硝酸甘油搽剂的制备及质量控制

Preparation and Quality Control of Nitroglycerin Liniment

目的 :设计阳痿治疗药物硝酸甘油搽剂的处方和制备工艺 ,建立制剂含量测定方法。方法 :采用紫外分光光度法测定硝酸甘油的含量。结果 :搽剂中其他成分不干扰测定 ,平均回收率 98.8% ,RSD 0 .2 4% (n =5 )。结论 :制剂稳定 ,含量测定方法简便、灵敏、准确 。

Objective:To design the formula and technology for the preparation of nitroglycerin liniment as a drug for the treatment of impotence and to set up a method for the content determination of the preparation. Method:The content of nitroglycerin in the liniment was assayed by UV spectrophotometry. Results:Other components of the liniment did not interfere with the determination of nitroglycerin. The average rate of recovery of nitroglycerin was 98.8%, the RDS being 0.24% (n=5). Conclusion:The preparation is stable. The method of determination of nitroglycerin content is simple, sensitive and accurate, with a good reproducibility.