复方替硝唑阴道泡腾片的研制及质量控制

Preparation of Compound Tinidazole Vaginal Effervescent Tablets and Its Quality Control

目的:研制以氧氟沙星和替硝唑为主的复方阴道泡腾片并探索其质量控制方法。方法:将氧氟沙星、替硝唑和酸、碱组分分别制成干燥品,整粒、混合后压片。采用双波长法测定泡腾片中氧氟沙星和替硝唑的含量。结果:本品在5min内可完全崩解。体外释药试验表明,10min内可释放65%以上的药物。结论:本品发泡迅速,药物释放快,无刺激性,稳定性良好,适用于治疗阴道炎及宫颈炎。

Objective:To study the preparation of tinidazole vaginal effervescent tablets consisting of ofloxacin and tinidazole and to establish its quality control method.Methods:The drying material was prepared with ofloxacin,tinidazole,acid and alkali and was used for pressing the tablets.The contents of the ofloxacin and tinidazole in the tablets were determined by dual wavelength spectrophotometry.Results:The tablets was distintegrated entirely in5minutes.The dis-solution in10minutes exceeded65%.Conclusion:The vaginal effervescent tablets swelled and released quickly.Also the tablets had good stability and no skin stimulus -reaction.It was confirmed that the tablets may be indicated for the treatment of colpitis and cervicitis.