiriri kugadzirira yakaoma kuturika kunofananidzwa neHPMC seanomisa mumiriri kugadzirira kumisa kuoma. Iyo yakaoma kumiswa iri nyore kugadzirira uye ine kugadzikana kwakanaka, uye iyo yakaumbwa kumiswa inosangana nezvinodiwa zvemhando dzakasiyana-siyana zviratidzo zvekumira kwakaoma. Naizvozvo, HPMC inowanzoshandiswa seanomisa mumiririri weophthalmic kugadzirira.
4.6 Kushandiswa kweHPMC se blocker, inononoka-kuburitsa mumiririri uye porogen
HPMC inogona kushandiswa sevhavha mumiririri, inosimudzira-kuburitsa mumiriri uye pore-inogadzira mumiriri kunonoka uye kudzora kuburitswa kwezvinodhaka. Mazuva ano, HPMC inoshandiswawo zvakanyanya mukugadzirira-kuburitswa-kuburitswa uye gadziriro dzemisanganiswa yemishonga yechivanhu yechiChinese, senge muTianshan Snow Lotus inosimudzira-kuburitsa matrix mapiritsi. Kushandisa, kusunungurwa kwayo kwakaramba kuchiitika kwakanaka, uye maitiro ekugadzirira ari nyore uye akagadzikana.
4.7 Kushandiswa kweHPMC seyakakora uye colloid inodzivirira glue
HPMC inogona kushandiswa seyakakora [9] kugadzira macolloid anodzivirira, uye ongororo dzakafanira dzakaratidza kuti kushandisa HPMC semukobvu kunogona kusimbisa kugadzikana kwemushonga wakagadzirwa kabhoni. Semuenzaniso, inowanzoshandiswa mukugadzirira pH-sensitive levofloxacin hydrochloride ophthalmic yakagadzirira-kushandisa gel. HPMC inoshandiswa seyakakora.
4.8 Kushandiswa kweHPMC sebioadhesive
Iwo anonamira anoshandiswa mubioadhesion tekinoroji macromolecular makomisheni ane bioadhesive zvivakwa. Nekunamatira kune gastrointestinal mucosa, oral mucosa uye zvimwe zvikamu, kuenderera uye kusimba kwekubatana pakati pemushonga uye mucosa kunosimbiswa kuti iwane zviri nani kurapa mhedzisiro. . Huwandu hukuru hwemienzaniso yekushandisa inoratidza kuti HPMC inogona kunyatso kuzadzisa izvo zviri pamusoro sezvinodiwa bioadhesive.
Pamusoro pezvo, HPMC inogona zvakare kushandiswa semvura inhibitor yema topical gels uye self-microemulsifying masisitimu, uye muindasitiri yePVC, HPMC inogona kushandiswa semudziviriri wekuparadzira muVCM polymerization.
5 Mhedziso
Mushoko, HPMC yakashandiswa zvakanyanya mukugadzirira kwemishonga uye zvimwe zvinhu nekuda kweiyo yakasarudzika physicochemical uye biological zvimiro. Kunyangwe zvakadaro, HPMC ichine matambudziko mazhinji mukugadzirira kwemishonga. Ndeipi basa chairo reHPMC mukushandisa; nzira yekuziva kana ine pharmacological effect; hunhu hupi hwainahwo mukuburitsa kwayo, nezvimwewo Zvinogona kuonekwa kuti nepo HPMC ichishandiswa zvakanyanya, mamwe matambudziko anoda kugadziriswa nekuchimbidza. Uye vaongorori vakawanda vari kuita basa rakawanda rekushandiswa kuri nani kweHPMC mukurapa, nekudaro vachiramba vachisimudzira kuvandudzwa kweHPMC mundima yemishonga yemishonga.
Nguva yekutumira: Nov-02-2022