米力农注射液动态浊度法细菌内毒素检查方法研究  

Detection of bacterial endotoxin in milrinone injection by the method of kinetic turbidimetric limulus test

作　　者：祝清芬[1] 国明[1] 魏霞[1] 李涛[1] 

机构地区：[1]山东省食品药品检验所,济南250101

出　　处：《中国新药杂志》2013年第3期355-358,共4页Chinese Journal of New Drugs

基　　金：山东省自然科学基金(Q2008C06)

摘　　要：目的:修订米力农注射液细菌内毒素检查法质量标准,并采用动态浊度法对其细菌内毒素检查进行方法学研究。方法:按《中华人民共和国药典》2010年版二部,修改本品细菌内毒素限值。使用动态浊度法,研究米力农注射液对细菌内毒素检查试验的干扰情况,并定量测定样品中细菌内毒素含量。结果:标准曲线回归方程相关系数绝对值为0.996 2(应≥0.980),标准曲线成立。本品在8倍稀释时细菌内毒素回收率在50%～200%范围内,表明此稀释倍数对细菌内毒素检查法无干扰作用,11批样品中的内毒素定量测定结果符合修订后的标准。结论:修订了本品细菌内毒素检查法质量标准,本品可采用动态浊度法进行细菌内毒素检查。Objective：To revise the criterion for bacterial endotoxins test of milrinone injection, and to measure the concentration of endotoxin in milrinone injection by kinetic turbidimetric technique. Methods ：The lim- it for bacterial endotoxin in this product was set according to ChP 2010. Endotoxin solutions of four concentrations were prepared to generate the standard curve. The interfering factors test was done by measuring the concentration of the endotoxin added to the sample solution, i.e. , the recovery of added endotoxin. The concentration of endo- toxin in the sample solution was measured. Results：The correlation coefficient was 0. 996 2, which indicated that the standard curve was valid because the correlation coefficient must be greater than or equal to 0. 980 according to ChP 2010. The recovery of the added endotoxin in the sample solution was within 50% to 200% when the sample was diluted to 8 times or more of its original volume. The measured concentration of endotoxin in the sample met the requirement for bacterial endotoxin. Conclusion：The bacterial endotoxin test method for milrinone injection has been revised. The kinetic turbidimetric technique is suitable for bacterial endotoxin test of this product.

关 键 词：米力农注射液 细菌内毒素 动态浊度法 

分 类 号：R917[医药卫生—药物分析学]