洛唑阴道泡腾片的制备及质量标准研究

Preparation of Compound Lomefloxacin Vagina Effervescent Tablets

目的 研制以盐酸洛美沙星和替硝唑为主药的复方阴道泡腾片并建立质量控制方法。方法 将盐酸洛美沙星、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盐酸洛美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 6 0 %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。

Aim To study the preparation of vagina effervescent tablets consisting of lomefloxacin and tinizole and establish the quality control method.Methods Lomefloxacin,tinizole acid and alkali constituents were made up into pellets respectively,then pressed the tablets.The contents of the lomefloxacin and tinidazole in the tablets were determined by dual wavelength spectrophotometry.Results The tablets disintegrated entirely in five minutes.The results of the dissolution trial in vitro showed that the dissolution rate in ten minutes exceeded 60%.Conclusion The vagina effervescent tablets swell and release quickly.The tablets have good stability and have no skin stimulus-reaction also.It is confirmed that the tablets are indicated for colpitis and cervicitis.