加味茵陈蒿口服液的质量控制研究

Study on Quality Control of Modified Yinchenhao Oral Liquid

对加味茵陈蒿口服液质量控制标准进行研究,为口服液开发提供基础依据。采用一般检查方法对加味茵陈蒿口服液的相对密度和pH进行检查,采用薄层色谱法对口服液定性鉴别,高效液相色谱法进行定量检测。结果显示,加味茵陈蒿口服液相对密度为1.06~1.10,pH为4.87~4.90。薄层色谱中,口服液样品中与对照品、对照药材在相对应的位置上显现出相同颜色的斑点,阴性样品无干扰。栀子苷、大黄素、甘草酸含量测定结果显示线性关系良好,阴性对照无干扰,平均回收率均高于95%。对10批样品检测后规定口服液中每1 mL含栀子苷、大黄素、甘草酸分别不得少于1.09 mg、7.12μg和0.73 mg。方法专属性强,准确易操作,可作为加味茵陈蒿口服液质量控制标准。

The quality control of modified Yinchenhao oral liquid was studied to provide the basis for the further development of oral liquid.The relative density and pH of modified Yinchenhao oral liquid were examined by general inspection methods.The oral liquid was qualitatively identified by thin layer chromatography and quantitatively detected by high performance liquid chromatography.The results showed that the relative density of modified Yinchenhao oral liquid was 1.06-1.10,and the pHvaluewas4.87-4.90.InTLC,spots of the same color appeared in the corresponding position of the oral liquid sample,the control substance and the control medicine,and there was no interference from the negative sample.The results of determination of geniposide,emodin and glycyrrhizic acid showed a good linear relationship,and there was no interference in the negative control.The average recoveries were higher than 95%.The contents of geniposide,emodin and glycyrrhizin in the oral solution should not be less than 1.09mg,7.12μg and 0.73mg per 1mL,respectively.The above method is specific,accurate and easy to operate,and can be used as the quality control standard of modified Yinchenhao oral liquid.