低分子肝素生物活性测定方法的比较研究  

Comparison of Methods for Evaluation the Potency of Low-molecular-weight Heparin

作　　者：李湛军[1] 徐康森[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《药物分析杂志》2005年第9期1111-1114,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:对低分子肝素(low molecular weight heparin,LMWH)生物活性即抗活化10因子(抗-FXa)和抗活化2因子(抗-FⅡa)测定的不同方法进行比较与研究,建立国家标准。方法:(1)比较量反应平行线与标准曲线2种分析方法在发色底物的分光光度法即利用发色底物对 FXa 或 FⅡa特异的405 nm 显色反应测定抗-FXa 或抗-FⅡa效价的差异。(2)比较发色底物的分光光度法与血液凝固法(观察兔全血或兔血浆的凝结时间)测定 LMWH 的抗凝血酶(抗-FⅡa)效价的异同。结果:量反应平行线法比标准曲线法测定结果可靠、准确、精确;发色底物分光光度法与血液凝固法的实验结果相似,其差异无统计学意义(P>0.05),并且具有良好相关性(r=0.997 P<0.01和 r=0.976 P<0.01)。结论:对 LMWH 的抗-FXa 和抗-FⅡa效价测定采用发色底物的分光光度法;并以量反应平行线法进行分析。Objective： Comparative study on the assay of anti - factor X a or anti - factor Ⅱ a for low - molecularweight heparin（LMWH） to set up standard method. Method：Chromogenic endpoint of detection at 405 nm for specific anti- factor X a or anti -factor Ⅱ a of LMWH were evaluated by parallel line analysis or linear standard curves analysis. Clotting method was in vitro evaluation of anti - factor Ⅱ a activity by clotting time of rabbit plasma or its whole blood. Results：The results demonstrated that chromogenic assay by parallel line analysis had superior reliability, accuracy. The results showed a high correlation between clotting time and chromogenic method for LMWH （ r = 0.997 and 0.976 P 〈 0. 01 ） and their differences were small and not statistically significant（ P 〉 0.05 ）. Condusion： Validation of the anti - factor X a or anti - factor Ⅱ a assays for the potency assessment of LMWH was chromogenic assays by parallel line analysis.

关 键 词：低分子肝素 效价 测定 量反应平行线 生物活性 测定方 MOLECULAR 分光光度法 HEPARIN 发色底物 

分 类 号：R541.4[医药卫生—心血管疾病] R318.08[医药卫生—内科学]