不同厂家华法林片剂溶出度的考察

Study on the dissolubilities of warfarin tablets produced by different manufactories

目的 建立华法林含量测定的高效液相色谱 (HPLC)方法 ,并以此方法考察比较 4个不同厂家华法林片的溶出度。方法 参照中国药典 2 0 0 0年版溶出度检查方法 ,建立华法林片剂溶出度高效液相色谱测定方法 ,考查 4个厂家的华法林不同时间内的累积溶出度 ,绘制溶出曲线 ,计算参数T50 、Td、T80 、m ,并对各参数值进行t检验。结果 华法林在 1.6 3～ 8.16 μg ml范围内线性关系良好 (r=0 .9996 ) ;平均回收率 10 0 .4 6 % ;精密度 (RSD)小于 2 %。 4个厂家 4 5min时华法林累积溶出度分别为 :91.8%、82 .1%、84 .6 %、84 .5 % ,均大于 80 %。结论 以HPLC法测定华法林溶出度 ,方法准确、灵敏、稳定 ;以此方法测定 4个厂家华法林片剂的溶出度 ,结果均符合规定 (70 % ) ,但各产品体外溶出参数T50 、Td、T80 、m间差异与高度显著性。

OBJECTIVE To establish a high performance liquid chromatography (HPLC) method for determining the dissolubility of warfarin tablets produced by four manufactories in vitro. METHODS A HPLC method was established and the dissolution of warfarin tablets produced by 4 different factories was determined according to the dissolution test of “Pharmacopoeia of the People′s Republic of China,2000”. The dissolution curve was illustrated, and the parameters of T 50、T d 、T 80、m were obtained from Weibull dstribution probability paper and were compared each other by t test. RESULTS Warfarin was linear at the range of 1.63～8.16μg/ml(r=0.9996). The mean recovery was 100.46%, the RSD of precision<2%.The dissolution at 45min of different warfarin tablets were 91.8%,82.1%,84.6%,84.5%, respectively. CONCLUSION HPLC is an accurate,sensitive and stable method for the determination of warfarin tablets dissolution. All the dissolulities of the 4 products determined by this method are higher than that of the requirement (>70%), but obvious differences are showed at the different sampling time.