Iityhubhu zeLebhu

Imveliso

Amphotericin B 1397-89-3 Antibiotic

Inkcazelo emfutshane:

Izithethantonye:Fungizone, Abelcet, Ambisome

Inombolo yeCAS:1397-89-3

Umgangatho:Endlini

Ifomula yemolekyuli:C47H73NO17

Ubunzima beFomula:924.08


Iinkcukacha zeMveliso

Iithegi zeMveliso

Intlawulo:T/T, L/C
Imvelaphi yeMveliso:eTshayina
Indawo yokuthumela ngenqanawa:Beijing/Shanghai/Hangzhou
Umthamo wemveliso:100kg/ngenyanga
Umyalelo(MOQ):25kg
Ixesha lokukhokhela:Iintsuku zokusebenza ezi-3
Imeko yokugcina:kunye nengxowa yomkhenkce yokuthutha.Gcina kwi-2-8℃ ixesha elide.
Ipakethe imathiriyeli:igubu
Ubungakanani bepakethi:25kg/igubu
Ulwazi ngokhuseleko:Ayizompahla eziyingozi

Amphotericin B

Intshayelelo

I-Amphotericin B, inokubizwa ngokuba yiFungizone okanye i-Ambisome, isibulala-zintsholongwane se-polyene esilwa nokungunda okwahlulwa kulwimi lwenkcubeko ye-Streptomycesnodosus.Ibekwe yodwa ngamalungu amabini ane-A kunye no-B, kodwa inxalenye engu-A ayisebenzi kangako kwi-antifungal engasetyenziswayo, ngoko ke abantu basebenzisa inxalenye engu-B kuphela ebizwa ngokuba yi-Amphotericin B.

Liyeza le-antifungal elisetyenziselwa usulelo olukhulu lomngundo kunye ne-leishmaniasis.Inokusetyenziswa ezimbini ezahlukeneyo ngomlomo kunye nesitofu.

I-Amphotericin B lukhetho lokuqala losulelo lomngundo olunzulu ngenxa yobubanzi bayo bokulwa nokungunda.Inomsebenzi wokuthintela ukungunda okufana ne-cryptococcus, coccidium, candida albicans kunye ne-blastomycetes, njl.njl. Iyakubulala i-fugal ekugxininiseni okuphezulu, elichiza elisebenzayo kunyango losulelo lomngundo olunzulu.

Iimpawu eziphambili zeklinikhi ezifana: 1. Unyango lwefungi ezifana ne-cryptococcosis, i-blastomycosis yaseMntla Melika, i-candidiasis esasazwayo, i-coccidiosis kunye ne-histoplasmosis.2. Unyango lwe-mucormycosis olubangelwa ezinye iifungi ezifana ne-Rhizopus, i-colporium, i-endomycetes kunye ne-fecal mold yesele.3. Unyango lwe-sporotrichosis olubangelwa yi-sporotrichosis schenckii.4. Unyango lwe-aspergillosis olubangelwa yi-Aspergillus fumigatus.5. Amalungiselelo asemgangathweni afanelekile kwi-pigmented mycosis.Ikwafanelene nosulelo lomngundo eluswini emva kokutsha, iphecana lokuphefumla iCandida kunye neAspergillus okanye usulelo lwe-cryptococcus, kunye nomsebenzi wezilonda ze-cornea.

Iziphumo ebezingalindelekanga eziqhelekileyo zibandakanya ukusabela ngomkhuhlane, ukugodola, kunye neentloko ezibuhlungu ngokukhawuleza emva kokuba iyeza linikezelwe, kunye nengxaki yezintso.Iimpawu ze-allergic eziquka i-anaphylaxis zingenzeka.Ezinye iziphumo ezibi kakhulu ziquka i-potassium ephantsi yegazi kunye nokuvuvukala kwentliziyo.Kubonakala ngathi kukhuselekile xa ukhulelwe.Kukho i-lipid formulation enomngcipheko omncinci wemiphumo emibi.Kukwiklasi ye-polyene yeyeza kwaye isebenza ngokuyingxenye ngokuphazamisa i-cell membrane yefungus.Kufuneka kusetyenziswe isilumkiso xa iimeko zithe zenzeka, kuba ukusetyenziswa kokhuseleko kufuneka kulandele iingcebiso kubasebenzi bezonyango.

Inkcazo yeBanga loMlomo (kwiMgangatho weNdlu)

Into

Inkcazo

Imbonakalo Umthubi ukuya kumgubo o-orenji-mthubi, ongenavumba okanye phantse awunavumba.
Ukuchongwa IR, HPLC
pH 4.0-6.0
Ilahleko ekomisweni ≤5.0%
Uthuthu lweSulfated ≤3.0%
Izinto ezinxulumeneyo ≤0.5%
303nm Ukungcola A (Amphotericin A) ≤5.0%

Ukungcola okungaziwayo komntu ≤1.0%

383nm Ukungcola B (Amphotericin X1) ≤4.0%

Ukungcola okungaziwayo komntu ≤2.0%

Ukungcola ngokupheleleyo ≤15.0%
Izinyibilikisi ezishiyekileyo IMethanol ≤0.3%

Iacetone ≤0.5%

Isivavanyi ≥850 amphotericin B iiyunithi/mg into eyomileyo.

Inkcazo yeBanga loMlomo (kwiMgangatho weNdlu)

Into

Inkcazo

Imbonakalo Umgubo omthubi ukuya kweorenji awunavumba.
Ukuchongwa IR, HPLC

Intsalela ekutshisweni

≤0.5%

Izinto ezinxulumeneyo

Kwi303nm

I-Amphotericin A ≤2.0%

Ukungcola okungaziwayo komntu ≤1.0%

Kwi383nm

I-Amphotericin X1 ≤4.0%

Ukungcola okungaziwayo komntu ≤2.0%

Ukungcola okupheleleyo

≤15.0%

Izinyibilikisi ezishiyekileyo

Iacetone ≤0.5%

IMethanol ≤0.3%

Umda weMicrobiological

Ubalo lweAerobic microbial ≤1000cfu/g

Ukungunda kunye negwele ≤100cfu/g

Escherichia coli Ukungabikho kwi-1g

I-endotoxins yebhaktheriya

<1.0EU/mg

Isivavanyi

≥850 i-amphotericin B iiyunithi / mg, ezibalwe kwisiseko esomileyo


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