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目的 为降低检验成本 ,提高检验方法的灵敏度 ,拟用细菌内毒素检查法代替家兔热原检查法。方法 参照《中国药典》2 0 0 0年版二部附录 ,用细菌内毒素检查法对胎脑注射液进行方法学研究。结果 胎脑 (沙赛普肽 )注射液L值为 15EU/ml,3批供试品经 30倍稀释 ,用不同厂家的鲎试剂进行干扰试验 ,结果均无干扰作用 ,而且干扰试验的结果与灵敏度复核的结果基本相同。结论 胎脑注射液的细菌对毒素检查可采用 30倍稀释 ,灵敏度为 0 .5EU/ml的鲎试剂检查即可。
The purpose is to reduce the cost of testing and improve the sensitivity of test methods, bacterial endotoxin test to be replaced by pyrogen test in rabbits. Methods With reference to the appendix of 2000 edition of Chinese Pharmacopoeia, the method of bacterial endotoxin test was used to study the fetal brain injection. Results The fetal brain (saemput peptide) injection L value of 15EU / ml, three batches of test samples were diluted 30 times, with different manufacturers of 鲎 reagent interference test, the results were no interference, and interference test results and The results of the sensitivity review are basically the same. Conclusion Fetal brain injection of bacteria toxins can be used 30-fold dilution, the sensitivity of 0.5EU / ml of 鲎 reagent can be checked.