六味甘草丸质量标准研究

Quality Standards of Liuwei Gancao Pills

目的:建立六味甘草丸的质量标准。方法:采用薄层色谱法对处方中甘草进行定性鉴别;采用高效液相色谱法测定甘草苷含量。结果:定性鉴别分离效果好,斑点显色清晰。甘草苷的进样浓度在4.0240～24.1440μg·mL-1范围内与峰面积积分值呈良好线性关系(r=0.9997);平均回收率为98.3%,RSD=0.96%(n=6);每丸含甘草以甘草苷计应不少于2.8mg。结论:所建立标准可用于该制剂的质量控制。

OBJECTIVE： To establish quality standards of Liuwei gancao pills. METHODS： TLC method was adopted for qualitative identification of Glycyrrhiza uralensis in prescription. The content of liquiritoside was detected by HPLC. RESULTS： TLC spot was separated well and clear; the linear range of liquiritoside was 4.024 0～24.144 0 μg·mL-1（r=0.999 7） with an average recovery of 98.3%（RSD=0.96%,n=6）; the content of G. uralensis in each pill was not less than 2.8 mg by the content of liquiritoside. CONCLUSION： Established quality standards can be used for the quality control of Liuwei gancao pills.