通淋口服冻干粉质量标准研究  

Quality Standard for Tonglin Oral Lyophilized Powder

作　　者：何锦钧[1] 陈华[1] 罗德祥[1] 李子鸿[1] 刘东文[1] 

机构地区：[1]广东省佛山市中医院制剂中心,广东佛山528000

出　　处：《中国药业》2009年第7期24-25,共2页China Pharmaceuticals

基　　金：广东省佛山市科学技术局科技攻关项目;项目编号:200608004

摘　　要：目的建立通淋口服冻干粉的质量控制方法。方法采用薄层色谱(TLC)法对制剂中广金钱草、白茅根进行定性鉴别,采用高效液相色谱(HPLC)法对制剂中主要成分桃叶珊瑚苷进行含量测定。结果薄层色谱中斑点清晰,阴性对照无干扰;HPLC法精密度、重现性良好,桃叶珊瑚苷进样量线性范围是0.30～1.8μg(r=0.9998),平均回收率为100.64%,RSD为3.15%(n=6)。结论该方法可有效控制通淋口服冻干粉的质量。Objective To establish the quality standards for Tonglin Oral Lyophilized Powder. Methods Herba Desmodii styracifolii and Rhizoma imperatae were identified by TLC, and aucubin was determined by HPLC. Results The TLC spots developed was fairly clear, and the blank showed no interference. The linear range of aucubin was 0. 30-1.8 μg（ r=0. 999 8）, the average recovery rate was 100.64% and RSD was 3. 15%（n =6）. Conclusion This method is simple, specific and reproducible. It can be used for the quality control of Tonglin Oral Lyophilized Powder.

关 键 词：通淋口服冻干粉 桃叶珊瑚苷 薄层色谱法 高效液相色谱法 

分 类 号：R284.1[医药卫生—中药学] R286.0[医药卫生—中医学]