胞磷胆碱钠片的制备与质量标准建立

Study on preparation of Cyticoline Sodium Tablets and its quality standard

目的研制胞磷胆碱钠片,考察其质量控制方法。方法通过处方筛选和工艺研究,确定最佳处方和工艺,制备胞磷胆碱钠片,并建立高效液相色谱法对其质量进行分析。结果制备的胞磷胆碱钠片外观、脆碎度、可压性、崩解均良好;含量测定方法的平均回收率为100.1%,RSD=0.28%(n=9),精密度RSD=0.21%,胞磷胆碱钠在浓度83.06～415.29μg.mL-1范围之间峰面积与浓度呈线性关系。色谱条件下胞磷胆碱钠与有关物质5'-胞苷酸的分离良好。结论胞磷胆碱钠片处方合理,制备工艺稳定,质量控制方法准确可靠。

Objective To develop Cyticoline Sodium Tablets and study its quality control method. Methods Through the study on prescription and technology, the optimum prescription and technology was determined, by which Cyticoline Sodium Tablets were prepared, and to establish an HPLC method for its quality analysis. Results The appearance,friability, compressibility disintegrating of Cytieoline Sodium Tablets were favorable. Average recovery of content method was 100. 1% ,RSD was 0.28% （n = 9）. The precision of content method was good（RSD = 0.21% ）. The peak area and the concen- tration showed a good linear relationship when Cytieoline sodium in the concentration range of 83.06 - 415.29 μg . mL^-1. A successful separation between cyticoline sodium and related substances 5＇ - CMP can be observed in chromatographic conditions. Conclusion The prescription of Cytieoline Sodium Tablets was reasonable,the preparation process was stable, and the method of quality control was accurate and reliable.