染料木素阴道片质量控制研究  

Study on Quality Control of Genistein Vaginal Tablets

作　　者：孟庆杰[1] 潘五九[1] 王伟明[1] 刘姗姗[1] 付磊[1] 薛岩[1] 

机构地区：[1]黑龙江省中医研究院中药所,哈尔滨150036

出　　处：《中国实验方剂学杂志》2013年第23期132-135,共4页Chinese Journal of Experimental Traditional Medical Formulae

摘　　要：目的： 建立染料木素阴道片的质量控制方法。 方法： 采用《中国药典》pH测定法测定染料木素阴道片的pH，采用薄层色谱法对染料木素进行定性鉴别，采用高效液相色谱法测定染料木素阴道片中染料木素的含量。 结果： 薄层色谱斑点清晰，分离度良好，专属性强;染料木素在0.201 2~1.006 0 μg（r=0.999 9）线性关系良好，平均回收率为97.72%，RSD 1.65%（n=6），且不同批次染料木素阴道片的pH及其染料木素的含量无明显差异。 结论： 所建立方法简便准确，重复性好，适用于染料木素阴道片的质量控制。Objective： To develop a method for the quality control of genistein vaginal tablets. Method： The Chinese Pharmacopoeia pH determination method was used for determination pH of genistein vaginal tablets. Genistein in genistein vaginal tablets was identified by TLC. The content of genistein in genistein vaginal tablets was determined by HPLC. Result： TLC spots were clear with high resolution and strong specialization. Genistein presented a good linear correlation in the range of 0.201 2-1.006 0 μg （r=0.999 9）. The average recovery was 97.72% with RSD of 1.65% （n=6）. The pH and the content of genistein in genistein vaginal tablets in different batches had no significant differences. Conclusion： The developed method was simple,accurate and repeatable. It can be used for the quality control of genistein vaginal tablets.

关 键 词：染料木素 阴道片 质量控制 PH 薄层色谱 高效液相色谱 

分 类 号：R284.1[医药卫生—中药学]