萘丁美酮分散片的制备与含量测定

Preparation and Content Determination of Nabumetone Dispersible Tablets

目的制备萘丁美酮分散片并建立其含量测定方法。方法通过正交试验考察处方中组分的影响因素,以崩解时限为指标对萘丁美酮分散片处方进行优选;用高效液相色谱(HPLC)法测定分散片中萘丁美酮的含量。结果最佳处方为羧甲基淀粉钠6%,十二烷基硫酸钠1%,微晶纤维素10%,聚乙烯吡咯烷酮浓度2%;优选处方的分散片崩解时间小于3min,分散均匀,均通过2目筛;萘丁美酮质量浓度线性范围为20～100μg/mL,r=0.9999(n=5),平均回收率为99.54%,RSD=0.48%(n=6)。结论用优选处方制备的萘丁美酮分散片崩解快,分散均匀,且含量测定结果符合限度要求。

Objective To prepare Nabumetone Dispersible Tablets and to establish HPLC method for the content determination of Nabumetone Dispersible Tablets. Methods The influencing factors in the formula of Nabumetone Dispersible Tablets were investigated by orthogonal design and the formula was optimized with disintegration time as parameter. Nabumetone Dispersible Tablets was determined by HPLC, using Kromasil C18 column, acetonitrile-water-triethylamine （520：480：2.5） as the mobile phase, the detection wavelength of 261 nm. The flow rate was 1.0mL/min. Results The optimized formula of the tablets was as follows：CMS-Na 6%,SLS I%,MCC 10% and PVP 2%,the optimized dispersible tablet could disintegrate uniformly in less than 3 min and mesh through No. 2 screen. The linear range of nabumetone was 20 - 100μg/mL, r = 0. 999 9 （ n = 5 ）, the average recovery rate of nabumetone was 99. 54% with RSD 0. 48% （ n = 6）. Conclusion Nabumetone Dispersible Tablets prepared in optimum condition is rapid in disintegration and homogenous in dispersal with a stable content.