HydroxyPropyl Methylcellse (HPMC) Abamugaye ba farumasi

Icyiciro: Ibikoresho byo ku nkota; Ibikoresho bya membrane; Ibikoresho byihuta bya Polymer yo kwitegura buhoro; Umukozi uhamye; Imfashanyo ihagarikwa, tablet ifatika; Adhesion Agenthesion.

1. Intangiriro y'ibicuruzwa

Iki gicuruzwa nikintu kitari uonic ether, cyagaragaye hanze nkifu yera, impumuro nziza kandi itaryoshye, yoroshye mumazi meza, kubyimba mumazi ya colloidal. Igisubizo cyamazi gifite ibikorwa byo hejuru, gukorera mu mucyo bikabije hamwe n'imikorere ihamye. HPMC ifite umutungo wa Gel ashyushye. Nyuma yo gushyushya, ibicuruzwa igisubizo cyibitangaza bigize imvura ya Gel, hanyuma irashonga nyuma yo gukonja. Ubushyuhe bwa Gel BITANDUKANYE buratandukanye. Impinduka zidahwitse hamwe na viscosiya, vinosity Zhao hasi, niko kwitonda, ibisobanuro bitandukanye bya HPMC bifite itandukaniro, HPMC irashonga mumazi ntabwo yibasiwe na PH agaciro.

Ubushyuhe bwo gutwika budasanzwe, ubucucike bukabije, ubushyuhe nyabwo nubushyuhe bwinzibacyuho ni 360 ℃, 0.341G / CM3, 1.326G / CM3 ~ 180 ℃. Nyuma yo gushyushya, ihinduka umukara muri 190 ~ 200 ° C kandi yatwitse kuri 225 ~ 230 ° C.

HPMC isuzuguwe muri chloroform, Ethanol (95%), na diethyl ether, kandi yashongesheje metlol na methilene, uruvange rwa methanol na methilene. Inzego zimwe na zimwe za HPMC zirashonga uruvange rwa acetone, methylene, na propanol 2, kimwe no mubindi bimera.

Imbonerahamwe 1: Ibipimo bya tekiniki

umushinga

Gauge,

60 GD (2910).

65GD (2906)

75GD (2208)

Memoxy%

28.0-32.0

27.0-30.0

19.0.4.0

HydroxyProxy%

7.0-12.0

4.0-7.5

4.0-12.0

Ubushyuhe bwa Gel ℃

56-64.

62.0-68.0

70.0-90.0

Viscosity mpa s.

3.5,6,6,50.50.50

50400 0

100400 0150 00100 000

Kugabanya ibiro byumye%

5.0 cyangwa munsi

Gutwika ibisigisigi

1.5 cyangwa munsi

pH

4.0-8.0

Ibyuma biremereye

20 cyangwa munsi

arsenic

2.0 cyangwa munsi

2. Ibiranga ibicuruzwa

2.1 hydroxypropyl methylcellse ishonga mumazi akonje kugirango akore igisubizo cya collous. Igihe cyose cyongewe kumazi akonje hanyuma ukangurwa gato, birashobora gushonga mu gisubizo kiboneye. Ibinyuranye, birashoboka cyane ko bidasubirwaho mumazi ashyushye hejuru ya 60 ℃ kandi arashobora kubyimba gusa. Mugutegura HydroxyPropyl Methicellee Igisubizo, nibyiza kongeramo igice cya hydroxypropyl metroxypropyl Meticedulose, hanyuma wongereho hydroxypropyl methicedulose, hanyuma ukoreshe amazi akonje kugirango winjire ku mubare ukenewe.

2.2 hydroxypropyl methylcellse ni selile itari ionic, igisubizo cyacyo ntabwo gikora hamwe ninyungu za kionic, kugirango zikemure ryibice byicyuma cyangwa kubanzi bikaba ari bibi mugihe cyo kwitegura umusaruro.

2 Ibiyobyabwenge ukoresheje HPMC nkabababaye bifite ireme rihamye mugihe cyiza kuruta ibiyobyabwenge kuruta abandi bantu bakuru (Stalrrin, Dextrin, isukari yifu).

2.4 hydroxypropyl methylcellse ni inerbolicial inert. Nk'igitumbuzi cya farumasi, ntabwo ari icyuma cyangwa cyakiriwe, bityo ntibitanga ubushyuhe mu biyobyabwenge n'ibiryo. Ifite ibikoresho byihariye kuri kashe nke, imiti idafite umunyu, ntabwo allergenic n'ibiryo byo kuri diyabete.

2.5hpmc ihagaze neza kuri aside hamwe na shingiro, ariko niba PH irenze 2 ~ 11 kandi umwanya muremure wo kubikamo cyangwa igihe kirekire, bizagabanya urwego rweze.

2.6 hydroxypropyl methylcellse igisubizo cyibitangaza birashobora gutanga ibikorwa byo hejuru, byerekana indangagaciro ziciriritse hamwe nimpacaro. Ifite ingero nziza muri sisitemu yicyiciro cyinshi kandi irashobora gukoreshwa nka stabilizer nziza kandi ikingira colloid.

2.7 hydroxypropyl methylcellse igisubizo cyamazebwe gifite imiterere nziza ya firime, kandi ni ibikoresho byiza byo gutwikira ibinini nibinini. Igiti cyakozwe nacyo ni ibara kandi ritoroshye. Niba Glycerol yongeyeho, plastike yayo irashobora kwiyongera. Nyuma yo kuvura hejuru, ibicuruzwa bitatanye mumazi akonje, kandi igipimo cyo gusebanya kirashobora kugenzurwa muguhindura ibidukikije ph. Ikoreshwa mugutegura buhoro buhoro imyiteguro yinjira.

3. Gusaba ibicuruzwa

3.1. Ikoreshwa nka adhesive kandi isenyuka

HPMC ikoreshwa mugutezimbere iseswa ry'ibiyobyabwenge ndetse no guswera gusaba mu buryo butaziguye nk'uko bigaragara mu mucyo mu mucyo, ibinini, ibinini, granules ku mutungo no gusenya Umukozi, na buscosity yo hejuru kuri kole, gusa gukoresha kubera ubwoko butandukanye hamwe nibisabwa bitandukanye, rusange ni 2% ~ 5%.

HPMC igisubizo cyibitangaza hamwe nibitekerezo bimwe bya Ethanol kugirango bibe binder ihuriro; Urugero: 2% HPMC Igisubizo gitangaje kivanze na 55% igisubizo cya Ethanol cyakoreshejwe mu gutwarwa na Amoxicillin, kugirango ugereranyije capsules ya Amoxicillin yiyongereye kuva 30% kugeza kuri 90% idafite HPMC.

HPMC irashobora gukorwa muburyo bwuzuye hamwe nuburyo butandukanye bwo kwibanda ku baparuzi nyuma yo gusesa; Iseswa rya erythromycin byinjira-petets yiyongereye kuva 38.2% kugeza 97.38% mugihe 2% HPMC na Starch 8% bahujwe.

2.2. Kora film ibikoresho byo gufunga no gukora firime

HPMC nkigikoresho cyo gufunga amazi gifite ibiranga bikurikira: Sisitemu yo gukemura ibicuruzwa; Inzira yo gutora iroroshye; Filime nziza yo gukora ibintu; Irashobora gukomeza imiterere yikibanza, kwandika; Birashobora kuba ubuhehere bw'ubushuhe; Irashobora kurabara, uburyohe bwo gukosora. Iki gicuruzwa gikoreshwa nkibikoresho byo gukosora amazi hamwe nibinini bifite ubushyuhe buke, kandi kumikino ishingiye ku mazi ashingiye ku mazi hamwe na visiyoni yo hejuru, amafaranga y'ikoreshwa ni 2%.

2.3, nkumukozi wijimye kandi wa comloidal frie

HPMC ikoreshwa nkumukozi wijimye ni 0.45% ~ 1.0%, irashobora gukoreshwa nkibitonyanga byamaso hamwe na mari yijimye; Ikoreshwa mu kongera imbaraga za slue ya hydrophobike, irinda amakarito, imvura, dosage isanzwe ni 0.5% ~ 1.5%.

2.4, nka Blocker, Ibikoresho byo kurekura buhoro, bigenzurwa neza umukozi na Pore

Moderi ya HPMC ikoreshwa mugutegura abatsinze kandi igenzurwa abakozi bashinzwe kurekura ibikoresho bya skeleton yakomeje kurekura ibinini na hydrophilic gel skeleton yakomeje kurekura ibinini. Icyitegererezo-cyiza cyane ni umukozi wo kwigomeka kugirango arekure cyangwa agenzure ibinini byateganijwe kugirango hakurikire ibinini byabigenewe byihuse, bikurikirwa no kurekura cyangwa kugenzurwa-kurekurwa kugirango bikomeze kwibanda ku maraso.

2.5. Gel na Matrix

Hydrogel Pustigtes hamwe nimyiteguro yo gukora gastric ikozwe ukoresheje ibiranga hydrogel ishyirwa kuri HPMC mumazi.

2.6 Ibinyabuzima bifatika

Metronidazole yavanze na HPMC na Polycarboyleylene 934 muri mixer kugirango ikore ibinyabuzima bigenzurwa birekurwa birimo 250mg. Mu kizamini cyo gusenya vitro cyerekanaga ko imyiteguro yajugunywe mu mazi, kandi ibiyobyabwenge byagenzurwaga n'ibiyobyabwenge na diffusion na karubone urunikiro rwo kuruhuka. Gushyira mu bikorwa inyamaswa byerekanaga ko sisitemu yo kurekura ibiyobyabwenge ibiyobyabwenge yari ifite imitungo ya biologiya kuri bovine mucosa.

2.7, nkubufasha bwo guhagarika

Ubukwe bwinshi bwiki gicuruzwa nimfashanyo nziza yo guhagarika ihagarikwa ryimikoreshereze yamazi, dosiye isanzwe ni 0.5% ~ 1.5%.

4. Ingero zo gusaba

4.1 Filime yo Guhuza Filime: HPMC 2Kg, Talc 2Kg, Amavuta ya Paator 1000ml, 95% Ethanol 53000ml, Amazi akwiye. Hariho inzira ebyiri zo kubikora.

4.1.1 Gutegura Imyenda Yoroheje Imyenda Yimyenda: Ongeraho umubare wabigenewe muri 95% Ethanol, shyiramo indi vector . Kuvanga 80% byigisubizo (20% byo gusya) hamwe namavuta yagenwe, twegeranijwe na 80, na propay glycol.

4.1.2 Gutegura ibicucu (nka crown oxide) guswera flow ethanol ijoro ryose, kandi amazi yongeweho kugirango akore igisubizo cya 2%. 20% by'iki gisubizo cyakuweho bwo gusya, kandi 80% igisigisigi cyateguwe n'uburyo bwo gusya amazi, hanyuma umubare w'amazi wongeyeho kandi uvanze no gukoresha. Inzira yo gupfukirana yamazi ya pication: Suka urupapuro rwibinyampeke mu nkono y'isukari, nyuma yo kuzunguruka, uharanira kugaburira kugaburira 4 ~ 15ML / min, ukomeje gukama Hamwe n'umwuka ushyushye kuri 5 ~ 10min birashobora kuba hanze yinkono, shyiramo kumisha kugirango byume kurenza 8h.

4.2 Ibicuruzwa bikozwe muburyo bwa firime.

4.3 Ibinini bya Cotmoxazole (0.4G ± 0.08G) SMZ (Mesh 80) 8Kgg, 3% Kuvanga smz na tmp, hanyuma wongere starch hanyuma uvange kuri 5min. Hamwe na 3% ya 3% HPMC Igisubizo cyamazi, ibikoresho byoroshye, hamwe na mesh ecran ya ecran, gukama ecran ya magnesium Iki gicuruzwa gikoreshwa cyane nka bunder. Iseswa ryibinini ni 96% / 20min.

4.4 Ibinini bya tableti (0,25g) Ipamba 80 Mesh 25Kg, ibikatsi (Mesh 120) 2.1Kg, magnesium iterwa umubare ukwiye. Uburyo bwacyo bwo gutanga umusaruro ni uguvanga aside ) ibisate. Hamwe nigito cyuko umukozi usenyuka, igipimo cy'imivugo cyiyi tablet ntabwo kiri munsi ya 80% / 2min, biruta ibicuruzwa bisa mubuyapani.

4.5 Amarira ya HPMC-4000, HPMC-4500 cyangwa HPMC-5000 0.3G, BODIUM THLOGIUMIUMUMWERU 0.09G, 10% Amoni Uburyo bwayo bwo gutanga umusaruro ni HPMC yashyizwe mumazi ya 15ml, kuri 80 ~ 90 Amazi Yuzuye Yafashe A, Ongeraho Amazi asigaye ya 40ml, hanyuma akirukane amazi yuzuye , gusuka witonze, wibasira muri kontineri bifunze, hapimwe kuri 98 ~ 100 ℃ kuri 308 ℃ kuri 88 ℃ kuri 8.6 ° C. Iki gicuruzwa gikoreshwa mu kubura amarira, ni umusimbura mwiza wo kurira, Iyo ukoreshwa kuri microscopi yimbere yimbere, irashobora kongera agaciro k'iki gicuruzwa, 0.7% ~ 1.5% birakwiye.

4.6 Methtthorphan igenzurwa na tableti zarekuye Meththorphan resin umunyu 187.5mg, PVP7.0MG, 40.0G. Itegurwa nkibinini nuburyo busanzwe. Iki gicuruzwa gikoreshwa nkibikoresho bigenzurwa.

4.7 Kuri Avantomycin ⅳ tableti, 2149g Avantomycin ⅳ Monohydrate na 1000ml Isopropyl Uruvange rwamazi ya 15% (yashizwemo, ruvanze, kandi rwumye kuri 35 ℃. Grannules yumye 575g na 62.5g hydroxyroproprilocellLlocellUlose E-50 yavanze rwose, hanyuma 7.5g acide yijimye hamwe na 3.25g magnesium yongerewe ku bisate kugirango arekurwe rya MyCin. Iki gicuruzwa gikoreshwa nko kurekura buhoro.

4.8 Nifdipine Ikomeza-Kurekura Granules 1 Igice cya Nifedipine, Ibice 3 HydroxyPropyl Methyl Methlorie (1: 1) buryo. Igipimo cyo kurekura ibiyobyabwenge ku granules nticyo cyatewe no guhindura ph y'ibidukikije kandi gahoro katinda kurenza granules. Nyuma yamasaha 12 yubuyobozi bwo mu kanwa, ibitekerezo byamaraso byabantu byari 12mg / ml, kandi nta tandukaniro kugiti cye.

4.9 Hydrochloride ya Erekana yakomeje gusohora Capsule Epranha wolkg 60kg, MicrocRyStalline Cellulose 40Kg, ongeraho amazi 50l kugirango ag granules. HPMC1KG na EC 9KG bavanze muburyo butandukanye (Methylene Chloride: methanol = 1: 1) 200l kugirango ubone ibice 750ml / min spray kunegura ubunini bwa 1.4 MM yerekana ibice byose, hanyuma yuzuza muri capsule ibuye hamwe na mashini isanzwe yo kuzura capsule. Buri capsule irimo 160mg ya prografiya hydrochlolol ibice byumuzingo.

4.10 Ibisate bya Naplelol HCL byateguwe no kuvanga Naprolol HCL: HPMC: CMC-NA Kuri Rati ya 1: 0.25: 2.25. Igipimo cyo kurekura ibiyobyabwenge cyari hafi ya zeru mu masaha 12.

Ibindi biyobyabwenge birashobora kandi gukorwa mubikoresho bivanze bya skeleton, nka metoprolol: hpmc: cmc-na dukurikije: 1: 1.25; AllylProlol: HPMC ukurikije 1: 2.8: 2.92 Ikigereranyo. Igipimo cyo kurekura ibiyobyabwenge cyari hafi ya zeru mu masaha 12.

4.11 Ibisate bya skeleton yibikoresho bivanze byibikomokaho bya Eththlaminasine byateguwe nuburyo busanzwe bakoresheje imvange ya micro powder silika: cmc-na: 4.4. Ibiyobyabwenge byashoboraga kurekurwa kuri 12h haba muri vitro no muri Viro, kandi uburyo bwo kurekura umurongo bwagize isano myiza. Ibisubizo by'ikizamini cyihuse ukurikije amabwiriza ya FDA ihanura ko ubuzima bwo kubika ibicuruzwa bugera ku 2.

4.12 HPMC (50MPA · s) (ibice 5), HPMC (4000 MPA · s) (ibice 3) na HPC1 byaciwe na 6 Spray yumye. Iki gicuruzwa kirimo 80% yubuvuzi bwingenzi.

4.13 Theophylline Ibisate bya Gel Skeleton byabazwe hakurikijwe uburemere bwa tablet yose, 18% -22.5% HPMF Komeza ibitekerezo byuzuye byumubiri wumuntu kuri 12h nyuma yubuyobozi bwa kanwa.


Igihe cyagenwe: Feb-05-2024