Igikoresho cyo mu rwego rwa farumasi cya Sodium Stearyl Fumarate (SSF) | Gifite ubushobozi bwo gukorana na API nyinshi, gisimbura Magnesium Stearate, GMP Grade

Sodium Stearyl Fumarate (SSF) yacu ni amavuta meza cyane yagenewe imiti yihariye yagenewe ibinini n'ibinini. Bitandukanye na magnesium stearate, itanga uburyo bwiza bwo guhuza API, irakomera iyo ikoreshejwe amavuta menshi, kandi nta ngaruka mbi ku kuboneka kw'ibinyabutabire.Ni amavuta akunda gushonga mu mazi, ashobora gushonga mu buryo bungana, agatanga ubukana bukomeye bw'ikinini ku mbaraga zingana zo gukanda kandi akagabanya ingaruka ku gihe cyo gusenyuka.. Ihuye na USP-NF, EP, na JP pharmacopoeias hamwe n'iyandikwa rya CDE (F20190000009) n'ubufasha bwa DMF (38822). Igipimo cy'ikoreshwa gisabwa: 0.5-3% w/w. Ni byiza cyane ku bikoresho byo gukanda byihuse cyane, ibinini bitanga umuriro, n'imiti ifite API zidahuye.

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Ibisobanuro birambuye ku gicuruzwa

Sodium Stearyl Fumarate yo mu rwego rwa farumasi (SSF)

Incamake y'ibicuruzwa

Sodium Stearyl Fumarate (SSF) ni amavuta yo mu rwego rwo hejuru akoreshwa mu buvuzi izwi cyane nk'uburyo bwiza bwo gusimbura amavuta gakondo nka magnesium stearate na talc.Ni umunyu wa sodiyumu wa aside stearyl fumaric, igaragara nk'ifu nziza y'umweru kuva kuri umweru kugeza kuri umweru ifite ubushobozi bwo gutera imbaraga mu mubiri ituma amavuta yo mu bwoko bwa amphiphilic akoreshwa neza mu gusiga ibinini n'ibinini..

Indangamuntu y'igicuruzwa:

Izina ry'ibinyabutabire:Sodium Stearyl Fumarate
Nimero ya CAS:4070-80-8
Nomero yo kwiyandikisha ya CDE:F20190000009
Nomero ya DMF:38822
Iyubahirizwa ry'amategeko agenga farumasi:USP-NF, EP, JP
Formula ya Molecular:C22H39NaO4
Uburemere bwa molekile:390.53 g/mol

Ibintu by'ingenzi n'inyungu

1. Guhuza API neza cyane

Ikemura ibibazo byo guhuza ibintu bikunze kugaragara kuri magnesium stearate
Ibyavuzwe ko API idahuye na magnesium stearate birimo: Azathioprine, Cefaclor, Cilazapril, Clopidogrel, Diclofenac, Ibuprofen, Omeprazole, n'ibindi byinshi
Ni byiza cyane ku miti ikoreshwa mu gushushanya aho ikibazo cy’uko imiti idahuye n’ibindi

2. Gukomera kugeza ku gusigwa amavuta menshi

Bitandukanye na magnesium stearate, SSF ikomeza gukora neza nubwo yamara igihe kirekire ivangavanga.
Itanga ubukana bw'ibinini kandi igasenyuka nta ngaruka zo "gusiga amavuta menshi"

3. Imiterere myiza ya Tablet

Ubukomere buhebujeku mbaraga zingana zo gukanda ugereranije n'andi mavuta yo kwisiga
Ingaruka nke ku gihe cyo gusenyuka- irinda kwangirika vuba kwa tableti
Nta ngaruka mbi ku kuba umuntu afite ubuzima bwiza- igenzura ko imiterere y'ibiyobyabwenge ikomeza kuba myiza

4. Imiterere y'amazi n'imiterere yayo ishongesha buhoro buhoro

Amavuta ashongeshwa n'amazi – 0.5 mg/100 mL kuri 25°C, yiyongera kugeza kuri 20 g/100 mL kuri 90°C
Bituma habaho ibisigazwa bike mu gisubizo, bigatuma kiba cyiza cyane kuriibinini bitanga umuriro
Kunoza imiterere y'imisemburo ya APIs zidashonga neza

5. Imiterere myiza cyane y'umubiri