1. Izakhiwo eziyisisekelo ze-HPMC
I-Hypromellose, igama lesiNgisi igama hydroxyproppropyl methylcellulose, alias hpmc. Ifomula yayo yamangqamuzana i-C8H15O8- (C10HL8O6) N-C8HL5O8, futhi isisindo samangqamuzana asomayelana ne-86000. Lo mkhiqizo yingxenye ye-methylyproxypropypropyprosyproseryryrlopypropyprosypropp. Ingakhiqizwa ngezindlela ezimbili: munye ukuthi ibanga elifanele le-methyl cellululose liphathwa nge-naoh, bese besabela nge-oxylene oxide ngaphansi kokushisa okuphezulu nengcindezi. Ifomu lixhumeke kwindandatho ye-anhydroglucose ye-cellulose, futhi ingafinyelela ezingeni elifanele; Okunye ukwelapha i-licrint yekotoni noma i-file ye-solip ene-caustic soda, bese usabela nge-methyl chloride ne-propelene oxide ngokulandelana ukuze uyithole, bese ucoca futhi ukuze ucindezelwe ukuze wenze i-powder noma i-granule noma umfaniswano. I-HPMC iyinqwaba yezitshalo zemvelo ze-cellulose yemvelo, futhi futhi iyi-excipieint enhle kakhulu yezemithi, enohlu oluhlukahlukene lwemithombo. Njengamanje, kusetshenziswa kabanzi ekhaya nakwamanye amazwe, futhi kungenye ye-Excipietietieticals yezemithi ngezinga eliphakeme kakhulu lokusebenzisa ezidakamizweni zomlomo.
Lo mkhiqizo mhlophe ku-Milky White ngombala, okungewona ubuthi futhi awunambitha, futhi usesimweni se-granular noma i-fibrous powder egeleza kalula. Kuzinzile ngaphansi kokuvezwa kokukhanya kanye nomswakama. Kuyavuvukala emanzini abandayo ukwakha isixazululo esimhlophe se-milky emhlophe, esinezinga elithile lokubonakala, futhi into ye-sol-gel ukuhlukaniswa ngenxa yokushintsha kwezinga lokushisa kwesixazululo esithile. Kuyancibilika kakhulu ku-70% utshwala noma i-dimethyl ketone, futhi ngeke ichithe ngokuphelele utshwala, i-chloroform noma i-ethoxoxorne.
Lapho i-PH ye-Hypromellose iphakathi kuka-4.0 no-8.0, inokuqina okuhle, futhi ingaba khona kungenzeka lapho i-PH iphakathi kuka-3.0 no-11.0. Lapho izinga lokushisa lingu-20 ° C kanti umswakama ohlobene ngu-80%, ugcinwe izinsuku eziyi-10. Ukuhlanganiswa komswakama kokutholwa kwe-HPMC kungu-6.2%.
Ngenxa yokuqukethwe okuhlukile kwe-methoxy ne-hydroxypropyl ngesakhiwo sezinhlobonhlobo, kuvele izinhlobo ezahlukahlukene zemikhiqizo. Ngokugxila okuthile, izinhlobo ezahlukahlukene zemikhiqizo zinokuvunywa okuthile kanye namazinga okushisa ashisayo we-gelation, ngakho-ke, anezakhiwo ezihlukile futhi angasetshenziselwa izinhloso ezihlukile. I-pharmacopoeis yamazwe ahlukahlukene inemithetho ehlukene kanye nezethulo ezihlukile kumamodeli: Ngokuya kwamabanga ahlukahlukene e-European, ngokusho kwamabanga ahlukahlukene we-viscosities ahlukene kanye nama-degrees ahlukahlukene, futhi iyunithi yi-MPAS; E-United States pharmacopoeia, igama elijwayelekile lengeza amadijithi ama-4 ekugcineni ukukhombisa okuqukethwe nohlobo lokungenisa ngakunye kwe-hypromellose, njengezinombolo ezimbili zokuqala zimele amaphesenti alinganiselwane amele ama-methoxy, futhi amadijithi amabili okugcina amelela amaphesenti alinganiselwa ku-hydroxypropp alinganiselwa.
2. Indlela yokuqeda i-HPMC echithiwe emanzini
2.1 Indlela Eshisayo Yamanzi
Njengoba i-Hypromellose ayincibiliki emanzini ashisayo, ingahlakazeka ngendlela efanayo emanzini ashisayo ekuqaleni, bese iphola. Izindlela ezimbili ezijwayelekile zichazwa ngale ndlela elandelayo:
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2.2 Indlela yokuxuba nje ye-powder
Izinhlayiya ze-powder zihlakazeka ngokugcwele ngokuxuba okomile nenani elilinganayo noma eliningi lezithako ezingezinhle, bese zincibilika emanzini. Ngalesi sikhathi, i-Hypromellose ingachithwa ngaphandle kokuqothuka.
3. Izinzuzo ze-HPMC
3.1 I-SOLUBO YAMANZI
Incibilika emanzini abandayo ngaphansi kwama-40 ° C noma ama-70% e-ethanol, ngokuyisisekelo incwajana emanzini ashisayo ngaphezulu kwama-60 ° C, kepha angagcinwa.
I-3.2 inertertness
I-Hypromellose (HPMC) uhlobo lwe-ether engeyona eye-cellulose. Isixazululo saso asinakho ukukhokhiswa kwe-ionic futhi akuhlangani nosawoti wensimbi noma amakhompiyutha we-onic arganic. Ngakho-ke, amanye ama-Excipients awaphenduli nakho ngesikhathi senqubo yokulungiselela.
3.3 Ukuqina
Kuqinile ku-acid ne-alkali, futhi kungagcinwa isikhathi eside phakathi kwe-ph 3 ne-1l ngaphandle koshintsho olusobala ekuboneni. Isixazululo samanzi se-hppromellose (HPMC) sinomphumela we-anti-mbutha futhi singagcina ukuqina okuhle kwentokozo ngesikhathi sokugcina isikhathi eside. Ama-Pharmaceuticals asebenzisa i-HPMC njengoba ama-Excipients anokuqina okungcono kwekhwalithi kunaleyo esebenzisa ama-excip wendabuko (njenge-dextrin, isitashi, njll.).
3.4 Ukuguqulwa kwe-Viscosity
Ukutholwa okuhlukile kwe-viscosives ye-HPMC kungahlanganiswa ngokuya ngezilinganiso ezahlukahlukene, futhi ukubonakala kwayo kungashintsha ngokuya ngemithetho ethile, futhi kunobudlelwano obuhle obuqondile, ngakho-ke isilinganiso singakhethwa ngokuya ngezidingo.
3.5 Metabolic inertia
I-HPMC ayimuzwanga noma ihlanjululwe emzimbeni, futhi ayinikezi ukushisa, ngakho-ke kungukulungiswa kwamakhambi kwezemithi.
3.6 Ezokuphepha
Ngokuvamile kukholelwa ukuthi i-HPMC iyinto engeyona enobuthi futhi engacasuli. Umthamo obulala amagundane amagundane yi-5G / kg, kanti umthamo obulalayo obulalayo wamagundane ngu-5.2g / kg. Imithamo yansuku zonke ayinangozi kubantu.
4. Ukusetshenziswa kwe-HPMC ukulungiselela
4.1 njengezinto zokuhlanganisa amafilimu nezinto zokwakha amafilimu
Kusetshenziswa i-Hypromellose (HPMC) njengezinto zethebhulethi ezihlanganisiwe zefilimu, uma kuqhathaniswa namathebhulethi entuthwane afana namathebhulethi anoshukela, kepha amaphilisi ahlanganisiwe angenazo izinzuzo ezisobala ekunciphiseni ukunambitheka kwemithi nokubukeka, ukumunwa kwawo, ukuncipha, ukuncishiswa kwesisindo, ezinye izinkomba zekhwalithi zingcono. Ibanga eliphansi le-viscosity lalo mkhiqizo lisetshenziswa njengezinto ezihlanganisiwe zamafilimu ezisebenza ngamathebulethi namaphilisi, futhi ibanga eliphakeme le-viscosity lisetshenziswa njengezinto zokubamba amafilimu ezinhlelweni ze-organic solvent systems. Ukuhlushwa kuvame ukuba ngu-2.0% kuye ku-20%.
4.2 njenge-binder nokuqhekeka
Ibanga eliphansi le-viscosity alo mkhiqizo lingasetshenziswa njenge-binder nokuqhekeka kwamathebulethi, amaphilisi kanye nama-granule, kanye nebanga eliphakeme elivelayo lingasetshenziswa kuphela njenge-binder. Umthamo uyahlukahluka ngamamodeli ahlukile nezidingo. Ngokuvamile, umthamo we-binder yamathebhulethi e-granung owomile yi-5%, kanye nomthamo we-binder yamathebhulethi anamanzi ama-2%.
I-4.3 njenge-ejenti yokumisa okwesikhashana
I-ejenti yokumisa i-gel ye-gel ebonakalayo ene-hydrophicility, enganciphisa ijubane le-sedimentation yezinhlayiya lapho isetshenziswa kumenzeli wokumisa, futhi ingafakwa ebusweni bezinhlayiya ukuvikela ebholeni. Ama-ejenti asolayo adlala indima ebalulekile ekwenzeni ukumiswa. I-HPMC iyizinhlobonhlobo ezinhle kakhulu zokumisa ama-ejenti asole, futhi isixazululo saso se-colloidal esichithiwe singanciphisa ukungezwani kwesibonisi esiqinile kanye namandla amahhala ezinhlayiyeni ezincane eziqinile, ngaleyo ndlela uthuthukise ukuqina kohlelo lokuhlakazeka oluqinile. Ibanga eliphakeme le-viscosity kulo mkhiqizo lisetshenziswa njengokulungiswa koketshezi wokumiswa okulungiselelwe njenge-ejenti esondelana. Inomphumela omuhle wokumisa kahle, kulula ukuyisebenzisa kabusha, ayinamatheli odongeni, futhi inezinhlayiya ezinhle ze-flecculated. Umthamo ojwayelekile ngu-0,5% kuya ku-1.5%.
4.4 Njenge-blocker, i-ejenti yokukhishwa okulondoloziwe kanye ne-ejenti ebangela ama-pore-ebange
Ibanga eliphakeme le-viscosity kulo mkhiqizo lisetshenziselwa ukulungiselela amaphilisi we-hydrophilic gel matrix amathebhulethi akhethekile, ama-blocker kanye nama-ejenti alawulwa ngokulawulwa kwamathebhulethi ahlanganisiwe matrix, futhi anomphumela wokubambezeleka kwezidakamizwa. Ukuhlushwa kwayo ukusetshenziswa kwayo kungu-10% ~ 80% (W / W). Amamaki okuvusa okuphansi asetshenziswa njengama-ejenti akha ama-pores angumalungiselelo wokukhishwa okususwayo noma okulawulwa okulawulwayo. Umthamo wokuqala odingekayo wezokwelapha walolu hlobo lwethebhulethi ungatholakala ngokushesha, bese ufaka umphumela okhethekile wokukhishwa noma wokulawulwa, kanye nokuhlushwa kwezidakamizwa ngegazi okusebenzayo kugcinwa emzimbeni. Lapho i-Hypromellose ihlangana namanzi, ama-hydrate ukwakha ungqimba lwejeli. Indlela yokukhishwa kwezidakamizwa kusuka kuthebhulethi ye-matrix ikakhulukazi ifaka phakathi ukuguquguquka kwe-gel ungqimba kanye nokuguguleka kwe-gel ungqimba.
4.5 I-glue evikela i-greater njenge-colloid ne-colloid
Lapho lo mkhiqizo usetshenziswa njengesikhulu, ukugxilwa okuvame ukusetshenziswa ngu-0.45% ~ 1.0%. Lo mkhiqizo ungaphinde wandise ukuqina kwe-hydrophobic glue, wakhe i-colloid evikelayo, uvikele izinhlayiya ezivela ku-agglomerating and agglomerating, ngaleyo ndlela kuvimbela ukwakheka kokudilizwa, kanye nokuhlushwa kwawo okujwayelekile kungu-0.5% ~ 1.5%.
4.6 I-Capsule Izinto Zama-Caplule
Imvamisa impahla ye-capsule Shell capsule ye-capsule isuselwe ku-gelatin. Inqubo yokukhiqiza ye-gelatin capsule Shell ilula, kepha kunezinkinga ezithile nezimo ezinjengokuvikelwa kabi kwezidakamizwa ezibucayi zomswakama, izidakamizwa ezibucayi zomoya, futhi zibambezele ukuhlukaniswa kwe-capsule Shell ngesikhathi sesitoreji. Ngakho-ke, i-Hypromellose, njengendawo yokufaka esikhundleni se-gelatin caplules, isetshenziswa lapho kulungiswa ama-caplule, athuthukisa ukwakheka kanye nokusebenzisa umphumela wamaphilisi, futhi kukhushulwe kakhulu ekhaya nakwamanye amazwe.
4.7 njenge-bioathive
Ubuchwepheshe beBiowion Technology, ukusetshenziswa kwe-Excipients nge-Biodhesive Polymers, ngokusebenzisa i-adhesion ku-mucosa yemvelo, kuthuthukisa ukuqhubeka nokuqina koxhumana naye phakathi kokulungiselela kanye ne-mucosa, ukuze umuthi yi-mucosa ukufeza izinhloso zokwelapha. Njengamanje isetshenziswa kabanzi isetshenziselwa ukwelapha izifo ze-nasal cavity, i-mucosa yomlomo nezinye izingxenye. Ubuchwepheshe be-gastrointesinal BIADHESION Technology uhlelo olusha lokulethwa kwezidakamizwa oluthuthukisiwe eminyakeni yamuva. Akugcini nje kuphela isikhathi sokuhlala kwamalungiselelo emithi epheshana lesisu, kodwa futhi kuthuthukisa ukusebenza kocingo phakathi kwesidakamizwa kanye nolwelwesi lwamaseli esitokisini samathumbu, ngaleyo ndlela kuthuthukise ukungatholakali kwesidakamizwa.
4.8 njenge-topical gel
Njengokulungiselela okunamathelayo kwesikhumba, i-gel inochungechunge lwezinzuzo ezinjengokuphepha, ubuhle, ukuhlanza okulula, izindleko eziphansi, inqubo elula yokulungiselela, kanye nokuhambisana okuhle nezidakamizwa. ukuqondisa.
Isikhathi sePosi: Feb-14-2025