凝血诊断药盒的制备和质量监测及临床应用

Preparation,Quality Control and Clinical Application of the Diagnosis Kits for Blood Coagulation

本文报道KPTT、PT、TT 3种凝血诊断试剂的制备,并用冻干质控血浆监测了这3种试剂在4℃和—20℃贮存1年内的稳定性.这3种冻干试剂在4℃和—20℃保存1年内稳定不变,复溶后再置4℃和—20℃放置3周(TT 试剂4℃放置6天)活性亦不降低.结果表明该凝血药盒质量可靠、稳定性好、操作简便,优于国内同类产品.本文对凝血诊断药盒的临床应用亦作了探讨.

In this article,we report the preparation of KPTT,PT and TT diagnostic reagents for bloodcoagulation.The stablity of these reagents at 4℃ and—20℃ within a year was examinated withlyophilized control plasma.All the reagents at 4℃ or—20℃ were stable within a year,and theactivity of these resolved reagents at 4℃ or—20℃ for three weeks(TT reagent for 6 d(?)vs)did not decrease.These results show that the diagnostic kits for blood coagulation not only have highquality and good stability,but also are easy to operate.It is apparent that the kits are superior tothe other similar kits on our country.The study on clinical application of the kits was also performed in this paper.