Zinthu zopanda pyrogen zimatha kudyedwa popanda endotoxin yakunja, kuphatikiza nsonga za pipette zopanda pyrogen (bokosi la nsonga), machubu oyesa opanda pyrogen kapena otchedwa machubu agalasi a endotoxin, ma ampoule agalasi opanda pyrogen, ma microplates opanda endotoxin opanda 96, ndi endotoxin- madzi aulere (kugwiritsa ntchito madzi a depyrogenated mu mayeso a bakiteriya endotoxin), Endotoxin free buffer ndi etc. Pakati pawo, madzi a bakiteriya endotoxintest mwa njira ya gel clot ndi kuchuluka kwa endotoxin kuyesa kuyesa mu zolemba zonse zokhudzana ndi Pharmacopoeia (USP, EP, BP, JP ndi China Pharmaceutica). Amatanthauza madzi osabala a jakisoni okhala ndi endotoxin yochepera 0.015EU/ml. Tsopano mtundu waposachedwa wa Pharmacopoeia, madzi a BET ndi ochepera 0.005EU/ml. Ngakhale muyezo wapamwamba kwambiri ndi wochepera 0.001EU/ml amatha kupangidwa ndikuperekedwa ndi Bioendo.
Kufotokozeraku kumapereka chithunzithunzi chatsatanetsatane chazinthu zogwiritsira ntchito zopanda pyrogen ndi ntchito zake, makamaka kutsindika gawo lawo lofunikira pakuyesa endotoxin pamiyezo yosiyanasiyana ya pharmacopoeia. Nachi chidule cha mfundo zazikuluzikulu:
- Tanthauzo:
- Zinthu zopanda pyrogen ndi zinthu zopanda endotoxins, kuphatikizapo:
- Malangizo a pipette opanda pyrogen(tip box).
- Machubu oyesera opanda endotoxin kapena machubu agalasi.
- Ma ampoules agalasi opanda endotoxin.
- Ma microplates opanda endotoxin opanda 96.
- Madzi opanda endotoxin (madzi opanda depyrogenated).
- Ma buffers opanda endotoxin.
- Zinthu zopanda pyrogen ndi zinthu zopanda endotoxins, kuphatikizapo:
- Madzi a Bacterial Endotoxin Test (BET):
- Amagwiritsidwa ntchito mu njira za kutsekeka kwa gel osakaniza ndi kuyezetsa kochulukira kwa endotoxin malinga ndi USP, EP, BP, JP, ndi China Pharmacopeia miyezo.
- Muyezo wakale: ≤0.015 EU/ml pamadzi osabala a jakisoni.
- Zofunikira pano (pharmacopoeia zaposachedwa): ≤0.005 EU/ml pamadzi a BET.
- Muyezo wapamwamba kwambiri: Bioendo imatha kupanga madzi okhala ndi ≤0.001 EU/ml endotoxin, kukwaniritsa zofunika kwambiri.
Malingaliro pa Kuwongolera:
- Tsindikani kuchuluka kwa ntchito, mwachitsanzo, ma laboratories, mankhwala, kapena biotech.
- Perekani zambiri zaukadaulo wa Bioendo pakupanga kuti alimbikitse mpikisano wake.
- Onetsani maubwino apadera azinthu zapamwamba za Bioendo, monga kulondola kwa mayeso kapena kutsata malamulo.
Kodi mungafune ndikuthandizeni kukonza izi kukhala chinthu chokhazikika kapena kufotokozera mwaukadaulo?
Mawu ofunikira okhudzana ndi endotoxins, ndi endotoxins free consumables, pyrogen ndi kutentha magwero ndi mfundo ziwiri zosiyana kotheratu:Purojeni: Amatchedwanso pyrogen kapena exothermic factor. zinthu zomwe zingayambitse kutentha kwa thupi.Gwero la Kutentha: Chinthu chomwe chimatulutsa kutentha. Monga machesi oyaka, makala, ndi zina zotero.Zomwe zimatchedwa "non-pyrogenic consumables" ndi "pyrogenic response" za ena opanga ndi amalonda kwenikweni ndi mayina osapindulitsa komanso osocheretsa. Zolondola ziyenera kukhala "Pyrogen Free" ndi "Pyrogen Response".
Chifukwa chiyani zopangira zaulere za Pyrogen ndizofunikira pakuyesa kwa endotoxin, kuyesa kwa gel clot endotoxin test assay komanso kuchuluka kwa endotoxin test assay?
Inde, zogwiritsira ntchito zopanda pyrogen ndizofunikira kuti muyese mayeso a endotoxin molondola komanso modalirika.Kupezeka kwa ma pyrogens, omwe ndi zinthu zomwe zimayambitsa kutentha kwa thupi zomwe nthawi zambiri zimachokera ku mabakiteriya endotoxins, zimatha kusokoneza zotsatira za mayeso ndikuyambitsa kuwerengera zabodza. mayeso a endotoxin, omwe amadziwika kuti Limulus amebocyte lysate (LAL) kapena amatchedwa Lyophilized mayeso a amebocyte lysate (LAL), amagwiritsidwa ntchito kuti azindikire ndikuyesa kupezeka kwa ma endotoxins a bakiteriya m'mankhwala, zida zamankhwala, ndi zinthu zina. Mayeso a LAL amadalira zomwe zimachitika pakati pa LAL reagent ndi endotoxins kuti apange kutsekeka kapena kuyankha kwa chromogenic. Ma pyrogens amatha kuyipitsa zinthu zosiyanasiyana za labotale, kuphatikizamagalasi, nsonga za pipette, machubu, ndi zotengera zitsanzo. Ngati zinthu zomwe zili ndi pyrogen zimakumana ndi reagent ya LAL kapena zitsanzo zoyesa, zimatha kuyambitsa zinthu zabodza, zomwe zimatsogolera ku malingaliro olakwika okhudzana ndi kupezeka kapena kuchuluka kwa endotoxins. kukhalapo kwa pyrogens. Amakhala ndi njira zowongolera bwino kuti awonetsetse kuti akukwaniritsa zofunikira pakuyezetsa endotoxin. Kugwiritsa ntchito zida zapaderazi kumathandizira kusunga umphumphu ndi kulondola kwa kuyesa kwa endotoxin, kuwonetsetsa kuti zotsatira zodalirika komanso kulimbikitsa chitetezo cha odwala pazamankhwala ndi zamankhwala.
Nthawi yotumiza: Nov-07-2022