猪纤维蛋白原中枸橼酸离子含量测定药典方法的改进  

Improvement of Chinese pharmacopoeia method for the determination of citrate ion content in porcine fibrinogen

作　　者：唐明花 刘璐 TANG Minghua;LIU Lu(Shanghai Likangrui Biological Engineering Co.,Ltd.,Shanghai 201707,China;Shanghai Haohai Biological Technology Co.,Ltd.,Shanghai 201613,China)

机构地区：[1]上海利康瑞生物工程有限公司,上海201707 [2]上海昊海生物科技股份有限公司,上海201613

出　　处：《上海医药》2023年第15期86-89,共4页Shanghai Medical & Pharmaceutical Journal

摘　　要：目的:对猪纤维蛋白原中枸橼酸离子含量测定药典方法进行改进。方法:通过对药典方法中稀释方式、线性范围、试剂用量和试验温度等的改进,建立紫外-可见分光光度计法测定猪纤维蛋白原中枸橼酸离子含量测定的检测方法,并进行方法学验证。结果:该方法可测定含量范围为22.3~67.0 mmol/L;中间精密度所得相对标准偏差(RSD)仅为1.57%(n=12);平均回收率为100.1%(n=9),RSD为1.48%(n=9)。结论:改进后的方法经验证专属性,耐用性、准确度和精密度等指标均良好,可作为猪纤维蛋白原中枸橼酸离子含量测定的检测方法。Objective:To improve the pharmacopoeia method for the determination of citrate ion content in porcine fibrinogen.Methods:A UV-Vis spectrophotometer method was established for the determination of citrate ion content in porcine fibrinogen by improvement of the dilution method,linear range,reagent dosage and test temperature in the pharmacopoeia method,and its verification was conducted.Results:The content range of this method was 22.3-67.0 mmol/L.The relative standard deviation(RSD)obtained from intermediate precision was only 1.57%(n=12).The average recovery rate was 100.1%with RSD 1.48%(n=9).Conclusion:The improved method has good specificity,durability,accuracy and precision by verification and can be used as a method for the determination of citrate ion content in porcine fibrinogen.

关 键 词：枸橼酸离子 紫外- 可见分光光度计法 方法改进 

分 类 号：R927.11[医药卫生—药学] R982