补血益母颗粒质量标准的提高  

Study on Quality Standard Improvement for Buxue Yimu Granule

作　　者：李雅静 孙辉 李文莉 

机构地区：[1]中南大学湘雅药学院,长沙410078 [2]湖南省药品检验研究院

出　　处：《中国药师》2018年第3期501-503,共3页China Pharmacist

基　　金：国家药典委员会国家药品标准提高行动计划项目(编号:615)

摘　　要：目的:提高完善补血益母颗粒的质量标准。方法:采用TLC法对当归、黄芪进行鉴别;采用HPLC法测定黄芪中黄芪甲苷的含量,色谱柱为Agilent Zorbax SB-C_(18)柱(250 mm×4.6 mm,5μm),流动相为乙腈-水(32∶68),柱温为35℃,流速为1.0 ml·min^(-1),检测器为ELSD。结果:薄层色谱均斑点清晰,分离度较好;黄芪甲苷对照品在1.577~13.140μg范围内线性关系良好(r=0.999 2),平均回收率为96.88%,RSD=3.01%(n=6)。结论:本方法操作简便、准确可靠、重复性好,可用于该制剂的质量控制。Objective： To improve the quality standard for Buxue Yimu granule. Methods： A TLC method was used to identify Angelica sinensis and Astragalus mongholicus. An HPLC method was used to determine the content of astragaloside in Astragalus mongholicus on an Agilent Zorbax SB-C18 column（ 250 mm × 4. 6 mm,5 μm）,and the mobile phase was acetonitrile-water（ 32∶ 68） at the column temperature of 35℃. The flow rate was 1. 0 ml·min^-1 and the detector was ELSD. Results： The TLC spots were clear and showed a good separation. The linear range of astragaloside was 1. 577-13. 140 μg（ r = 0. 999 2）,the average recovery was 96. 88%,and the RSD was 3. 01%（ n = 6）. Conclusion： The method is simple and accurate with good reproducibility,which can be used for the quality control of the preparation.

关 键 词：补血益母颗粒 质量标准 薄层色谱法 高效液相色谱法 

分 类 号：TQ460.72[医药卫生—药物分析学]