Gel Yambaye Lyophilized Amebocyte Lysate Ikizamini kimwe muri Ampoule G01

Gel Yambaye Lyophilized Amebocyte Lysate Ikizamini kimwe (Ikirahuri Ampoule G01)

Ikizamini cya Gel Clot Lyophilized Amebocyte Lysate (LAL) Ikizamini kimwe muri Ampoule ni ubwoko bwikizamini cya endotoxine gikoreshwa cyane munganda zikora imiti nubuvuzi kugirango hamenyekane ko endotoxine iba mu ngero zitandukanye.

Dore bimwe mubiranga iki kizamini kimwe endotoxin ikizamini:

1. Ibyiyumvo: Gel Clot imwe ya LAL Ikizamini muri Ampoule irumva cyane kandi irashobora kumenya urugero rwa endotoxine munsi ya 0.03 EU / mL.

2. Umwihariko: Isuzuma ryihariye rya endotoxine, ikizamini cyihariye kuri endotoxine kandi ntigishobora guhura nibindi bintu murugero.

3. Ibyoroshye: Imiterere yikizamini kimwe cya Gel Clot imwe ya LAL Ikizamini muri Ampoule ituma byoroha kandi byoroshye gukoresha, kuko bivanaho gukenera gutegura reagent hamwe nu murongo usanzwe.

4. Igihagararo: Imiterere ya lyofilize ya LAL reagents itanga ituze ryiza, ituma ikizamini kibikwa mubushyuhe bwicyumba igihe kinini bitabangamiye imikorere yacyo.

5. Ikiguzi-cyiza: Imiterere yikizamini kimwe cya Gel Clot LAL Ikizamini kimwe muri Ampoule irahenze cyane kuruta ubundi bwoko bwibizamini bya endotoxine, nka kinetic chromogenic LAL assay, kinetic turbidimetric LAL assay, amaherezo ya chromogenic LAL assay and recombinant factor C endotoxin ikizamini.

Ikizamini cya Gel Clot imwe ya LAL muri Ampoule nuburyo bwizewe, bworoshye, kandi bworoshye bwo kumenya endotoxine mubice byinshi byintangarugero, bigatuma iba igikoresho cyingenzi mukurinda umutekano nubwiza bwibikoresho bya farumasi nubuvuzi.

1. Amakuru y'ibicuruzwa

Gel Yambaye Lyophilized Amebocyte Lysate Ikizamini kimwemuri ampoule Irimo endotoxine yihariye ya Amebocyte Lysate ikubiyemo beta-glucan inhibitor muri formulaire kandi ntabwo izitabira beta-glucan.Kubizamini Byacu Byonyine mubirahuri, ushobora kongeramo icyitegererezo kumirahuri ampule.Ibi bivuze ko udakeneye kongera kubaka Amebocyte Lysate hakiri kare, kandi uzahitamo umubare wibizamini ukoresha buri gihe kugirango wirinde imyanda, nanone iri ni itandukaniro nyamukuru riterwa na endotoxine yipimisha byinshi.Endotoxine yubusa kubusa ya Lyophilized CSE irakenewe.Imikorere yo kumenya endotoxine ikoreshe Bioendo Gel Yambaye Lyophilized Amebocyte Lysate Ikizamini kimwe muri ampoule ihuye na Pharmacopoeia yigihugu.

2. Ibipimo byibicuruzwa

Gel yambaye imyenda isuzuma ikirahuri ampoule.

Ibyiyumvo: 0.03EU / ml, 0.06EU / ml, 0.125EU / ml, 0.25 EU / ml, 0.5EU / ml.

3.Ibicuruzwa biranga nibisabwa

Intambwe imwe ya endotoxin gutahura, byoroshye-gukoresha-mugeragezwa wa testi ya bagiteri.

Ubusanzwe amazi yo kwiyuhagira cyangwa ubushyuhe bwumye burahari kubwububiko bwa gel clot uburyo LAL reagent.

Birakwiriyeigeragezwa rya endotoxinmbere yuko ibicuruzwa bisohoka.

Koresha ibizamini bya endotoxine, ibikoresho bya sensibilité byujuje ubuziranenge ukurikije Ubushinwa Pharmacopoeia.

Icyitonderwa:Lyophilized Amebocyte Lysate (LAL) reagent yakozwe na Bioendo ikozwe muri lysate ya amebocytes (selile yamaraso yera) iva mu gikona.

Ibyiyumvo bya Lyophilized Amebocyte Lysate nimbaraga zo kugenzura Standard Endotoxin bisuzumwa na USP Reference Standard Endotoxin.Lyophilized Amebocyte Lysate reagent ibikoresho bizana amabwiriza y'ibicuruzwa, Icyemezo cyo gusesengura.

Impamvu yatoranijwe cyane gel yambaye imyenda G01:

1. Ikizamini cyubukungu kandi gikunze gukoreshwa reagent kugirango tumenye endotoxine.

2. Ikizamini kimwe muri ampule kumuntambwe imwe igabanya ibyago byo kwanduza.

3. Gel yambaye imyenda isuzuma ikirahuri kimwe ampoule ntakeneye umusomyi wa microplate ikomeye.

4. Kuzigama umuyoboro wa endotoxine mugihe ukoresheje serivise ya G01 kugirango ugerageze endotoxine muburyo bwo gukora ibizamini bya endotoxine.

Ibicuruzwa bifitanye isano na test ya endotoxin:

Amazi yo Kwipimisha Indwara ya Bagiteri (BET), Saba TRW02, TRW50 cyangwa TRW100,

Endotoxin yubusa ikirahure (tube dilution), Saba T1310018 Inama yubusa ya Pyrogen, Saba PT25096 cyangwa PT100096

Umuyoboro,Saba PSB0220

Ikizamini cya Tube Rack,

Igikoresho cya Incubation (Ubwogero bw'amazi cyangwa Ubushyuhe bwumye Incubator),

Saba Ubushyuhe Bwumye Incubator TAL-M2

Kuvanga Vortex, Saba VXH.

Kugenzura Standard Endotoxin, CSE10A.