微量生色底物法测定复方肝素钠乳膏抗Ⅱα因子活性  

Determination of Anti-FIIα Activity in Compound Heparin Sodium Cream by a Trace Chromogenic Substrate Method

作　　者：刘艳芳[1] 马宏达[1] 颜鸣[1] 候明晓[1] 

机构地区：[1]沈阳军区总医院,沈阳110016

出　　处：《中国药师》2016年第6期1071-1073,共3页China Pharmacist

基　　金："重大新药创制"科技重大专项课题(编号:2013ZX09J13109-03B)

摘　　要：目的:建立复方肝素钠乳膏抗Ⅱα因子活性的测定方法。方法:采用微量生色底物法,按生物检定统计法中量反应平行线原理4×4法完全随机实验设计,测定复方肝素钠乳膏抗Ⅱα因子活性。结果:肝素钠抗Ⅱα因子活性在0.005 04~0.021 IU·ml^(-1)范围内线性关系良好(r=0.992),平均回收率为101.6%(RSD=2.76%,n=9)。结论:本法准确、可靠、重复性好,可有效控制复方肝素钠乳膏质量。Objective： To establish a trace chromogenic substrate method for the determination of anti-FⅡa activity in compound heparin sodium cream. Methods： The anti-FⅡa activity in compound heparin sodium cream was determined by a trace chromogenic substrate method according to the completely random design of experiment based on the amount reaction principle of 4 ＊ 4 parallel lines in the biological test statistics method. Results： The calibration curve was linear within the range of 0.00504～0.021IU·ml-1 （ r = 0.992）. The average recovery was 101.6% with RSD of 2.76% （ n = 9 ）. Conclusion： The method is accurate, reliable and reproducible, and can be used for evaluating the quality of compound heparin sodium cream.

关 键 词：微量生色底物法 复方肝素钠乳膏 抗Ⅱα因子活性 

分 类 号：TQ460.72[医药卫生—药物分析学]