吲达帕胺缓释片的制备及体外释放度测定

目的制备吲达帕胺缓释片并测定其释放度。方法以进口市售片为对照片,以高效液相色谱法为测定释放度的方法,以释放度为指标筛选缓释片处方,考察填充剂类型（乳糖、可溶性淀粉及微晶纤维素）及羟丙基甲基纤维素（HPMC K4M）用量对释放度的影响;并对自制片和对照片的释放曲线进行相似性评价。结果以乳糖作填充剂,HPMC K4M的质量分数为25%时,自制缓释片的释放度与对照片比较差异无统计学意义。释放度测定方法：吲达帕胺的质量浓度在0.2～1.5μg.mL-1范围内与峰面积线性关系良好,低、中、高3个浓度的回收率分别是100.08%、99.67%、99.58%。结论自制缓释片处方工艺简单、经济,释放曲线与对照片相似。

Preparation and release of indapamide sustained-release tablets in vitro

Objective To prepare sustained-release tablets of indapamide and investigate its release in vitro.Methods HPLC was employed to determine indapamide compared with imported products,evaluating different fillers（lactose,starch and MCC） and HPMC K4M percentage in formulations on accumulative release,and similarity analysis was performed between them.Results Lactose as the filler,HPMC K4M is at 25% in the formulation,the self-made tablets have a similar release profile with reference tablets.It is linear with concentration range from 0.2 μg·mL-1 to 1.5 μg·mL-1.The recovery rates of three different concentrations（low concentration,middle concentration and high concentration） were 100.08%、99.67%、99.58% respectively.Conclusion The preparation method is simple and economical.The self-made sustained-release tablets have the similar drug release characteristics with the reference tablets.