对ACL 300全自动血凝仪测定低分子肝素的评价  

Evaluation of the performance of ACL 300 for measuring low molecular weight heparin

作　　者：陆学军[1] 吴巍[1] 艾效曼[1] 

机构地区：[1]卫生部北京医院检验科,北京100730

出　　处：《检验医学》2006年第3期269-271,共3页Laboratory Medicine

摘　　要：目的对ACL300全自动血凝仪测定低分子肝素(LMWH)进行评价,并对国产低分子肝素钙与进口参比制剂速避凝进行人体生物等效性对比。方法采用Heparin试剂盒在ACL300全自动血凝仪上测定血浆中LMWH抗Xa因子活性。结果日内精密度(变异系数,CV)均<10%,日间精密度中的高值、中值CV<10%,低值>10%(21.0%),携带污染率<0.4%,LMWH浓度在0.00 IUAXa/m l和1.0 IUAXa/m l内线性良好;国产低分子肝素钙与参比制剂的血药峰值时间(Tm ax)分别为(2.97±0.53)h和(3.31±0.69)h,血药峰值浓度(Cm ax)分别为(0.68±0.08)IUAXa/m l和(0.64±0.09)IUAXa/m l,曲线下面积(AUC0-t)分别为(5.38±0.79)(IUAXa/m l).h和(5.03±0.73)(IUAXa/m l).h。结论ACL300全自动血凝仪测定LMWH时的精密度、携带污染率和线性良好,经生物等效性计算程序处理,相同剂量被试制剂与参比制剂为生物等效制剂。Objective To evaluate the performance of ACL 300 for measuring low molecular weight heparin （ LM- WH） and observe the bioequivalence of domestic and imported LMWH. Methods Anti-X activity of LMWH in the plasma was measured by ACL 300. Results Within-day and between-day coefficients of variation （CV） were lower than 10% , except for low ranges CV between-day, carryover was lower than 0.4%. There was a good linearity of LM- WH from 0.0 IUAXa/ml to 1.0 IUAXa/ml. The main pharmacokinetics of the two products were as follow： peak time （Tmax） were （2.97 ±0.53） h and （3.31 ±0.69） h, peak concentration（Cmax） were （0.68 ±0.08） IUAXa/ml and （0. 64 ± 0. 09 ） IUAXa/ml, area under the curve （ AUC0, ） were （ 5. 38 ± 0.79） （IUAXa/ml） · h and （5.03 ±0.73） （IUAXa/ml） · h. Conclusions Precision, carryover and linearity studies of measuring LMWH by ACL300 were good. Domestic reagent and imported reagent shows bioequivalence.

关 键 词：低分子肝素 抗XA因子 自动化 生物等效性 

分 类 号：R446.11[医药卫生—诊断学]