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Croscarmellose Sodium Superdisintegrant ku binini bya farumasi | Ibyimba vuba, ikoreshwa gake 0.5-5% | USP/EP/JP ikurikije amategeko

Sodium yacu ya Croscarmellose ni superdisintegrant ifite isuku nyinshi yagenewe gukoreshwa mu buryo busanzwe bwo kunywa harimo ibinini, capsules, na granules. Ni sodium carboxymethylcellulose ifatanye imbere mu mazi, idashonga mu mazi ariko yiyongera vuba ikagera ku nshuro 4-8 z'ingano yayo y'umwimerere iyo ihuye n'amazi.Iyi miterere idasanzwe y’imitsi itanga ubushobozi bwiza bwo gukurura amazi no gukora neza mu mitsi, bigatuma ibinini bishonga neza kandi imiti ikanashonga neza.Ihuye na USP-NF, EP, JP, na ChP pharmacopoeias hamwe na CDE registration F20209990136Urwego rusanzwe rw'ikoreshwa: 0.5-5.0% w/w (2% mu gukandagira mu buryo butaziguye, 3% mu gutose)Bikwiriye gukoreshwa mu gukandagira mu buryo butaziguye, gukandagira mu mazi (imbere cyangwa hanze y'udusimba), gukandagira mu mitsi, no mu gukaraba udusimba

    Sodium Croscarmellose yo mu rwego rwa farumasi (CCS)

    Incamake y'ibicuruzwa

    Croscarmellose Sodium ni sodium carboxymethylcellulose ifitanye isano n'imiti, yagenewe gukoreshwa nk'ikintu gikoreshwa mu gukora imiti.Bitandukanye n'ibintu bisanzwe bivunjwa, itanga ubushobozi bwo kuvunjwa neza ku rugero ruto, bigatuma ibinini bivunjwa vuba kandi bigashonga neza kugira ngo birusheho kuboneka neza..

    Indangamuntu y'igicuruzwa:

    • Izina ry'ibinyabutabire:Sodium ya Croscarmellose

    • Nimero ya CAS:74811-65-7

    • Nomero yo kwiyandikisha ya CDE:F20209990136

    • Iyubahirizwa ry'amategeko agenga farumasi:ChP, USP-NF, EP, JP, BP

    • Nomero ya EC:629-739-2

    • Amagambo asa:Carboxymethylcellulose ifitanye isano na Cross-linked Sodium, CCNa, Sodium Croscarmellose, E468

    Ibintu by'ingenzi n'inyungu

    1. Uburyo bwo Gusenya Bukomeye

    • Gusenyuka kw'ibikorwa bibiri:Ihuza ibikorwa byo gukurura imitsi no kubyimba vuba

    • Irazamuka kuriInshuro 4-8 z'ingano yayo y'umwimerereiyo bibaye mu mazi

    • Imiterere y'imigozi itanga ubushobozi bwiza bwo kwinjiza amazi

    • Ikora kwaguka kwa mashini ku buryo igabanya vuba ibinini

    2. Urwego rwo hasi rwo gukoresha - imikorere myiza cyane

    • Ikora neza ku gipimo kiri hasi nk'uko0.5-5.0% w/w 

    • Ikoreshwa risanzwe: 2% mu gukandagira mu buryo butaziguye, 3% mu gutose

    • Igisubizo gihendutse cyo guteza imbere ifumbire mvaruganda

    3. Guhindura imiterere y'ibinyabutabire

    • Bikwiriye uburyo bwose bwo gutera imiti: gukandagira mu buryo butaziguye, gukandagira mu mazi, gukandagira mu migozi

    • Mu gutose, bishobora gukoreshwa mu buryo buvanze, mu buryo buvanze, cyangwa bigabanyijwemo ibice byombi.

    • Ihuye n'imiti ya capsule (ikoreshwa rya 10-25%)

    4. Imiterere myiza cyane y'umubiri

    • Ishusho:Ifu y'umweru kuva kuri umweru kugeza kuri umweru, itemba buhoro buhoro

    • Impamyabushobozi yo gusimbuza:0.60 – 0.85

    • Ingano yo Gukemura:10.0 – 30.0 ml

    • pH (1% by'umuti):5.0 – 7.0

    • Igihombo ku Kumisha:≤10.0%

    • Ibisigaye ku ishyushya:14.0% – 28.0%

    • Ibintu Bishongesha Amazi:≤10.0%

    • Ibyuma biremereye:≤10 ppm

    5. Guhuza API n'Iterambere

    • Esentabwo irimo peroxide– bitanga umutekano mwiza kuri API zifata ogisijeni

    • Nta ngaruka mbi ku gukomera cyangwa gucika intege kw'ibinini

    • Imikorere yo gusenyuka kw'ibice ikomeza kuba myiza uko igihe kigenda gihita

    • Ntiritera GMO, nta ubwivumbure

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