阿卡波糖片溶出度测定方法研究

摘要

Objective To explore the testing method of Acarbose Tablets dissolution rate ,and to lay a foundation for the preparation research ,such as sustained release tablet and so on .Methods Dissolution rate was determined by oar paddle ,in which water was used as the dissolution medium with a speed of 50 r · min-1 .HPLC method was performed on testing Acarbose Tablets dissolution rate .Chromatographic conditions :C18 column(150 mm × 4 .6 mm ,5μm) ,mobile phase:phosphate buffer‐acetonitrile (93∶7) .The flow rate was 1 .5 mL · min-1 ,the detection wave length was set at 210 nm ,and the column temperature was 40 ℃ .Results The linear relationship of acarbose concentration and chromatographic peak area was in the range of 12 .5‐400 μg · mL -1 .The regres‐sion equation was Y=2 533 .4X+57 .085 ,r=0 .999 8 ,the average rate of recovery was 99 .0% ,the precision RSD was 1 .2% (n=6) ,and the repeatability RSD was 0 .76% (n=5) .Conclusion The dissolution determination method is simple ,reasonable ,and ac‐curate ,which can reflect the dissolution behavior of acarbose .%目的：探索阿卡波糖片溶出度测定方法，为阿卡波糖固体分散体、缓释片等制剂研究奠定基础。方法采用桨法进行溶出度实验，以水为溶出介质，转速为50 r · min－1。用高效液相色谱法测定阿卡波糖片的溶出度。色谱条件：C18色谱柱（150 mm ×4．6 mm ，5μm）；流动相：磷酸盐缓冲液‐乙腈（93∶7）；流速：1．5 mL · min－1；检测波长：λ＝210 nm ；柱温：40℃。结果阿卡波糖质量浓度在12．5～400μg · m L －1范围内与色谱峰面积呈良好的线性关系，回归方程：Y ＝2533．4 X＋57．085，r＝0．9998，平均加样回收率为99．0％，精密度RSD值为1．2％（n＝6），重复性RSD值为0．76％（n＝5）。结论所建立的溶出度测定方法简单、合理、准确，能够反映阿卡波糖的溶出行为。