低分子肝素胶囊稳定性的初步研究

PRELIMINARY STUDY ON STABILITY OF LOW MOLECULAR WEIGHT HEPARIN CAPSULES

考察了低分子肝素（１）胶囊在不同条件下的稳定性，其中抗凝活性采用羊血浆法测定，平均回收率为９８．８％（ＲＳＤ＝１．４％）；溶出度以天青Ａ法测定，平均回收率为１０２．６％（ＲＳＤ＝０．９％）。结果表明，１胶囊在各考察条件下其外观性状、抗凝效价、红外图谱基本无变化，有效期可暂定１～２年。

The stability of low molecular weight heparin capsules was studied.The anticoagulant potency was determined by sheep plasma method with an average recovery of 98.8%( RSD =1.4).Azure A method was used to determine the dissolution rate with an average recovery of 102.6% ( RSD =0.9).The shelf life could be tentatively given for 1￣2 years.