CAJ | 학술논문

目的：建立注射用血凝酶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《中国药典》2010年版二部,计算本品细菌内毒素限值。使用动态浊度法,研究注射用血凝酶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0.9886,标准曲线成立。本品在0.25 KU·ml-1浓度时细菌内毒素回收率在50%~200%范围内,表明此浓度供试品对细菌内毒素检查法无干扰作用。结论：建立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。
목적：건립주사용혈응매세균내독소검사법질량표준,병채용동태탁도법대기세균내독소검사진행방법학연구。방법：안《중국약전》2010년판이부,계산본품세균내독소한치。사용동태탁도법,연구주사용혈응매대세균내독소검사시험적간우정황,병정량측정양품중세균내독소함량。결과：표준곡선회귀방정상관계수절대치위0.9886,표준곡선성립。본품재0.25 KU·ml-1농도시세균내독소회수솔재50%~200%범위내,표명차농도공시품대세균내독소검사법무간우작용。결론：건립료본품세균내독소검사법질량표준,본품가채용동태탁도법진행세균내독소검사。
Objective:To establish the criterion of bacterial endotoxins test for hemocoagulase atrox for injection and measure the endotoxin concentration in hemocoagulase atrox for injection by the kinetic turbidimetric technique. Methods:The limit of bacterial en-dotoxins in the product was designed according to ChP 2010. Four endotoxin concentrations were prepared to obtain the standard curve. The interfering test was done by measuring the concentration of endotoxin added into the sample solution. The endotoxin concentration in the sample solution was measured. Results:The absolute value of the correlation coefficient was 0. 988 6 (must be above or equal to 0. 980), suggesting the standard curve was valid. The recovery of the added endotoxin in the sample solution was within 50 to 200%when the concentration of the product sample was 0. 25 KU·ml-1 . The measured endotoxin concentration in the sample met the re-quirements for bacterial endotoxins. Conclusion:The bacterial endotoxins assay method for milrinone injections is established, and the kinetic turbidimetric technique is suitable for the bacterial endotoxin test of the product.