复方替硝唑凝胶剂的制备及临床应用

Preparation of Compound Tinidazole Gel and Its Clinical Application

目的建立制备复方替硝唑凝胶剂及含量测定方法,并对制剂进行临床疗效观察。方法以替硝唑和司帕沙星为主药、羧甲基纤维素钠为基质制备复方替硝唑凝胶剂,采用双波长紫外分光光度法不经分离直接测定两主药含量,将制剂用于阴道感染的治疗。结果制剂疗效确切,无刺激性,处方配伍合理,质量可控。结论该凝胶制备工艺简单、质量稳定、临床疗效好,含量测定方法准确。

Objective To establish the methods of preparation for Compound Tinidazole Gel and its content determination, and to observe the clinical effect. Methods CMCNa was used as a base to prepare gel with tinidazole and sparfloxacin, The content of two drugs in the gel were directly determined by dualwavelength UV spectrophotometry without separation. The gel was used to treat vaginitis, Results The curative effect and no stimulus was proved in clinic, and the prescription was reasonable and controlled in quality. Conclusion The preparation is technology simple, the quality is stable, and the assaying is accurate. The clinical effect is effective.