肾康注射液细菌内毒素检查法的研究

目的建立肾康注射液细菌内毒素检查方法，以期能够替代家兔热原法控制产品的热原，达到快速尧高效尧可靠尧简便的 目的遥方法按叶中国药典2015 年版四部曳通则1143 细菌内毒素检查法进行试验遥采用两个不同厂家的的鲎试剂，对7 个不同 批次的样品开展干扰试验，确定最小不干扰稀释倍数，并对样品进行了细菌内毒素检查遥结果供试品4倍稀释液无干扰作用， 细菌内毒素限值定为1.0 Eu/ml遥结论用细菌内毒素检查法代替热原法是可行的遥

Study on Bacterial Endotoxin Test of Shenkang Injection

Abstract:Objective To establish a bacterial endotoxin test for Shenkang injection in order to replace the pyrogen of rabbits' pyrogen control system and achieve the goal of rapid,high efficiency,reliability and simplicity.Methods According to the"Chinese Pharmacopoeia 2015 edition four"general rule 1143 bacterial endotoxin test method for testing.Tropsch reagents from two different manufacturers were used to perform interference tests on 7 different batches of samples to determine the smallest non-interfering dilution and bacterial endotoxin testing of the samples.Results 4-fold dilution of the test sample without interference,bacterial endotoxin limits set at 1.0 Eu/ml.Conclusion Bacterial endotoxin test instead of pyrogen method is feasible.