细菌内毒素检查法中供试品阳性对照试验方法的改进

Improvement of the Method of Positive Control Test in Bacterial Endotoxin Test

目的:改进《中国药典》细菌内毒素检查中供试品阳性对照试验的方法。方法:以供试品溶液或其稀释液直接溶解鲎试剂,再加入2.0λ浓度的内毒素溶液作供试品阳性对照试验,代替常规方法对常用注射剂(甲硝唑注射液、葡萄糖氯化钠注射液等)进行细菌内毒素检查。结果:所有检品经改进及常规方法进行干扰试验的Et值基本一致,均为2.0Es～0.5Es,表明改进方法对细菌内毒素检查无干扰。结论:本方法操作简单、省时。

OBJECTIVE： To improve the method of positive control test in bacterial endotoxin test. METHODS： A new method rather than a routine method was adopted for the bacterial endotoxin test in which the tachyplens amebocyte lysate （TAL） was dissolved directly by sample solutions or its diluted solution, which was then added with 2.0 X endotoxins solution for positive control test for the common injections including metronidazole and glucose saline etc. RESULTS： The Et values of all the test samples detected by the improved method were similar to those by the routine method, which stood at 2.0 Es-0.5 Es, suggesting that the improved method has no interfere on the bacterial endotoxin test. CONCLUSION： The method is simple and timesaving.