血凝仪-APTT法测定肝素的效价  

Heparin assay on activated partial thromboplastin time(APTT) by coagulometer

作　　者：王碧松[1] 王志斌[1] 高阳[2] 郭玉东[1] 左泽平[2] 

机构地区：[1]北京市药品检验所,北京100035 [2]北京中医药大学中药药理系,北京100102

出　　处：《药物分析杂志》2012年第7期1154-1157,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立一种基于血液凝固分析仪测定活化部分凝血活酶时间(APTT)的肝素生物测定法(简称血凝仪-APTT法)。方法:将高、中、低浓度的肝素钠标准品和供试品分别与血浆混和,用血液凝固分析仪测定各含药血浆的活化部分凝血活酶时间(APTT),结果进行对数转换后,按量反应平行线3.3法计算供试品的效价。结果:对数凝血时间与肝素钠的浓度在0.7～3 IU.mL-1范围内线性关系良好(r=0.9965);当供试品的测得效价与估计效价的比值在80%～120%范围内时,血凝仪-APTT法的测定结果准确可靠,重复性(RSD=1.45%,n=6)及中间精密度(RSD=1.61%,n=6)良好。以兔全血法、羊血浆法和血凝仪-APTT法分别测定同一批肝素钠供试品的效价(IU.mg-1,n=3),结果依次为207.56±6.87,205.59±3.62,202.79±2.08,无显著性差异(P>0.05);兔全血法和血凝仪-APTT法的可信限率(%,n=3)分别为8.51±0.77和2.63±0.21,具有显著性差异(P<0.01)。使用不同仪器测定样品效价的结果基本一致。结论:血凝仪-APTT法与兔全血法和羊血浆法的效价测定结果一致,可信限率比兔全血法更低。该法操作简便,客观准确,重复性好,精密度高,适用于不同仪器,可以用于肝素钠生物效价的测定。Objective ：To establish a new method for heparin assay based on the activated partial Thromboplastin time by coagulometer （ abbreviated as coagulometer - APTY method）. Methods： Prepare the heparin standard and the article of high, middle and low concentration, mixed them with plasma separately, and determinate the AFTT of the drug - containing plasma by coagulometer. Results： Within the range of 0. 7 - 3 IU . mL^- 1, the heparin sodium concentration and the log clotting time shows a good linear relationship （ r = 0. 9965 ） ; within the range of 80% - 120% of the ratio of PT and estimated potency of the test article, coagulometer -APTY method was accurate and re- liable with good reproducibility （ RSD = 1.45%, n = 6） and intermediate precision （ RSD = 1.61%, n = 6 ）. The results （ IU . mg^-1, n = 3 ） of rabbit blood method, sheep plasma method and coagulometer - APTY method were 207.56 ± 6.87, 205.59 ± 3.62 and 202. 79 ± 2. 08, no significant differences （ P 〉 0. 05 ） ; the FL% （ %, n = 3） of rabbit blood method and coagulometer - APqq？ method were 8.51 ±0. 77 and 2.63 ±0.21, with significant difference （P 〈0. 01 ）. The results of coagulometer- APTT method by different coagulometers were basically con- sistent. Conclusion： Coagulometer- APTT method coincided with rabbit blood method and sheep plasma method in the potency result, and its FL was lower than the rabbit blood method＇s. The results demonstrated that coagulometer -APIT method is simple, objective, accurate, reproducible, precise and applying to different instruments. It could be used for the assay of heparin.

关 键 词：肝素 生物检定法 效价 活化部分凝血活酶时间 

分 类 号：R917[医药卫生—药物分析学]