肝素钠及其制剂效价测定方法的改进

目的建立用羊血浆法测定肝素钠及其制剂效价方法,并与现行药典的兔全血法比较。方法在梯度剂量的标准溶液和供试品溶液中加入等量的羊血浆,经重钙化一定时间后观察凝固程度,测定供试品效价。结果羊血浆法与兔全血法测定结果比较,无显著性差异(P>0.05),羊血浆法精密度、重现性良好(RSD<1.0%)。结论羊血浆法准确、可靠,较兔全血法操作更简便,适于肝素钠及其制剂的效价测定。

Improvement in potency determination of heparin sodium and its preparations

Purpose To develop a method for the potency determination of heparin sodium with sheep plasma and to compare it with the method of rabbit whole blood.MethodsPrepared plasma was added to the graded amount of standard preparation and assay preparation.After the addition of the calcium chloride solution,determine the extent of clotting in each tube and calculate the potency.ResultsCompared with the results by the method of rabbit whole blood,the method of sheep plasma has no prominent difference(P>0.05)and has good precision and reproducibility.ConclusionThe method of sheep plasma is simple and accurate for the determination of heparin sodium and its preparations.