新生牛血清细菌内毒素的检测

The Endotoxin Content Analysis Methed of New Bovine Serum

按中国药典2000版二部细菌内毒素检查法及其应用原则,建立了新生牛血清细菌内毒素的检查方法 用同一厂家生产的三个批号的鲎试剂与同一厂家生产的三个批号的新生牛血清分别进行干扰试验,在血清最大有效稀释倍数为40时,对鲎试剂无干扰;用其中一个批号的鲎试剂法对10批同一厂家生产的新生牛血清进行了细菌内毒素测定,7批新生牛血清细菌内新生牛血清细菌内毒素符合中国药典2000年版的要求,3批不符合

According to the Chinese pharmacopoeia two of the 2000 edition bacterium endotoxins were examined that the law reached such application rule,established the new bovine serum bacterium endotoxin check means. Result showed that it is feasible that in the way of limulus test is examined the new bovine serum bacterium endotoxin means.