摘要
目的 制备盐酸曲马多口腔药膜并对其质量控制进行研究。方法 以水溶性壳聚糖、聚乙二醇 60 0 0、聚乙二醇 4 0 0 0、明胶及甘油为基质制备盐酸曲马多口腔药膜 ,建立其质量控制。采用高效液相色谱法测定本品中盐酸曲马多的含量 ,检测波长为 2 71nm ,流动相为醋酸 -醋酸钠缓冲液 (pH 4 .5 )—甲醇 (4 0 :60 )。结果 盐酸曲马多口腔药膜处方组成恰当 ,质量控制方法简便、可靠、准确。HPLC法测定盐酸曲马多口腔药膜的含量 ,平均回收率为 10 0 .2 8% ,RSD为 1.4 4% (n =6)。结论 该膜剂处方组成合理 ,制备方法可行 ,质量控制能够控制该制剂的质量。
Objective To prepare tramadol hytrochloride oral pellicles and study its quality control. Methods Tramadol hytrochloride oral pellicles was prepared with soluble chitosan, macrogol 6 000, macrogol 4 000 and glycerin as materals. Its quality control was established.The content of tramadol hytrochloride in tramadol hytrochloride oral pellicles was determined by HPLC, detection wavelength was 271nm, acetate solution(pH 4.5)-methanol(40:60)was used as mobile phase on C 18 column.Results This recipe constitutes was felicitous, quality control was convenient , reliable and accurate . Tramadol hytrochloride in tramadol hytrochloride oral pellicles was determined by HPLC, and the average recovery was 100.20% with RSD=1.44%( n =6).Conclusion This recipe component was reasonable , and the prepared procedure was practicable .Its quality control be able to control the quality of this product.
出处
《兰州医学院学报》
2001年第4期14-16,共3页
Journal of Lanzhou Medical College
