舒马曲坦胶囊的制备与质量控制  

Preparation and Quality Control of Sumatriptan Capsule

作　　者：张敬如[1] 赵凯[1] 黄复生[1] 王昆[1] 

机构地区：[1]中国人民解放军第三军医大学基础部病原生物学教研室,重庆400038

出　　处：《中国药业》2012年第21期32-34,共3页China Pharmaceuticals

基　　金：重庆市基金面上项目;项目编号:CSTC2010BB5168

摘　　要：目的制备舒马曲坦胶囊并建立其质量控制方法。方法采用高效液相色谱(HPLC)法测定制剂中舒马曲坦。结果舒马曲坦质量浓度在50～1 600 ng/mL范围内与峰面积线性关系良好(r=0.999 9),平均回收率为(105.73±4.58)%,RSD为4.33%(n=6),日内、日间精密度平均RSD为2.20%和2.59%。结论质量控制方法稳定可靠,可用于舒马曲坦胶囊的质量控制。Objective To prepare sumatriptan capsules and establish the quality standard for them. Methods HPLC was used to deter-mine the content of sumatriptan. Results Sumatriptan showed a good linear relationship in the range of 50-1 600 ng/mL（r =0. 999 9） and the average recovery was up to （105.73±4.58）%, RSD was 4. 33%.The mean intra-day RSD and inter-day RSD were 2.20% and 2.59%. Conclusion This standard is precise and can be used for the quality control of sumatriptan capsules.

关 键 词：舒马曲坦胶囊 质量控制 高效液相色谱法 

分 类 号：R927.2[医药卫生—药学] R971