Endotoxins Test yog dab tsi?

Endotoxins Test yog dab tsi?

Endotoxins yog hydrophobic molecules uas yog ib feem ntawm lipopolysaccharide complex uas tsim feem ntau ntawm cov txheej txheem ntawm cov kab mob Gram-negative.Lawv raug tso tawm thaum cov kab mob tuag thiab lawv cov txheej txheem sab nrauv tawg.Endotoxins raug suav hais tias yog qhov tseem ceeb hauv kev txhawb nqa pyrogenic cov lus teb.Thiab cov khoom lag luam parenteral kis nrog pyrogens tuaj yeem ua rau muaj kev txhim kho kub taub hau, ua rau cov lus teb inflammatory, poob siab, lub cev tsis ua haujlwm thiab kev tuag ntawm tib neeg.

Kev kuaj Endotoxins yog qhov ntsuas los kuaj lossis ntsuas cov endotoxins los ntawm cov kab mob Gram-negative.

Cov luav tau ua haujlwm los kuaj xyuas thiab ntsuas cov tshuaj endotoxins hauv cov khoom siv tshuaj thawj zaug.Raws li USP, RPT suav nrog kev saib xyuas qhov kub thiab txias los yog kub taub hau tom qab txhaj tshuaj ntawm cov tshuaj rau hauv cov luav.Thiab 21 CFR 610.13(b) yuav tsum tau kuaj cov luav pyrogen rau cov khoom siv roj ntsha.

Nyob rau xyoo 1960, Fredrick Bang thiab Jack Levin pom tias amebocytes ntawm horseshoe crab yuav txhaws nyob rau hauv lub xub ntiag ntawm endotoxins.CovLimulus Amebocyte Lysate(los yog Tachypleus Amebocyte Lysate) tau tsim raws li hloov RPT feem ntau.Ntawm USP, LAL xeem yog hu ua kab mob endotoxin test (BET).Thiab BET tuaj yeem ua tiav los ntawm kev siv 3 txoj kev: 1) cov txheej txheem gel-clot;2) cov txheej txheem turbidimetric;3) cov txheej txheem chromogenic.Cov kev xav tau rau LAL xeem muaj qhov zoo pH, ionic zog, kub, thiab lub sij hawm incubation.

Piv nrog RPT, BET yog nrawm thiab ua haujlwm tau zoo.Txawm li cas los xij, BET tsis tuaj yeem hloov RPT kiag li.Vim tias LAL kev soj ntsuam tuaj yeem cuam tshuam los ntawm cov xwm txheej thiab nws tsis tuaj yeem kuaj pom tsis muaj endotoxin pyrogens.