Udidi: Izinto zokuKhathalela; Izixhobo ze-membrane; Izinto ezilawulwa ngesantya ezilawulwa ngu-polly zamalungiselelo okukhululeka kancinci; Iarhente yokuzinzisa; Uncedo lokumiswa, ubumbethe beetafile; Yomeleza iarhente yobumbano.
1. Intshayelelo
Le mveliso i-ionic ye-ionsulose ether, ngaphandle komgubo omhlophe, engenantlonelo kwaye engenantsingiselo, inyibilika emanzini kwaye isuswe emanzini e-coolbidid tolloidid. Isisombululo esikhulu sinomsebenzi womphezulu, ukungafihli nto kunye nokusebenza ngokuzinzileyo. I-HPMC inepropathi yejeli eshushu. Emva kokufudumeza, isisombululo semveliso esiyimfihlo senza ububanzi be-gel, kwaye emva koko inyibilike emva kokupholisa. Iqondo lokushisa le-gene lenkcazo eyahlukileyo. I-Solbability itshintsha ngohlobo lwe-viscosity yeZhao, kokukhona i-solity ye-solity, imigaqo eyahlukeneyo yepropathi ineempawu ezithile, i-HPMC ichithwe emanzini ayichaphazeli ixabiso le-pH.
Iqondo lobushushu lokuhlambela, ukuxinana okukhululekileyo, ukuxinana kokwenyani kunye neglasi yeglasi yayingama-360 ℃, i-0.34G / CM3 kunye ne-170 ~, ngokulandelelana. Emva kokufudumeza, ijika iBrown ngo-190 ~ 200 ° C kwaye ivutha kwi-225 ~ 230 ° C.
I-HPMC iphantse yangena kwi-chloroform, ethanol (i-95%), kunye ne-Diegyl Hethenol kunye ne-Methylene Chlolol kunye noMxube wamanzi kunye ne-ethanol. Amanye amanqanaba e-HPMC ayanyibilika kwimixube ye-acetone, i-methylene chloride, kunye ne-2-propanol, kunye nezinye izinyibilikisi eziphilayo.
Itheyibhuli 1: Izalathi zezobugcisa
iprojekthi
Igeji,
I-60 GD (2910).
I-65GD (2906)
I-75GD (2208)
I-APEXY%
28.0-32.0
27.0-30.0
19.0-24.0
Hydroxypropoxy%
7.0-12.0
4.0-7.5
4.0-12.0
Iqondo lokushisa le-℃
I-56-64.
I-62.0-68.0
I-70.0-90.0
I-viscofity MPA s.
I-3,5,6,15,50,4000
I-50400 0
I-100400 0150 00100 000
Ukulahleka kwesisindo esomileyo%
5.0 okanye ngaphantsi
Intsalela yentsalela%
1.5 okanye ngaphantsi
pH
4.0-8.0
Intsimbi enzima
20 okanye ngaphantsi
i-arsenic
2.0 okanye ngaphantsi
2. Iimpawu zemveliso
2.1 I-hydroxypropyl methylcelceluplose ichithwe kumanzi abandayo ukwenza isisombululo se-colloidal. Ngalo lonke ixesha longezwa kumanzi abandayo kwaye ivuseleleke kancinci, inokuchithwa kwisisombululo esibonakalayo. Ngokuchasene noko, ngokusisiseko i-insulafazwe kumanzi ashushu ngaphezulu kwe-60 ℃ kwaye inokudumba kuphela. Kwilungiselelo le-HydroxyPOpyl MethicellulUlose isisombululo, kungcono ukongeza inxenye ye-Hydroxypropy kwinani elithile lamanzi, ishushu ngamandla e-Hydroxyproplose, kwaye ekugqibeleni basebenzise amanzi abandayo ukongeza kwinani elifunekayo.
2.2 I-HydroxyPOpyl Methylcelcelcelsulose i-Ionic ye-Ionic sether, isisombululo sayo asikuthwala i-ionic ye-ionic, i-ionic ye-organic ye-organic, ukuze i-Ionic yeService, ukuze i-Ionic Subs ikwazisa ezinye izinto zokulungiselela.
2.3 I-HydroxyPOpyl Methylcelcelgalose inemvakalelo eyomeleleyo ye-anti-imvakalelo, kunye nokwanda kwesidanga sokufaka endaweni yemolekyuli, i-anti-ubuntu ikwaphuculwa. Iziyobisi zisebenzisa i-HPMC njengoko iziyobisi zinemigangatho emihle kakhulu kwixesha elisebenzayo kunamanye amachiza esebenzisa ezinye izivumelwano zemveli (isitatshi, iswekile ye-pixtrin, iswekile ye-pixtrin, iswekile evelisiweyo).
2.4 I-HYDROXPOPOPLL MethylcelceLiase i-Intebogs. Njengombono wamayeza, ayisiyonto inyanzeliswa okanye ingene, ngenxa yoko ayiboneleli ngobushushu kwiziyobisi kunye nokutya. Inokwenziwa okwahlukileyo kwixabiso lesoloritic eliphantsi, ityiwa-engenazo ityiwa, ingeyo-allergenic kunye nokutya kwiswekile.
I-2.5hpmc izinzile kwii-acids kunye neziseko, kodwa ukuba i-PH ingaphezulu kwe-2 ~ 11 kwaye ichaphazelekile kubushushu obuphezulu okanye ixesha elide kugcino, iya kunciphisa inqanaba lokuvuthwa.
2.6 I-HYDROXCOPLL Methylcelcelgalose isisombululo se-ACTEAUR Sinokubonelela ngomsebenzi, obonisa ubungakanani bexabiso eliphakathi kunye nexabiso lempindezelo. Inesipomente esisebenzayo kwinkqubo yesigaba esibini kwaye inokusetyenziswa njengesiqhelo kunye ne-colloid esebenzayo kunye nokukhusela.
2.7 I-HYDROXYLL MTHYLCELCELCELXELXELXEXalose I-ACTEAUR YENKCAZO YENKCAZO YOKUGQIBELA YENKQUBO YOKUGQIBELA, kwaye yindawo entle yokuhamba kweetafile kunye neepilisi. I-membrane eyenziwe yiyo ayinantsingiselo kwaye inzima. Ukuba i-glycerol yongezwa, iplasitiki yayo ingenwe. Emva konyango lomphezulu, imveliso ichithwa kumanzi abandayo, kwaye ireyithi yokuchithwa inokulawulwa ngokutshintsha imeko ye-p ye-p ye-p ye-p. Isetyenziswe kumalungiselelo okukhululeka kancinci kunye namalungiselelo anezinto ezinamaphepha.
3. Isicelo semveliso
3.1. Isetyenziswe njenge-adherive kunye nearhente ye-enrivegrafic
I-HPMC isetyenziselwa ukukhuthaza ukonakaliswa kweziyobisi kunye nenqanaba lokukhutshwa kwezicelo, kunokuchithwa ngokuthe ngqo kwi-SOLDEP ye-Colloid ye-Colloid, kunye ne-viscofity ephezulu ye-HEE, kunye neemfuno ezahlukeneyo, ngokubanzi yi-2% ~ I-5%.
I-HPMC ACTICEOOUROOONOUCOOOOORATICY NOKUXHASA I-ETHANoL ukwenza umngxunya ohlanganisiweyo; Umzekelo: 2% I-HPMC AXCOOUR EXELWE NGE-55% ye-ETHANol ye-Ethanol ye-Pelles, ukuze ukuchithwa kwe-Amoxillin Capsules kunyuke ukusuka kwi-38% ukuya kwi-HPMC.
I-HPMC inokwenziwa ngokwenzakala okunamathela ngokudibeneyo kwe-starry slicry emva kokupheliswa; Ukuchithwa kweetafile ze-erythycin zaye zanda ukusuka kwi-38.26% ukuya kwi-97.38% xa i-2% ye-HPMC kunye ne-8% isitatshi sasidityaniswe.
2.2. Yenza i-filim couides ezinemibandela kunye nezinto zokwenza ifilimu
I-HPMC njengento yokuhamba kwamanzi anyibilikayo inezi mpawu zilandelayo: I-Viscofity ePhezulu; Inkqubo yokuthuka ilula; Ifilimu elungileyo yokwakha ipropathi; Inokugcina ubume besiqwenga, ukubhala; Ingakwazi ukufuma; Ingaba i-fato, incasa yolungiso. Le mveliso isetyenziswa njengefilimu enyibilikayo yamanzi ehlobene iitafile kunye neepilisi ezinophawu olusezantsi, kunye nefilimu esekwe emanzini kunye nefilimu ephezulu, isixa semali yokusetyenziswa yi-2% -5%.
2.3, njengearhente yokuthintela kunye ne-colloidal yoKhuseleko lweGlue
I-HPMC isetyenziswa njengearhente yokuthambisa yi-0.45% ~ 1.0%, inokusetyenziswa njengamahla e-rops yamehlo kunye nearhente ye-Tearting ye-Tare; Isetyenziselwa ukwandisa uzinzo lwe-hydrophobic glue, thintela i-parcicle coleescence, i-preciage, idosi eqhelekileyo yi-0.5% ~ 1.5%.
2.4, Njengebhloko, ukukhulula kancinci, iarhente yokukhupha i-arhente kunye nearhente ye-pore
Imodeli ye-HPMC ye-VPMC isetyenziselwa ukulungiselela iibhlokhi kunye neearhente zokukhupha ezilawulwayo zezinto ezifundiswayo ze-skeleton ezithengisiweyo kunye ne-hydrophilic gel skeleton ineetafile zokukhululwa. Imodeli yokufumana i-viscofity yiarhente yokukhupha i-pore-i-Poreping egcinwe okanye idonki egunyazisiweyo ukuze idosi yokuqala yonyango ifunyenwe ngokukhawuleza, ilandelwe ngokukhululwa okuzinzileyo okanye ukukhululwa okulawulwayo ukugcina ugxininiso olusebenzayo egazini.
2.5. I-gel kunye ne-gepository matrix
I-Hydrogel ReadIrithiries kunye namalungiselelo okunamathela ka-Gestric anokulungiswa ngokusebenzisa uphawu lwe-hydrogel eqhelekileyo esetyenziswa yi-HPMC emanzini.
2.6 Izixhobo ezingenantlonelo zebhayoloji
I-metronidole ixutywe ne-HPMC kunye ne-polycaryyleylene 934 kumxube ukwenza amacwecwe e-bilousive enolawulo lwe-250mg. Uvavanyo lokuchithwa kweVitro Ukubonisa ukuba amalungiselelo akhawuleza aqondeni emanzini, kwaye ukukhutshwa ngamachiza kwakulawulwa ngokuphumla kunye nokuhlaselwa kwecarbon. Ukuphunyezwa kwezilwanyana kubonise ukuba inkqubo entsha yokukhupha iziyobisi yayinemihlaba ye-odheion ebonakalayo kwi-bovine sublical Mucosa.
I-2.7, njengoncedo olunqunyanyisiweyo
I-viscosity ephezulu yale mveliso iluncedo oluhle lokumiswa kwamanzi anqunyanyisiweyo, idosi yayo eqhelekileyo yi-0.5% ~ 1.5%.
4. Imizekelo yesicelo
I-4.1 Isisombululo sokuqaqamba kwefilimu: i-HPMC 2KG, Talc 2kg, ioyile ye-cascar, i-twiin, i-propyle, i-propyle, i-proplene, amanzi afanelekileyo. Zimbini iindlela zokwenza.
4.1.1 Ukulungiswa kwe-pigment yokunyibilikisa edityanisiweyo: Yongeza isixa esimiselweyo se-HPMC ibe yi-95% ye-ethanol, inyibilikise enye i-veriment, inyibilikise enye yezisombululo kwaye ivuselele i-SOSOSTE ukwenza isisombululo esibonakalayo. Hlanganisa i-80% yesisombululo (iipesenti ezingama-20 zokushicilela) ngexabiso elimiselweyo leoyile yeCastor, phakathi kwe-80, kwaye i-propleylene Glycol.
4.1.2 Ukulungiswa kwe-pigment ye-insolfor (njenge-iron oxide) i-HPMC ye-HPMC ifakwe kwi-95% ye-eshanol ngobusuku, kwaye amanzi kongezwa ukwenza isisombululo se-2% ye-HPMC. Iipesenti ezingama-20 zesisombululo bakhutshelwa ngaphandle, kwaye isisombululo esiseleyo se-80% kwaye i-oxide ye-oxide ilungiselelwe ngendlela yokugcoba i-griting, emva koko inani lamanye amacandelo longezwa kwaye lidityaniswe ngokulinganayo ukuze lisetyenziswe. Inkqubo yokuhlambela ye-windows yolwelo: Thela iphepha lokudla okuziinkozo kwi-Suid Shot, emva kokujikeleza, ukuqhubeka nomoya ovuthuzayo, qhubeka ukoma ngaphezulu kwe-8h.
4.22 I-Extran Af membrane 50μ00 ye-α-i-α-Interferon yachithwa kwi-10ml0.0ml Hydrochloric Acid, ixutywe ne-90ml ethanol kunye ne-60ml ethanol, idityaniswe kwi-60 ℃ kwaye yomile emoyeni. Le mveliso yenziwe kwifilimu.
4.3 Iitafile zeCotruloxazole (0.4G ± 0.08G) I-SMZ (80 Mesh) 8KG, I-TASP (I-TMP) 8kg, i-TMP Ngokuphathelwe isisombululo se-3% ye-HPMC, isixhobo esithambileyo, nge-16 mesh screen, soma, kwaye emva koko i-mesh stearate i-met, i-12mm ye-12mm ngegama (i-SMZCO) inamacwecwe (i-SMZCO) itafile (i-SMZCO) inamacwecwe (i-SMZCO) inamacwecwe (i-SMZCO) itafile (i-SMZCO) inamacwecwe (i-SMZCO) itafile (i-SMZCO) inamacwecwe (i-smpsco) inamacwecwe (i-SMZCO) itafile (i-SMZCO) inamacwecwe (i-smpsco) inamatwa. Le mveliso isetyenziswa ikakhulu njenge-binder. Ukupheliswa kweetafile yayingama-96% / 20min.
4.4 Iitafile zepipile (0.25g) I-Piesh 25kg, isitatshi (i-120 mesh) 2.1kg, Magnesis Stearate inani elifanelekileyo. Indlela yayo yemveliso kukudibanisa i-puioperic acid, isitatshi, i-HPMC ngokuhlwa, i-16% ye-ethanol ye-ethanol, i-mesh screen i-venchote, i-vector ye-vectorate ye-Tet. Ngesitatshi iarhente, ireyithi yokuchithelwa kwetafile ayingaphantsi kwe-80% / i-2min, ephelileyo kunemveliso efanayo eJapan.
4.5 I-HPMC-4000, i-HPMC-4500 okanye i-HPMC-5000 0.45g i-storide 0.45g i-scloride 0.19g, i-10% ye-Ammox ChlorbnBenzymium 0,02ml, amanzi ongezelelweyo kwi-100ml. Indlela yayo yemveliso yi-HPMC ibekwe kumanzi ayi-15ml, kwi-80 ~ 90 ℃ ithathe i-ATT ye-ATML egcwele, emva koko ifakwe kwi-90 ~ i-80 ° C ukuya kwi-8,6 I-C. Le mveliso isetyenziselwa ukunqongophala kwe-Tear, yinto entle yokuphatha, xa isetyenziselwa i-microscopy ye-AMARE, inokuthi inyuswe ngokufanelekileyo umthamo wemveliso, i-0.7% ~ 1.5% ifanelekile.
4.6 I-METHTHOTAN EYENZIWEYO IINTSHUZO ZE-METHTORNARINS PERID 187.5MG, I-Lact Melg-Procrystalline ye-Phthalate-102 neMagnesis Stearate 2.5mg. Ilungiselelwe njengamacwecwe ngendlela eqhelekileyo. Le mveliso isetyenziswa njengezinto ezilawulwa.
4.7 Kwi-Avanamtomycin ⅳ Iitafile, ezingama-2149G AvantomyCin ⅳ Monohydrate kunye ne-1000ml Isopropyl i-Eudrapyl-100 (9: 1) yayichukumisekile, ixutywe, kwaye yomile kwi-35 ℃. The dried granules 575g and 62.5g hydroxypropylocellulose E-50 were thoroughly mixed, and then 7.5g stearic acid and 3.25g magnesium stearate were added to the tablets to obtain continuous release of vanguard mycin ⅳ tablets. Le mveliso isetyenziswa njengezinto zokukhululwa kancinci.
I-4.8 I-Nafdipine enee-Granules ezi-1 ze-Granules 1 Inxalenye ye-Nydroxylypropyl Methyl SellUlose ye-SOZYL ye-SOLYLLS (i-ETYYY: I-TETHINE COLOPRE = 1: 1), kunye ne-8 ye-8: Ireyithi yokukhupha iziyobisi yegranubes ayichaphazeleki lutshintsho lwendalo kwaye lalicothisile kunezixhobo ezifumanekayo ezifumanekayo kwezorhwebo. Emva kweeyure ezili-12 zolawulo ngomlomo, uxinzelelo lwegazi lomntu lwalungama-12mg / ml, kwaye kwakungekho mehluko.
4.9 I-Gropranhaolol Hydrochloride i-Capsule ye-Capsule ye-proprocrancride 60kg, microcrystalline seluplose i-40kg, ukongeza amanzi angama-50kg ukwenza amaqhinga. I-HPMC1kg kunye ne-9KG ixutywe kwi-solvent exubeneyo (i-methylene pheride: i-methanol = 1: 1) i-spirical spericals i-spericals ye-1,4mm igcwaliswe kwi-cepsule ye-store ye-Subsule enomatshini wokugcwalisa amatye. I-capsule nganye iqukethe i-160mg ye-proprachlol ye-hydrochloride isuntsu.
4.10 I-Naprol HCL SKELETTS ilungiselelwe ngokuxuba i-charlol hcl: i-HPMC: CMC-NA kumyinge we-1: 0.25: 2.25. Ireyithi yokukhupha iziyobisi yayikufuphi ne-odolo zero ngaphakathi kweeyure ezili-12.
Ezinye iziyobisi zingenziwa zezinto ezixubeneyo ze-skeleton, ezinjengeMetoprolol: I-HPMC: CMC-NAI ngokoku: 1: 1.25: 1.25; UAllybprolol: I-HPMC ye-1: 2.8: 2.92 umyinge. Ireyithi yokukhupha iziyobisi yayikufuphi ne-odolo zero ngaphakathi kweeyure ezili-12.
I-4.11 Iipilisi ze-skeleton zeZinto ezixubeneyo zeSylaminine zalungiswa ngendlela eqhelekileyo usebenzisa umxube we-Muber Silica Gel: Cmc-na: HMCMC 1: 4.4. Ichiza linokukhululwa ngenxa ye-12h zombini e-vitro naseVivo, kunye nepateni yokukhutshwa komgca yayinepateni elungileyo. Iziphumo zovavanyo oluzinzileyo lozinzo ngokwemigaqo ye-FDA iqikelela ukuba ubomi bokugcina kule mveliso bungaphezulu kweminyaka emi-2.
4.12 HPMC (50mpas) (iinxalenye ezi-5), i-HPMC (i-HPMC (i-HPMC (i-3000 Mpatrophene yongezwa kwi-1000 yamanzi, iinxalenye ezi-6 ze-Acetaminophen zachithwa, kwaye ikhutshiwe ibulawa. Le mveliso iqulethe i-80% yeyeza eliphambili.
4.13 I-Theophylline hydrophilic gel skeleton ibaliwe ngokobunzima bethebhulethi, i-18% -3% ye-HOCMC, kunye nexabiso elifanelekileyo le-HPMOPIC, kwaye inokugcina uxinzelelo lwegazi elilawulayo nge-12h emva kolawulo lomlomo.
IXESHA LOKUQALA: NgoFebwe-05-2024