【摘要】 目的探讨几种因素对人凝血酶原复合物(prothrombin complex concentrates,PCC)中凝血因子活性测定的影响。方法参照《中国药典》(2010版),采用不同样品前处理、不同稀释剂、不同盐离子浓度制品、不同测定标准品及不同厂家试剂分析其对PCC中凝血因子II、VII、IX、X活性测定结果的影响。结果 PCC加入硫酸鱼精蛋白,凝血因子II、VII、X活性降低,凝血因子IX活性升高;样品37℃温浴15min与否,4种因子活性测定统计显示无显著差异。乏浆、生理盐水、蒸馏水及配套稀释液稀释对4种因子活性测定结果影响统计显示有显著差异(P<0.05);含1mol/L氯化钠的制品,凝血因子II、X活性测定结果显著低于含0.25mol/L氯化钠制品(P<0.05),而凝血因子VII、IX无统计学差异。不同标准品,测定的因子活性均不同。不同厂家试剂对4种凝血因子测定结果统计显示有显著差异(P=0.00)。结论 PCC前处理条件、测定稀释剂、制品所含的盐离子浓度、测定标准品及不同厂家的试剂均影响其凝血因子的活性测定,在检测过程中应予重视。更多还原

【Abstract】 Objective To study the influencing factors on detection of four coagulation factors’ activity in prothrombin complex concentrates(PCC). Methods Using Pharmacopoeia of the People’s Republic of China(2010) as reference, the activity of four coagulation factors in PCC were investigated by choosing different pre-treatments, different diluents, different salt concentration, different standard human plasma and different company reagents. Results The activity of FII, FVII, FX were decreased and FIX was increased in the condition of adding protamine sulfate, and there were no differences of four coagulation factors whether warm bath in 37 for 15 min or not. However, the differences of four coagulation factors were significant by using deficient plasma, saline, distilled water and commercial dilution buffer(P<0.05). The activity of coagulation factor II, X in 1 mol/L salt concentration of PCC were significantly lower than in 0.25 mol/L(P<0.05), while coagulation factor VII, IX were not. The activity of FII, FVII, FIX, and FX were different by using different standard human plasma to make standard curve. The activity of four coagulation factors existed significant difference(P=0.00) by using SIEMENS company reagents and domestic reagents. Conclusion Choosing different pre-treatments, different dilution buffers, salt concentration, standard human plasma and commercial kits will influence the detection result of coagulation factors.更多还原