USP34-细菌内毒素《85》_原创文档.pdfVIP

REAGENTSANDTESTSOLUTIONS试剂和测试溶液

AmoebocyteLysate—Alyophilizedproductobtainedfromthelysateofamoebocytes

(whitebloodcells)fromthehorseshoecrab(LimuluspolyphemusorTachypleus

tridentatus).Thisreagentrefersonlytoaproductmanufacturedinaccordancewith

theregulationsofthecompetentauthority.[AmoebocyteLysatereactstosome

NOTE—

-glucansinadditiontoendotoxins.AmoebocyteLysatepreparationsthatdonotreact

toglucansareavailable:theyarepreparedbyremovingtheGfactorreactingto

glucansfromAmoebocyteLysateorbyinhibitingtheGfactorreactingsystemof

AmoebocyteLysateandmaybeusedforendotoxintestinginthepresenceofglucans.]

变形细胞溶解液—由鲎的〔白血细胞〕变形细胞溶解液制得的冻干产品。该试

剂仅指那些按照相关的监管机构的法规要求制得的产品。[注：变形细胞溶解液

除了与内毒素反响外，还会与某些-葡聚糖反响。可以制成不与-葡聚糖发生

反响的变形细胞溶解液制品：可通过从变形细胞溶解液中去除会与葡聚糖反响的

G因子或抑制变形细胞溶解液的G因子反响系统来制得该制品，这些制品可用

于在存在葡聚糖时进行内毒素检测。]

WaterforBacterialEndotoxinsTest(BET)—UseWaterforInjectionorwater

producedbyotherproceduresthatshowsnoreactionwiththelysateemployed,atthe

detectionlimitofthereagent.细菌内毒素检测〔BET〕用水—使用注射用水或

用其他方式制得的不会与鲎试剂检测限对应浓度的溶菌液发生反响的水。

LysateTS—DissolveAmoebocyteLysateinWaterforBET,orinabuffer

recommendedbythelysatemanufacturer,bygentlestirring.Storethereconstituted

lysate,refrigeratedorfrozen,accordingtothespecificationsofthemanufacturer.鲎试

剂—在缓慢搅拌的同时，将变形细胞溶解液溶于细菌内毒素检测用水中或溶于

溶菌液生产商推荐的缓冲液中。按照生产商的说明来冷藏或冷冻储存该再生溶菌

液。

GEL-CLOTTECHNIQUE凝胶法

TheGel-ClotTechniqueisfordetectingorquantifyingendotoxinsbasedonclottingof

thelysatereagentinthepresenceofendotoxin.Theminimumconcentrationof

endotoxinrequiredtocausethelysatetoclotunderstandardconditionsisthelabeled

sensitivityofthelysatereagent.Toensureboththeprecisionandvalidityofth