Kodi Endotoxins Test ndi chiyani?

Kodi Endotoxins Test ndi chiyani?

Endotoxins ndi mamolekyu a hydrophobic omwe ndi gawo la lipopolysaccharide complex lomwe limapanga zambiri zakunja kwa mabakiteriya a Gram-negative.Amatulutsidwa pamene mabakiteriya afa ndipo nembanemba yake yakunja imasweka.Endotoxins amawonedwa ngati omwe amathandizira kwambiri pakuyankha kwa pyrogenic.Ndipo mankhwala a parenteral omwe ali ndi ma pyrogens angayambitse kutentha thupi, kuyambitsa kuyankha kwa kutupa, kugwedezeka, kulephera kwa ziwalo ndi imfa mwa anthu.

Kuyesa kwa Endotoxins ndiko kuyesa kuti muwone kapena kuwerengera ma endotoxins kuchokera ku mabakiteriya a Gram-negative.

Akalulu amagwiritsidwa ntchito kuti azindikire ndikuwerengera ma endotoxins muzinthu zamankhwala poyamba.Malinga ndi USP, RPT imaphatikizapo kuyang'anira kuchuluka kwa kutentha kapena kutentha thupi pambuyo pa jekeseni wa mankhwala mu akalulu.Ndipo 21 CFR 610.13(b) imafuna kuyesa kwa kalulu pyrogen pazachilengedwe.

M'zaka za m'ma 1960, Fredrick Bang ndi Jack Levin adapeza kuti amebocytes a nkhanu ya horseshoe amaundana pamaso pa endotoxins.TheLimulus Amebocyte Lysate(kapena Tachypleus Amebocyte Lysate) adapangidwa moyenerera kuti alowe m'malo ambiri a RPT.Pa USP, kuyesa kwa LAL kumatchedwa kuyesa kwa bakiteriya endotoxin (BET).Ndipo BET ikhoza kuchitidwa pogwiritsa ntchito njira zitatu: 1) njira ya gel-clot;2) njira ya turbidimetric;3) njira ya chromogenic.Zofunikira pakuyezetsa kwa LAL zili ndi pH yoyenera, mphamvu ya ionic, kutentha, ndi nthawi yoyamwitsa.

Poyerekeza ndi RPT, BET ndiyofulumira komanso yothandiza.Komabe, BET sinathe m'malo mwa RPT kwathunthu.Chifukwa kuyesa kwa LAL kumatha kusokonezedwa ndi zinthu ndipo sikungathe kuzindikira ma pyrogen omwe si a endotoxin.