中文摘要：

目的研究一种快速检测热毒宁注射液中内毒素的新方法。方法根据细菌内毒素在溶液中团聚的光散射特征,建立内毒素浓度与团聚粒子平均粒径的线性方程对热毒宁注射液中的内毒素进行检查,并以鲎试剂法作验证。结果经方法学考察,线性关系良好,稳定性、精密度、重复性的相对误差（RSD）均控制在1.0%左右,加样回收率达到100%以上及RSD为3.5%;分别测量3个批次热毒宁注射液的内毒素浓度均值为0.36 EU/m L,经鲎试剂法验证测得为0.39 EU/m L。结论与家兔法和鲎试剂法测定内毒素相比,本法检测热毒宁注射中内毒素快速简便,可满足临床要求。

英文摘要：

AIM To establish a quick and simple way for detecting endotoxins in Reduning Injection.METHODS According to specific aggregate of the bacterial endotoxin,the linear equation of light scattering and particle size distribution were used for the inspection of endotoxin in Reduning Injection,and this method was put to the test through Limulus Amebocyte Lysate（LAL）.RESULTS The method had the advantages of good linearity,stability,precision and reproducibility with the relative standard deviation by about 1.0%.The recovery was more than 100% with RSD 3.5% in methodology.The endotoxin contents in Reduning Injections from three batches were obtained 0.36 EU / m L as compared with 0.39 EU / m L measured with kinetic microplate reader and in LAL turbidity method.Both results were similar to each other.CONCLUSION In comparison with the rapid method and kinetic microplate reader and LAL,the method is reliable,quick and simple and can be used for clinic needs.