肾康注射液细菌内毒素检查法的研究

Study on Bacterial Endotoxin Test of Shenkang Injection

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、高效、可靠、简便的目的。方法按《中国药典2015年版四部》通则1143细菌内毒素检查法进行试验。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。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。结论用细菌内毒素检查法代替热原法是可行的。

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.