【摘要】 目的:研究动态比浊法定量测定内毒素的标准曲线斜率与回收率的关系。方法:将特征反应时间 t（0.02）与相应的内毒素工作标准品浓度或样品稀释倍数的倒数作双对数曲线,计算斜率 b_s 和 b。结果:（1）标准曲线与其稀释曲线的斜率 b_s 相等;（2）在稀释倍数为 D_s1、D_s2的测定范围内,.比值 b/b_s 和 D_s1/D_s2决定着回收率 a 的大小;（3）测定了内毒素工作标准品与鲎试剂反应的斜率 B_s,大部分斜率 b_s 的数值相同;（4）测定了4种工作标准品的斜率 b_s、重复性、支间差异;（5）计算了水样品、两性霉素 B 样品的 b/b_s 值,根据计算,前者满足回收率的要求,后者不满足。结论:根据样品与标准品的 b/b_s 比值、标准品的浓度测定范围,可以计算样品的回收率是否满足中国药典的规定。更多还原

【Abstract】 To study the relation between slope of the endotoxin standard curve and the recovery by the dynamic turbidity method.Methods:Endotoxin standards or samples in different concentrations were reacted with Tachypleus Amebocyte Lysate（TAL）in the BET-32C Bacterial Endotoxin Tester and the slope b_s of the standard curve or the slope b of the dilution curve were calculated by the characteristic reactive time t（0.02）and their con- centrations or dilution multiples.Results:（1）The slope b_s were-0.1646 and-0.2698 for endotoxin standards of 160 EU vial^-1and 20 EU vial^-1,respectively.（2）The judgment equation was b/b_s=[1g(D_s1/D_s2)]/[1g（α）+ 1g(D_s1/D_s2)],while α was the recovery and the D_s1,D_s2were the dilution multiple of endotoxin standards.（3）The slope b_s-were-0.2828,-0.2138 and-0.2898 for 200 EU·vial^-1endotoxin standards reacted with TAL with sensitivity of 0.06,0.125,0.5 EU·mL^-1respectively from producer A.The slope b_s were-0.2403,-0.2892,- 0.2848 and -0.2896 for 20 EU vial^-1endotoxin standards reacted with 0.125 EU mL^-1TAL from producer A,B, C and D respectively.（4）The slope b_s were -0.140,-0.150,-0.214 and -0.279 for endotoxin standards of 9000,160,200 and 20 EU vial^-1respectively.（5）The b/b_s of water and amphotericin B sample vs 20 E U vial^-1 were 99.8% and 147%,respectively.Based upon those observations,the endotoxin content of water sample could be determined within the recovery of 50%-200% in the concentration range of 1000 times,and not for amphoteri- tin B sample.Conclusion:The relation between the endotoxin standard curve slope and the recovery is set up and it can be used to judge the endotoxin recovery in samples by the use of the b/b_s ratio.更多还原