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作为PCC活性检测,国际上通常直接测定其所含Ⅱ、Ⅶ、Ⅸ、Ⅹ四种因子的活性,但目前国内尚不具备分别缺Ⅱ、Ⅶ、Ⅸ、Ⅹ因子的基质血浆,所以难以实现。1990年版《中国生物制品规程》收载了冻干人凝血酶原复合物效价测定法,即血浆当量法(PE法)。该方法是限量法,其测定结果只能表示PCC中所含凝血因子的总活性,大体上能纠正基质血浆的凝血缺陷,使之恢复至与标准血浆的凝血活性“相当”而已。因此,PE法测PCC效价存在着一些问题。为此,我们比较了含肝素样品的中和法和稀释法、不同来源的凝血活酶和不同样品稀释液对效价测定的影响,现报告如下。
As the detection of PCC activity, the activity of four factors including Ⅱ, Ⅶ, Ⅸ and Ⅹ is usually measured directly in the world, but it is hard to be realized in our country without matrix Ⅱ, Ⅶ, Ⅸ and Ⅹ factors. 1990 edition of “China Biological Products Regulations” contains freeze-dried human prothrombin complex potency assay, namely, plasma equivalent method (PE method). This method is a limit-based method and its measurement can only indicate the total activity of clotting factors contained in PCC, and it can substantially correct the coagulation defect of stroma plasma and restore it to “equivalent” to the coagulation activity of standard plasma. Therefore, PE method to measure PCC titer there are some problems. To this end, we compared the neutralization and dilution methods containing heparin samples, different sources of thromboplastin and different sample dilution on the determination of potency, are as follows.