凝血酶原复合物中肝素含量的测定

凝血酶原复合物按标示量加蒸馏水溶解成１０ＰＥ／ｍｌ。通过加入适量的硫酸鱼精蛋白中和凝血酶原复合物样品中肝素。取中和后的样品加入缺血小板血浆、脑磷脂和氯化钙，记录凝固时间，挑选凝固时间最短的样品管计算肝素含量。该方法误差２０％。以５家血制品生产单位生产的２４批ＰＣＣ肝素含量的测定，按ＰＣＣ效价标示量小于等于１３０％计算，不合格６批占２５％。

Assay of heparin in prothrombin complex concentrate

The potency of the preparation,reconstituted as stated on the label with distilled water,is 10 PE/ml.The heparin present in prothombin comlex concentrate(PCC)is neutralized by the addition of an appropriate amount of protamine sulphate.The clotting time of the neutralized samples are measured by the addition of platelet poor plasma and cephalin and calcium chloride.The amount of heparin is calculated by choosing shortest coagulation time.The method showed 20% divergence.As label stated potency per vial not more than 130%,we assayed heparin for 24 lots of PCC from 5 domestic blood products manufactures,6 lots were not passed,which is 25%.