瑞格列奈片的制备和质量标准研究

Preparation and quality standard of repaglinide tablets

目的制备瑞格列奈片,并建立其质量标准。方法以溶出度、硬度、外观为指标,通过正交试验L9（34）筛选出最优处方;采用高效液相法测定瑞格列奈的含量、含量均匀度和溶出度。结果优选出的瑞格列奈片的处方组成为：微晶纤维素∶PVP-K30∶CCNa的质量比为74∶5∶20;含量测定方法学考察结果：瑞格列奈质量浓度在9.90599.05μg.mL^-1范围内与峰面积呈良好线性关系,回收率为100.83%、RSD为0.98%（n=9）,最低检测限为2.0 ng,最低定量限为8.0 ng;含量均匀度为6.84;30 min累积溶出度为98.25%。结论筛选的处方合理,制备工艺简单可行,制备的瑞格列奈片符合制剂质量要求。

Objective To prepare repaglinide tablets and establish the quality standard.Methods Orthogonal array testing was conducted to optimize the formulation with the indices of dissolution rate,appearance and hardness.HPLC method was established to measure content,content uniformity and dissolution rate.Results The optimum formulation of repaglinide tablets was MCC∶PVP K-30∶CCNa=74∶5∶20,and a good linear relationship was obtained in the range of 9.905～99.05 μg·mL-1,r=1.0 000.The average recovery was 100.83%,with RSD 0.98%（n=9）.The LOD was 2.0 ng and the LOQ was 8.0 ng,content uniform was 6.84,and dissolution was 99.25%.Conclusion The reasonable formulation was obtained and preparation was simple,and the prepared tablets met the requirements.