动态比浊法测定复方苦参注射液中细菌内毒素的研究

Determination of bacterial endotoxin in Fufang Kushen injection by kinetic urbidimetry

目的:建立复方苦参注射液中细菌内毒素的含量测定方法。方法:采用动态比浊法,将复方苦参注射液作100倍稀释,通过预干扰试验和干扰试验,测定其中细菌内毒素的含量。结果:将样品作100倍稀释可有效消除对鲎试剂的干扰,测定其平均回收率在50%～200%范围内。结论:本方法与热原检查的家兔法和半定量凝胶法比较,具有检测灵敏度高、周期短、结果准确、重现性好等优点。

Objective：To establish a method for the contents determination of bacterial endotoxin in Fufang Kushen injection. Methods：The kinetic turbidimetric technique was adopted to dilute the Fufang Kushen injection by 100 -f0ld, in which, the contents of bacterial endotoxin was determinated by preliminary interference test and interference test .Results： Diluting the sample by 100-fold could effectively eliminated its interference to tachypleus amebocyte lysate（TAL） .The average recovery rate was at the range of 50%-200%. Conclusion： Compare with the pyrogen rabbit determination method and the half-quantity gel method, the kinetic turbidimetic technique has many merits such as high determination sensitivity , short cycle,accurate result and better reproduction quality,etc.