1. Uhlobo olusisiseko lwe-HPMC
I-Hypromellose, igama lesiNgesi i-Hydroxypropyl Methylcelcelose, alias hpmc. Ifomula yayo ye-moleula i-C8H15O8- (C10H8O6) N-C8HL5O8, kwaye ubunzima bemolekyuli bumalunga nama-86,000. Le mveliso yinto ye-semi-switntletion, eyinxalenye yeqela le-methyl kunye nenxalenye ye-polyhydropvyl tethel ye-seluplose. Inokwenziwa ngeendlela ezimbini: enye kukunyanga i-methyl yenqanaba elifanelekileyo nge-naoh, emva koko iphendule nge-proplene oxide iphantsi kobushushu obuphezulu kunye noxinzelelo oluphezulu. Ixesha lokuphendula kufuneka lixhaswe ukuvumela i-methyl kunye namaqela e-hydroxypropy ukuya kwi-Ether kunye ne-ether. Indlela exhunyiweyo kwi-anhhydrogluplucose ye-sellyuolose, kwaye inokufikelela kwinqanaba elifunekayo; Enye yeyokunyanga i-cotton icocekile okanye i-fiber ye-fiber ene-caustic soda, kwaye emva koko ifumane ngokusalela nge-cethane editweyo kunye ne-propleynene oxisayo, emva koko icofe umgubo okanye i-provisim ye-proplerm. I-HPMC yintlobo ngeentlobo zeselfowuni yendalo, kwaye ikwangumbono wexesha elihle kakhulu, olunomthombo obanzi. Okwangoku, isetyenziswa ngokubanzi ekhaya nakwamanye amazwe, kwaye yenye yezona zineziso semigangatho ephezulu yokusetyenziswa kwamachiza aphezulu.
Umbala wale mveliso mhlophe ukuya eMildy White, engenabungozi kwaye engenambulukwa, kwaye ngumgubo we-Granular okanye ongena lula. Ihlala phantsi kokuvezwa kokukhanya kunye nokufuma. I-Shushu emanzini ebandayo ukwenza isisombululo esimhlophe se-spedy scoloidal kunye nenqanaba elithile le-vickosity. I-Sol-Gel-GelConversion inokwenzeka yenzeka ngenxa yokutshintsha kobushushu bokutshintsha kwesisombululo. Kulula kakhulu ukunyibilikisa nge-70% yotywala okanye i-dimthyl kethyl ketone, kwaye ayiyi kunyibilika kulwaphulo-mthetho olunotywala, kwaye i-chloroform okanye ethoxyene.
I-Hypromellose inozinzo olulungileyo xa i-PH iphakathi kwe-4.0 ne-8.0, kwaye inokubakho phakathi kwe-3.0 ne-11.0. Emva kokugcina iintsuku ezili-10 kwiqondo lobushushu lama-20 ° kunye nomswakama we-80%, i-Abssus yokufumana i-HPMC yi-6.2%.
Ngenxa yomehluko kumxholo wezinto ezimbini ezikhoyo kwi-Hypromellose, Malunga ne-hydroxylpyl, iintlobo ezahlukeneyo zeemveliso zivele. Kwingcinezelo ethile, iintlobo ezahlukeneyo zeemveliso zinee-viscofity ezikhethekileyo kunye nobushushu be-thermal, ke ngoko, zineempawu ezahlukeneyo kwaye zinokusetyenziselwa iinjongo ezahlukeneyo. I-pharmacopoeiaias yamazwe awahlukeneyo ineenkcazo ezahlukeneyo kunye neenkcazo zemodeli: i-European PharmacoeOpoeia isekwe kumabakala ahlukeneyo okufana neemveliso ezahlukeneyo zentengiso. Ivezwe libakala kunye nenani. Iyunithi yi-MPA. Emva kongeza amanani ama-4 ukubonisa umxholo kunye nohlobo lwendlela nganye ye-Hypromellose, umzekelo, i-Hypromellose i-2208, amanani amabini okuqala amele ipesenti ye-ExdroxyPOpyl eqingqiweyo.
2.Undlela yokuphelisa i-HPMC emanzini
2.1 indlela eshushu yamanzi
Kuba i-hypromellose ayinyibili amanzi ashushu, inokuba isasazeke ngamanzi ashushu kwinqanaba lokuqala, kwaye emva koko xa ipholile, iindlela ezimbini eziqhelekileyo zichazwe ngolu hlobo lulandelayo:
(1) Beka inani elifunekayo lamanzi ashushu kwisikhongozeli kwaye ubushushu malunga ne-70 ℃. Ngokuthe ngcembe yongeza imveliso phantsi kokukhulisa kancinci. Ekuqaleni, imveliso iphakama kumphezulu wamanzi, emva koko icotha i-slurry. Ipholile ukuthambisa.
. Kumanzi ashushu athambileyo kwisilayidi, upholile umxube emva kokuvuselela.
2.2 Indlela yokuxuba yomgubo
Amasuntswana omgubo kunye nezinye izithako zepowdery zexabiso elilinganayo okanye elikhulu asasazeke ngokupheleleyo ngokuxuba elomileyo, kwaye emva koko amanzi kongezwa ukuze anyibilike. Ngeli xesha, i-hypromellose inokuchithwa ngaphandle kwe-algimeration.
3. Izibonelelo ze-HPMC
3.1 Ukuzenzela amanzi okubandayo
Inyibilika emanzini abandayo ngaphantsi kwe-40 ° C okanye i-70 i-ethanol. Kuyinto engagungqiyo emanzini ashushu ngaphezulu kwe-60 ° C, kodwa inokugungqa.
3.2 Ukungazi
I-Hypromellose (i-HPMC) luhlobo lwe-ionic seluplose ether. Isisombululo sayo asinayo i-ionic call kwaye ayisebenzi ngeetyuwa zensimbi okanye i-ionic yendalo. Ke ngoko, ezinye izinto ziyasebenza azisabeli ngayo ngexesha lenkqubo yokulungiselela.
3.3 Uzinzo
Inokuzinza zombini i-acid kunye ne-alkali, kwaye zinokugcinwa ixesha elide phakathi kwe-PH 3 ukuya ku-1L, kwaye i-viscosity yayo ayinatshintsho olucacileyo. Isisombululo se-ACPOELLLLONSOSE (HPMC) sinefuthe lokungasebenziyo kwaye linokugcina uzinzo lolwazi oluhle ngexesha lokugcina ixesha elide. I-chigmc i-HPMC inezinzo ezisemgangathweni ezingcono kunezo zisebenzisa umdla wesintu (njenge-dextrin, isitatshi, njl njl.).
3.4 UCWANGCISO LOKUGQIBELA
I-Viscovitity eyahlukileyo ye-HPMC inokudityaniswa kwindawo eyahlukeneyo, kwaye uVecofity wayo unokutshintsha ngokomgaqo othile, kwaye unobudlelwane obulungileyo obulungileyo, ukuze ukhethwe ngokweemfuno.
3.5 I-Metabolic Intia
I-HPMC ayifumani okanye ifakwe imerimbo emzimbeni, kwaye ayiboneleli ngekhalori, ngoko ke iyinto ekhuselekileyo yamalungiselelo amayeza.
3.6 Ukhuseleko
Kuyikholelwa ngokubanzi ukuba i-HPMC yinto engenatyhefu kunye nokungakhathali. Idosi ye-menage ye-metal yempuku ye mig i-5G / kg, kunye nedosi ye-metal ye-metal ye-rats ye-RTS i-5.2G / kg. Idosi yemihla ngemihla ayinabungozi emzimbeni womntu.
I-4. Ukusetyenziswa kwe-HPMC kumalungiselelo
4.1 isetyenziswe njengokukhathalela ifilimu kunye nezinto zokwenza ifilimu
I-Hypromellose (i-HPMC) isetyenziswa njengendawo yetafile yefilimu. Xa kuthelekiswa neepilisi ezihlanganisiweyo zemveli ezinje ngamacwecwe ahlanganisiweyo zeswekile, amacwecwe ahlanganisiweyo akanazibonelelo ezibonakalayo ekuthandeni incasa kunye nembonakalo, ukwahlula-ntatha, ukudibanisa ubunzima kunye nezinye izikhombisi zobunzima. Ibakala lokufumana le mveliso lisetyenziswa njengezinto ezinamanzi ezinyibilikisi zamanzi kwiitafile kunye neepilisi, kunye neBanga le-viscofity ePhakamileyo isetyenziswa njengezixhobo zokuhambisa ifilimu kwiinkqubo zeShocic. Uxinzelelo lokusetyenziswa luhlala luyi-2.0% -20%.
4.2 Njengomthi we-Binder kwaye ihlazo
Ibakala lokufumana le mveliso linokusetyenziswa njengendawo yokubhabha kwaye ihlambuluki kwiitafile, iipilisi, kunye ne-grantis, kunye nenqanaba le-viscosity ephezulu linokusetyenziswa kuphela njenge-binder. Umthamo uyahluka ngeemodeli ezahlukeneyo kunye neemfuno. Ngokubanzi, isixa se-binder esisetyenziselwa iitafile zegranungs ezomileyo yi-5%, kunye nenani le-binder elisetyenziselwa iitafile ezimanzi ngamanzi yi-2%.
4.3 Njengearhente yokumiselwa
Iarhente yokumisa i-viscous ye-viscous ene-hydrophicicity. Ukusetyenziswa kwearhente yokumisa kwiarhente yokumisa kunokucothisa isantya se-sedition yamasuntswana, kwaye inokudityaniswa kumphezulu wamasuntswana okuthintela amasuntswana avela kwi-polymering kunye ne-pro okonakalisa ubunzima. Iiarhente zokumisa iinkcitho zidlala indima ebalulekileyo kwimveliso yokumiswa. I-HPMC ngohlobo olufanelekileyo lweearhente zokumisa iinkcitho. Isisombululo seColoidal sichithwe kuyo sinokunciphisa uxinzelelo lwe-screen-quert kunye namandla asimahla kumachiza amancinci aqinileyo, ngaloo ndlela aphucule uzinzo lwenkqubo yokusasazeka kwenkqubo yokusasazeka. Le mveliso i-viscofity ye-viscofity ye-viscosity yokumiswa kwexabiso elilungisiweyo njengearhente yokumisa. Inesiphumo sokumisa okuhle, kulula ukuhlengahlengisa, i-stisus inamathele, kwaye inamachaphaza aqholiweyo. Isixa esiqhelekileyo siyi-0.5% ukuya kwi-1.5%.
4.4 Isetyenziswe njengebhloko, iarhente ecothayo nengalawulekiyo nengalawulwayo kunye nearhente ye-pore-forment
Inqanaba le-viscosity lemveliso yale mveliso isetyenziselwa ukulungiselela i-hydrophilic gests ye-hydrophilic ye-hytrix ye-gerix, i-remers kunye neearhente zokukhutshwa ezilawulayo ze-matrix. Inefuthe lokulibazisa ukukhutshwa ngamachiza. Ukusetyenziswa kwayo kukusetyenziswa yi-10% ~ 80% (W / W). Ibakala eliphantsi lohlobo lisetyenziswa njenge-arhente yokwenza i-pore-forment forling curulions okanye elawulwa. Idosi yokuqala efunwayo yefuthe lonyango lolu hlobo lwecwecwe linokufunyanwa ngokukhawuleza, kwaye emva koko kwenziwa ifuthe eligciniweyo okanye elilawulwayo, kwaye ugxininiso lweziyobisi olusebenzayo lugcinwa emzimbeni. Hypromellose hydrates ukwenza i-gel fall xa idibana namanzi. Indlela yokukhululwa kweziyobisi kwithebhulethi ye-matrix ikakhulu ingumlinganiswa we-gel kunye nokukhukuliseka kwegel.
4.5 Ukukhusela iglue esetyenziselwa i-tickener kunye ne-colloid
Xa le mveliso isetyenziswa njenge-thickener, uxinzelelo oluqhelekileyo yi-0.45% ~ 1.0%. Le mveliso inokwandisa uzinzo lweglue ye-hydrophobic, yenza i-colloid ekhuselweyo, thintele i-sualeccence coalescence kunye ne-algicleres, malunga nokonakaliswa kwe-sediments. Ugxininiso lwayo oluqhelekileyo yi-0.5% ~ 1.5%.
4.6 Isetyenziswe njengempahla ye-capsule
Ngokwesiqhelo, i-capsule ye-capsule ye-capsule ikakhulu ye-getitin. Inkqubo yemveliso ye-supsule ilula, kodwa zikho iingxaki kunye ne-phenomena njengokukhuselwa kakubi kwamachiza kunye neziyobisi ezinobuthathaka zeoksijini, kunye nokulibaziseka kwe-supsule yeqokobhe le-capsule ngexesha lokugcina ityhefu. Ke ngoko, i-hypromellose isetyenziswa njengokufaka isixhobo se-capsule kumalungiselelo eecapsules, eziphucula ubumbano kwaye zisebenzisa ifuthisi, kwaye zikhuthazwe kakhulu ekhaya nakwelinye ilizwe.
4.7 Njengebhayilopha
Itekhnoloji yebhayiloji, ukusetyenziswa kwezivumelwano ezinamatye e-bioadive, ngokulandela ukuqhubeka kunye nokuqina komnxibelelanisi okhutshiweyo kwaye kuncitshiswe yi-MUCOSA ukuba ifezekise injongo ye unyango. Isetyenziswe ngokubanzi ngoku isetyenziselwa ukunyanga izifo ze-nasal cavity kunye ne-mucosa yomlomo. Itekhnoloji ye-gustrointentinion ye-biadisernion luhlobo olutsha lwenkqubo yokuhanjiswa kweziyobisi ephuhliswe kule minyaka idlulileyo. Ayisondisi kuphela ixesha lokuhlala leGestrointenal Tect, kodwa iphucula ukusebenza kwechiza kunye neseli yeseli yeseli kwaye itshintsha ulwelo lwe-membrane yeseli. Amandla okufumana ichiza kwiseli epifilial ye-epitine yamathumbu aphuculwe, ngaloo ndlela ukuphuculwa kwebhayili yechiza yechiza.
4.8 Njengejeli ephezulu
Njengokulungiselela ukunamathela kulusu, ijeli inoluhlu lweenzuzo ezifana nokhuseleko, ubuhle, ukucoca ngokulula, indleko eziphantsi, kunye nokuhambelana neziyobisi. Kwiminyaka yakutshanje, ifumene ingqalelo ebanzi kwaye iba luphuhliso lwamalungiselelo olusu lwangaphandle. umkhombandlela.
4.9 Njengommi othintelayo kwinkqubo ye-emolsation
IXESHA LOKUQALA: I-DEC-16 ukuya ku-2001