生色底物法测定低分子肝素抗FⅩa以及抗FⅡa效价的方法研究  

Anti-FⅩa and Anti-FⅡa Test Method for Low Molecular Weight Heparin by Chromagenic Substrate Method

作　　者：陈群英 陈宁 崔萍 郑马庆 丁逸梅[1,2] CHEN Qunying;CHEN Ning;CUI Ping;ZHENG Maqing;DING Yimei(Jiangsu Provincial Institute of Materia Media,Nanjing University of Technology,Nanjing 210009;School of Pharmaceutical Sciences,Nanjing University of Technology,Nanjing 211816)

机构地区：[1]南京工业大学江苏省药物研究所有限公司,江苏南京210009 [2]南京工业大学药学院,江苏南京211816

出　　处：《中国医药工业杂志》2019年第8期905-909,共5页Chinese Journal of Pharmaceuticals

摘　　要：建立了微量生色底物法测定低分子肝素抗FⅩa以及抗FⅡa效价的方法。参考美国药典及相关文献,调整反应体系,测定了市售伊诺肝素钠注射液(克赛)的抗FⅩa以及抗FⅡa效价,利用生物检定统计程序BS2000进行统计计算,比较了日间差,并与兔全血法测定结果进行比较。结果表明测得的效价与标示效价相符,并且4 d分别测定的结果基本一致,95%可信限范围低于10%,回归方程具有显著性(P<0.01),试验结果可靠。证明该反应体系可用于低分子肝素的效价测定。An anti-FⅩa and anti-FⅡa test method for low molecular weight heparin(LMWH)was established.The anti-FⅩa and anti-FⅡa activities of enoxaparin sodium injection(Clexane)were determined by chromagenic substrate method according to the US pharmacopoeia and other reference documents.The determination results of antiFⅩa and anti-FⅡa in the sample were close to their labelled values.Moreover,the assay results for the same sample in 4 different days were compared.The anti-FⅩa activity was also measured based on rabbit whole blood.And there were no significant differences between the assay results of the two methods.

关 键 词：生色底物法 低分子肝素 抗FⅩa 抗FⅡa 

分 类 号：R927.2[医药卫生—药学] R973.2