罂硝软膏的制备及质量控制

Study on the Preparation and Quality Control of Papaverine-nitroglycerin Ointment

目的 :制备罂硝软膏 ,并建立质量控制方法。方法 :以硝酸甘油、盐酸罂粟碱、双氯芬酸钾为主药研制软膏剂 ,用紫外分光光度法及酸碱滴定法分别测定硝酸甘油、盐酸罂粟碱、双氯芬酸钾3组分的含量。结果 :硝酸甘油、盐酸罂粟碱、双氯芬酸钾的平均回收率分别为100 65 %、99 86 %、100 55 %,相对标准差分别为0 4945 %、0 1719 %、0 3205 %(n=3)。结论 :该软膏制备工艺可行 ,质量可控 ,性质稳定。

OBJECTIVE:To prepare papaverine-nitroglycerin ointment and to establish a method for its quality control.METHODS:Nitroglycerin,papaverine hydrochloride and diclofenac potassium were used as basic remedies to prepare ointˉment.The contents of nitroglycerin,papaverine hydrochloride and diclofenac potassium were determined by UV-specˉtrophotometric methods.RESULTS:The average recovery rates of Nitroglycerin,papaverine hydrochloride and diclofenac potassium were100.65%、99.86%、100.55%respectively,and RSD equal to0.4945%、0.1719%、0.3205%respectively(n=3). CONCLUSION:The ointment preparation is feasible in technique,reliable in quality control and stable in quality.