LAL Reagent ko TAL Reagent don gwajin gwajin endotoxin

Limulus amebocyte lysate (LAL) ko Tachypleus tridentatus lysate (TAL) wani tsantsa mai ruwa ne na sel jini daga kaguwar doki.

Kuma endotoxins kwayoyin halitta ne na hydrophobic wadanda ke cikin hadaddun lipopolysaccharide wanda ke samar da mafi yawan kwayar cutar Gram-negative.Kayayyakin iyaye da aka gurbata da pyrogens na iya haifar da mummunan sakamako kamar zazzabi, girgiza, gazawar gabbai, ko ma mutuwa.

LAL/TAL reagent na iya amsawa tare da endotoxin na kwayan cuta da lipopolysaccharide (LPS).Ƙarfin endotoxin na LAL da iyawar jini shine abin da ya sa ya zama mai kima ga masana'antar harhada magunguna ta mu.Kuma wannan shine dalilin da ya sa za a iya amfani da LAL/TAL reagent don gano ko ƙididdige endotoxin na kwayan cuta.

Kafin gano cewa za a iya amfani da LAL/TAL don yin gwajin ƙwayoyin cuta na ƙwayoyin cuta, ana amfani da zomaye don ganowa da ƙididdige endotoxins a cikin samfuran magunguna.Idan aka kwatanta da RPT, BET tare da LAL / TAL reagent yana da sauri da inganci, kuma shine sanannen hanyar yin saka idanu mai ƙarfi na maida hankali na endotoxin a cikin masana'antar magunguna, da sauransu.

Gel clot endotoxin test assay, wanda kuma aka sani da gwajin Limulus Amebocyte Lysate (LAL), ko kuma ake kira Lyophilized Amebocyte Lysate (LAL) hanya ce da ake amfani da ita sosai don ganowa da ƙididdige endotoxins a cikin samfura daban-daban, musamman a cikin masana'antar magunguna da na'urorin likitanci.An yi la'akari da mahimmancin bayani a fagen gano endotoxin saboda tasirinsa da yarda da tsari.

Jarabawar LAL ta dogara ne akan ka'idar cewa ƙwayoyin jini na kaguwar doki (Limulus polyphemus ko Tachypleus tridentatus) sun ƙunshi wani abu mai ɗorewa wanda ke amsawa tare da endotoxins na kwayan cuta, wanda ke haifar da samuwar jini mai kama da gel.Wannan halayen yana da matukar damuwa kuma yana keɓance ga endotoxins, waɗanda abubuwa ne masu guba na jikin ƙwayoyin gram-korau.

Akwai dalilai da yawa da yasa ake ɗaukar gwajin gwajin endotoxin na gel clot a matsayin mafita mai mahimmanci a cikin gano endotoxin:

1. Karɓar Ka'ida: An gane gwajin LAL kuma an yarda da shi ta hanyar hukumomin gudanarwa kamar Amurka Pharmacopeia (USP) da Turai Pharmacopoeia (EP) a matsayin daidaitaccen hanyar gwajin endotoxin.Bi waɗannan ƙa'idodin wajibi ne don tabbatar da aminci da ingancin samfuran magunguna.

2. Hankali da ƙayyadaddun ƙayyadaddun bayanai: Gwajin LAL yana da babban hankali, yana ba da izinin gano ƙananan matakan endotoxins.Yana da ikon gano adadin endotoxin ƙasa da 0.01 raka'a endotoxin a kowace millilita (EU/ml).Ƙayyadaddun gwajin yana tabbatar da cewa da farko yana gano endotoxins kuma yana rage sakamako mai kyau na karya.

3. Ƙididdigar Ƙimar: Gel clot endotoxin test assay ana la'akari da shi azaman maganin tattalin arziki idan aka kwatanta da hanyoyin da za a iya amfani da su kamar chromogenic ko turbidimetric assays.Yana buƙatar ƙarancin reagents da kayan aiki, rage ƙimar gwaji gabaɗaya.Bugu da ƙari, kasancewar daidaitattun ingantattun magunguna na LAL a kasuwa yana sa ya dace da dakunan gwaje-gwaje don yin gwajin.

4. Matsayin Masana'antu: An karɓi gwajin LAL sosai a cikin masana'antun magunguna da na'urorin likitanci a matsayin daidaitaccen hanyar gano endotoxin.Wani bangare ne na tsarin sarrafa inganci yayin kera samfuran magunguna da na'urorin likitanci, yana tabbatar da bin ka'idoji.

Duk da haka, yana da mahimmanci a lura cewa gwajin gwajin endotoxin na gel clot na iya samun iyakancewa, kamar tsangwama daga wasu abubuwa da yuwuwar samun sakamako mai kyau ko ƙarya.A cikin takamaiman yanayi, ana iya amfani da madadin hanyoyin kamar gwajin chromogenic ko turbidimetric don haɓaka ko inganta sakamakon da aka samu daga gwajin LAL.