Pyrogen inama yubusa - Endotoxin yubusa yubusa / inama / microplates

Ibiryo bidafite pyrogene birashobora gukoreshwa nta endotoxine idasanzwe, harimo inama ya pirate idafite pyrogen (agasanduku k'iposita), imiyoboro yipimisha idafite pyrogen cyangwa yitwa ibirahuri byubusa bya endotoxin, ibirahuri bidafite ibirahuri bya pirogene, microplate ya endotoxine idafite 96, na endotoxine- amazi yubusa (gukoresha amazi ya depyrogenated mugupima kwa bagiteri endotoxine), buffer ya endotoxine yubusa nibindi Muri byo, amazi ya bagiteri endotoxintest by gel clot uburyo hamwe na testoto ya endotoxine yipimisha mubisobanuro byose bifitanye isano na Pharmacopoeia (USP, EP, BP, JP na Pharmaceutica y'Ubushinwa). Yerekeza kumazi meza yo guterwa hamwe na endotoxine iri munsi ya 0.015EU / ml. Noneho verisiyo yanyuma ya Pharmacopoeia, amazi meza ni munsi ya 0.005EU / ml. Ndetse ibipimo bihanitse biri munsi ya 0.001EU / ml irashobora kubyazwa umusaruro no gutangwa na Bioendo.

Ibisobanuro bitanga ibisobanuro birambuye kubikoresha bidafite pyrogene nibisabwa, cyane cyane bishimangira uruhare rwabo mugupima endotoxine mubipimo bitandukanye bya farumasi. Dore incamake yingingo zingenzi:

1. Ibisobanuro:
   • Ibiryo bidafite pyrogene ni ibintu bidafite endotoxine ya exogenous, harimo:
     • Inama ya pyrogen idafite inama(agasanduku k'inama).
     • Endotoxine itagira ibizamini cyangwa ibirahuri.
     • Endotoxine idafite ibirahuri ampules.
     • Endotoxin-yubusa 96-neza microplates.
     • Amazi adafite Endotoxine (amazi ya depyrogene).
     • Endotoxin-yubusa.
2. Amazi yo Kwipimisha Endotoxine (BET):
   • Ikoreshwa muburyo bwa gel clot hamwe nibipimo bya endotoxine yipimishije nkuko USP, EP, BP, JP, na China Pharmacopeia mubushinwa.
   • Ibisanzwe mbere: ≤0.015 EU / ml kumazi meza yo gutera inshinge.
   • Ibisabwa muri iki gihe (pharmacopoeia iheruka): ≤0.005 EU / ml kumazi meza.
   • Ibipimo ngenderwaho bigezweho: Bioendo irashobora gutanga amazi hamwe na .00.001 EU / ml ya endotoxine, yujuje ibyangombwa bisabwa.

Ibyifuzo byo Kunonosora:

• Shimangira urwego rusaba, urugero, laboratoire, imiti, cyangwa biotech.
• Tanga ibisobanuro birambuye kubuhanga bwa Bioendo mubikorwa byo gushimangira irushanwa ryayo.
• Garagaza ibyiza byihariye bya Bioendo yibicuruzwa byo mu rwego rwo hejuru, nko kongera ibisobanuro byukuri cyangwa kubahiriza amabwiriza.

Urashaka ko mfasha gukora ibi mubicuruzwa bisanzwe cyangwa ibisobanuro bya tekiniki?

Amagambo y'ingenzi ajyanye na endotoxine, hamwe na endotoxine ikoreshwa kubuntu, pyrogene nubushyuhe ni ibintu bibiri bitandukanye rwose:Pyrogen: Nanone bita pyrogen cyangwa ibintu bituruka hanze. ibintu bishobora gutera kwiyongera k'ubushyuhe bw'umubiri.Ubushyuhe: Ikintu gisohora ubushyuhe. Nkumuriro wo gutwika, amakara, nibindi .Ibyo bita "ibiribwa bitari pyrogenic" na "igisubizo cya pyrogenic" bya bamwe mubakora ibicuruzwa nabacuruzi mubyukuri ni amazina adasanzwe kandi ayobya. Ibikwiye bigomba kuba "Pyrogen Free" na "Igisubizo cya Pyrogen".

Kuberiki Pyrogen ikoreshwa kubusa irakenewe mugupima endotoxin, byombi gel clot endotoxin yipimisha hamwe na testoto ya endotoxin yuzuye?

Nibyo, ibiribwa bidafite pyrogene nibyingenzi mugukora ibizamini bya endotoxine neza kandi byizewe.Kubaho pyrogène, aribintu bitera umuriro akenshi biva muri bagiteri endotoxine, birashobora kubangamira ibisubizo byikizamini kandi biganisha ku gusoma ibinyoma. ikizamini cya endotoxine, kizwi cyane ku izina rya Limulus amebocyte lysate (LAL) cyangwa cyitwa Lyophilized amebocyte lysate (LAL), ni ikoreshwa mu kumenya no kugereranya ahari endotoxine ya bagiteri muri farumasi, ibikoresho byubuvuzi, nibindi bicuruzwa. Ikizamini cya LAL gishingiye ku myitwarire iri hagati ya LAL reagent na endotoxine kugirango itange igisubizo cyambaye cyangwa chromogenic. Kugirango habeho ibisubizo nyabyo, ni ngombwa gukoresha ibikoreshwa bitarimo pyrogene. Pyrogene irashobora kwanduza ibikoresho bitandukanye bya laboratoire, harimoibikoresho by'ibirahure, inama za pipeti, tebes, hamwe nicyitegererezo. Niba ibirungo byanduye byitwa pyrogene bihuye na LAL reagent cyangwa ibizamini byikigereranyo, birashobora gukurura reaction-yibinyoma, biganisha ku myanzuro itari yo kubyerekeranye no kubaho kwa endotoxine cyangwa kwibumbira hamwe. ahari pyrogene. Bahura nuburyo bukomeye bwo kugenzura ubuziranenge kugirango barebe ko bujuje ibipimo bisabwa kugirango bapimwe endotoxine. Gukoresha ibyo bikoresho byihariye bifasha kugumana ubunyangamugayo nukuri kwipimisha rya endotoxine, gutanga ibisubizo byizewe no guteza imbere umutekano wumurwayi mubikorwa bya farumasi nubuvuzi.