陈香露白露片质量标准修订研究  

Quality standard for Chenxianglubailu Tablet

作　　者：童珂 马杰 孙辉 丁野 李文莉 

机构地区：[1]湖南省食品药品检验研究院,长沙410001

出　　处：《中南药学》2012年第9期644-648,共5页Central South Pharmacy

基　　金：国家药品标准提高行动计划(编号:9)

摘　　要：目的建立陈香露白露片(甘草、碱式硝酸铋、陈皮、碳酸镁、氧化镁、大黄等)的质量标准。方法采用化学反应鉴别处方中的铋盐和镁盐;采用TLC分别对处方中的陈皮、大黄等进行定性鉴别;采用HPLC法测定甘草酸铵和橙皮苷的含量。结果在TLC图谱中可检出陈皮、大黄等药材的特征斑点;甘草酸铵对照品在42.24～2 112 ng与峰面积线性关系良好,r=1,精密度试验RSD=0.4%(n=5),平均回收率为101.3%(RSD=2.5%,n=9);橙皮苷对照品在61.44～1843.2 ng与峰面积线性关系良好,r=1,精密度试验RSD=0.1%(n=5),平均回收率为100.7%(RSD=1.1%,n=9)。结论所采用的方法准确、可靠,可行性及重复性良好,能有效控制该制剂的质量。Objective To establish the quality standard for Chenxianglubailu Tablet（Radix et Rhizoma Glycyrrhizae,bismuth subnitrate,Pericarpium Citri Reticulatae,magnesium carbonate,Radix et Rhizoma Rhei,etc）.Methods Bismuth and magnesium were identified by chemical reactions,PericarpiumCitri Reticulatae and Radix et Rhizoma Rhei were identified by TLC,and the content of ammonium glycyrrhizinate and hesperidin was determined by HPLC.Results Pericarpium Citri Reticulatae and Radix et Rhizoma Rhei were identified by TLC.Ammonium glycyrrhizinate showed a good linearity at 42.24-211 2 ng,r=1,the RSD of measurement precision was 0.4%（n=5）,the average recovery was 101.3%（RSD=2.5%,n=9）.Hesperidin showed a good linerity at 61.44-1 843.2 μg,r=1,the RSD of measurement precision test was 0.1%（n=5）,the average recovery was 100.7%（RSD=1.1%,n=9）.Conclusion The method is accurate,reliable and reproducible,and can be used to control the quality of this preparation effectively.

关 键 词：陈香露白露片 薄层鉴定 高效液相色谱法 质量标准 

分 类 号：R922[医药卫生—药学]