复方乌龙胶囊的质量控制方法研究  

Study on Quality Control Methods of Compound Wulong Capsules

作　　者：沈娟 刘云 尹蕊 陈玉敏 刘文尧 

机构地区：[1]总后药品仪器检验所,北京100071

出　　处：《药物分析杂志》2005年第5期587-589,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立复方乌龙胶囊的质量控制方法。方法:采用薄层色谱法对制剂中的3种主要成分青黛、防风和白芷进行定性鉴别;用高效液相色谱法测定制剂中靛蓝含量。结果:薄层色谱法能准确鉴定出制剂中的青黛、防风和白芷;靛蓝在0.016-0.16μg范围内,线性关系良好(r=0.9995)。平均回收率为98.4%,RSD=1.9%(n=5)。结论:本方法专属性强、重现性好,可作为复方乌龙胶囊的质量控制标准。Objective:To establish the quality control methods of compound Wulong capsules.Methods:Indigo Naturalis,Radix Saposhnikoviae and Radix Angelicae Dahuricae were identified by TLC,and the content of indigo was determined by HPLC.Results:Indigo Naturalis,Radix Saposhnikoviae and Radix Angelicae Dahuricae can be identified by TLC.Indigo showed a good linear relashionship at a range of 0.016-0.16μg,r=0.9995.The aver- age recovery was 98.4%,RSD=1.9%(n=5).Conclusion:These methods have high selectivity and good repro- ducibility,which can be used as the quality control methods of compound Wulong capsules.

关 键 词：质量控制方法 胶囊 复方 高效液相色谱法 质量控制标准 薄层色谱法 平均回收率 主要成分 定性鉴别 线性关系 制剂 专属性 重现性 青黛 白芷 防风 靛蓝 

分 类 号：R284.1[医药卫生—中药学] R978.11[医药卫生—中医学]