调经助孕颗粒剂质量控制研究  

Study on quality control of Tiaojing Zhuyun Granules

作　　者：李陆军[1] 初云海[1] 冯丽彬[1] 

机构地区：[1]黑龙江中医药大学附属第一医院制剂室,黑龙江哈尔滨150040

出　　处：《现代药物与临床》2010年第6期460-462,共3页Drugs & Clinic

基　　金：黑龙江省中医管理局研究课题(ZHY08-W101)

摘　　要：目的更好地控制调经助孕颗粒剂的质量。方法采用TLC法对调经助孕颗粒剂中的白芍、川楝子进行定性鉴别;HPLC法对柚皮苷进行定量检测,色谱柱为Symmetry C18(150mm×2.1mm,3.5μm),流动相为乙腈-0.1%磷酸溶液(18:82),体积流量0.8mL/min,柱温35℃,检测波长283nm。结果 TLC显色清晰;柚皮苷在0.404～5.05μg有良好线性关系(r=0.9993),平均回收率为99.26%,RSD为2.03%。结论本研究可用于调经助孕颗粒剂的质量控制,方法简便、可靠,能较好地控制该制剂的内在质量。Objective To control effectively the quality of Tiaojing Zhuyun Granules.Methods Paeoniae Radix Alba and Toosendan Fructus in this medicine were identified by TLC.Naringin was determined by HPLC,using Symmetry C18 column with a mixture of acetonitrile-0.1% phosphoric acid（18：82）as the mobile phase.The temperature of column was 35 ℃.The velocity was 0.8 mL/min.The detection wavelength was 283 nm.Results TLC spots were quite clear.There was a good linear relationship at a range of 0.404—5.05 μg（r=0.999 3）.The average recovery rate was 99.26%,and RSD was 2.03%.Conclusion The method is simple,reliable and reproducible.It can be used for the quality control of Tiaojing Zhuyun Granules.

关 键 词：调经助孕颗粒剂 薄层色谱 柚皮苷 HPLC法 

分 类 号：R927.11[医药卫生—药学]