熟地强筋浓缩丸质量标准研究  

Quality Standard Study of Shudi Qiangjin Concentrated Pills

作　　者：宋潇潇[1] 王建文[1] 王淑红[1] 

机构地区：[1]深圳市药品检验所,广东深圳518057

出　　处：《中国药师》2012年第7期947-949,共3页China Pharmacist

摘　　要：目的:建立熟地强筋浓缩丸质量控制方法。方法:对制剂中山药、茯苓、泽泻、续断中有专属性的粉末特征进行显微鉴别;采用薄层色谱法对制剂中牡丹皮进行定性鉴别;采用高效液相色谱法对制剂中马钱苷进行含量测定。结果:薄层色谱显色清晰且阴性对照无干扰;马钱苷在2.048～204.800μg·ml^(-1)浓度范围内呈良好的线性关系(r=1.000 0),平均回收率为105.2%,RSD为2.9%。结论:本法操作简便,结果准确、重复性好,可用于熟地强筋浓缩丸的质量控制。Objective： To develop a method for the quality control of Shudi Qiangjin concentrated pills. Method： Dioscoreae Rhizoma, Poria, Alismatis Rhizoma and Dipsaci Radix were identified by Microscope. Moutan Cortex was identified by TLC. HPLC was used for the determination of loganin. Result： The chromatographic spots were clear without interference of the negative control. Loga- nin had a good linearity over the concentration range of 2. 048-204. 800 μg · ml- 1 （ r = 1. 000 0 ）, and the average recovery was 105.2% with RSD of 2.9%. Conclusion： The method is reliable, accurate and specific, and can be used in the quality control of Shudi Qiangjin concentrated pills.

关 键 词：高效液相色谱法 马钱苷 薄层色谱法 显微鉴别 熟地强筋浓缩丸 

分 类 号：TQ460.72[医药卫生—药物分析学]