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I-Carboxymethylcellulose Calcium (CMC-Ca) Superdisintegrant | Amandla aphezulu okudumba okuKhawuleza ukuQothuka kweThebhulethi | I-USP/EP/ChP Compliant

I-Carboxymethylcellulose Calcium yethu (iCarmellose Calcium, i-CMC-Ca) sisithako samayeza esicocekileyo kakhulu esisebenza njengesinyibilikisi, isihlanganisi, kunye nesinyibilikisi esisebenzayo kwiifom zedosi eqinileyo yomlomo.Yityuwa yecalcium ye-carboxymethylcellulose, ebonakala njengomgubo omhlophe ukuya komhlophe oxutyiweyo onganyibilikiyo emanzini kodwa ngokukhawuleza uvuthuluka ukuya kutsho kumthamo wayo wokuqala xa udibana nemithombo yamanzi.Le ndlela ikhethekileyo yokudumba iqinisekisa ukubola ngokukhawuleza kwethebhulethi kunye nokuphuculwa kokunyibilika kwamayeza. Iingenelo eziphambili ziquka: ukungabikho komxholo wesodium (ofanelekileyo kwizigulane ezinentliziyo kunye nezithintelwe yisodium), ukucinezeleka okugqwesileyo, kunye nokuhambelana neenkqubo zokucinezelwa ngokuthe ngqo kunye neenkqubo zokuxozwa okumanzi. Ihambelana ne-USP-NF, EP, JP, kunye ne-ChP pharmacopoeias kunye ne-CDE registration F20230000328. Inqanaba eliqhelekileyo lokusetyenziswa: 0.5-15% w/w.

    Ibanga leMithi iCarboxymethylcellulose Calcium (iCarmellose Calcium, iCMC-Ca)

    Isishwankathelo seMveliso

    I-Carboxymethylcellulose I-Calcium yityuwa ye-calcium ye-polycarboxymethyl ether ye-celluloseSisithako samayeza esisebenza ngeendlela ezininzi esisetyenziswa kakhulu njengesinyibilikisi, isihlanganisi, kunye nesinyibilikisi kwiifom zedosi eqinileyo yomlomo kuquka iipilisi kunye neekhaphuNgokungafaniyo ne-sodium, ityuwa ye-calcium inika ithuba lokwenziwa kwe-sodium-free, okwenza ukuba ifaneleke ngakumbi kubantu abaneengxaki zentliziyo kunye ne-sodium..

    Ubume beMveliso:

    • Igama leKhemikhali:I-Carboxymethylcellulose I-Calcium / iCarmelose I-Calcium

    • Inombolo ye-CAS:9050-04-8

    • Inombolo yoBhaliso lwe-CDE:F20230000328

    • Ukuthobela i-Pharmacopoeia:I-ChP, i-USP-NF, i-EP, i-JP

    • Izithethantonye:I-calcium carboxymethylcellulose, i-calcium CMC, i-CMC-Ca, i-carmelose i-calcium

    • ABANYE:UTY7PDF93L

    • Inkangeleko:Umgubo omhlophe ukuya kotyheli-mhlophe okanye omhlophe qhwa, othambileyo emva kokomiswa

    • Ukunyibilika:Ayinyibiliki emanzini, i-acetone, utywala, kunye ne-toluene; idumba emanzini ukuze yenze i-suspension

    Iimpawu eziphambili kunye neenzuzo

    1. Indlela Ebalaseleyo Yokuqhekeka

    • Ayinyibiliki emanzini kodwa idumba ngokukhawulezaamaxesha amaninzi umthamo wayo wokuqalaxa udibana nemithombo yamanzi

    • Yenza uxinzelelo loomatshini oluqhekeza iipilisi ngokukhawuleza

    • Iqinisekisa ukubola ngokukhawuleza nangokupheleleyo ukuze ichithwe kakuhle iziyobisi

    • Isebenza kakuhle nakwiipilisi eziqinileyo apho ezinye izinto eziqhekekayo zisenokungasebenzi ngokwaneleyo

    2. Isincedisi semisebenzi emininzi

    • Ukwahlukana:Umsebenzi oyintloko njenge-tablet disintegrant kwi-concentrations ye-0.5-15%

    • Isibopheleli:Isibopheleli esisebenzayo kwiinkqubo ze-granulation ezimanzi

    • Isinyibilikisi/Isizalisi:Ingasebenza njenge-tablet diluent

    • Uncedo lokuxhoma:Isetyenziswa njengesiqinisi sokumiswa ekulungiseleleni ngomlomo nangaphandle

    3. Inzuzo engenaSodium

    • Ayinasodium – ilungele amayeza entliziyo kunye nezigulane ezine-sodium encinci

    • Ijongana neemfuno ezikhulayo zolawulo kunye nezigulana zefomyula ezinesodium ephantsi

    • Ihlangabezana neendlela zokwenza imveliso ecocekileyo neqonda impilo

    4. Ukuhambelana kakuhle kwe-API

    • Isebenza ngakumbi kwiamayeza e-cephalosporin, kunye neempawu zokuphucula ukunyibilika ezibonisiweyo

    • Ulwakhiwo oluhle lwe-chelating lunceda iiklasi ezithile ze-API

    • Iyahambelana nezithako ezahlukeneyo ezisebenzayo eziquka: iPioglitazone HCl, iAminophylline, iBerberine HCl, iMilnacipran HCl, iCefixime, iNicorandil, kunye nezinye ezininzi.

    5. Iimpawu Eziphezulu Zomzimba

    • Ukucinezeleka okugqwesileyo kunye nobunzima bethebhulethi

    • Igcina ukuthembeka kwethebhulethi ngelixa iqinisekisa ukuqhekeka ngokukhawuleza

    • Iimpawu ezilungileyo zokuhamba kakuhle koxinzelelo oluthe ngqo

    • Izinzile nangona ingena hygroscopic - gcina kwizikhongozeli ezivalwe kakuhle

    6. Iprofayili yoLawulo kunye noMgangatho

    • Ihlangabezana nemigangatho ye-pharmacopoeia ye-USP-NF, EP, JP, kunye ne-ChP

    • I-CDE ibhalisiwe (F20230000328) kwimarike yaseTshayina

    • I-GMP yenziwe ngolawulo oluqinileyo lomgangatho

    • Ifumaneka ngenkxaso yolawulo kwiifayile zehlabathi

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