【摘要】 目的:制备复方加替沙星阴道泡腾片及建立其质量控制方法。方法:以加替沙星和益康唑为主药,制备复方加替沙星阴道泡腾片。采用紫外分光光度法于360nm波长处测定益康唑含量,于293nm波长处测定加替沙星含量,并进行40℃RH75%180d的稳定性考察。结果:益康唑和加替沙星线性范围的平均回收率分别为100.17%(RSD=0.62%)和99.43(RSD=0.95%);本制剂有效期可达二年以上。结论:本制剂制备工艺简单、稳定性好,质量控制方法简易、快速、准确,适合医院制剂。更多还原

【Abstract】 Objective To investigate the preparation process and method of quality control of Compound Gatifloxacin Vaginal Effervescent Tablets(CGVE).Methods Gatifloxacin and Econagol were taken as the chief Components for the preparation of CGVE.The spectrophotometry was used to determine the content of econazole at 360nm.The content of Gatifloxacin was determined at 293nm.The stability with 40℃,RH75%180d of CGVE were observed.Results The average recovery of econazole and Gatifloxacin was 100.17%(RSD=0.62%) and 99.43%( RSD=0.95%),respectively.The expiry date(shelf life) were more than two years.Conclusion The CGVE is simple in preparation,good in stability,and method of quality control is simple,rapid and accurate,so is good for Hospital.更多还原