利福平原料细菌内毒素检查方法的建立  

Establishment of bacterial endotoxin test method for rifampicin raw material

作　　者：李岩 马俊奇 段沛沛 LI Yan;MA Jun-qi;DUAN Pei-pei(Luohe Product Quality Inspection and Testing Center,Luohe 462600,China;不详)

机构地区：[1]漯河市产品质量检验检测中心,河南漯河462600 [2]漯河南街村药业集团制药有限公司,河南漯河462600

出　　处：《中国处方药》2024年第3期71-73,共3页Journal of China Prescription Drug

摘　　要：目的确定合理的内毒素限值,建立利福平原料细菌内毒素检查方法。方法计算出利福平原料合理的内毒素限值。而后按照《中国药典》2020年版四部通则1143细菌内毒素检查法中的凝胶法。对3批原料样品采用2个厂家的鲎试剂进行干扰试验,对利福平原料细菌内毒素进行方法学验证。结果结合临床用药利福平原料内毒素限值设置在0.5 EU/mg。实验中供试品采用甲醇溶解,稀释至质量浓度不大于0.5 mg/ml时,对细菌内毒素试验结果无干扰。结论建立利福平原料的细菌内毒素检查方法,更有利于成品质量控制和用药安全。Objective To set up a reasonable limit of bacterial endotoxin and establish a bacterial endotoxin test for rifampicin.Methods Reasonable endotoxin limits for rifampicin raw materials were calculated.And then the gel method was followed in accordance with the Chinese Pharmacopoeia 2020 edition of the four general rules 1143 bacterial endotoxin examination method.Interference tests were performed on three batches of raw material samples using horseshoe crab reagents from two manufacturers for the methodological validation of bacterial endotoxin in rifampicin raw materials.Results The endotoxin limit was set at 0.5 EU/mg in combination with the clinical use of rifampicin,and the test sample was dissolved in methanol and diluted to a mass concentration of not more than 0.5 mg/ml without interference with the results of the bacterial endotoxin test.Conclusion Establishing a method for the inspection of bacterial endotoxins in rifampicin raw materials,which is more conducive to the quality control of finished products and drug safety.

关 键 词：利福平原料 细菌内毒素 内毒素限值 难溶 干扰试验 

分 类 号：R927.1[医药卫生—药学]