枸橼酸莫沙必利糖浆的制备及质量控制

Preparation and quality control of Mosapride Citrate Syrup

目的制备枸橼酸莫沙必利糖浆并建立其质量控制方法。方法以枸橼酸莫沙必利为主药制备糖浆;采用高效液相色谱法测定其中主药含量,并考察其稳定性。结果枸橼酸莫沙必利检测浓度在60～160μg.mL-1范围内,线性关系良好(r=0.999 8),平均回收率为99.97%(RSD=0.389%,n=9)。结论本制剂制备工艺简便可行,质量稳定可控。

Objective To prepare Mosapride Citrate Syrup and establish a method for its quality control. Methods The syrup was prepared with mosapride citrate as chief agent, and the content of which was determined by HPLC and the stability of which was investigated. Results There was a good linear relationship within the concentration range of 60 - 160 μg ·mL -1 （ r = 0. 999 8 } , and the average recovery was 99.7% （ RSD = 0. 389%, n = 9 ）. Conclusion The preparation technology for syrup was simple and feasible and the quality of preparation was stable and controllable.