罂硝软膏的研制及临床疗效观察

Studies on the Preparation and Clinical Efficacy for Papaverine-nitroglycerin Ointment

目的制备罂硝软膏并建立质量控制方法。观察罂硝软膏治疗静脉炎的临床疗效。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,用紫外分光光度法测定硝酸甘油的含量。将本品用于临床观察,分为实验组及对照组,观察其治疗静脉炎的疗效。结果本制剂设计合理,制备方法简便,硝酸甘油、罂粟碱、双氯芬酸钾的平均回收率为100.65%,99.86%,100.55%,RSD=0.4945%,0.1719%,0.3205%(n=3)。对Ⅰ°,Ⅱ°静脉炎的治愈率为91.48%和77.42%,实验组与对照组相比差异均有显著性。结论该软膏制备工艺可行,质量控制方法可靠,性质稳定。临床疗效确切。

Objective To prepare papaverine-nitroglycerin ointment and to establish a method for its quality control. To observe the clinical efficacy of papaverine-nitroglycerin ointment on the treatment of phlebitis. Methods Nitroglycerin, papaverine hydrochloride and diclofenac were used as basic remedy to prepare ointment. Finally the content of Nitroglycerin was determined by UV-spectrophotometric methods. In order to observe the efficacy of papaverine-nitroglycerin ointment on the treatment of phlebitis ,we have divided the patients into phlebitis treatment group and the control group. Results This preparation was rational in design and the method was simple. The average recovery rate of Nitroglycerin,papaverine hydrochloride and diclofenac were 100.65% ,99.86%, 100.55% ,RSD =0.4945% ,0. 1719% ,0. 3205% （n =3 ）. The curative rate was 91.48% for Ⅰ° phlebitis and 77.42% for Ⅱ °phlebitis. There was significant difference between the experiments group and the controlled group. Conclusion The ointment is feasible in preparation technique, reliable in quality control and stable in quality. The clinical efficacy of papaverine-nitroglycerin ointment was accurate.