Idanwo Idanwo Endotoxin nipasẹ Lyophilized Amebocyte Lysate (LAL Reagent)

Idanwo Idanwo Endotoxin nipasẹ Lyophilized Amebocyte Lysate (LAL Reagent)

Awọn aṣoju LALLyophilized amebocyte lysate (LAL) jẹ ẹya olomi jade ti ẹjẹ ẹyin (amebocytes) lati Atlantic horseshoe akan.
TAL Reagents: TAL reagent jẹ iyọkuro olomi ti awọn sẹẹli ẹjẹ lati Tachypleus tridentatus.
Lọwọlọwọ, iṣelọpọ akọkọ ti awọn reagents LAL/TAL wa ni Amẹrika ati China.

Gel clot endotoxin test assay, ọna yii tun jẹ awọn ohun elo akọkọ ni gbogbo agbala aye, lati le pade ibeere aabo ti awọn oogun abẹrẹ eniyan.
Lọwọlọwọ Bioendo ṣe agbejade ati pese jeli didi LAL reagent pẹlu si awọn ampules gilasi idanwo ẹyọkan ati awọn lẹgbẹrun idanwo pupọ.
https://www.bioendo.com/gel-clot-endotoxin-assay/ G01, GS44, G02, G17 ati G52
Eyi ni ojutu ti ọrọ-aje fun wiwa endotoxins agbara ninu idanwo oogun naa.Paapa fun awọn oogun abẹrẹ tabi awọn oogun obi lati ṣe idanwo awọn endotoxins ni WFI, API tabi awọn ọja oogun ti pari.Idanwo idanwo Endotoxin jẹ ibeere giga ti awọn iṣe iṣiṣẹ, nilo oniṣẹ oye lati wo pẹlu idanwo geli didi lati rii daju pe awọn atunṣe to pe.

A pipe ojutu funG52Idanwo Endotoxin:
LAL Reagent
Iṣakoso Standard Endotoxin
BET Omi
Endotoxin-free pipette awọn italolobo
Awọn tubes gilasi ti ko ni Endotoxin, pẹlu iṣẹ dilution ati awọn tubes ifaseyin.
Ohun elo abuku, lati ṣeduro iwẹ omi tabi incubator ti o gbẹ.Gbogbo awọn ẹrọ abeabo nilo iwọn otutu konge.
Gbogbo awọn ohun elo lati fi ọwọ kan idanwo LAL eyiti o ni ibamu pẹlu boṣewa ti ipele ọfẹ endotoxin ”<0.005EU/ml” .
Ayika idanwo yẹ ki o baamu si wiwa endotoxin.

San ifojusi si:
Awọn ohun elo ṣiṣu bi awọn imọran pipette tabi awọn awopọ multiwell jẹ lilo pupọ fun idanwo endotoxin.Pharmacopoeias ti o ni ibamu (USP/CP) nilo pe eyikeyi awọn ohun elo ṣiṣu ati awọn tubes gilasi ni lati ni ominira ti endotoxin ti a rii ati pe o ṣe pataki ṣugbọn nigbagbogbo kii ṣe akiyesi, wọn gbọdọ jẹ boṣewa ti laisi awọn ifosiwewe idilọwọ.

Bii o ṣe le ṣiṣẹ idanwo idanwo endotoxin lati rii awọn endotoxins ninu apẹẹrẹ?
Ni akọkọ, idanwo fun idaniloju ifamọ lysate ti o ni aami yẹ ki o ṣe.Lati jẹrisi ifamọ jẹ kanna si awọn aami aami.
Fun itupalẹ apẹẹrẹ, ṣe awọn idanwo idanwo endotoxin ṣaaju kikọlu.
Lati ṣiṣẹ idanwo pipe endotoxin ti “idanwo kikọlu”.
Lati ṣiṣẹ idanwo opin fun gbigba bawo ni ipele endotoxins ninu apẹẹrẹ.

Nigbati o ba ṣiṣẹ idanwo fun idaniloju ifamọ lysate ti o ni aami, abajade jẹ ajeji, 2 Lamada havenot gel formation?
Ṣayẹwo boya ọna igbaradi ti endotoxin boṣewa iṣakoso kokoro jẹ deede.
A nilo idapọ Vortex fun diluent kọọkan (wo itọnisọna itọnisọna tabi ti a npe ni ifibọ ti endotoxin boṣewa iṣakoso ni awọn alaye).
Lati ṣayẹwo boya reagent lysate ibaamu boṣewa iṣakoso endotoxin.

A ṣe iṣeduro lati lo iwẹ omi tabi incubator gbigbẹ fun ilana iwọn otutu igbagbogbo ti reagent lysate (fun apẹẹrẹ, incubator tabi apoti gbigbẹ ko munadoko).
Lakoko abeabo, agbegbe omi ninu iwẹ omi ti o jẹ aimi ati iduroṣinṣin, gbogbo awọn gbigbọn ni a yago fun.
San ifojusi pataki si iwẹ omi lati pa fifa omi ṣiṣan omi.

Ti o ṣe idajọ abajade, rọra yọ tube idanwo tabi ampoule gilasi lati iwọn otutu, yiyipada awọn iwọn 180 laiyara,
Ibiyi jeli ninu tube kii yoo ni idibajẹ, ati pe kii yoo yọ kuro, abajade ti gbasilẹ nipasẹ ifihan “+”;
ko si jeli Ibiyi ti wa ni akoso tabi awọn jeli didi ko le wa ni pa mule biotilejepe o ti wa ni akoso.
Iyọkuro odi jẹ odi, abajade ti gbasilẹ nipasẹ ifihan “-”.
Apo idanwo endotoxin gel didi jẹ ti ọna idanwo endotoxin gel clot.
Ninu idanwo endotoxin gel didi iyara, iṣakoso rere ayẹwo ko ṣe ina jeli?
Ni akọkọ, lo omi idanwo endotoxin kokoro-arun lati rii daju awọn reagents lysate, rii daju pe awọn oniṣẹ ati agbegbe ti pade awọn ilana;

Ti ohun elo naa ba jẹ oṣiṣẹ, lẹhinna iṣakoso rere ti apẹẹrẹ kii ṣe agbekalẹ gel nitori ipa idinamọ ti apẹẹrẹ, ati pe o yẹ ki a ṣe itọju ayẹwo naa ki o ṣe itọju.
Ọna ṣiṣe ayẹwo ti o wọpọ julọ jẹ dilution.