洁阴液质量标准研究

Study on Quality Standard of Jieyin Liquids

目的:建立洁阴液的质量标准。方法:采用薄层色谱法对洁阴液中的黄柏、苦参、甲硝唑进行定性鉴别,并采用高效液相色谱法对制剂中的甲硝唑进行含量测定。结果:薄层鉴别的色谱斑点清晰、阴性对照无干扰;甲硝唑在80.32～401.6μg·ml^(-1)范围内具有良好的线性关系,r=0.999 9,平均回收率为100.2%,RSD为0.76%(n=9),洁阴液中甲硝唑含量不得超过标示量的90.0%～110.0%。结论:本法简便,准确,重复性好,可有效控制该制剂的质量。

Objective：To establish the standard for the quality control of Jieyin liquids.Method：Cortex phellodendri chinensis. Radix sophorae flavescentis and metronidazole in Jieyin liquids were qualitatively identified by TLC.Metronidazole was determined by HPLC.Result：The developed TLC spots were clear without interference of negative samples.The linear range of metronidazole was 80.32401.6μg ？ ml^（-1）,r=0.999 9.The average recovery was 100.2%and RSD was 0.77%（n =9）.Conclusion：The method is simple,accurate and reproducible,and can be used for the quality control of Jieyin liquids.