摘要
目的:研制洛美沙星泡腾片并建立质量标准。方法:以正交设计筛选构成泡腾剂的酸源、碱源及稳泡剂的处方辅料,制备洛美沙星泡腾片;建立酸碱度、发泡量、有关物质及含量测定等质量控制标准。结果:制剂质量稳定,pH值为4.0～5.5,洛美沙星在50～400μg/ml范围内呈良好线性关系,平均回收率为99.74%。结论:本方法设计合理,质量控制方法准确、可靠,可应用于临床。
Objective：To prepare Lomefloxacin effervescent tablet and establish quality specifications.Methods：Based on orthogonal design,suitable acid source, alkali source and foam stabilizer for the constitution of supplementary materials of effervescent were screened,Lomefloxacin tablets were produced,and quality specifications including acidity and alkalinity, expanding foam, ralated substances and assay were established.Results：The preparation was stable, pH was between 4.0- 5.5.Lomefloxcin had a good linear range from 50 to 400 ;xg/ml and the average rate of recovery was 99.74%.Conclusion： The analytical method is accurate and reliable for quality control and suitable for clinical use.
出处
《中国医药导报》
CAS
2007年第03Z期19-20,108,共3页
China Medical Herald
关键词
洛关沙星
泡腾片
质量控制
Lomefloxacin
Effervescent tablet
Quality control
