司帕沙星锌软膏剂制备及临床应用.doc

司帕沙星锌软膏剂制备及临床应用马素英尚校军张青霞徐红珍海 莹 （1.新乡医学院药学院，河南 新乡453003；2.郑州仁济医院，河南 郑州450064； 3.郑州永和制药有限公司，河南 郑州450001） 【摘要】目的：评价司帕沙星锌合成的可行性及品质可控性。方法：用司帕沙星做原料，在碱性条件下反应生成司帕沙星钠，司帕沙星钠再和硫酸锌反应生成司帕沙星锌；以凡士林和羊毛脂为基质制备软膏剂，用分光光度法检测主药的含量，以临床烧伤患者为使用对象，司帕沙星锌软膏剂配合其他常规治疗方法治疗烧伤疾病。结果：司帕沙星锌软膏剂质量稳定，符合临床需要，临床应用疗效显著。结论：司帕沙星锌合成工艺可行，软膏剂成品品质可控，疗效显著，该方法简单可行，适合于临床应用和推广。 【关键词】司帕沙星锌；软膏剂；制备；临床应用 文章编号：1009-5519（2007）11-1596-03中图分类号：R9文献标识码：A Preparation and clinical application of sparfloxacin zinc ointment MA Su-ying1，SHANG Xiao-jun1，ZHANG Qing-xia2，et al. (1.Pharmacy College in Xinxiang Medicinal College，henan 453003,China；2.Zhengzhou Renji Hospital，henan 450064，China;3.Zhengzhou Yonghe Pharmaceutical Corporation，henan 450001,China) 【Abstract】Objective：Sparfloxacin zinc was synthesized and sparfloxacin zinc ointment was prepared，the study of drug quality and clinical application were performed in order to suffice the demand of therapy in clinics. Methods：Sparfloxacin sodium was synthesized in alkaline condition with sparfloxacin， and then sparfloxacin sodium react with zinc sulfate to sparfloxacin zinc；Sparfloxacin zinc ointment was prepared with vaseline and lanolin as drug excipient and the concentration of sparfloxacin zinc was analyzed with ultraviolet-visible spectrophotometer；Burn patients were treated with sparfloxacin zinc ointment and other routine techniques.Results：Results showed that the sparfloxacin zinc ointment was stable and clinical effect was excellent， It was completely fulfilled the application in clinics.Conclusion：The synthesis techniques of sparfloxacin zinc was feasible， the quality of sparfloxacin zinc ointment could be controlled by effective standard procedure， and clinical effect was eminent. The method was fit for wider application in clinics. 【Key words】Sparfloxacin zinc；Ointment；Preparation；Clinical application 我们参考磺胺咪啶锌的合成工艺合成了司帕沙星锌并且制成了软膏剂应用于临床[1]，发挥了司帕沙星和锌的联合作用，对烧伤疾病的治疗效果显著，现将结果报道如下。 1仪器与试药 SHIMADZU2550紫外分光光度计、pHS-3TC数显pH计、精天FA2104A分析天平，DF-10